dissertation ethics approval

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Research ethics

You may be able to learn about the ethical approach used in the main journal article (if this is discussed), but more often than not, it is better to focus on your own dissertation when it comes to setting out the approach towards research ethics you will take. At the undergraduate or master's level, the extent to which you will have to consider research ethics in your dissertation and the role that such ethics will play in shaping your research strategy will depend on a number of factors: (a) your dissertation and university ethics guidelines; (b) your chosen research method, the way that the research method is used, and the specific measures that are selected; and (c) your chosen sampling strategy, including the type of sampling technique used, your sample size, and the use of gatekeepers when selecting your sample.

• CONSIDERATION ONE: Your dissertation and university ethics guidelines
• CONSIDERATION TWO: The nature of the research method and measures you select
• CONSIDERATION THREE: The sampling strategy that you select

CONSIDERATION #1 Your dissertation and university ethics guidelines

Whilst ethical requirements in research can vary across countries, there are a number of basic principles of research ethics that you will be expected to follow. Broadly speaking, your dissertation research should not only aim to do good (i.e., beneficence ), but also avoid doing any harm (i.e., non-malfeasance ). The five main ethical principles you should abide by, in most cases , include: (a) minimising the risk of harm; (b) obtaining informed consent; (c) protecting anonymity and confidentiality; (d) avoiding deceptive practices; and (e) providing the right to withdraw. In the article, Principles of research ethics in the Research Ethics section of the Fundamentals part of Lærd Dissertation, we explain these five basic principles in more detail. It is worth reading this article before reading on.

Following these basic principles is not only important for ethical reasons , but also practical ones, since a failure to meet such basic principles may lead to your research being (a) criticised, potentially leading to a lower mark, and/or (b) rejected by your supervisor or Ethics Committee , costing you valuable time. We mention your supervisor and the university Ethics Committee because the extent of the ethical requirements that you have to take into account will differ considerably from dissertation to dissertation. As a starting point, your dissertation guidelines should indicate whether you are required to complete an Ethics Proposal and/or Ethics Consent Form , even at the undergraduate or master's level, and if so, whether this should first be passed by your supervisor to see if ethical approval from the university Ethics Committee will be necessary. Even if such an Ethics Proposal is not required, it is still advisable to discuss the ethical implications of your dissertation with your supervisor; something that we discuss in STAGE SEVEN: Assessment point . At the very least, you will have to consider the role that research ethics will play in shaping your research strategy .

CONSIDERATION #2 The nature of the research method and measures you select

Research ethics is not a one size fits all approach. The research strategy that you choose to guide your dissertation often determines the approach that you should take towards research ethics. When we talk about an approach to research ethics, we are referring to ethical choices that you may make that are specific to your dissertation. For example, many students will be able to obtain informed consent from participants to take part in their research. However, there may be reasons that you cannot obtain informed consent from participants to take part, perhaps because the research design guiding your dissertation and the research method you use make this difficult or impossible (e.g., an experimental research design and the use of covert structured observation to study people in a nightclub or an Internet chat room).

When you consider the five practical ethical principles you read about earlier, it may appear obvious that your dissertation should include these. However, there are many instances where it is not possible or desirable to obtain informed consent from research participants. Similarly, there may be instances where you seek permission from participants not to protect their anonymity. More often than not, such choices should reflect the research strategy that you adopt to guide your dissertation. The potential ethical issues raised by different research methods not only differ from one type of research method to the next (e.g., surveys versus structured observation), but also the way in which a research method is used (e.g., overt versus covert observation) and your choice of measures (e.g., the specific questions that you ask in a survey). In each of our articles on different research methods, you can read up on the potential issues that your choice of research method will have for your dissertation (see the Research Methods section of the Fundamentals part of Lærd Dissertation and click on the relevant research method; there is a section on research ethics in each article).

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Methodology

• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on June 22, 2023.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

• protect the rights of research participants
• enhance research validity
• maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Prevent plagiarism. Run a free check.

