future research direction example

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• GETTING STARTED
• Introduction
• FUNDAMENTALS
• Acknowledgements
• Research questions & hypotheses
• Concepts, constructs & variables
• Research limitations
• Getting started
• Sampling Strategy
• Research Quality
• Research Ethics
• Data Analysis

FUTURE RESEARCH

Types of future research suggestion.

The Future Research section of your dissertation is often combined with the Research Limitations section of your final, Conclusions chapter. This is because your future research suggestions generally arise out of the research limitations you have identified in your own dissertation. In this article, we discuss six types of future research suggestion. These include: (1) building on a particular finding in your research; (2) addressing a flaw in your research; examining (or testing) a theory (framework or model) either (3) for the first time or (4) in a new context, location and/or culture; (5) re-evaluating and (6) expanding a theory (framework or model). The goal of the article is to help you think about the potential types of future research suggestion that you may want to include in your dissertation.

Before we discuss each of these types of future research suggestion, we should explain why we use the word examining and then put or testing in brackets. This is simply because the word examining may be considered more appropriate when students use a qualitative research design; whereas the word testing fits better with dissertations drawing on a quantitative research design. We also put the words framework or model in brackets after the word theory . We do this because a theory , framework and model are not the same things. In the sections that follow, we discuss six types of future research suggestion.

Addressing research limitations in your dissertation

Building on a particular finding or aspect of your research, examining a conceptual framework (or testing a theoretical model) for the first time, examining a conceptual framework (or testing a theoretical model) in a new context, location and/or culture.

• Expanding a conceptual framework (or testing a theoretical model)

Re-evaluating a conceptual framework (or theoretical model)

In the Research Limitations section of your Conclusions chapter, you will have inevitably detailed the potential flaws (i.e., research limitations) of your dissertation. These may include:

An inability to answer your research questions

Theoretical and conceptual problems

Limitations of your research strategy

Problems of research quality

Identifying what these research limitations were and proposing future research suggestions that address them is arguably the easiest and quickest ways to complete the Future Research section of your Conclusions chapter.

Often, the findings from your dissertation research will highlight a number of new avenues that could be explored in future studies. These can be grouped into two categories:

Your dissertation will inevitably lead to findings that you did not anticipate from the start. These are useful when making future research suggestions because they can lead to entirely new avenues to explore in future studies. If this was the case, it is worth (a) briefly describing what these unanticipated findings were and (b) suggesting a research strategy that could be used to explore such findings in future.

Sometimes, dissertations manage to address all aspects of the research questions that were set. However, this is seldom the case. Typically, there will be aspects of your research questions that could not be answered. This is not necessarily a flaw in your research strategy, but may simply reflect that fact that the findings did not provide all the answers you hoped for. If this was the case, it is worth (a) briefly describing what aspects of your research questions were not answered and (b) suggesting a research strategy that could be used to explore such aspects in future.

You may want to recommend that future research examines the conceptual framework (or tests the theoretical model) that you developed. This is based on the assumption that the primary goal of your dissertation was to set out a conceptual framework (or build a theoretical model). It is also based on the assumption that whilst such a conceptual framework (or theoretical model) was presented, your dissertation did not attempt to examine (or test) it in the field . The focus of your dissertations was most likely a review of the literature rather than something that involved you conducting primary research.

Whilst it is quite rare for dissertations at the undergraduate and master's level to be primarily theoretical in nature like this, it is not unknown. If this was the case, you should think about how the conceptual framework (or theoretical model) that you have presented could be best examined (or tested) in the field . In understanding the how , you should think about two factors in particular:

What is the context, location and/or culture that would best lend itself to my conceptual framework (or theoretical model) if it were to be examined (or tested) in the field?

What research strategy is most appropriate to examine my conceptual framework (or test my theoretical model)?

If the future research suggestion that you want to make is based on examining your conceptual framework (or testing your theoretical model) in the field , you need to suggest the best scenario for doing so.

More often than not, you will not only have set out a conceptual framework (or theoretical model), as described in the previous section, but you will also have examined (or tested) it in the field . When you do this, focus is typically placed on a specific context, location and/or culture.

If this is the case, the obvious future research suggestion that you could propose would be to examine your conceptual framework (or test the theoretical model) in a new context, location and/or culture. For example, perhaps you focused on consumers (rather than businesses), or Canada (rather than the United Kingdom), or a more individualistic culture like the United States (rather than a more collectivist culture like China).

When you propose a new context, location and/or culture as your future research suggestion, make sure you justify the choice that you make. For example, there may be little value in future studies looking at different cultures if culture is not an important component underlying your conceptual framework (or theoretical model). If you are not sure whether a new context, location or culture is more appropriate, or what new context, location or culture you should select, a review the literature will often help clarify where you focus should be.

Expanding a conceptual framework (or theoretical model)

Assuming that you have set out a conceptual framework (or theoretical model) and examined (or tested) it in the field , another series of future research suggestions comes out of expanding that conceptual framework (or theoretical model).

We talk about a series of future research suggestions because there are so many ways that you can expand on your conceptual framework (or theoretical model). For example, you can do this by:

Examining constructs (or variables) that were included in your conceptual framework (or theoretical model) but were not focused.

Looking at a particular relationship aspect of your conceptual framework (or theoretical model) further.

Adding new constructs (or variables) to the conceptual framework (or theoretical model) you set out (if justified by the literature).

It would be possible to include one or a number of these as future research suggestions. Again, make sure that any suggestions you make have are justified , either by your findings or the literature.

With the dissertation process at the undergraduate and master's level lasting between 3 and 9 months, a lot a can happen in between. For example, a specific event (e.g., 9/11, the economic crisis) or some new theory or evidence that undermines (or questions) the literature (theory) and assumptions underpinning your conceptual framework (or theoretical model). Clearly, there is little you can do about this. However, if this happens, reflecting on it and re-evaluating your conceptual framework (or theoretical model), as well as your findings, is an obvious source of future research suggestions.

How to Write the Discussion Section of a Research Paper

The discussion section of a research paper analyzes and interprets the findings, provides context, compares them with previous studies, identifies limitations, and suggests future research directions.

Updated on September 15, 2023

Structure your discussion section right, and you’ll be cited more often while doing a greater service to the scientific community. So, what actually goes into the discussion section? And how do you write it?

The discussion section of your research paper is where you let the reader know how your study is positioned in the literature, what to take away from your paper, and how your work helps them. It can also include your conclusions and suggestions for future studies.

First, we’ll define all the parts of your discussion paper, and then look into how to write a strong, effective discussion section for your paper or manuscript.

Discussion section: what is it, what it does

The discussion section comes later in your paper, following the introduction, methods, and results. The discussion sets up your study’s conclusions. Its main goals are to present, interpret, and provide a context for your results.

What is it?

The discussion section provides an analysis and interpretation of the findings, compares them with previous studies, identifies limitations, and suggests future directions for research.

This section combines information from the preceding parts of your paper into a coherent story. By this point, the reader already knows why you did your study (introduction), how you did it (methods), and what happened (results). In the discussion, you’ll help the reader connect the ideas from these sections.

Why is it necessary?

The discussion provides context and interpretations for the results. It also answers the questions posed in the introduction. While the results section describes your findings, the discussion explains what they say. This is also where you can describe the impact or implications of your research.

Adds context for your results

Most research studies aim to answer a question, replicate a finding, or address limitations in the literature. These goals are first described in the introduction. However, in the discussion section, the author can refer back to them to explain how the study's objective was achieved. 

Shows what your results actually mean and real-world implications

The discussion can also describe the effect of your findings on research or practice. How are your results significant for readers, other researchers, or policymakers?

What to include in your discussion (in the correct order)

A complete and effective discussion section should at least touch on the points described below.

Summary of key findings

The discussion should begin with a brief factual summary of the results. Concisely overview the main results you obtained.

Begin with key findings with supporting evidence

Your results section described a list of findings, but what message do they send when you look at them all together?

Your findings were detailed in the results section, so there’s no need to repeat them here, but do provide at least a few highlights. This will help refresh the reader’s memory and help them focus on the big picture.

Read the first paragraph of the discussion section in this article (PDF) for an example of how to start this part of your paper. Notice how the authors break down their results and follow each description sentence with an explanation of why each finding is relevant. 

State clearly and concisely

Following a clear and direct writing style is especially important in the discussion section. After all, this is where you will make some of the most impactful points in your paper. While the results section often contains technical vocabulary, such as statistical terms, the discussion section lets you describe your findings more clearly. 

Interpretation of results

Once you’ve given your reader an overview of your results, you need to interpret those results. In other words, what do your results mean? Discuss the findings’ implications and significance in relation to your research question or hypothesis.

Analyze and interpret your findings

Look into your findings and explore what’s behind them or what may have caused them. If your introduction cited theories or studies that could explain your findings, use these sources as a basis to discuss your results.

For example, look at the second paragraph in the discussion section of this article on waggling honey bees. Here, the authors explore their results based on information from the literature.

Unexpected or contradictory results

Sometimes, your findings are not what you expect. Here’s where you describe this and try to find a reason for it. Could it be because of the method you used? Does it have something to do with the variables analyzed? Comparing your methods with those of other similar studies can help with this task.

Context and comparison with previous work

Refer to related studies to place your research in a larger context and the literature. Compare and contrast your findings with existing literature, highlighting similarities, differences, and/or contradictions.

How your work compares or contrasts with previous work

Studies with similar findings to yours can be cited to show the strength of your findings. Information from these studies can also be used to help explain your results. Differences between your findings and others in the literature can also be discussed here. 

How to divide this section into subsections

If you have more than one objective in your study or many key findings, you can dedicate a separate section to each of these. Here’s an example of this approach. You can see that the discussion section is divided into topics and even has a separate heading for each of them. 

Limitations

Many journals require you to include the limitations of your study in the discussion. Even if they don’t, there are good reasons to mention these in your paper.

Why limitations don’t have a negative connotation

A study’s limitations are points to be improved upon in future research. While some of these may be flaws in your method, many may be due to factors you couldn’t predict.

Examples include time constraints or small sample sizes. Pointing this out will help future researchers avoid or address these issues. This part of the discussion can also include any attempts you have made to reduce the impact of these limitations, as in this study .

How limitations add to a researcher's credibility

Pointing out the limitations of your study demonstrates transparency. It also shows that you know your methods well and can conduct a critical assessment of them.  

Implications and significance

The final paragraph of the discussion section should contain the take-home messages for your study. It can also cite the “strong points” of your study, to contrast with the limitations section.

Restate your hypothesis

Remind the reader what your hypothesis was before you conducted the study. 

How was it proven or disproven?

Identify your main findings and describe how they relate to your hypothesis.

How your results contribute to the literature

Were you able to answer your research question? Or address a gap in the literature?

Future implications of your research

Describe the impact that your results may have on the topic of study. Your results may show, for instance, that there are still limitations in the literature for future studies to address. There may be a need for studies that extend your findings in a specific way. You also may need additional research to corroborate your findings. 

Sample discussion section

This fictitious example covers all the aspects discussed above. Your actual discussion section will probably be much longer, but you can read this to get an idea of everything your discussion should cover.

Our results showed that the presence of cats in a household is associated with higher levels of perceived happiness by its human occupants. These findings support our hypothesis and demonstrate the association between pet ownership and well-being. 

The present findings align with those of Bao and Schreer (2016) and Hardie et al. (2023), who observed greater life satisfaction in pet owners relative to non-owners. Although the present study did not directly evaluate life satisfaction, this factor may explain the association between happiness and cat ownership observed in our sample.

Our findings must be interpreted in light of some limitations, such as the focus on cat ownership only rather than pets as a whole. This may limit the generalizability of our results.

Nevertheless, this study had several strengths. These include its strict exclusion criteria and use of a standardized assessment instrument to investigate the relationships between pets and owners. These attributes bolster the accuracy of our results and reduce the influence of confounding factors, increasing the strength of our conclusions. Future studies may examine the factors that mediate the association between pet ownership and happiness to better comprehend this phenomenon.

This brief discussion begins with a quick summary of the results and hypothesis. The next paragraph cites previous research and compares its findings to those of this study. Information from previous studies is also used to help interpret the findings. After discussing the results of the study, some limitations are pointed out. The paper also explains why these limitations may influence the interpretation of results. Then, final conclusions are drawn based on the study, and directions for future research are suggested.

How to make your discussion flow naturally

If you find writing in scientific English challenging, the discussion and conclusions are often the hardest parts of the paper to write. That’s because you’re not just listing up studies, methods, and outcomes. You’re actually expressing your thoughts and interpretations in words.

• How formal should it be?
• What words should you use, or not use?
• How do you meet strict word limits, or make it longer and more informative?

Always give it your best, but sometimes a helping hand can, well, help. Getting a professional edit can help clarify your work’s importance while improving the English used to explain it. When readers know the value of your work, they’ll cite it. We’ll assign your study to an expert editor knowledgeable in your area of research. Their work will clarify your discussion, helping it to tell your story. Find out more about AJE Editing.

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Research statement, what is a research statement.

The research statement (or statement of research interests) is a common component of academic job applications. It is a summary of your research accomplishments, current work, and future direction and potential of your work.

The statement can discuss specific issues such as:

• funding history and potential
• requirements for laboratory equipment and space and other resources
• potential research and industrial collaborations
• how your research contributes to your field
• future direction of your research

The research statement should be technical, but should be intelligible to all members of the department, including those outside your subdiscipline. So keep the “big picture” in mind. The strongest research statements present a readable, compelling, and realistic research agenda that fits well with the needs, facilities, and goals of the department.

Research statements can be weakened by:

• overly ambitious proposals
• lack of clear direction
• lack of big-picture focus
• inadequate attention to the needs and facilities of the department or position

Why a Research Statement?

• It conveys to search committees the pieces of your professional identity and charts the course of your scholarly journey.
• It communicates a sense that your research will follow logically from what you have done and that it will be different, important, and innovative.
• It gives a context for your research interests—Why does your research matter? The so what?
• It combines your achievements and current work with the proposal for upcoming research.
• areas of specialty and expertise
• potential to get funding
• academic strengths and abilities
• compatibility with the department or school
• ability to think and communicate like a serious scholar and/or scientist

Formatting of Research Statements

The goal of the research statement is to introduce yourself to a search committee, which will probably contain scientists both in and outside your field, and get them excited about your research. To encourage people to read it:

• make it one or two pages, three at most
• use informative section headings and subheadings
• use bullets
• use an easily readable font size
• make the margins a reasonable size

Organization of Research Statements

Think of the overarching theme guiding your main research subject area. Write an essay that lays out:

• The main theme(s) and why it is important and what specific skills you use to attack the problem.
• A few specific examples of problems you have already solved with success to build credibility and inform people outside your field about what you do.
• A discussion of the future direction of your research. This section should be really exciting to people both in and outside your field. Don’t sell yourself short; if you think your research could lead to answers for big important questions, say so!
• A final paragraph that gives a good overall impression of your research.