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

• what the study is about
• the risks and benefits of taking part
• how long the study will take
• your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Normal distribution
• Measures of central tendency
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Thematic analysis
• Cohort study
• Peer review
• Ethnography

Research bias

• Implicit bias
• Cognitive bias
• Conformity bias
• Hawthorne effect
• Availability heuristic
• Attrition bias
• Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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Applying for ethical approval: Basic principles

• List of RECs
• Guidance & resources

If you plan to apply for ethical approval for research involving human participants or personal data from one of the University’s research ethics committees their applications forms and local guidance will help you to understand what to include in your application and what issues need to be addressed.

The information requested by your local committee will depend on your discipline and the type of research that you intend to undertake.

There are, however, some core issues that ethics committees will normally expect you to have addressed as part of your application:

Respecting autonomy

Wherever possible, ethics committees will expect you to demonstrate that you intend to respect the autonomy of individuals involved in your research. Normally this will include:

• Providing research participants with sufficient information to make an informed decision as to whether to take part in research (informed consent);
• Ensuring that participants are not subject to coercion to take part or penalty for not taking part;
• Ensuring that participants are, and are aware that they are, free to withdraw from the research at any time without giving a reason and without a prejudice;
• Protecting and respecting personal data provided by participants through rigorous and appropriate procedures for confidentiality and anonymisation.

Maximising benefit

Ethics committees will expect you to show that your research is worthwhile and will have beneficial effects that outweigh the risks posed by the project (see below). The recipient of the benefit will vary from project to project, but may include, among others, society, science, scholarship, health, and/or the participant themselves. The potential benefits of research should be presented realistically and not be exaggerated.

Ensuring that you maximise the benefits of your work is part of your obligation to research participants and scholarship and ethics committees will normally expect you to have taken efforts to do so. This would normally include:

• Designing, reviewing and conducting research in a manner that ensures quality and integrity and maximises the chance of obtaining useful results;
• Ensuring that research is effectively and appropriately disseminated;
• Ensuring that the aims of the research are transparent and that the methodology used is appropriate to addressing them.

Minimising harm

Ethics committees will expect you to have thoroughly considered the potential (and potential severity) for harm to come to research participants or others as part of your research.

You will be expected to consider all possible risks of harm that might be posed by your research, keeping in mind that certain harms, such as distress, embarrassment or anxiety, can be subjective and difficult to predict.

Harm (where identified) should normally be avoided and you will be expected to show how you will do so. Where the risk of harm cannot be avoided, an ethics committee will expect to see that you have taken robust precautions to mitigate the potential for harm and deal with harm should it occur.

It will normally be expected that the degree of risk (and potential severity) of harm should be proportionate to the potential benefits of the research. Research posing a high risk of harm or a risk of severe harm will require careful consideration by the researcher and ethics committee before being approved.

Research ethics committees will also expect research to be, where possible, fair to those participating in research.

The nature of your research will not always allow the benefits, risks and costs of the research to be distributed in a strictly fair manner, but ethics committees will normally expect you to show that you have made efforts to do so wherever possible and that your research does not unfairly discriminate against certain individuals or groups.

Behaving with integrity

Researchers have an obligation to conduct their research with integrity and transparency. Research ethics committees will expect you to declare any actual or potential conflicts of interest that affect your research and to be honest and transparent throughout the ethical approval process and the research process. Any plans to withhold information from research participants should be explained and justified in your application for ethical approval.

Applicants for ethical approval should consider the core principles above and address any that apply to their work as part of their application. Failure to address the aspects above may lead to delays to your application for ethical approval.

In particular, researchers should ensure that their applications address both the risks posed by their research and the potential benefits offered. Research ethics committees will normally look for the benefits of your research to outweigh the risk of harm and will assess your application to ensure that this is the case. It is therefore important that you address both in a manner appropriate to your research.   