Writing Research Statements

• Avoid jargon. Make sure that you describe your research in language that many people outside your specific subject area can understand. Ask people both in and outside your field to read it before you send your application. A search committee won’t get excited about something they can’t understand.
• Write as clearly, concisely, and concretely as you can.
• Keep it at a summary level; give more detail in the job talk.
• Ask others to proofread it. Be sure there are no spelling errors.
• Convince the search committee not only that you are knowledgeable, but that you are the right person to carry out the research.
• Include information that sets you apart (e.g., publication in  Science, Nature,  or a prestigious journal in your field).
• What excites you about your research? Sound fresh.
• Include preliminary results and how to build on results.
• Point out how current faculty may become future partners.
• Acknowledge the work of others.
• Use language that shows you are an independent researcher.
• BUT focus on your research work, not yourself.
• Include potential funding partners and industrial collaborations. Be creative!
• Provide a summary of your research.
• Put in background material to give the context/relevance/significance of your research.
• List major findings, outcomes, and implications.
• Describe both current and planned (future) research.
• Communicate a sense that your research will follow logically from what you have done and that it will be unique, significant, and innovative (and easy to fund).

Describe Your Future Goals or Research Plans

• Major problem(s) you want to focus on in your research.
• The problem’s relevance and significance to the field.
• Your specific goals for the next three to five years, including potential impact and outcomes.
• If you know what a particular agency funds, you can name the agency and briefly outline a proposal.
• Give broad enough goals so that if one area doesn’t get funded, you can pursue other research goals and funding.

Identify Potential Funding Sources

• Almost every institution wants to know whether you’ll be able to get external funding for research.
• Try to provide some possible sources of funding for the research, such as NIH, NSF, foundations, private agencies.
• Mention past funding, if appropriate.

Be Realistic

There is a delicate balance between a realistic research statement where you promise to work on problems you really think you can solve and over-reaching or dabbling in too many subject areas. Select an over-arching theme for your research statement and leave miscellaneous ideas or projects out. Everyone knows that you will work on more than what you mention in this statement.

Consider Also Preparing a Longer Version

• A longer version (five–15 pages) can be brought to your interview. (Check with your advisor to see if this is necessary.)
• You may be asked to describe research plans and budget in detail at the campus interview. Be prepared.
• Include laboratory needs (how much budget you need for equipment, how many grad assistants, etc.) to start up the research.

Samples of Research Statements

To find sample research statements with content specific to your discipline, search on the internet for your discipline + “Research Statement.”

• University of Pennsylvania Sample Research Statement
• Advice on writing a Research Statement (Plan) from the journal  Science

Improving the Nation's Water Security: Opportunities for Research (2007)

Chapter: 6 recommendations for future research directions, 6 recommendations for future research directions.

Progress has been made in the Environmental Protection Agency’s (EPA’s) water security research program (see Chapter 4 ), but many important research questions and technical support needs remain. In Chapter 3 , a framework is suggested for evaluating water security research initiatives that gives priority to research that improves response and recovery and/or develops risk reduction or consequence mitigation measures. The research should also produce tools with a reasonable likelihood of implementation and, where feasible, dual-use benefits. Based on this framework and the review of water security efforts already under way, two important water security research gaps are identified and discussed briefly in this chapter. In addition, short- and long-term water security research recommendations are made. The research recommendations are organized in this chapter according to the three long-term program objectives proposed in Chapter 5 emphasizing pre-incident, incident, and post-incident applications: (1) develop products to support more resilient design and operation of facilities and systems, (2) improve the ability of operators and responders to detect and assess incidents, and (3) improve response and recovery. Both drinking water and wastewater research priorities are addressed together within these three objectives to maximize research synergies that may exist.

KEY RESEARCH GAPS

The Water Security Research and Technical Support Action Plan (EPA, 2004a) set out a comprehensive guide for the EPA’s near-term research initiatives. Although the Action Plan was intended to provide a short-term (three- to four- year) research agenda, the previous National Research Council review (NRC, 2004) noted that several of the Action Plan projects represented long-term research questions not easily ad-

dressed in the original time frame. Therefore, the Action Plan provides a reasonable starting point for building the EPA’s future research program. Nevertheless, the short-term planning horizon of the Action Plan prevented consideration of two key subjects that are critical to a long-term water security research program: behavioral science and innovative system design. The committee recommends the EPA work in collaboration with other organizations to build research initiatives in these two areas.

Behavioral Science

The threat of bioterrorism presents new and different types of risks that are dynamic and pose difficult trade-offs, bringing about intellectual challenges and an emotional valence possibly more important than the risks themselves. Developing an effective communication strategy that meets the needs of the broad range of stakeholders (e.g., response organizations, water organizations and utilities, public health agencies, the public, the media) while addressing security concerns is clearly a high-priority research area. The EPA’s work on risk communication is focused primarily on the development of guidance, protocols, and training, and little emphasis has been devoted to interdisciplinary behavioral science research to better prepare stakeholders for water security incidents or to build confidence in their ability to respond. Behavioral science research could help address, for example, what the public’s beliefs, opinions, and knowledge about water security risks are; how risk perception and other psychological factors affect responses to water-related events; and how to communicate these risks with the public (Gray and Ropeik, 2002; Means, 2002; Roberson and Morely, 2005b). A better understanding of what short-term disruptions customers are prepared to tolerate may also guide response and recovery planning and the development of recovery technologies.

Previous experience with natural disasters and environmental risks provides a basis for investigating and predicting human behavior in risky situations (Fischoff, 2005). Existing models of human behavior during other kinds of crises, however, may not be adequate to forecast human behavior during bioterrorism or water security incidents (DiGiovanni et al., 2003).

Risk communicators consider empirical findings from psychology, cognitive science, communications, and other behavioral and social sciences to varying extents (Bostrom and Lofstedt, 2003). Although decision makers frequently predict panic and irrational behavior in times of

crisis, behavioral science researchers have found that people respond reasonably to such challenges (e.g., Fishoff, 2005). Given the urgency of terror risk communication, risk communicators are obliged to incorporate existing behavioral science research as it relates to water security risks.

The EPA should take advantage of existing behavioral science research that may be applicable to water security issues, but this requires knowledge and experience in behavioral science research. Where gaps exist, the EPA will need to engage in interdisciplinary, rigorous empirical research to obtain the necessary knowledge.

Innovative Designs for Secure and Resilient Water and Wastewater Systems

Innovative designs for water and wastewater infrastructure were not addressed in the EPA Action Plan, but the topic deserves a place in a long-term water security research program. The EPA’s research mission has traditionally included the development and testing of new concepts, technologies, and management structures for water and wastewater utilities to achieve practical objectives in public health, sustainability and cost-effectiveness. The addition of homeland security to its mission provides a unique opportunity to take a holistic view of current design and management of water and wastewater infrastructures. Innovation is needed to address the problem of aging infrastructures while making new water systems more resilient to natural hazards and malicious incidents. The EPA should, therefore, take a leadership role in providing guidance for the planning, design, and implementation of new, more sustainable and resilient water and wastewater facilities for the 21st century.

Disagreggation of large water and wastewater systems should be an overarching theme of innovation. Large and complex systems have developed in the United States following the pattern of urban and suburban sprawl. While there are clear economies of scale for large utilities in construction and system management, there are distinct disadvantages as well. The complexity of large systems makes security measures difficult to implement and complicates the response to an attack. For example, locating the source of incursion within the distribution system and isolating contaminated sections are more difficult in large and complex water systems. Long water residence times are also more likely to occur in large drinking water systems, and, as a result, disinfectant residual may be lacking in the extremities of the system because of the chemical and biological reactions that occur during transport. From a security perspec-

tive, inadequate disinfectant residual means less protection against intentional contamination by a microbial agent.

A breadth of possibilities exists for improving security through innovative infrastructure design. Satellite water treatment plants could boost water quality. Strategic placement of treatment devices (e.g., ultraviolet lamp arrays) within the distribution system could counter a bioterrorism attack. Wastewater treatment systems could be interconnected to provide more flexibility in case of attack, and diversion devices could be installed to isolate contaminants. Box 6-1 describes some of these concepts in greater detail, and specific research recommendations are suggested in the following section.

RESEARCH RECOMMENDATIONS: DEVELOP PRODUCTS TO SUPPORT MORE RESILIENT DESIGN AND OPERATION OF FACILITIES AND SYSTEMS

Specific research topics are suggested here in two areas to support development of more resilient water and wastewater systems: (1) innovative designs for water and wastewater and (2) improved methods for risk assessment, including processes for threat and consequence assessments.

Innovative Designs for Water and Wastewater Systems

Innovative changes to water infrastructure will require long-term investment in research. Existing systems have been in place for more than a century in older cities. Thus, bold new directions will understandably require intensive research at the outset to produce a defensible economic argument for change. On the other hand, the EPA has the opportunity to develop innovative approaches that can be implemented almost immediately in relatively new, as well as planned, urban and suburban areas. The first step in research would be to enumerate the opportunities for innovation, recognizing the constraints brought about by the size, age, and complexity of existing water and wastewater infrastructures. A broad-gauge, economic analysis should follow that would quantify the costs and multiple benefits of these innovative designs (e.g., increased security, improved drinking water quality, enhanced sustainability of water resources). In addition, there is an implicit need for EPA research-

ers to coordinate with the agency’s regulatory branch to validate the feasibility of the innovative concepts that are proposed.

Each of the infrastructure concepts illustrated in Box 6-1 require far more research to become feasible. The recommendations below outline specific research topics that, if addressed, could improve the safety and sustainability of water resources in the 21st century.

Disaggregation of Water and Wastewater Systems

The “distributed optimal technology network” (DOT-Net) concept (Norton and Weber, 2005; Weber, 2002; 2004) hinges upon the feasibility of distributed treatment via point-of-use (POU)/point-of-entry (POE) devices installed at the scale of individual buildings or perhaps small neighborhoods. The corollary premise is that installation of expensive advanced treatment technology at the centralized water treatment facility is unnecessary when only a fraction of the service area outside a “critical radius” requires additional protection. Only a broad economic analysis of this concept has been published thus far for a hypothetical urban center, but the assumptions need to be verified for actual systems, particularly because of the unique characteristics of individual cities. In addition, far more research is needed on the utility management required to ensure the reliability of POU/POE devices in widespread implementation.

Dual water systems have also been proposed to address aging infrastructure (see Box 6-1 ; Okun, 1997; 2005). As with the DOT-Net concept, long-term research is needed to determine the costs and benefits of constructing an entirely new paradigm for distribution system design. Research issues would include assessing the acceptability of reclaimed water for progressively more intense levels of nonpotable use (e.g., irrigation, toilet flushing, laundering), the acceptability and management demands of decentralized wastewater treatment facilities, and the net benefits to water security.

In-Pipe Interventions to Reduce Exposure

In-pipe engineering interventions (see Box 6-1 ) are deserving of research in a long-term water security research strategy. For example, research is needed to optimize the location of disinfection booster stations or to examine the effectiveness and feasibility of in situ ultraviolet (UV)

irradiation systems as a decontamination strategy. EPA research could also examine various pipe materials (e.g., stainless steel) and evaluate their benefits for security and sustainability relative to their costs.

Infrastructure Designs to Enable Isolation and Interconnection

Most large drinking water systems have the ability to isolate portions of their distribution systems during necessary system repairs, but security concerns provide a new impetus for rapid and effective isolation mechanisms. Research on innovative mechanisms to isolate or divert contaminated water in drinking water and wastewater systems would be useful. The EPA should identify these design options, research their costs and benefits (including dual-use benefits) and their feasibility both for existing systems and new infrastructure, and make this information available to system managers.

Improved Risk Assessments Procedures

A sound risk assessment process allows utilities to make better resource management decisions for enhancing their recovery capacity or security strategies to mitigate the consequences of an attack. The risk assessment process includes assessments of threat, consequences, and vulnerability. To date, most of the efforts to guide utilities in their own risk assessments have focused on vulnerabilities.

Threat Assessment

Water and wastewater utilities today are making resource management decisions related to security without adequate information about the nature and likelihood of threats to their systems. As discussed in Chapter 4 , the EPA has focused their efforts on identifying contaminant threats without conducting similarly detailed analyses of possible physical and cyber threats. Both the nature and likelihood of these threats are needed for efficient allocation of resources at the utility level and within the EPA’s research program. Improved threat assessment would require the EPA and/or a consortium of water experts to work closely with the intelligence community and local law enforcement agencies. Other national and federal laboratory expertise within the Department of Energy,

Department of Defense, and private-public community might be needed as well. Threat assessments for water and wastewater should be periodically reviewed to identify threat scenarios that should be added to the list and to remove those that are no longer a concern. The development of a threat assessment process for local water and wastewater utilities with current techniques used in other infrastructures would also be helpful, provided the threat information could be communicated to those who need it (ASME, 2004; Sandia National Laboratories, 2001).

Consequence Assessment

A consequence assessment should accompany the threat assessment within the risk assessment process. Consequence assessments would provide decision makers with information on the potential for fatalities, public health impacts, economic impacts, property damage, systems disruption, effects on other infrastructures, and loss of public confidence. Procedures for determining the expected consequences from an attack or natural disaster are not currently being systematically developed. As a result, water system managers do not have sufficient data to make decisions about the benefits of risk reduction relative to the costs. The development and application of a consequence assessment procedure would provide decision makers with information needed to decide whether to mitigate the consequences, upgrade with countermeasures, take steps to improve response and recovery capacity, and/or decide to accept the level of risk and take no further action. A fault tree analysis that includes, for example, options for redundant systems or contingency water supplies could provide vital information on whether to invest in security upgrades or less costly consequence mitigation strategies . Many of these approaches have already been developed for other infrastructures (e.g., Risk Assessment Methodology [RAM]-T for the high-voltage power transmission industry or RAM-D for dams, locks, and levees; see Sandia National Laboratories, 2001; 2002). A thorough review of other RAM methodologies could provide guidance for consequence assessment strategies that could be incorporated into the Risk Assessment Methodology for Water Utilities (RAM-W).

The EPA has worked to develop the AT Planner tool to assist utilities in assessing the consequences from physical attacks (see Chapter 4 ). While AT Planner has been validated against actual blast test data for nonwater systems, there remains significant uncertainty in the applicability of the modeling for water security because it has not been validated

against the structures specific to those systems. Therefore, the ongoing evaluation of AT Planner by the EPA and select water utility operators should include an assessment of the applicability of AT Planner for each of the critical and high-consequence components of a water system. The EPA and water utilities should then consider whether any additional validation testing is needed to determine specific failure modes of relevant water system components (e.g., actual storage tanks, pumps, water conduits, chlorine tanks) and possible countermeasures.