Sources and further reading

The Research Ethics Guidebook,   http://www.ethicsguidebook.ac.uk/

Association of Research Ethics Committees, A Framework of Policies and Procedures for University Research Ethics Committee (2013), http://arec.org.uk/wp-content/uploads/Framework-of-policies-and-procedures.pdf

The British Psychological Society, Code of Human Research Ethics (2010), http://www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf

ESRC, Framework for Research Ethics (2016), http://www.esrc.ac.uk/funding/guidance-for-applicants/research-ethics/

UK Clinical Ethics Network, Ethical Issues, http://www.ukcen.net/index.php/ethical_issues

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The Research Whisperer

Just like the thesis whisperer – but with more money, how to write a successful ethics application.

She has a particular interest in tuberculosis, viral hepatitis, adolescent health, and the health of people in criminal justice settings.

Kat advises colleagues from diverse backgrounds on research ethics, study design, and data analysis.

She tweets from @epi_punk .

The word “ethics” strikes fear into the hearts of most early career researchers.

Some of the reasons are beyond our control, but there’s actually a lot we can do to make our own experiences of the ethics approval process less painful.

I’m writing this from two perspectives: as an early career researcher (I finished my PhD in 2019), and as a committee member (I’ve sat on an ethics advisory group since the start of my PhD in 2014).

The job of ethics committees is to identify the possible risks in a project, and then assess whether the research team:

• are aware of the risks.
• are taking appropriate steps to minimise them.
• have a plan to handle anything that does go wrong.

To do this, ethics committees need information. If you want your ethics application to get through the process as quickly as possible, you need to give the committee enough detail so that they understand your project and how you are managing any risks.

Getting your application as right as possible the first time makes the whole process go more quickly. If you don’t provide enough information, the committee will come back with questions. You may need to resubmit your application to the next meeting, which could be a month or two away.

Spending more time on your application for the first meeting can save you months later on!

Here are the main questions ethics committees will ask themselves when they assess your project:

• Are there any risks to the researchers? (e.g. Injuries in the lab, safety risks  travelling to study sites, exposure to distressing topics during interviews or data analysis.)
• Are there any risks to the study participants? (From the study procedures themselves; risks to their privacy; risks of distress if they are asked about or exposed to upsetting content)
• Are there any risks to third parties? (i.e. people who aren’t directly participating)
• Could anybody’s privacy be invaded by the data collection process?
• Are there other staff in a lab who might be hurt if there were an accident?
• Are the research team aware of these risks, are they taking steps to minimise them, and do they have a plan if things go wrong?

The only way for the ethics committee to assess this is from the information you put into your application. Carefully think through your project and ask yourself those questions. And then put all of the answers into your application.

Here’s an example:

I am planning a project at the moment that involves interviewing health care providers about vulnerable people that they work with.

What are the risks to me? There aren’t any physical safety risks – I’ll be sitting in my office on the phone.

What about psychological risks? Could I be distressed by the content of the interviews? It’s possible. Some of the people I’ll interview are working with clients who have experienced child abuse, and some of their stories about their work might be upsetting.

What am I doing about these risks? I’m conducting interviews on the phone, rather than travelling to other people’s workplaces or homes. I won’t ask specifically about any distressing topics (minimising the risk), although they might come up anyway. If I get upset about the content of the interviews, I will probably be okay: I’ve worked in this area for many years, and I have strategies for dealing with it when my work upsets me (taking a break, talking to a colleague on the same project later on to help me process my feelings about it).

All of this goes into my application! I don’t write “I will conduct interviews with providers” and then say there are no risks, or that I have managed the risks. I give the committee all the details about each of the foreseeable risks I’ve identified, and exactly what I’m doing about them.

What about the risks to my participants? They could also find the content of the interviews upsetting. Again, my interview tool doesn’t ask directly about any distressing topics (minimising the risk), but it may come up. What’s my plan if my participants get upset? I’ll offer to change the topic, take a break, or stop the interview entirely. I mention this risk in the consent form, and the form will tell participants that they will have these options if they feel distressed. I will repeat this to them verbally at the start of the interview, and remind them that they don’t need to discuss anything with me that they don’t want to. Again, all these details go into my application.