Summary of Research Priorities for Secure and Resilient Systems

Short-term priorities.

Develop an improved understanding of physical, cyber, and contaminant threats to water and wastewater systems, especially focusing on physical and cyber threats.

Communicate information on threats and consequences to water system managers through training and information exchange.

Develop an improved threat assessment procedure for water and wastewater utilities that will assist local utilities with their security and response planning.

Develop a process to assist local utilities in determining the consequences from physical, cyber, and contaminant attacks.

Update the risk assessment methodology for water systems to incorporate the latest approaches used in other industries, including developing credible threat descriptions and identifying cascading consequences.

Long-Term Priorities

Develop innovative design strategies for drinking water and wastewater systems that mitigate security risks and identify their costs and benefits in the context of public health, sustainability, cost-effectiveness, and homeland security. These designs might include:

In-pipe intervention strategies for drinking water systems,

Disaggregation of water and wastewater treatment facilities to achieve dual-use benefits, and

Designs that allow for interconnections and isolation.

Evaluate the need to validate AT Planner against structures specific to water systems.

Periodically review the EPA’s prioritized list of threats, contaminants, and threat scenarios to identify items that should be added to the list and remove items that are no longer a concern.

Continue development of technology transfer/training programs so that utilities understand the value of the EPA’s products for both homeland security incidents and natural disasters and know how to utilize the tools to their full extent.

Implementation of Priorities

Some of the research recommendations to support more resilient design and operation of drinking water and wastewater systems lie outside of the EPA’s traditional areas of expertise. To support the Action Plan efforts so far, the EPA has relied heavily on expert contractors to conduct this type of work. The EPA should continue to seek the relevant expertise of other federal agencies and national laboratories in these future efforts. However, the EPA will need to consider how best to balance intramural and extramural research funding to carry out this research, while maintaining appropriate oversight and input into the research activities (see also Chapter 5 ). Increasing staff expertise in some key areas, such as physical security, will be necessary to build a strong and well-rounded water security research program to support more resilient system design and operation.

RESEARCH RECOMMENDATIONS: IMPROVE THE ABILITY OF OPERATORS AND RESPONDERS TO DETECT AND ASSESS INCIDENTS

Suggestions are provided in this section for future research that should improve the ability of operators and responders to detect and assess water security incidents. Specific research suggestions in the areas of analytical methodologies and monitoring and distribution system modeling are discussed below.

Analytical Methodologies and Monitoring

Expanding existing analytical methods.

For some analytes of relevance to water security concerns, the available or approved detection methods are poor (e.g., some nonregulated analytes). More work needs to be done to expand existing methods to a broader range of analytes. For example, method 300.1 (EPA, 2000) covers only the common anions but could be extended to others, including toxic substances. The extension of existing methods to new analytes would allow a broader range of laboratories to expand their capabilities into the water security area.

Screening methods using conventional gas chromatography (GC) or high-performance liquid chromatography (HPLC) should also be investigated. Modern high-resolution chromatography combined with high-sensitivity detection (e.g., electron capture, fluorescence) is a powerful, yet accessible tool. Protocols should be developed to make the best use of these widely available capabilities. Software will have to be developed to facilitate the documentation of normal, background signals (fingerprint-type chromatograms). This background information can then be used to detect anomalies. Final protocols would have to be tested thoroughly against priority chemical contaminants. Chromatographic finger-prints have been used to monitor water supplies for nonintentional contamination, so this line of research would provide a dual benefit (D. Metz, Ohio River, personal communication, 2006; P. Schulhof, Seine River, personal communication, 2006).

Progress is being made with the protocol to concentrate samples and identify biological contaminants by polymerase chain reaction (PCR) analysis. Continued research, however, needs to be directed towards reducing the time and effort required to collect, process, and identify samples by automating portions of the protocol such as the concentration step. Such automated collection and sample processing systems would be especially valuable in response to security threats, when water samples could be channeled to existing or new detection technologies capable of onsite processing. The EPA should continue to expand the number of biothreat agents tested with the concentration/PCR protocol to include microbes other than spores, prioritizing test organisms that are both a threat to public health and resistant to chlorine (Morales-Morales, et al., 2003; Straub and Chandler, 2003). Continued testing of the concentration/PCR protocol should include various mixed suspensions of a target

microbe and background microbes to determine specificity of detection and various dilutions of the target microbe to determine sensitivity of detection. The protocol should also be tested on chloraminated water samples.

Developing New Monitoring Technologies

Chemical Detection. New chemical monitoring technologies for security-relevant analytes should be investigated. Examples include quartz crystal microbalance (QCM) sensors, microfluidic devices (lab-on-a-chip), ion-sensitive field-effect transistors (ISFETs), and larger-scale optrodes. Extramural agency and corporate partnerships developed by the EPA and longer-term research projects will help the evaluation and consideration of a broader range of detection platforms.

Biological Detection. Biological monitoring devices are essential to assess the type and extent of contamination in a suspected water security event. A broader range of innovative and developing detection technologies for biological agents, including methods that are field deployable and reagent-free, should be considered and evaluated. Innovative, field-deployable detection technologies (e.g., genetic fingerprinting, immunodetection, other technologies in development by universities, the Department of Defense, and industry) could reduce the time and effort for detection and enable earlier response efforts (Iqbal et al., 2000; Ivnitski et al., 2003; Lim et al., 2005; Monk and Walt, 2004; Yu and Bruno, 1996; Zhu et al., 2004). These new technologies might also increase the accuracy of detecting deliberate contamination events and reduce false alarms. Methods that can detect multiple biological agents and those with dual-use benefits should be emphasized over those methods limited to very specific agents (Peruski and Peruski, 2003; Rogers and Mulchandani, 1998). For example, DNA fingerprinting might be more useful than immunodetection systems dependent on a highly specific antibody for operation. The accuracy of these detection methods will depend on availability of quality reagents such as antibodies and primers; therefore, researchers will need to work closely with the Centers for Disease Control and Prevention (CDC) and other agencies that have access to such reagents.

Monitoring Devices for Wastewater Collection Systems . Contamination incidents have the potential to disrupt wastewater biological treat-

ment systems; thus, a long-term research program should also include research on monitoring technologies relevant to wastewater security concerns. Although a number of devices are available that can be used to monitor physical, chemical, and biological parameters, none of the currently available devices are robust or reliable enough when used in untreated wastewater to meet security requirements. The EPA should, therefore, encourage development of robust or reliable monitoring devices for wastewater infrastructure.

Syndromic Surveillance Tools. Syndromic surveillance tools may have the potential for detecting disease outbreaks and for investigating the possible role of water in such outbreaks (Berger et al., 2006). The EPA is already working to test two syndromic disease surveillance tools (RODS, ESSENCE) against prior water contamination outbreak data. There are substantive research needs that should be undertaken, however. Clearly, the improvement of existing syndromic surveillance tools is a long-term research objective. For syndromic surveillance to become worthwhile, it should achieve a favorable cost-benefit ratio considering the costs of false positives, and syndromic surveillance should also be adequately integrated into response plans. The implementation of syndromic surveillance systems on a large scale would require a more detailed linkage between disparate databases used in the public health sector and the water supply sector. Research to develop tools to allow local systems to readily fuse information from these disparate sources would be desirable. Such linkages would improve detection and response to waterborne disease outbreaks and more rapidly exclude water as a possible vehicle of disease. This would have important applications for both intentional and nonintentional water contamination events.

Real-Time Monitoring Systems

The development of a fully functional, easy-to-maintain, real-time monitoring system (RTMS) that could someday be used to prevent harm from deliberate attacks on the water system (“detect to prevent”), even with substantial research investments, is many years away. Therefore, the primary emphasis of future research on RTMSs, at least in the near term, should be on developing these technologies to assess the spread of contaminants, not to prevent exposure.

The committee also questions the likelihood of implementation of real-time monitoring devices for specific chemical or biological parame-

ters that are not useful in the day-to-day operation of a system (see Chapters 2 and 4 ). However, there are a few scenarios where implementation of continuous monitors for biological contaminants might be valuable, such as their use in certain water systems under heightened threat conditions (e.g., utilities for which specific intelligence information indicates they may be targeted). As discussed in Chapter 4 , deployment under these circumstances has a greater likelihood for success because the probability of an event is estimated to be much higher and the length of monitoring time is shortened. The use of highly sensitive and specific detection devices under such targeted circumstances would significantly lower the probability of false alarms and reduce the problem of poor positive predictive value (see Chapter 2 ) while also minimizing implementation and maintenance costs. Thus, improving monitoring systems for specific chemical or biological agents in drinking water is a valid long-term research goal. The EPA may find that longer-term research on more speculative sensor development could benefit from a further broadening of the circle of collaborators. Such speculative research may be more appropriately funded through the National Science Foundation or the Homeland Security Advanced Research Projects Agency, thus freeing up EPA resources for other purposes. To encourage such research, the EPA may wish to build its connections with the private sector on this technology.

Research on detection methods for RTMSs should proceed with careful consideration of the likelihood of implementation of the monitoring devices. In its near-term research plans, the EPA should adopt a first-stage approach to RTMSs, emphasizing generic sensors to detect intrusion or a system anomaly. The intrusion detection would then trigger more resource-intensive follow-up monitoring and analysis. Such an approach has significant dual-use benefits for routine contamination events that could outweigh the costs of implementing and operating these systems. Additional effort to develop cheaper, more accurate, and more easily deployable and maintainable sensors for routine water quality parameters would be useful both for anomaly detection and routine operation. Additional research is also needed, even in first-stage RTMSs, to understand normal water quality variations and distinguish variations that might be caused by a deliberate contamination attack. For example, continuous monitoring of chlorine residual at multiple points in the distribution system often reveals wide variations at different temporal scales due to changes in water demand that affect water residence time (e.g., operation of storage tanks). Although some work to understand inherent water quality variability in distribution systems is being conducted through the

Water Sentinel program, a significant amount of work is needed to translate the findings of this research into criteria for RTMSs to develop systems that have a reasonable likelihood of implementation.

An important component of RTMS research should include data fusion, whereby multiple anomalies must occur before an alarm signal is sent (see also Chapter 4 ). The private sector seems to be taking the lead on many types of multiparameter approaches to RTMSs and the processing of data, especially as described by contaminant or event signatures. It is important that the algorithms are open to peer review and can be accessed by all for development of new and refined approaches.

RTMS sensor research should consider a broader range of technologies, including full-spectrum UV and visible absorption, fluorescence excitation emission matrices, and ionization sensors (Alupoaei et al., 2004; Fenselau and Demirev, 2001; Lay, 2001). Many of these techniques are used as nonspecific chromatography detectors, and as such, they are highly sensitive. Most prototype RTMSs are composed of existing sensors that are designed to measure a specific contaminant, and some technologies have been excluded because they have not led to sensors with a high degree of selectivity. However, RTMSs need not be contaminant-specific; they only need to detect anomalies. Detection of an anomaly can then be followed by more specific contaminant analyses.

The problem of false positive signals from real-time contaminant-specific warning systems has been discussed in Chapter 2 . In essence, the problem is one of unfavorable arithmetic when the probability of a true positive is very small, as it would be for an intentional contamination attack on any particular water system of the tens of thousands of such systems. Therefore, most contaminant-specific alarm signals will be false positives. The EPA should consider the consequences of various rates of false positive signals for both large and small utilities and collect information on how alarms are currently handled by utilities. Workshops and structured surveys on this issue would provide valuable information on current practices, the extent to which positive signals are confirmed, the costs of false alarms, and the views of utility operators on their tolerance for various levels and types of false alarms. This research would provide useful guidance for the developers of water quality monitoring devices, for utilities that are considering implementing devices that are commercially available, and for local and state regulatory agencies who will need assistance interpreting alarm signals in light of the public health consequences.

Technology Testing

The EPA has developed a rigorous technology testing program to provide security product guidance to end users focusing on monitoring and decontamination technology. However, as noted in Chapter 4 , the number of relevant security technologies and agents of interest exceed the capacity and budget of the Technology Testing and Evaluation Program (TTEP). Therefore, developing a test-prioritization plan for TTEP seems especially important and is strongly recommended. Although the process of identifying technologies of interest has begun through the use of stakeholder meetings and advisory boards, activities to date have been weighted toward doing the easiest things first, and only some of these tests provided dual-use benefits. Balancing the homeland security benefits and the benefits to routine water system operations in TTEP will likely require additional strategic planning. One strategy has been to test equipment that is commercially available regardless of whether it addresses a high-risk agent. Instead, the EPA should look beyond the easy-to-identify commercially available equipment and make a greater effort to identify technologies in development that have the potential to address those agents identified as posing the greatest risk to water, considering the likelihood of the threat (including the ease of acquiring particular chemical or biological agents), the potential consequences, and the likelihood of implementing the technology. For a few of the highest-priority threats, the EPA may wish to consider providing technical support and/or funding to encourage more rapid development of a particularly promising technology that has a high likelihood of implementation and significant dual-use benefits, similar to the EPA Superfund Innovative Technology Evaluation (SITE) Emerging Technology Program.

Develop Laboratory Capability and Capacity

Adequate laboratory capacity is critical for responding to a terrorist incident affecting water supplies, and although this is not a research issue, the EPA has much to contribute from an applied perspective. The need for mobile analysis units capable of supplementing local laboratories and rapidly responding to geographical areas impacted by terrorist events should be considered. Such mobile laboratories could also address analytical needs that arise during natural catastrophes, such as Hurricane Katrina. Many states have begun to develop mobile laboratory

capabilities as part of their water security activities, and the EPA could glean information on their experiences to date.

The EPA is working with utilities and state and federal agencies to build a national laboratory response network for water sample analysis (i.e., the Water Laboratory Alliance). Some university laboratories may have capabilities that could merit inclusion in the nationwide network. Other laboratories may be stimulated to conduct additional research on improved analytical methods for toxic and biothreat agents if they were better informed of the current state of knowledge and had access to reference standards (access to some reference standards is currently limited due to security concerns). To be successful, a dual-use philosophy should be adopted whenever possible in the development of laboratory capacity (e.g., employing methods/instruments that can also be used for standard analytes).

Distribution System Modeling Tools

Distribution system models provide valuable tools for locating the source of contamination or assessing the spread if the source is known, estimating exposure, identifying locations for sampling, and developing decontamination strategies (see also Chapter 4 ). Distribution system models also have important dual-use applications to routine water quality concerns, and the EPA should continue to emphasize the dual-use value of its modeling tools. Specific recommendations are provided below to advance the capabilities and implementation of the Threat Ensemble Vulnerability Assessment (TEVA) and EPANET models.

Experimental Verification of Species Interaction Subcomponent Models

The final goal of producing a more flexible EPANET model through Multi-Species EPANET (MS-EPANET) is commendable. However, the new subcomponents are based upon developing better fundamental knowledge of reactions within the distribution system involving chemistry (e.g., disinfection kinetics, chemical partitioning), biology (e.g., development of biofilms, release and attachment of microbes), and materials science (e.g., corrosion of pipe materials and its relationship to disinfection efficacy). The large number of system constants in both MS-EPANET and TEVA necessitate significant investment in sensitivity

analysis research to quantify the accuracy of model predictions. The development and testing of all new features of MS-EPANET should be a long-term research goal. Until the validity of these subcomponents is verified and system constants can be assigned with more certainty, the water industry will be reluctant to use the full capability of MS-EPANET. Limitations in the accuracy of model predictions will need to be addressed in guidance to decision makers. A significant commitment will be needed in resources for experimental verification.

Alternate Approaches to Uncertainty Modeling

The Action Plan acknowledges correctly that the distribution system model simulations should incorporate an analysis of uncertainty because the point of attack is unknown. This has led to the use of the well-known Monte Carlo analysis to randomize the location of the attack and run repeated distribution system model simulations (1,000 or more) to generate a probability distribution to relate point of attack to human exposure impact. The focus on short-term results, however, has produced weaknesses in the current EPA approach to uncertainty research.

A broader discussion about how to incorporate uncertainty into the TEVA model should be invited. Approaches such as fuzzy logic (McKone and Deshpande, 2005) and Bayesian Maximum Entropy modeling (Serre and Christakos, 1999) are showing promise but have been applied mainly to homogenous space rather than to network domains. The EPA should encourage alternative ideas for handling uncertainty. If the expertise is not available within the agency, there needs to be a mechanism to expand extramural support for research, particularly within the university community.

Technology Transfer and Training in Use of the TEVA and EPANET Models

Advances in the TEVA model add significant complexity to the EPANET model, which may limit its widespread implementation. The EPA should work to communicate the capabilities of EPANET, MS-EPANET, and TEVA to utilities, emphasizing their value for routine water quality concerns, advanced homeland security planning, and contamination assessment and response activities. Until TEVA and MS-EPANET are further developed and widely available, the EPA should

consider an interim strategy to better inform water utilities on the value and use of existing distribution system models, such as EPANET. Progressive water utilities are already using EPANET to examine possible locations of attack and to track the concentration of contaminants within the distribution system.

Training in the use of MS-EPANET and the proposed TEVA model is also needed. Water utility managers need to be convinced that the costs for adapting a new model for their respective distribution systems are worthwhile, because many utilities have already invested heavily in development, verification, and calibration of existing models. The complexity of the TEVA model may increase these costs further, because many more implementation steps follow those for EPANET to adapt the TEVA “template” to the specifics of each water utility.

Summary of Research Priorities for Better Equipping Operators to Detect and Assess Incidents

Automate the concentration step of the concentration/PCR protocol.

Continue to test the concentration/PCR protocol:

Expand the number of biothreat agents tested to four or five organisms that include microbes other than spores, focusing on microbes that are both a threat to public health and resistant to chlorine.

Test the concentration/PCR protocol with chloraminated water samples.

Test the concentration/PCR protocol to determine sensitivity and specificity of detection.

Field-test RTMSs to determine false positive/false negative rates and maintenance requirements and develop basic criteria for the technology that might lead to a reasonable likelihood of implementation.

Continue research to develop a first-stage RTMS based on routine water quality sensors with dual-use applications.

Analyze the consequences of false positive signals from realtime monitoring systems, emphasizing current practices, the extent to which positive signals are confirmed, the costs of false alarms, and the tolerance of utility operators for false alarms.

Test standard chromatographic methods for their ability to screen for a broad range of toxic agents in routine laboratory testing.

Develop a test-prioritization strategy for TTEP to optimize the resources devoted to this effort.

Invite external peer review of the TEVA model before investing in field testing.

Long-term Priorities

Continue to develop portable, field-deployable systems that can be used to collect and process samples at event locations.

Formulate protocols and develop software for using GC- and HPLC-based fingerprinting to detect suspicious anomalies.

Stimulate research and ultimately development of new sensors for water security analytes based on innovative technologies, such as QCM, ISFETS, and microfluidics.

Evaluate and develop new field-deployable detection technologies for biological agents, including genetic fingerprinting, immunodetection, and reagentless technologies, that have the necessary sensitivity, specificity, and multiplex capabilities.

Develop improved, cheaper, and accurate RTMSs for routine water quality measurements.

Examine the use of nonspecific detection technologies for RTMSs.

Develop data fusion approaches for RTMSs that can minimize false positives.

Develop and test new monitoring technologies suitable for wastewater security applications.

Improve syndromic surveillance tools and develop a health surveillance network with appropriate linkages to water quality monitoring.

Continue to develop and refine the efficiency of a system-wide laboratory response network, including the development of mobile analysis units.

Continue fundamental research to understand the chemical and biological reactions that affect the fate and transport of contaminants in distribution systems to verify the constants used in MS-EPANET and TEVA.

Include alternative approaches to uncertainty design (e.g., fuzzy logic, Bayesian Maximum Entropy) in the TEVA model that are based more strongly upon stochastic than deterministic principles given that many of the input parameters to the current TEVA model are highly uncertain.

Develop projects for training water utilities in the value and use of EPANET, MS-EPANET, and TEVA.

Some of these research priorities may be more appropriately accomplished by universities, companies, or other agencies that have the necessary expertise, resources, and funding to successfully complete these tasks. The development of multiplex detection protocols and portable, field-deployable platforms are examples of tasks that might be better managed by some group other than the EPA. Work to determine the sensitivity and specificity of designated protocols for different biothreat agents could be conducted by university laboratories or private industry, with collaborative input from the EPA, considering their understanding of the needs of the water sector. Utilization of research resources outside the EPA would expand the variety of emerging, innovative analytical technologies that might be used to support the EPA’s efforts in enhancing the nation’s water security.

RESEARCH RECOMMENDATIONS: IMPROVED RESPONSE AND RECOVERY

Recommendations are provided in this section for future research that should improve response and recovery after a water security incident. Research suggestions related to tools and data for emergency planning and response, contingencies, risk communication and behavioral sciences, decontamination, and lessons learned from natural disasters are presented below.

Tools and Data for Emergency Planning and Response

Continued development of emergency response databases.

The EPA released preliminary versions of the Water Contamination Information Tool (WCIT) and the Consequence Assessment Tool (CAT) to provide data on contaminant properties, toxicity, and exposure threats (see Chapter 4 ), but the databases are still in their infancy, and numerous data gaps exist. The EPA will need to prioritize its continued efforts to further develop these response databases. Therefore, the EPA should develop strategic plans for WCIT and CAT, outlining the long-term goals for the databases and addressing questions such as:

What stakeholders will be served by the databases?

What categories of information do these stakeholders need?

How many contaminants should be included?

What linkages to other databases should be established?

The EPA will need to determine criteria for prioritizing what contaminants are added to the database and how to maintain and update the information. If WCIT and CAT are not continually revised to incorporate the latest scientific knowledge, the databases will become outdated. Expanding or even maintaining a database requires considerable resources, both intellectual and financial. If a commitment is not made initially for the necessary resources to update and maintain a database, spending the resources to create it becomes debatable. The EPA is currently facing similar issues maintaining its Integrated Risk Information System (IRIS) database.

The EPA should also clearly define the data quality objectives for WCIT/CAT and incorporate peer review of the data, as necessary, to meet these objectives. For example, the EPA may decide that some information about a contaminant is better than none, even if that information has limitations. This is a legitimate approach; however, the EPA should provide a mechanism that helps to ensure that individuals using the databases understand the data quality and their limitations. One mechanism for accomplishing this would be to add quality notations for each datum. Regardless of the approach taken, the EPA needs to describe the extent to which the data have been reviewed.

Evaluation and Improvement of Tools and Databases

With the forthcoming completion of at least the first stages of many tools and databases (e.g., WCIT, CAT), the EPA should consider the evaluation/improvement cycle. This will require the development of procedures to evaluate the utility and usability of these tools by potential constituencies. In addition, the EPA should take advantage of the tests afforded in response to “real-life” incidents. For example, some of the tools and databases were used (albeit in an early stage of their development) in the response to Hurricane Katrina. A formal assessment of knowledge gained from this experience could assist in the improvement and development of the tools.

Filling Data Gaps

The state of knowledge of the health risks from water contaminants that could be used in a malicious event is quite limited, as shown by the limited number of chemicals and even fewer biologicals in the WCIT/CAT databases and the many blank data fields in these databases. Important experimental and computational research is under way at the EPA to address some of these data gaps (see Chapter 4 , Section 3.6), but many gaps remain. There are two applications of toxicity/infectivity information that would be useful to the EPA for response and recovery efforts. The first is development of guidance for dissolved concentrations that would pose an immediate acute risk to exposed individuals, analogous to the inhalation immediate danger to life and health values of the National Institute for Occupational Safety and Health. The EPA is currently working on this problem by developing a database on acute and

chronic health effects associated with priority contaminants, although much work remains to be done. The second is guidance for determining the appropriate “acceptable” level remaining after cleanup/decontamination. This second aspect has not yet been strongly emphasized in the EPA research program. It is recommended that the EPA convene a working group to develop research and prioritization strategies for filling these data gaps and for ascertaining current gaps in knowledge with respect to rapid estimation of toxicity/infectivity in the absence of specific experimental information. Decisions for setting priorities for the data gathering efforts should be made with full consideration of dual-use benefits.

Contingencies for Water System Emergencies

Further study of water supply alternatives should be a high priority, considering their pivotal role in response and recovery and their dual-use applications for natural disasters or system failures. However, the subject of water supply contingencies seems to have been given a low priority in the EPA’s research program to date. Completion of the work in progress should be the first priority. The committee debated the value of investing significant resources in developing technologies that could supply drinking water for large communities over long-term disruptions because of the rarity of the need for such technologies. Nevertheless, the EPA should draw upon the research and development efforts of the Department of Defense in this area and work to test the application of these technologies to water security scenarios.

The EPA should consider including new research on contingencies for failures of the human subsystem in water system security. Such research could examine current practices for identifying back-up operators in the case of widespread incapacitation in both short-term and long-term scenarios. This research could also identify best practices, which could be incorporated into EPA guidance to water utilities for their emergency response planning.

Preliminary research suggests that geographic information systems (GIS) could be of significant value to utilities for identifying contingencies in the event of system failures. Therefore, further efforts may be needed to inform utilities about the value of GIS for emergency response and provide guidance for integrating GIS into their emergency planning procedures. National geodata standards may be needed to promote consistency and facilitate data exchange among users.

Behavioral Sciences and Risk Communication

The National Homeland Security Research Center (NHSRC) has made substantial progress in the development of risk communication guidance and training (see Chapter 4 ), but very little emphasis has been devoted to research on understanding how the public may respond to risk communication messages and how to improve communication of risks to the public. Terrorism presents risks that are new, evolving, and difficult to characterize; thus, water security poses communication challenges that should be addressed using scientifically rigorous research in the fields of risk communication and behavioral sciences. The EPA should continually reassess the role risk communication has in its overall risk management framework and fully integrate risk communication efforts into the overall risk management program. Behavioral science and associated risk communication research should be a high priority in the EPA’s future water security research plans. The following recommendations are targeted toward water-security events, but the proposed research has dual benefits for improving non-security-related communications with the public.

Analysis of Factors that Build Trust and Improve Communication

Research and experience prove that one of the most important keys to communication success is an organization’s ability to establish, maintain, and increase trust and credibility with key stakeholders, including employees, regulatory agencies, citizen groups, the public, and the media. To improve overall communication strategies in a water-related emergency, research is needed that analyzes factors that build trust and reduce fear (e.g., What types of concerns do people have related to public health emergencies, water security issues, or bioterrorism? How do utilities build trust and credibility with the public around water security incidents?). In addition, research is needed to analyze methods to counter and reduce the possibility of misinformation or false information being distributed to the public and key stakeholders.

Understanding Institutional Behavior

Building response and recovery capacity requires agencies that might be involved in a water security event to develop stronger working relationships. Although water utilities, public health agencies, law enforcement, emergency responders, and the media do not have a long history of collaborating and working together, several state drinking water programs have taken the lead in carrying out tabletop exercises as well as on-the-ground exercises to address this issue. These state programs have also undertaken measures to facilitate an understanding of the roles and responsibilities of the various potential players, including federal, state, and local law enforcement; state and local health agencies; state and local emergency response agencies; and water utilities. The EPA could glean useful information from these ongoing state and local activities. Nevertheless, additional research is needed to better understand the culture of the agencies that will be responding to events, how these agencies will interact in a water-related crisis, and what level of effort is needed to maintain collaboration in planning and preparedness. This research could identify barriers to more effective collaboration, and these findings could be used to create training scenarios that could improve coordination and resolve potential conflicts in advance. This research is a short-term priority given the importance of coordinated interaction during a crisis. The research could be performed relatively quickly because there is a wealth of experiences, particularly at the state level, related to agency interactions in water-related crises.

Investigate Applicability of Research in Behavioral Science

While some of the recommended research on risk communication and behavioral science may need to be managed by the EPA to address specific water security-related issues, the EPA should also take advantage of other behavioral science research currently being conducted through university-based partnerships, including those established by the Homeland Security Centers of Excellence program. For example, the University of Maryland’s National Consortium for the Study of Terrorism and Responses to Terror (START) is conducting original research on issues that are poorly understood, including risk perception and communication, household and community preparedness for terrorist attacks, likely behavioral responses by the public, social and psychological vulnerability to terrorism, and strategies for mitigating negative psychologi-

cal effects and enhancing resilience in the face of the terror threat. The START center is also synthesizing existing research findings in order to provide timely guidance for decision makers and the public, paying special attention to how diverse audiences react to and are affected by threats and preparedness efforts.

In addition, the CDC has developed a national network of 50 Centers for Public Health Preparedness (CPHP) to train the public health workforce to respond to threats to our nation's health, including bioterrorism. These centers work to strengthen terrorism preparedness and emergency public health response at the state and local level and to develop a network of academic-based programs contributing to national terrorism preparedness and emergency response capacity. Information from the CPHP may be relevant and useful to the water sector.