What about risks to other people? Some health care providers might tell me private or sensitive information about their clients, by giving me specific examples instead of talking in general terms. To avoid this, I will ask them at the start of the interview not to talk about specific individuals, but to rather keep their answers general. If a participant does start to talk about an individual, I’ll remind them that this isn’t appropriate. I’ll also erase that part of the recording later on, so that those information isn’t transcribed. Again, all these details go into my application so that the ethics committee can see that I’m aware of the risk and I have a plan to manage it if it occurs.

As a committee member, I see applications get into trouble for a few common reasons.

The first is a lack of information , giving a very brief description of what will be done, without enough detail for the committee to understand the risks and what is being done about them.

The second is inconsistency , when a researcher says one thing on their application form, and something else in their consent form. Check carefully for consistency across all your documents before you submit.

A third is when a researcher proposes to do something that directly goes against the national ethical standards for research (e.g. collecting data without consent when they could get consent, or storing sensitive data in an insecure manner). Do not do this.

Some general tips:

• Find out the deadlines for your committee now, and start your application well in advance. It’s very hard to do a good job at the last minute, especially if you need details from your supervisor or other people in the project.
• Ask a colleague for a previous successful application for a similar project. Take note of the risks they identified, and how they managed them. Look at their consent forms and other documents, and see what you can adapt and reuse.
• Use grant applications for the project as a source of information on background, aims, methods, and outcomes. The format and level of detail required by the ethics committee is often similar.
• Read your country’s ethical guidance for research projects: this is what the ethics committee is working off. Think about which issues apply to your project, and how you can meet each of the standards. Spell this out for the committee.
• Find out whether your institution has specific requirements regarding wording in consent forms, storage of data, handling chemicals in the lab, etc. In your application, tell the committee that you are aware of these requirements and say how your project will meet them. Make sure that your consent forms and other documents are consistent with your institution’s standards. If your institution offers templates, use them!
• Ethics committees also assess the technical soundness of the research because poor quality research wastes time and resources, and exposes people to risks that aren’t justified by adequate benefits. Most committees include statistician and methods experts specifically for this reason (I’m one of them). Give a detailed explanation of your methods, and make sure they are appropriate to your research question. Get advice from a methods expert or a statistician to check that your project is sound – it’s much better to identify problems at the planning stage, rather than after you’ve gotten approval and collected your data.
• If you are doing an application for the first time, get help from your supervisor or thesis advisor. They shouldn’t make you do the application on your own. The more help you can get before you submit, the more quickly your project will get approved.

Share this:

Also I suggest doing the ethics training offered by your institution, or professional body. Recently I attended ANU’s Human Ethics training session. While I occasionally teach ethics, and have been a Chief Investigator on a project, I still found it useful. https://services.anu.edu.au/training/aries-human-ethics-training-sessions

Another useful resource is The Research Ethics Application Database (TREAD), an online database of successful research ethics applications from around the world, some of which include supporting documents such as consent forms and information sheets. (TREAD is also glad to have new submissions so if you have made a successful application, please consider sharing your paperwork – fully anonymised of course.) Info here https://tread.tghn.org/

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• Volume 36, Issue 7
• Research ethics in dissertations: ethical issues and complexity of reasoning
• Article Text
• Article info
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• S Kjellström 1 ,
• S N Ross 2 , 3 ,
• B Fridlund 4
• 1 Institute of Gerontology, School of Health Sciences, Jönköping University, Jönköping, Sweden
• 2 Antioch University Midwest, Yellow Springs, Ohio, USA
• 3 ARINA, Inc., Cincinnati, Ohio, USA
• 4 Department of Nursing, School of Health Sciences, Jönköping University, Jönköping, Sweden
• Correspondence to Sofia Kjellström, Institute of Gerontology, School of Health Sciences, Jönköping University, PO Box 1026, SE-551 11 Jönköping, Sweden; sofia.kjellstrom{at}hhj.hj.se

Background Conducting ethically sound research is a fundamental principle of scientific inquiry. Recent research has indicated that ethical concerns are insufficiently dealt with in dissertations.