Pretesting Risk Communication Messages

Although the message mapping workshops are a good start to assist stakeholders in preparing messages that will be relevant in a water security incident, the messages have not been tested and evaluated. Therefore, the EPA should engage the research community in pretesting messages being developed by the Center for Risk Communication so that case studies and scenarios can be analyzed for effectiveness in reaching key audiences, and problems can be corrected in advance. Sophisticated evaluation techniques and standard research procedures are used by the CDC to pretest public messages. This evaluation research should be based on standard criteria established in the risk communication literature (e.g., Mailback and Parrott, 1995; National Cancer Institute, 2002; Witte et al., 2001).

Analysis of the Risks and Benefits of Releasing Security Information

The decision of when to release or withhold water security information is critical to the development of a risk communication strategy. Therefore, the EPA should analyze the risks and benefits of releasing water security information, considering input from its broad range of constituents, and develop transparent agency guidance on when to release information versus when to withhold it due to security concerns.

The committee considers this a priority because of the difficulty and importance of the information sharing problem.

Water-Related Risk Communication Training

As the lead U.S. agency in water system security, the EPA should assume the responsibility for developing a national training program on water-related risk communication planning and implementation for water managers. This should be done in collaboration with the water and wastewater organizations, state government agencies, public health officials, health care officials, and others engaged in communication of risks during water-related emergencies.

Decontamination

Decontamination research is critical to improving response and recovery, and the products are applicable to address unintentional contamination events from natural disasters (e.g., hurricanes, floods, earthquakes) and routine malfunctions (e.g., pipe breaks, negative pressures due to power losses). The EPA has numerous ongoing projects in this area that should be completed, but additional research topics are also suggested below.

Addressing Data Gaps

EPA decontamination research products released thus far have shown that fundamental physical, chemical, and/or biological characteristics of many threat agents of concern are not yet known. Therefore, additional laboratory research is needed related to the behavior of contaminants in water supply and wastewater systems and methods for decontaminating water infrastructure. For example, one research priority would be to develop inactivation rate data for all microbes of concern with both free and combined chlorine strategies, because both approaches are used in the water industry. Rate and equilibrium data for adsorption/desorption of contaminants on pipe walls is also needed, although the EPA could also take advantage of existing databases on structure-activity relationships to predict these behaviors. Long-term re-

search, perhaps in partnership with other Office of Research and Development units, could enhance our understanding of the fate, transport, and transformation of toxics in water and wastewater environments.

Decontamination Strategies

The EPA should build on its ongoing work in the area of decontamination and address gaps in the current knowledge base. For example, research is needed to examine readily available household inactivation methods for biological agents (including spore-formers), such as microwaving. The EPA should also work to further the development of innovative decontamination technologies that address important water security concerns. Research and development on new POU/POE technologies, such as superheated water devices, could help overcome operational disadvantages of the products currently on the market.

Prioritizing Future Surrogate Research

Surrogates are relevant to numerous water security research applications, including research on contaminant fate and transport, human exposure risks, and decontamination. Research is ongoing to identify surrogates or simulants for biological agents, to determine which surrogates are appropriate, and to determine the ability of typical drinking water disinfection practices (chlorination and chloramination) to inactivate those agents (see Chapter 4 , Section 3.2). Much of the research has focused on Bacillus anthracis and other bacterial agents, but the EPA should determine if surrogates for research on biotoxins and viruses are needed and whether additional surrogates are needed for other bacterial agents. A viral simulant or surrogate would be helpful to examine virus survival in fresh water, drinking water, and sewage, as well as virus susceptibility to water disinfectants. Research in this area has relevance to viral bioterrorism agents and also has strong dual-use research applications because viral surrogates could facilitate risk assessment studies on natural viruses (e.g., SARS, avian influenza).

Surrogate research is a laborious experimental process (see Box 4-1 ) that must be conducted in one of the few laboratories already authorized to keep and work with select agents. Considerable research is required to compare the select agent with candidate surrogates under the experimental conditions of interest. As discussed in Chapter 4 , surrogates need not

mimic in all respects the agents they stand in for. For some important security or decontamination uses, it may only be necessary that they provide an appropriate bound on the characteristic of interest in the target agent (e.g., persistence, disinfectant sensitivity). Therefore, the EPA should carefully consider and prioritize the agents and the research applications for which surrogates are needed. The prioritization process for surrogates should consider the following:

Which types of research could be greatly facilitated through the availability of surrogates?

Which types of research with surrogates might have “dual-use” applications (i.e., could the properties of certain surrogates also be usefully extrapolated to other common organisms)?

Which types of research should be done only with select agents?

How closely should the surrogate properties of interest match that of the target organism?

What are the costs and benefits to the research program associated with surrogate development versus use of the pathogenic agents?

The EPA should engage a limited number of individuals (e.g., federal partners, academics) who are involved in similar research in this prioritization process.

Lessons Learned from Natural Disasters

Midway through the committee’s work, NRC (2005; see Appendix A ) suggested the EPA take advantage of experience gained in the aftermath of Katrina so as to improve future response and recovery efforts for water security. While a hurricane caused this catastrophe, it is conceivable that a similar result might have occurred if the levees had been destroyed by terrorist explosives. Thus, New Orleans offered a living laboratory to study many aspects of the impacts of a disaster on water and wastewater systems of all sizes. Failure modes, infrastructure interdependencies, decontamination and service restoration strategies, the availability of alternative supplies, communication strategies, and the ability to service special institutions (e.g., hospitals) and special needs individuals could all have been examined in the immediate aftermath of the hurricane. To the best of the committee’s knowledge, however, the EPA has not attempted to compile a knowledge base from this experience. As

time passes, it will become increasingly difficult to reconstruct what transpired. Other natural or manmade disasters, such as the earthquakes in California in 1989 and 1994 or the “Great Flood of 1993” in the Mid-west, or natural contamination events, such as the Milwaukee C ryptosporidium outbreak, may also offer opportunities to mine important data about the failure or recovery of water and wastewater systems, but detailed information on these earlier occurrences may be lacking. In the future, the NHSRC should be poised to seize opportunities for learning about response and recovery after major natural or man-made disasters affecting water or wastewater systems.

Summary of Research Priorities for Improving Response and Recovery

Determine strategic plans for managing and maintaining the WCIT/CAT databases, considering the likely uses and long-term goals for the databases.

Develop and implement a strategy for evaluating the utility and usability of the response tools and databases, including stakeholder feedback and lessons learned during their use under “real-life” incidents.

Convene a working group to develop research strategies for filling the data gaps in WCIT/CAT and other planned emergency response databases.

Contingencies for Water Emergencies

Complete the work in progress on contingencies and infrastructure interdependencies under Section 3.5 of the Action Plan.

Test and evaluate the most promising innovative water supply technologies that enable or enhance the short- or long-term delivery of drinking water in the event of systemic failure of water systems. Analyze the positive features and those areas needing improvement prior to full-scale deployment.

Conduct research on potential contingencies for failures of the “human subsystem.”

Analyze factors that build trust, reduce fear, and prevent panic to improve overall communication strategies in a water-related emergency.

Investigate the behavioral science research being conducted by the Homeland Security University Centers of Excellence and other federal agencies for applicability to the water sector.

Pretest messages being developed by the Center for Risk Communication and analyze case studies and scenarios for effectiveness.

Analyze the risks and benefits of releasing security information to inform the EPA’s risk communication strategies and its practices on information sharing.

Fully integrate risk communication efforts into the overall risk management program and provide adequate resources that ensure these efforts remain a high priority in the EPA’s future water security research program.

Conduct research to better understand how agencies will interact in a water-related crisis situation and determine what strategies will be most effective in encouraging and maintaining collaboration in planning and preparedness.

Complete the many decontamination projects in progress under Section 3.4 of the Action Plan.

Develop predictive models or laboratory data for inactivation of bioterrorism agents in both free chlorine and chloramines that can be used in MS-EPANET and the TEVA model.

Explore development and testing of new POU/POE devices that may overcome the disadvantages of existing devices.

Examine readily available household inactivation methods for biological agents (including spore-forming agents), such as microwaving.

Determine the costs and benefits of further research to identify additional surrogates, considering which agents under which conditions or applications should be prioritized for surrogate development research.

Use the remaining data from the experience of Hurricane Katrina to analyze the optimal response and recovery techniques (e.g., water supply alternatives, contingency planning, and infrastructure interdependencies) that would also apply to water security events.

Integrate experience with decontamination of the distribution system in New Orleans after Hurricane Katrina to improve EPA guidance for water security decontamination.

Evaluate risk communication strategies related to Hurricane Katrina or other past disaster events to determine if communication strategies related to drinking water safety reached the most vulnerable populations.

Develop a post-event strategy for learning from future natural disasters affecting water systems. This strategy should support on-site assessments of impacts and interdependencies and evaluations of successes and failures during response and recovery.

Continue to develop and maintain the WCIT/CAT databases according to the objectives set forth in the strategic database management plan. Incorporate a mechanism to provide on-going peer review of the data to meet its data quality objectives.

Continue experimental and computational research to fill critical data gaps in WCIT/CAT, including research on the health effects of both acute and chronic exposure to priority contaminants.

Develop new, innovative technologies for supplying drinking water to affected customers over both short- and long-term water system failures.

Risk Communication and Behavioral Sciences

Develop a program of interdisciplinary empirical research in behavioral sciences to better understand how to prepare stakeholders for water security incidents. The EPA should support original research that will help address critical knowledge gaps. For example:

What are the public’s beliefs, opinions, and knowledge about water security risks?

How do risk perception and other psychological factors affect responses to water-related events?

How can these risks be communicated more effectively to the public?

Develop a national training program on water-related risk communication planning and implementation for water managers.

Continue laboratory research to fill the data gaps related to behavior of contaminants in water supply and wastewater systems and methods for decontaminating water infrastructure.

Continue surrogate research based on the research prioritization determined in collaboration with an interagency working group. The EPA should also explore ways that this surrogate research could assist in responding to everyday agents or to other routes of exposure (e.g., inhalation, inactivating agents on surfaces).

The EPA has historically been a lead federal agency in understanding the fate and transport of contaminants in the environment and has a clear understanding of the practical concerns of the water sector. Thus, the EPA remains the appropriate lead agency to develop the tools for emergency response and to prioritize the research needed to fill the remaining gaps, with input from key stakeholders. The EPA is also well suited to develop a national training program on water-related risk communication and to evaluate lessons learned from Hurricane Katrina and other past disaster events. However, innovative technology development research, such as the development of novel technologies for supplying water during system failures, should be conducted by other agencies,

university researchers, or firms with the greatest expertise. The EPA, instead, should focus its efforts on harvesting information on existing technologies, synthesizing this information for end users, and providing guidance to developers on unique technology needs for water security. Behavioral science research and evaluation research is more appropriately conducted by universities or other federal agencies (e.g., CDC) that have the necessary expertise to complete these tasks. However, the EPA still needs in-house behavioral science experts able to supervise and use this work to best advantage.

CONCLUSIONS AND RECOMMENDATIONS

In this chapter, recommendations are provided for future research directions in the area of water security. Two key water security research gaps—behavioral science and innovative future system design—that were not considered in the short-term planning horizon of the Action Plan are identified. In accordance with the committee’s charge (see Chapter 1 ), short- and long-term water security research priorities are presented in three areas: (1) developing products to support more resilient design and operation of facilities and systems, (2) improving the ability of operators and responders to detect and assess incidents, and (3) improving response and recovery.

The EPA should develop a program of interdisciplinary empiri cal research in behavioral science to better understand how to pre pare stakeholders for water security incidents. The risks of terrorism are dynamic and uncertain and involve complex behavioral phenomena. The EPA should take advantage of existing behavioral science research that could be applied to water security issues to improve response and recovery efforts. At the same time, when gaps exist, the EPA should support rigorous empirical research that will help address, for example, what the public’s beliefs, opinions, and knowledge about water security risks are; how risk perception and other psychological factors affect responses to water-related events; and how to communicate these risks effectively to the public.

The EPA should take a leadership role in providing guidance for the planning, design, and implementation of new, more sustainable and resilient water and wastewater facilities for the 21st century. Given the investments necessary to upgrade and sustain the country’s water and wastewater systems, research on innovative approaches to make the infrastructure more sustainable and resilient both to routine and

malicious incidents would provide substantial dual-use benefits. The EPA should help develop and test new concepts, technologies, and management structures for water and wastewater utilities to meet objectives of public health, sustainability, cost-effectiveness, and homeland security. Specific research topics related to drinking water and wastewater, such as decentralized systems and in-pipe interventions to reduce exposure from contaminants, are suggested.

Recommended research topics in the area of supporting more resilient design and operation of drinking water and wastewater systems include improved processes for threat and consequence assessments and innovative designs for water and wastewater. A thorough and balanced threat assessment encompassing physical, cyber, and contaminant threats is lacking. To date, the EPA has focused its threat assessments on contaminant threats, but physical and cyber threats deserve more attention and analysis because this information could influence the EPA’s future research priorities and utilities’ preparedness and response planning.

Research suggestions that improve the ability of operators and responders to detect and assess incidents build upon the EPA’s current research in the areas of analytical methodologies and monitoring and distribution system modeling. In the short term, the EPA should continue research to develop and refine a first-stage RTMS based on routine water quality parameters with dual-use applications. Long-term research recommendations include the development of innovative detection technologies and cheaper, more accurate RTMSs. To support the simulation models in development, a substantial amount of fundamental research is needed to improve understanding of the fate and transport of contaminants in distribution systems. Based on the number of emerging technologies and agents of interest, the EPA should develop a prioritization strategy for technology testing to optimize the resources devoted to this effort.

Recommendations for future research priorities to improve response and recovery emphasize the sustainability of tools for emergency planning and response (e.g., WCIT/CAT) and improving research on water security contingencies, behavioral sciences, and risk communication. The EPA should also evaluate the relative importance of future laboratory work on surrogate development and address data gaps in the knowledge of decontamination processes and behavior. So far, the EPA has not taken advantage of the many opportunities from Hurricane Katrina to harvest lessons learned related to response and recovery, and the window of opportunity is rapidly closing.

Some of the research recommendations provided in this chapter lie outside of the EPA’s traditional areas of expertise. The EPA will need to consider how best to balance intramural and extramural research funding to carry out this research, while maintaining appropriate oversight and input into the research activities. Increasing staff expertise in some key areas, such as physical security and behavioral sciences, will be necessary to build a strong and well-rounded water security research program.

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Suggestions for Future Research

Your dissertation needs to include suggestions for future research. Depending on requirements of your university, suggestions for future research can be either integrated into Research Limitations section or it can be a separate section.

You will need to propose 4-5 suggestions for future studies and these can include the following:

1. Building upon findings of your research . These may relate to findings of your study that you did not anticipate. Moreover, you may suggest future research to address unanswered aspects of your research problem.

2. Addressing limitations of your research . Your research will not be free from limitations and these may relate to formulation of research aim and objectives, application of data collection method, sample size, scope of discussions and analysis etc. You can propose future research suggestions that address the limitations of your study.

3. Constructing the same research in a new context, location and/or culture . It is most likely that you have addressed your research problem within the settings of specific context, location and/or culture. Accordingly, you can propose future studies that can address the same research problem in a different settings, context, location and/or culture.

4. Re-assessing and expanding theory, framework or model you have addressed in your research . Future studies can address the effects of specific event, emergence of a new theory or evidence and/or other recent phenomenon on your research problem.

My e-book,  The Ultimate Guide to Writing a Dissertation in Business Studies: a step by step assistance  offers practical assistance to complete a dissertation with minimum or no stress. The e-book covers all stages of writing a dissertation starting from the selection to the research area to submitting the completed version of the work within the deadline. John Dudovskiy

Research Implications & Recommendations

A Plain-Language Explainer With Examples + FREE Template

By: Derek Jansen (MBA) | Reviewers: Dr Eunice Rautenbach | May 2024

The research implications and recommendations are closely related but distinctly different concepts that often trip students up. Here, we’ll unpack them using plain language and loads of examples , so that you can approach your project with confidence.

Overview: Implications & Recommendations

• What are research implications ?
• What are research recommendations ?
• Examples of implications and recommendations
• The “ Big 3 ” categories
• How to write the implications and recommendations
• Template sentences for both sections
• Key takeaways

Implications & Recommendations 101

Let’s start with the basics and define our terms.

At the simplest level, research implications refer to the possible effects or outcomes of a study’s findings. More specifically, they answer the question, “ What do these findings mean?” . In other words, the implications section is where you discuss the broader impact of your study’s findings on theory, practice and future research.

This discussion leads us to the recommendations section , which is where you’ll propose specific actions based on your study’s findings and answer the question, “ What should be done next?” . In other words, the recommendations are practical steps that stakeholders can take to address the key issues identified by your study.

In a nutshell, then, the research implications discuss the broader impact and significance of a study’s findings, while recommendations provide specific actions to take, based on those findings. So, while both of these components are deeply rooted in the findings of the study, they serve different functions within the write up.

Need a helping hand?

Examples: Implications & Recommendations

The distinction between research implications and research recommendations might still feel a bit conceptual, so let’s look at one or two practical examples:

Let’s assume that your study finds that interactive learning methods significantly improve student engagement compared to traditional lectures. In this case, one of your recommendations could be that schools incorporate more interactive learning techniques into their curriculums to enhance student engagement.

Let’s imagine that your study finds that patients who receive personalised care plans have better health outcomes than those with standard care plans. One of your recommendations might be that healthcare providers develop and implement personalised care plans for their patients.

Now, these are admittedly quite simplistic examples, but they demonstrate the difference (and connection ) between the research implications and the recommendations. Simply put, the implications are about the impact of the findings, while the recommendations are about proposed actions, based on the findings.

The “Big 3” Categories

Now that we’ve defined our terms, let’s dig a little deeper into the implications – specifically, the different types or categories of research implications that exist.

Broadly speaking, implications can be divided into three categories – theoretical implications, practical implications and implications for future research .

Theoretical implications relate to how your study’s findings contribute to or challenge existing theories. For example, if a study on social behaviour uncovers new patterns, it might suggest that modifications to current psychological theories are necessary.

Practical implications , on the other hand, focus on how your study’s findings can be applied in real-world settings. For example, if your study demonstrated the effectiveness of a new teaching method, this would imply that educators should consider adopting this method to improve learning outcomes.

Practical implications can also involve policy reconsiderations . For example, if a study reveals significant health benefits from a particular diet, an implication might be that public health guidelines be re-evaluated.

Last but not least, there are the implications for future research . As the name suggests, this category of implications highlights the research gaps or new questions raised by your study. For example, if your study finds mixed results regarding a relationship between two variables, it might imply the need for further investigation to clarify these findings.

To recap then, the three types of implications are the theoretical, the practical and the implications on future research. Regardless of the category, these implications feed into and shape the recommendations , laying the foundation for the actions you’ll propose.

How To Write The  Sections

Now that we’ve laid the foundations, it’s time to explore how to write up the implications and recommendations sections respectively.

Let’s start with the “ where ” before digging into the “ how ”. Typically, the implications will feature in the discussion section of your document, while the recommendations will be located in the conclusion . That said, layouts can vary between disciplines and institutions, so be sure to check with your university what their preferences are.

For the implications section, a common approach is to structure the write-up based on the three categories we looked at earlier – theoretical, practical and future research implications. In practical terms, this discussion will usually follow a fairly formulaic sentence structure – for example:

This research provides new insights into [theoretical aspect], indicating that…

The study’s outcomes highlight the potential benefits of adopting [specific practice] in..

This study raises several questions that warrant further investigation, such as…

Moving onto the recommendations section, you could again structure your recommendations using the three categories. Alternatively, you could structure the discussion per stakeholder group – for example, policymakers, organisations, researchers, etc.

Again, you’ll likely use a fairly formulaic sentence structure for this section. Here are some examples for your inspiration: 

Based on the findings, [specific group] should consider adopting [new method] to improve…

To address the issues identified, it is recommended that legislation should be introduced to…

Researchers should consider examining [specific variable] to build on the current study’s findings.

Remember, you can grab a copy of our tried and tested templates for both the discussion and conclusion sections over on the Grad Coach blog. You can find the links to those, as well as loads of other free resources, in the description 🙂

FAQs: Implications & Recommendations

How do i determine the implications of my study.

To do this, you’ll need to consider how your findings address gaps in the existing literature, how they could influence theory, practice, or policy, and the potential societal or economic impacts.

When thinking about your findings, it’s also a good idea to revisit your introduction chapter, where you would have discussed the potential significance of your study more broadly. This section can help spark some additional ideas about what your findings mean in relation to your original research aims. 

Should I discuss both positive and negative implications?

Absolutely. You’ll need to discuss both the positive and negative implications to provide a balanced view of how your findings affect the field and any limitations or potential downsides.

Can my research implications be speculative?

Yes and no. While implications are somewhat more speculative than recommendations and can suggest potential future outcomes, they should be grounded in your data and analysis. So, be careful to avoid overly speculative claims.

How do I formulate recommendations?

Ideally, you should base your recommendations on the limitations and implications of your study’s findings. So, consider what further research is needed, how policies could be adapted, or how practices could be improved – and make proposals in this respect.

How specific should my recommendations be?

Your recommendations should be as specific as possible, providing clear guidance on what actions or research should be taken next. As mentioned earlier, the implications can be relatively broad, but the recommendations should be very specific and actionable. Ideally, you should apply the SMART framework to your recommendations.

Can I recommend future research in my recommendations?

Absolutely. Highlighting areas where further research is needed is a key aspect of the recommendations section. Naturally, these recommendations should link to the respective section of your implications (i.e., implications for future research).

Wrapping Up: Key Takeaways

We’ve covered quite a bit of ground here, so let’s quickly recap.

• Research implications refer to the possible effects or outcomes of a study’s findings.
• The recommendations section, on the other hand, is where you’ll propose specific actions based on those findings.
• You can structure your implications section based on the three overarching categories – theoretical, practical and future research implications.
• You can carry this structure through to the recommendations as well, or you can group your recommendations by stakeholder.

Remember to grab a copy of our tried and tested free dissertation template, which covers both the implications and recommendations sections. If you’d like 1:1 help with your research project, be sure to check out our private coaching service, where we hold your hand throughout the research journey, step by step.

Psst... there’s more!

This post was based on one of our popular Research Bootcamps . If you're working on a research project, you'll definitely want to check this out ...

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Limitations and Future Research Directions

• First Online: 01 September 2022

Cite this chapter

• Feifei Yang 4 ,
• Mirjam Goudsmit 5 &
• George Shinkle 6  

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Research is often conducted progressively. Acknowledging limitations helps to define what is yet to be investigated and can provide avenues for future research. This chapter presents the limitations of this research and suggests ideas for future research directions.

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Aguinis, H., Boyd, B. K., Pierce, C. A., & Short, J. C. (2011). Walking new avenues in management research methods and theories: Bridging micro and macro domains. Journal of Management, 37 (2), 395–403.

Article   Google Scholar  

Ansoff, H. I. (1979). Strategic management . Macmillan.

Book   Google Scholar  

Ansoff, H. I. (1984). Implanting strategic management . Prentice Hall.

Google Scholar  

Ansoff, H. I. (1987). The emerging paradigm of strategic behavior. Strategic Management Journal, 8 (6), 501–515.

Bagozzi, R., & Phillips, L. (1982). Representing and testing organizational theories: A holistic construal. Administrative Science Quarterly, 27 , 459–489.

Barnard, C. I. (1938). The functions of the executive . Harvard University Press.

Bascle, G. (2008). Controlling for endogeneity with instrumental variables in strategic management research. Strategic Organization, 6 (3), 285–327.

Bluedorn, A. C., Kalliath, T. J., Strube, M. J., & Martin, G. D. (1999). Polychronicity and the inventory of polychronic values (IPV) the development of an instrument to measure a fundamental dimension of organizational culture. Journal of Managerial Psychology, 14 (3/4), 205–231.

Cardinal, L. B. (2001). Technological innovation in the pharmaceutical industry: The use of organizational control in managing research and development. Organization Science, 12 (1), 19–3.

Cardinal, L. B., Sitkin, S. B., & Long, C. P. (2004). Balancing and rebalancing in the creation and evolution of organizational control. Organization Science, 15 (4), 411–431.

Cyert, R. M., & March, J. G. (1963). A behavioral theory of the firm . Prentice Hall.

Dess, G. G., Newport, S., & Rasheed, A. M. A. (1993). Configuration research in strategic management: Key issues and suggestions. Journal of Management, 19 (4), 775–795.

Eckert, C., & Hohberger, J. (2022). Addressing endogeneity without instrumental variables: An evaluation of the Gaussian Copula approach for management research. Journal of Management , forthcoming.

Eisenhardt, K. M. (1985). Control: Organizational and economic approaches. Management Science, 31 (2), 134–149.

Eisenhardt, K. M., Furr, N. R., & Bingham, C. B. (2010). Microfoundations of performance: Balancing efficiency and flexibility in dynamic environments. Organization Science, 21 (6), 1263–1273.

Evans, K. R., Landry, T. D., Li, P. C., & Zou, S. (2007). How sales controls affect job-related outcomes: The role of organizational sales-related psychological climate perceptions. Journal of the Academy of Marketing Science, 35 (3), 445–459.

Evans, M. G. (1985). A Monte Carlo study of the effects of correlated method variance in moderated multiple regression analysis. Organizational Behavior and Human Decision Processes, 36 (3), 305–323.

Fayol, H. (1949). General and industrial management . Pitman Publishing.

Fiegenbaum, A., Hart, S., & Schendel, D. (1996). Strategic reference point theory. Strategic Management Journal, 17 (3), 219–235.

Fischer, R. (2004). Standardization to account for cross-cultural response bias a classification of score adjustment procedures and review of research in JCCP. Journal of Cross-Cultural Psychology, 35 (3), 263–282.

Frey, B. S., Homberg, F., & Osterloh, M. (2013). Organizational control systems and pay-for-performance in the public service. Organization Studies, 34 (7), 949–972.

Gaba, V., & Greve, H. R. (2019). Safe or profitable? The pursuit of conflicting goals. Organization Science, 30 (4), 647–667.

Gagné, M., & Deci, E. L. (2005). Self-determination theory and work motivation. Journal of Organizational Behavior, 26 (4), 331–362.

Govindarajan, V. (1988). A contingency approach to strategy implementation at the business-unit level: Integrating administrative mechanisms with strategy. Academy of Management Journal, 31 (4), 828–853.

Govindarajan, V., & Fisher, J. (1990). Strategy, control systems, and resource sharing: Effects on business-unit performance. Academy of Management Journal, 33 (2), 259–285.

Greckhamer, T., Furnari, S., Fiss, P. C., & Aguilera, R. V. (2018). Studying configurations with qualitative comparative analysis: Best practices in strategy and organization research. Strategic Organization, 16 (4), 482–495.

Harris, M. L., Collins, R. W., & Hevner, A. R. (2009). Control of flexible software development under uncertainty. Information Systems Research, 20 (3), 400–419.

Kaplan, R. S., & Norton, D. P. (1996). The balanced scorecard: Translating strategy into action . Harvard Business School Press.

Kirsch, L. J. (1996). The management of complex tasks in organizations: Controlling the systems development process. Organization Science, 7 (1), 1–21.

Kreutzer, M., Cardinal, L. B., Walter, J., & Lechner, C. (2016). Formal and Informal control as complement or substitute? The role of the task environment. Strategy Science, 1 (4), 235–255.

Kreutzer, M., Walter, J., & Cardinal, L. B. (2015). Organizational control as antidote to politics in the pursuit of strategic initiative performance. Strategic Management Journal, 36 (9), 1317–1337.

Levinthal, D. A., & Rerup, C. (2020). The plural of goal: Learning in a world of ambiguity. Organization Science, 32 (3), 527–543.

Li, H., & Zhang, Y. (2007). The role of managers political networking and functional experience in new venture performance: Evidence from Chinas transition economy. Strategic Management Journal, 28 (8), 791.

Lindenberg, S., & Foss, N. J. (2011). Managing joint production motivation: The role of goal framing and governance mechanisms (article). Academy of Management Review, 36 (3), 500–525.

Locke, E. A., & Latham, G. P. (1990). A theory of goal setting and task performance . Prentice Hall.

Locke, E. A., Shaw, K. N., Saari, L. M., & Latham, G. P. (1981). Goal setting and task performance: 1969–1980. Psychological Bulletin, 90 (1), 125.

Marginson, D. E. W. (2002). Management control systems and their effects on strategy formation at middle-management levels: evidence from a U.K. organization. Strategic Management Journal , 23(11), 1019–1031.

Misangyi, V. F., Greckhamer, T., Furnari, S., Fiss, P. C., Crilly, D., & Aguilera, R. (2017). Embracing causal complexity: The emergence of a neo-configurational perspective. Journal of Management, 42 (1), 255–282.

Ouchi, W. G. (1977). The relaionship between organizational structure and organizational control. Academy of Management Journal, 22 (1), 95–113.

Papalexandris, A., Ioannou, G., Prastacos, G., & Soderquist, K. E. (2005). An integrated methodology for putting the balanced scorecard into action. European Management Journal, 23 (2), 214–227.

Phillips, L. W. (1981). Assessing measurement error in key informant reports: A methodological note on organizational analysis in marketing. Journal of Marketing Research, 18 (4), 395–415.

Podsakoff, P. M., MacKenzie, S. B., Lee, J., & Podsakoff, N. P. (2003). Common method biases in behavioral research: A critical review of the literature and recommended remedies. Journal of Applied Psychology, 88 (5), 879.