Purpose To examine which research ethical topics were addressed and how these were presented in terms of complexity of reasoning in Swedish nurses' dissertations.

Methods Analyses of ethical content and complexity of ethical reasoning were performed on 64 Swedish nurses' PhD dissertations dated 2007.

Results A total of seven ethical topics were identified: ethical approval (94% of the dissertations), information and informed consent (86%), confidentiality (67%), ethical aspects of methods (61%), use of ethical principles and regulations (39%), rationale for the study (20%) and fair participant selection (14%). Four of those of topics were most frequently addressed: the majority of dissertations (72%) included 3–5 issues. While many ethical concerns, by their nature, involve systematic concepts or metasystematic principles, ethical reasoning scored predominantly at lesser levels of complexity: abstract (6% of the dissertations), formal (84%) and systematic (10%).

Conclusions Research ethics are inadequately covered in most dissertations by nurses in Sweden. Important ethical concerns are missing, and the complexity of reasoning on ethical principles, motives and implications is insufficient. This is partly due to traditions and norms that discount ethical concerns but is probably also a reflection of the ability of PhD students and supervisors to handle complexity in general. It is suggested that the importance of ethical considerations should be emphasised in graduate and post-graduate studies and that individuals with capacity to deal with systematic and metasystematic concepts are recruited to senior research positions.

• Research ethics
• human development
• dissertation
• graduate education
• applied and professional ethics
• scientific research

https://doi.org/10.1136/jme.2009.034561

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Research has a potential to encroach on people's lives, autonomy and integrity. To prevent or mitigate the potential for such effects, the research community has created ethics codes and regulations, institutionalised ethics review boards and formalised ethics requirements in scientific journals. 1–3 However, how do we know whether the formalisations of research ethics actually result in researchers' ability to operationalise ethics in the ways intended? One way is to analyse how they write about research ethics.

Including a well-written section about research ethics in a dissertation is important for several reasons. Compared to protocols written for research ethics committees, this section allows a comparison of the expected and actual research ethics as reflected in the entire research process. Scientific journals increasingly require that ethical considerations are elucidated, but most journals severely limit space for elaboration. 4 Since studies have questioned the ethical skills of doctoral students, dissertations provide a forum for students to expound on ethics and enable an assessment of acquired proficiencies. One purpose of graduate school is to train doctoral students in skills necessary for future research careers, including more critical thinking and more complex reasoning. The quality and depth of the research ethics section is essential to examine whether a researcher has acquired necessary skills to reflect and report on ethics.

Despite an increasing interest in research ethics, surprisingly little is known about the quality of research ethics in dissertations, particularly in nursing research. Research on written materials focuses primarily on research review boards 5–9 and journals—for example, ethics guidelines 10 and research ethics in articles. 4 Research on Turkish nursing dissertations showed deficiencies in informing participants and protecting privacy. 11 A study on Swedish nurses' dissertations from 1987 to 2007 showed that an increase in occurrence and proportions of reported ethical considerationsand that the texts were short, had few references and covered a narrow range of topics. 12 We found no other studies that address the design of the research ethics section and how different topics were combined.

The study's purpose was to examine which research ethical topics were addressed and how these were presented in terms of complexity of reasoning in Swedish nurses' dissertations approved in 2007. The research questions were: Which research ethics issues are reported? How is the research ethics section organized around different ethical issues? How is the information coordinated in terms of the complexity of reasoning that structures the text? What is the relationship between ethical issues and complexity of reasoning in the text?

Design and methodological approaches

The study used a mixed-methods approach to address the four research questions. 13 We performed a qualitative content analysis and a quantitative analysis of the hierarchical complexity of ethics-related content. The quantification method was the Hierarchical Complexity Scoring System (HCSS) (Commons, et al , unpublished manual), which derives from the Model of Hierarchical Complexity, a mathematics-based, formal general theory applicable to all actions in which information is organised. 14 15 All reasoning involves organising information. The theory and validated scoring method enable reliable measures of discrete stages of reasoning complexity. 16–20 In accord with Swedish law, ethical approval was not obtained for this study, 21 but ethical principles were used and issues were addressed in ongoing reflective processes.