Ryan, R. M., & Deci, E. L. (2000). Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. American Psychologist, 55 (1), 68–78.

Shinkle, G. A., Kriauciunas, A. P., & Hundley, G. (2013). Why pure strategies may be wrong for transition economy firms. Strategic Management Journal, 34 (10), 1244–1254.

Shinkle, G. A., Yang, M. M., Yang, F., Elshaw, J., & Schleicher, D. J. (2021). Enacting formal controls in information system development: Process guidance and goal importance. Information & Management, 58 , 103430.

Short, J. C., Payne, G. T., & Ketchen, D. J. (2008). Research on organizational configurations: Past accomplishments and future challenges. Journal of Management, 34 (6), 1053–1079.

Siemsen, E., Roth, A., & Oliveira, P. (2010). Common method bias in regression models with linear, quadratic, and interaction effects. Organizational Research Methods, 13 (3), 456–476.

Simon, H. A. (1947). Administrative behavior: A study of decision-making processes in administrative organizations . Macmillan.

Sitkin, S. B., Cardinal, L. B., & Bijlsma-Frankema, K. M. (2010). Organizational control . Cambridge University Press.

Snell, S. A. (1992). Control theory in strategic human resource management: The mediating effect of administrative information. Academy of Management Journal, 35 (2), 292–327.

Turner, K. L., & Makhija, M. V. (2006). The role of organizational controls in managing knowledge. Academy of Management Review, 31 (1), 197–217.

Weber, M. (1947). Theory of social and economic organization . Free Press.

Weibel, A. (2007). Formal Control and Trustworthiness Shall the Twain Never Meet? Group & Organization Management, 32 (4), 500–517.

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Yang, F., Goudsmit, M., Shinkle, G. (2022). Limitations and Future Research Directions. In: Managing Multiple Organizational Goals in Turbulent Environments. Springer, Singapore. https://doi.org/10.1007/978-981-19-5319-4_10

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Institute of Medicine (US) Committee on Pharmacokinetics and Drug Interactions in the Elderly. Pharmacokinetics and Drug Interactions in the Elderly and Special Issues in Elderly African-American Populations: Workshop Summary. Washington (DC): National Academies Press (US); 1997.

Pharmacokinetics and Drug Interactions in the Elderly and Special Issues in Elderly African-American Populations: Workshop Summary.

• Hardcopy Version at National Academies Press

3 Conclusions and Future Research Directions

The ongoing study of pharmacokinetics, pharmacodynamics, and drug interactions in elderly persons is critical for the development of safe and effective therapies and for the prevention of drug toxicities and adverse drug reactions. Aging is associated with an increase in chronic illness and anatomical and physiological changes that affect drug distribution, metabolism, and excretion. Thus, as the number of older Americans increases, it can be expected that polypharmacy in this population will have significant health, social, and economic consequences. Additionally, research should focus on alleviating the disease burden in elderly minority populations.

Box 3.1 summarizes the committee's conclusions regarding future directions for research in this field. The remainder of this chapter provides a more detailed discussion of the committee's conclusions.

Major Conclusions and Future Directions. Research Develop an integrated approach to researching the effects of aging on multiple organ systems

• RESEARCH NEEDS AND OPPORTUNITIES

Expanding the Scientific Knowledge Base

Although progress has been made in understanding the aging process, there is still a paucity of data at the intracellular, organ, system, and population levels. The impact of aging on cells and organ systems has commonly been studied in isolation; however, a more integrated approach is needed that will examine the effects of aging on the body. Pharmacokinetic and pharmacodynamic models need to be developed that encompass the entire range of changes occurring at multiple levels throughout the body.

The following list highlights specific areas of research that would add to the body of knowledge and clarify our understanding of the aging process especially with regard to improving pharmacotherapy. This list is by no means comprehensive, as numerous research avenues could yield important information on the impact of pharmacotherapy and drug interactions in the elderly. Areas for future research include the impact of aging, gender, genetics, and ethnicity on physiology and metabolic processes. Specifically,

• age-related changes in cellular transport mechanisms and extrahepatic metabolism and transport including the activity of different enzyme isoforms;
• biomarkers of drug exposure;
• mechanisms that cause variable responses to medications in aging racial and ethnic populations;
• age-related hormonal changes affecting drug metabolism or drug sensitivity;
• the impact of nutrition on the aging process;
• mechanisms underlying diseases prevalent in the elderly (e.g., hypertension, diabetes, osteoporosis, and Parkinson's and Alzheimer's disease);
• in vitro models for multiple drug regimens and multiple drug interactions that may be predictive of and correlated with in vivo research;
• models for drug interaction related to altered reflex activity and changing homeostatic mechanisms;
• the potential beneficial and adverse health effects of nutraceuticals; and
• social and psychological aspects of medication use in the elderly (e.g., access to medications, adherence to prescription regimens), with a special emphasis on minority populations.

Addressing Issues in Minority Populations

Many diseases are disproportionately prevalent in elderly African-American and other minority populations. The causes and implications of this excess burden need to be more completely understood and addressed. For example, hypertension and the impact of antihypertensive medications in elderly African Americans have not been fully studied even though the morbidity and mortality is higher in this population than in other segments of the aging population.

Research is needed on multiple levels (molecular, cellular, system, population) to clarify the effect of race and ethnicity on disease prevalence and on variations in the effectiveness of pharmacotherapeutic and other treatment interventions. Such research would be a valuable tool in increasing our understanding of the physiology of aging for all populations and may have implications for pharmacotherapies aimed at various elderly groups. Research on diseases and health conditions that primarily affect minority elderly populations needs to be a priority to alleviate the disease burden experienced by these populations.

Recruitment of Elderly Patients into Clinical Trials

In 1989, the FDA published a guideline for the inclusion of elderly persons in clinical trials ( FDA, 1989 ). However, a number of characteristics of the elderly population may present barriers to conducting clinical trials that are representative of this population. Studies need to include the oldest segment of the population (see Chapter 2 ). In addition, subgroups of the elderly population should be stratified based primarily on their functional status and disease burden and less on their chronological age.

Recruiting minorities for inclusion in studies should be a priority, although it is important to recognize the trends toward multiracial backgrounds and the complexities associated with categorizing race or ethnicity. The workshop speakers presented many innovative ideas about increasing the recruitment of minority populations. The committee supports a number of approaches, including providing transportation, involving the minority community, providing extensive patient education, and decentralizing clinical trials (i.e.., going to patients' homes or to community centers to provide and assess treatment). In addition, collaborative efforts and consortia need to be strengthened between historically minority and other academic institutions. These partnerships will be vital to recruiting minority investigators and to attracting and sustaining minority students in research programs. Further, patient recruitment efforts can draw on the populations available to both institutions.

Obtaining informed consent in elderly populations involves complex issues that need to be addressed including the extent of dementia or cognitive impairment in some elderly patients and their vulnerability to coercion. Informed consent forms have evolved into highly technical legal documents, and a reevaluation of how to best meet their original purpose is needed. Other ethical issues that need to be addressed include studies on vulnerable populations (e.g., nursing home residents) and the confidentiality of patient information.

Research Methodologies and Tools

Trials of acute drug use are well funded; however, there are few long-term studies that examine chronic effects and drug interactions. Inasmuch as elderly persons are living longer and may take the same medications for many years, increased postmarketing surveillance is needed to examine the effects of long-term use of drugs. Incentives to strengthen postmarketing surveillance should be considered. Some of these drugs (e.g., hormone replacement therapy, antidepressants, and lipid-lowering medications) may be used as preventive measures (e.g., treating high cholesterol levels in the absence of cardiovascular disease or prescribing hormone replacement therapy to prevent hip fractures); however, their long-term health effects are not fully known. Further, the pharmacodynamics of many of these medications are only beginning to be investigated.

Research Methodologies

Studying the impact of pharmacotherapy on the elderly population is often difficult from a methodological standpoint. Cross-sectional studies are problematic because confounding variables abound among the elderly, and it is difficult to distinguish the effects of aging from those of disease. Randomized clinical trials often recruit study subjects who represent the younger segments of the elderly population, and who have fewer comorbid conditions, use fewer medications, and may be more compliant in terms of following prescription medication regimens. In addition, many studies use small numbers of patients, frequently with homogenous geographic and ethnic backgrounds. Longitudinal studies are needed that involve large numbers of patients who reflect the diversity of “real world” populations. Furthermore, studies of elderly populations should include observational studies, case-control studies, and cohort studies to take advantage of the realm of methodological approaches that are available. Studies of optimal pharmacotherapies need to consider their cost-effectiveness and delivery. Outcome measures must also be reexamined, and quality-of-life outcomes need to be considered. One workshop speaker recalled the adage that, “adding life to years is at least as important as adding years to life.”

Databases Available for Research

There is a notable lack of adequate databases to research the prevalence and health impact of adverse drug reactions in elderly populations. Prescription information on elderly persons is not currently linked to diagnostic information or health outcomes data. For example, state Medicaid databases are used to reimburse pharmacies for prescriptions, therefore, the data on medication utilization are quite complete and accurate. However, diagnostic information for outpatient care is often incomplete or unavailable, and is not linked to pharmacy utilization databases.

Current changes underway in the health care delivery system may provide opportunities for new databases to be developed, although there are concerns that these changes may instead result in the loss of publicly available data. Trends of interest include the purchase of pharmacy benefit companies by pharmaceutical manufacturers and the increased use of managed care through proprietary health plans paid for by Medicaid and Medicare. Increased use of managed care to provide health care for the elderly offers opportunities for databases to be implemented that would link health outcomes (particularly adverse drug reactions) and prescription information, while paying close attention to patient confidentiality issues. However, these changes may instead be implemented to restructure datasets and require new levels of approval for data use or publishing. It is crucial that the larger issues involving potential censoring or loss of publicly available data on prescription drug use and health outcomes be addressed. The increased privatization of health care services for the elderly may lead to barriers to accessing datasets due to proprietary and competitive interests.

An area of interest to the committee is exploring the feasibility of developing a cooperative national data resource that would expand the researcher's ability to examine population-based data rather than utilizing a piecemeal approach to data collection. This data resource could include information on diagnosis, medications prescribed, clinical interventions, health outcomes, and other relevant data. Of utmost importance would be maintaining patient confidentiality. This resource could be utilized as a repository to which individual researchers could submit peer-reviewed and approved research questions. Examining the feasibility of developing such a data resource would require the input of patients, health care providers, researchers, ethicists, and other interested persons and groups.

Dissemination of Information

Drug-related information can be complex, and information overload is a common phenomenon among health professionals and patients. Because information regarding drug use and interactions changes rapidly, information systems should be available to health care professionals that can provide up-to-date information that is unbiased, case specific, interactive, and readily accessible. In addition, it is important to develop diverse information dissemination strategies to effectively meet the needs of the heterogeneous elderly population. The information provided should be presented in a manner that can be understood by patients who cannot necessarily process complex information, yet need to make informed decisions and understand their options for treatment. Private- and public-sector initiatives are required to address this critical challenge. Health sciences centers that focus on training medical, nursing, and pharmacy students should be used to conduct independent, unbiased research and continuing education programs for practicing physicians, pharmacists, nurses, and the interested public ( Woosley, 1994 ).

Capacity Building: Researchers and Clinicians

One of the major factors limiting the expansion of research in the area of geriatrics, and particularly geriatric pharmacology and clinical therapeutics, is the small number of health professionals entering this field. This is an area in which, as demographers can attest, the patient base is expanding and will continue to grow. Quality geriatric care depends on the development of multidisciplinary teams (including nursing, physical and occupational therapy, social work) to assess the concomitant problems and implement multiple interventions. However, reimbursements do not adequately cover the time required to handle the complexity of geriatric care. A recent report by the Alliance for Aging Research (1996) found that the United States has less than one fourth the number of academic physician-scientists needed in geriatrics to teach and conduct research.

There is a pressing need to develop innovative approaches for recruiting and retaining researchers and clinicians. Programs are needed at many points along the career path, beginning early in the college and postbaccalaureate years to kindle an interest in the field of geriatrics and continuing throughout the professional years to retain the best investigators and clinicians available. Recruitment of minority investigators should be included within broader programs supporting young and mid-career investigators. The options available for approaching this issue include

• 1- to 2-year postbaccalaureate programs to provide research and clinical experience to young people considering a career in this field;
• opportunities for medical, nursing, pharmacy, and other health professional students to have additional exposure to geriatric treatment and research during their education;
• collaborative efforts between minority academic institutions and academic health sciences centers to encourage minority students to pursue a research program in this field;
• loan-forgiveness programs to assist young researchers with high debt loads from health professional or graduate schools;
• new sources of fellowships (e.g., through FDA, pharmaceutical companies, or insurance companies);
• increased commitment to funding from fellowship training to first awards to independent grant support;
• merit awards at the midcareer level and specialized sabbaticals to retrain midcareer professionals; and
• retraining in research methodologies during sabbaticals for midcareer level geriatricians.

Currently there is only a limited understanding of the impact of aging on pharmacokinetics, pharmacodynamics, and drug interactions. Research is needed at the molecular, cellular, organ, system, and population levels for safer and more effective medications to be developed, delivered, and utilized by elderly persons. In addition, attention must be given to understanding and alleviating the disproportionate disease burden in elderly African-American and other minority populations.

The committee's major conclusions are summarized in Box 3.1 at the beginning of this chapter. The committee discussed and reflected only on the workshop presentations and acknowledges that there are numerous research opportunities in geriatric pharmacology that need to be explored. Research in geriatric pharmacology and clinical therapeutics will require a commitment to fund studies that can further elucidate the relationship between pharmacokinetics and adverse drug interactions in the elderly and the complex individual variability of the aging process. Increasing the knowledge base will enable more effective therapeutic interventions and improved quality of life for the growing population of elderly persons.

• Alliance for Aging Research. The National Shortage of Geriatricians. Washington, DC: Alliance for Aging Research; 1996. Will You Still Treat Me When I'm 65?
• FDA (Food and Drug Administration). Guideline for the Study of Drugs Likely to Be Used in the Elderly. Rockville, MD: FDA Center for Drug Evaluation and Research; 1989.
• Woosley RL. Centers for education and research in therapeutics. Clinical Pharmacology and Therapeutics. 1994; 56 (6 Part 1):693–697. [ PubMed : 8143390 ]
• Cite this Page Institute of Medicine (US) Committee on Pharmacokinetics and Drug Interactions in the Elderly. Pharmacokinetics and Drug Interactions in the Elderly and Special Issues in Elderly African-American Populations: Workshop Summary. Washington (DC): National Academies Press (US); 1997. 3, Conclusions and Future Research Directions.
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Cultural Relativity and Acceptance of Embryonic Stem Cell Research

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There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities.