Data collection

The sample consisted of 64 dissertations from Swedish universities in 2007 (Appendix 1). The primary inclusion criteria were that the dissertation was written by a nurse and that it was a PhD dissertation (4 years of full-time studies). Suitable dissertations were identified from the Swedish Society of Nursing's list of self-reported dissertations (n=65) followed by a systematic comparative analysis with the Swedish National Library (n=1). One of the self-reported dissertations discussed no research ethics and one was by an unsuccessful doctoral candidate: they were not included in the sample. Dissertation languages were English (n=48), Swedish (n=15) and Norwegian (n=1). Dissertations were retrieved via full-text online access or as books from the university library.

Data analysis

The dissertations were examined to identify research ethics sections, often under the subheadings “Ethical considerations” or “Ethical approval”. The texts were analysed for the topics addressed and how they were reported. An unstructured matrix of research ethics issues was created and grounded in the data. The coded texts were further analysed for subcategories through an inductive process. Descriptions of meanings of quantitative and qualitative character, that is manifest and latent content analysis, were sought. The analysis was performed by SK with BF—with extensive experience in qualitative methods.

In hierarchical complexity scoring, such content is “seen through” to examine its underlying structure. The method measures the levels of abstraction and how information is coordinated. Each section and subsection of a research ethics discussion was assessed on stage of hierarchical complexity. The overall discussion was scored based on the highest stage of performance the text demonstrated. The correlation of content and its complexity indicated which topics were addressed at different stages of complexity. Scoring was performed independently by SK and SR, then discussed to reach consensus. Both authors scored the English texts, and SK scored the ones in Scandinavian languages and discussed with SR. SR is an expert HCSS stage-and-transition scorer while SK is a qualified HCSS scorer of stages 8 through 11. See table 1 for stage complexity information. 22

• View inline

Common range of stages of performance in adult tasks' hierarchical complexity

Research ethics issues in dissertations

Dissertations contained one to seven research ethics topics: approval of research ethics board (94%); information process and informed consent (86%); confidentiality (67%); ethical aspects of methods (61%); use of ethical principles and regulations (39%), rationale for the study (20%) and fair participant selection method (14%; table 2 ). All but three of the dissertations involved direct interaction with study participants; three were register-based studies.

Design of research ethics sections in Swedish nurses' dissertations

Ethics approval

The ethics approval category included descriptions of whether the dissertation has been vetted by an ethics review board. Almost all dissertations included a discussion of ethics approval (n=60), and a majority stated they had been approved by a research ethics review board (n=55). A quality and transparency concern was that several sections included no name of the ethics board and/or registration number (n=13). A minority related the issue of ethics approval to ethical codes, the Helsinki declaration or current national research ethics laws (n=14) by either stating that studies were performed in accordance with ethics regulations (n=8) or by arguing against the need for an ethics approval due to national laws (n=6).

Information and informed consent

We broadened the traditional informed consent category to accommodate information-giving processes discussed but not always expressed in terms of informed consent. Most dissertations discussed information-giving and informed consent (n=56). A third of these explicitly mentioned the concept of informed consent (n=19). A substantial amount of space was typically used to detail the informing phase of research, including the information's form (written and/or verbal) (n=41) and type. The most often-given information was freedom to withdraw from the study (n=33) and a declaration of voluntariness (n=30). Other information included confidentiality (n=22), withdrawals' non-interference with further treatment (n=7), the right to not answer questions (n=4), aim of the study (n=2), risks and benefits (n=2) and feedback of results (n=1). Those responsible for providing information as well as those receiving the information were described. Some informed consent discussions included an ethical rationale for the information process by referring to principles, codes or laws (n=16).