INTRODUCTION

Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve.

Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes. [1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research. [2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.” [3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops. [4]  Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture.

I.     Global Cultural Perspective of Embryonic Stem Cells

Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense, [5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research. [6] Consequently, global engagement in ESC research depends on social-cultural acceptability.

a.     US and Rights-Based Cultures

In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism, [7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.” [8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed. [9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field. [10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture. [11]

b.     Ubuntu and Collective Cultures

African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama , which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,” [12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth. [13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole. Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value. [14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society.

Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.” [15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail.

Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable. [16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus [17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines. [18]

Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim. [19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research. [20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF.  Their use is conditioned on consent, and available only to married couples. [21] The community's receptiveness to stem cell research depends on including communitarian African ethics.

c.     Asia

Some Asian countries also have a collective model of ethics and decision making. [22] In China, the ethics model promotes a sincere respect for life or human dignity, [23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life. [25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research. [26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions. [27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency. [28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021. [29] However, issues still need to be addressed in implementing effective IRB review and approval procedures.

The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy, [30] research ethics should also adapt to ensure respect for the values of its represented peoples.

Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies. [31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells. [32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval, [33] and in another instance, the oocyte source was unclear and possibly violated ethical standards. [34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust.

d.     Middle East

Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells, [35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research. [36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors. [37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so. [38]

Jordan has a positive research ethics culture. [39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial. [40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation. [41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.” [42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes.

e.     Europe

In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected. [43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44]

For example, in Germany, Lebenzusammenhang , or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.” [45]  Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount. [46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007. [47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization. [48] Spain’s approach differs still, with a comprehensive regulatory framework. [49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility. [50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices. [51]

II.     Religious Perspectives on ESC

Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives.

The Qur'an states:

“And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.” [52]

Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception. [53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible. [54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research. [55]

In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided. [56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden. [57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all. [58] Acceptance varies on applied beliefs and interpretations.

Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero, [59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all. [60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime. [61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit. [62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets. [63]

Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life. [64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception: [65]

“If she is found pregnant, until the fortieth day it is mere fluid,” [66]

Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation. [67] Stem cell research is accepted due to application of these religious laws.

We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory , which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions. [68] We only wish to show that the interaction with morality varies between cultures and countries.

III.     A Flexible Ethical Approach

The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities.

While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe. [69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation.

For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent. [70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context, [71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders.  This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research.

Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values. [72]

An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions. [73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion.

IV.     Concerns

Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values. [74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions.

Other concerns include medical tourism, which may promote health inequities. [75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments. [76]

For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.” [77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices. [78]

The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.” [79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds. [80]

While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research.

For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society.

This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model.

[1] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice.  Orthopedic reviews ,  14 (3), 37498. https://doi.org/10.52965/001c.37498

[2] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice.  Orthopedic reviews ,  14 (3), 37498. https://doi.org/10.52965/001c.37498

[3] International Society for Stem Cell Research. (2023). Laboratory-based human embryonic stem cell research, embryo research, and related research activities . International Society for Stem Cell Research. https://www.isscr.org/guidelines/blog-post-title-one-ed2td-6fcdk ; Kimmelman, J., Hyun, I., Benvenisty, N.  et al.  Policy: Global standards for stem-cell research.  Nature   533 , 311–313 (2016). https://doi.org/10.1038/533311a

[4] International Society for Stem Cell Research. (2023). Laboratory-based human embryonic stem cell research, embryo research, and related research activities . International Society for Stem Cell Research. https://www.isscr.org/guidelines/blog-post-title-one-ed2td-6fcdk

[5] Concerning the moral philosophies of stem cell research, our paper does not posit a personal moral stance nor delve into the “when” of human life begins. To read further about the philosophical debate, consider the following sources:

Sandel M. J. (2004). Embryo ethics--the moral logic of stem-cell research.  The New England journal of medicine ,  351 (3), 207–209. https://doi.org/10.1056/NEJMp048145 ; George, R. P., & Lee, P. (2020, September 26). Acorns and Embryos . The New Atlantis. https://www.thenewatlantis.com/publications/acorns-and-embryos ; Sagan, A., & Singer, P. (2007). The moral status of stem cells. Metaphilosophy , 38 (2/3), 264–284. http://www.jstor.org/stable/24439776 ; McHugh P. R. (2004). Zygote and "clonote"--the ethical use of embryonic stem cells.  The New England journal of medicine ,  351 (3), 209–211. https://doi.org/10.1056/NEJMp048147 ; Kurjak, A., & Tripalo, A. (2004). The facts and doubts about beginning of the human life and personality.  Bosnian journal of basic medical sciences ,  4 (1), 5–14. https://doi.org/10.17305/bjbms.2004.3453

[6] Vazin, T., & Freed, W. J. (2010). Human embryonic stem cells: derivation, culture, and differentiation: a review.  Restorative neurology and neuroscience ,  28 (4), 589–603. https://doi.org/10.3233/RNN-2010-0543

[7] Socially, at its core, the Western approach to ethics is widely principle-based, autonomy being one of the key factors to ensure a fundamental respect for persons within research. For information regarding autonomy in research, see: Department of Health, Education, and Welfare, & National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.; For a more in-depth review of autonomy within the US, see: Beauchamp, T. L., & Childress, J. F. (1994). Principles of Biomedical Ethics . Oxford University Press.

[8] Sherley v. Sebelius , 644 F.3d 388 (D.C. Cir. 2011), citing 45 C.F.R. 46.204(b) and [42 U.S.C. § 289g(b)]. https://www.cadc.uscourts.gov/internet/opinions.nsf/6c690438a9b43dd685257a64004ebf99/$file/11-5241-1391178.pdf

[9] Stem Cell Research Enhancement Act of 2005, H. R. 810, 109 th Cong. (2001). https://www.govtrack.us/congress/bills/109/hr810/text ; Bush, G. W. (2006, July 19). Message to the House of Representatives . National Archives and Records Administration. https://georgewbush-whitehouse.archives.gov/news/releases/2006/07/20060719-5.html

[10] National Archives and Records Administration. (2009, March 9). Executive order 13505 -- removing barriers to responsible scientific research involving human stem cells . National Archives and Records Administration. https://obamawhitehouse.archives.gov/the-press-office/removing-barriers-responsible-scientific-research-involving-human-stem-cells

[11] Hurlbut, W. B. (2006). Science, Religion, and the Politics of Stem Cells.  Social Research ,  73 (3), 819–834. http://www.jstor.org/stable/40971854

[12] Akpa-Inyang, Francis & Chima, Sylvester. (2021). South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study. BMC Medical Ethics . 22. 10.1186/s12910-021-00678-4.

[13] Source for further reading: Tangwa G. B. (2007). Moral status of embryonic stem cells: perspective of an African villager. Bioethics , 21(8), 449–457. https://doi.org/10.1111/j.1467-8519.2007.00582.x , see also Mnisi, F. M. (2020). An African analysis based on ethics of Ubuntu - are human embryonic stem cell patents morally justifiable? African Insight , 49 (4).

[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics , 22 (2), 112–122. https://doi.org/10.1111/dewb.12324

[15] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324

[16] Jackson, C.S., Pepper, M.S. Opportunities and barriers to establishing a cell therapy programme in South Africa.  Stem Cell Res Ther   4 , 54 (2013). https://doi.org/10.1186/scrt204 ; Pew Research Center. (2014, May 1). Public health a major priority in African nations . Pew Research Center’s Global Attitudes Project. https://www.pewresearch.org/global/2014/05/01/public-health-a-major-priority-in-african-nations/

[17] Department of Health Republic of South Africa. (2021). Health Research Priorities (revised) for South Africa 2021-2024 . National Health Research Strategy. https://www.health.gov.za/wp-content/uploads/2022/05/National-Health-Research-Priorities-2021-2024.pdf

[18] Oosthuizen, H. (2013). Legal and Ethical Issues in Stem Cell Research in South Africa. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_80 , see also: Gaobotse G (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[19] United States Bureau of Citizenship and Immigration Services. (1998). Tunisia: Information on the status of Christian conversions in Tunisia . UNHCR Web Archive. https://webarchive.archive.unhcr.org/20230522142618/https://www.refworld.org/docid/3df0be9a2.html

[20] Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[21] Kooli, C. Review of assisted reproduction techniques, laws, and regulations in Muslim countries.  Middle East Fertil Soc J   24 , 8 (2020). https://doi.org/10.1186/s43043-019-0011-0 ; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics , 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247

[23] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[24] Wang, Y., Xue, Y., & Guo, H. D. (2022). Intervention effects of traditional Chinese medicine on stem cell therapy of myocardial infarction.  Frontiers in pharmacology ,  13 , 1013740. https://doi.org/10.3389/fphar.2022.1013740

[25] Li, X.-T., & Zhao, J. (2012). Chapter 4: An Approach to the Nature of Qi in TCM- Qi and Bioenergy. In Recent Advances in Theories and Practice of Chinese Medicine (p. 79). InTech.

[26] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[27] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[28] Zhang, J. Y. (2017). Lost in translation? accountability and governance of Clinical Stem Cell Research in China. Regenerative Medicine , 12 (6), 647–656. https://doi.org/10.2217/rme-2017-0035

[29] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[30] Chen, H., Wei, T., Wang, H.  et al.  Association of China’s two-child policy with changes in number of births and birth defects rate, 2008–2017.  BMC Public Health   22 , 434 (2022). https://doi.org/10.1186/s12889-022-12839-0

[31] Azuma, K. Regulatory Landscape of Regenerative Medicine in Japan.  Curr Stem Cell Rep   1 , 118–128 (2015). https://doi.org/10.1007/s40778-015-0012-6

[32] Harris, R. (2005, May 19). Researchers Report Advance in Stem Cell Production . NPR. https://www.npr.org/2005/05/19/4658967/researchers-report-advance-in-stem-cell-production

[33] Park, S. (2012). South Korea steps up stem-cell work.  Nature . https://doi.org/10.1038/nature.2012.10565

[34] Resnik, D. B., Shamoo, A. E., & Krimsky, S. (2006). Fraudulent human embryonic stem cell research in South Korea: lessons learned.  Accountability in research ,  13 (1), 101–109. https://doi.org/10.1080/08989620600634193 .

[35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

[36] Association for the Advancement of Blood and Biotherapies.  https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia

[37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia.  BMC medical ethics ,  21 (1), 35. https://doi.org/10.1186/s12910-020-00482-6

[38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics , 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics , 23 (3), 260–268. https://doi.org/10.1111/dewb.12355 ; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know . Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know

[39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[41] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France.  Biotechnology Law Report ,  32 (6), 349–356. https://doi.org/10.1089/blr.2013.9865

[45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf

[47] Regulation of Stem Cell Research in Germany . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany

[48] Regulation of Stem Cell Research in Finland . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland

[49] Regulation of Stem Cell Research in Spain . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain

[50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered:

Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110.

Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ...  Revista do Colegio Brasileiro de Cirurgioes ,  41 (5), 374–377. https://doi.org/10.1590/0100-69912014005013

Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India . Routledge.

For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe   

[51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.  Cultura (Iasi, Romania) ,  14 (2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent?  Research Ethics ,  13 (1), 23-41.  https://doi.org/10.1177/1747016116650235

[52] The Qur'an  (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23

[53] Lenfest, Y. (2017, December 8). Islam and the beginning of human life . Bill of Health. https://blog.petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/

[54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics , 31: 399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386

[55] Rashid, R. (2022). When does Ensoulment occur in the Human Foetus. Journal of the British Islamic Medical Association , 12 (4). ISSN 2634 8071. https://www.jbima.com/wp-content/uploads/2023/01/2-Ethics-3_-Ensoulment_Rafaqat.pdf.

[56] Sivaraman, M. & Noor, S. (2017). Ethics of embryonic stem cell research according to Buddhist, Hindu, Catholic, and Islamic religions: perspective from Malaysia. Asian Biomedicine,8(1) 43-52.  https://doi.org/10.5372/1905-7415.0801.260

[57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation.  Journal of Religion and Health ,  30 (1), 35–41. http://www.jstor.org/stable/27510629 ; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva . A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm

[59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. (( King James Bible . (1999). Oxford University Press. (original work published 1769))

Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…”

In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David.

Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…”

These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth.

[60] It should be noted that abortion is not supported as well.

[61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day . Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html

[62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells . Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html ; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology . Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf.

[63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed . Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/

[64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society , (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law).  Journal of assisted reproduction and genetics ,  25 (6), 271–276. https://doi.org/10.1007/s10815-008-9221-6

[66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet) . Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en

[67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[68] Gert, B. (2007). Common morality: Deciding what to do . Oxford Univ. Press.

[69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA , 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association .; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979).  The Belmont report: Ethical principles and guidelines for the protection of human subjects of research . U.S. Department of Health and Human Services.  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes.  Journal of assisted reproduction and genetics ,  35 (7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine , 10 (12), 1715–1716. https://doi.org/10.1002/sctm.21-0234

[71] Klitzman, R., & Sauer, M. V. (2009). Payment of egg donors in stem cell research in the USA.  Reproductive biomedicine online ,  18 (5), 603–608. https://doi.org/10.1016/s1472-6483(10)60002-8

[72] Krosin, M. T., Klitzman, R., Levin, B., Cheng, J., & Ranney, M. L. (2006). Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa.  Clinical trials (London, England) ,  3 (3), 306–313. https://doi.org/10.1191/1740774506cn150oa

[73] Veatch, Robert M.  Hippocratic, Religious, and Secular Medical Ethics: The Points of Conflict . Georgetown University Press, 2012.

[74] Msoroka, M. S., & Amundsen, D. (2018). One size fits not quite all: Universal research ethics with diversity.  Research Ethics ,  14 (3), 1-17.  https://doi.org/10.1177/1747016117739939

[75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry.  Voices in Bioethics ,  8 . https://doi.org/10.52214/vib.v8i.9894

[76] Stem Cell Tourism: False Hope for Real Money . Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism , See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis.  Voices in Bioethics ,  3 . https://doi.org/10.7916/vib.v3i.6027

[77] Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation,  New Genetics and Society , 30:2, 141-153, DOI:  10.1080/14636778.2011.574375

[78] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[79] International Society for Stem Cell Research. (2024). Standards in stem cell research . International Society for Stem Cell Research. https://www.isscr.org/guidelines/5-standards-in-stem-cell-research

[80] Benjamin, R. (2013). People’s science bodies and rights on the Stem Cell Frontier . Stanford University Press.

Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

Olivia Bowers

MS Bioethics Columbia University (Disclosure: affiliated with Voices in Bioethics)

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