Confidentiality

Items coded in the confidentiality category reported that information was accessible to only authorised persons. Confidentiality procedures were succinctly reported (n=43). Besides describing confidentiality as something that participants were guaranteed and informed about, some researchers identified how confidentiality had been handled: data were safely stored protecting participant's identity (n=12); data were analysed and reported without identifying participants (n=19) and participants in focus group interviews were counselled in ways to promote freedom of expression and confidentiality (n=2).

Ethical aspect of the methods

The category for ethical aspect of the methods included the research ethics issues in collecting data, except for questions regarding informing participants. Ethical aspects of study methods were comprised of descriptions of interviews and questionnaires (n=37). Explanations of why interviews were ethically problematic were done by referring to principles or risks of harm (n=17). The negative aspects stated (n=24) were physical and psychological with an emphasis on emotional. Strategies to impede negative consequences were depicted (n=20): adopt a sensitive attitude, adapt to the physical and mental status of the interviewee, reduce questions, provide time to reflect on the interview and arrange for a contact person. Sometimes, statements about how the participants seemed to enjoy the interview experience were included (n=14). A few sections described problems that appeared during the research interview (n=14)—for example, interviewees who cried or did not answer all questions. The most comprehensive sections covered all these issues, but the most common strategy was to mention the potential laboriousness of the interview yet argue that participants benefited from practical solutions that were provided in the interview situation or by claiming that research participants appreciated the opportunity to tell their stories. The reported ethical problems with questionnaires were primarily the tedium of answering questions and how researchers adjusted the number of requests for completion out of respect and concern for participants' possible fatigue.

Use of ethical principles and regulations

Discussions that included the usage of principles and ethical regulations like laws and research ethics codes were coded to the category of ethical principles and regulations. This category was analytically different from others because it revealed how ethics were applied in the research sections. Explicit report of laws, ethics codes and principles occurred in fewer than half of the dissertations (n=25). Principles were employed but performed in qualitatively different ways (n=17). The simplest form was to state that the study had been performed in accordance with a research ethics declaration, code or rules outlined in a research ethics book. The most elaborate ones integrated the principles and described how they were used as compasses for research procedures (n=8).

Rationale for the study

To provide an ethical rationale for the study means to justify why the study is important in a wider perspective. Thirteen dissertations featured an ethical rationale for the study, and when included, it was framed in terms of risks and benefits. The need for new and valuable knowledge that could potentially improve conditions for other people weighed heavier than the extra demand and little direct gain that the research subjects gained from participating. Some reported that the value of pursuing the research outweighed the disadvantages but entailed the necessity of protecting the autonomy of the research participants.

Fair participant selection

Fair selection of participants signifies reflections on a justified choice of participants. The reason to include vulnerable groups and groups that previously has been excluded from research was sometimes given (n=9). A few sections justified the choice of participants (n=8). The importance of including important and vulnerable groups so their voices would be heard was the main reason reported.

Design of the research ethics section

The topics of the research ethics sections are outlined in table 2 . Most frequent was to report four ethics issues (n=16), followed by three (n=14) or five issues (n= 14). The majority (72%) included 3–5 issues. Four sections stated one topic and only one dissertation section reported seven issues. The most common composition of a section about research ethics discussed five topics: the approval from a research review board, information and informed consent, ethical aspects of the methods, confidentiality and principles.

Complexity of reasoning

The analysed texts demonstrated three stages of performance as measured by hierarchical complexity: abstract (n=4), formal (n=54) and systematic (n=6).

Abstract stage text performances consisted of declarative statements ( table 3 ). Unsupported categorical assertions were made and justified by invoking another assertion. Generalisations were created by quantifying people and events. Often-used quantifications in the sample were “all participants” and “all studies”. Research ethics sections included mainly generalisations about actions that had been performed.

Representative examples of reasoning in research ethics at three stages of complexity

Reasoning at the formal stage of performance used empirical or logical evidence ( table 3 ). Assertions were supported by explicit logic or evidence to justify the assertion—for example, by providing a logical explanation—for example, using such terms as because, in order to, since, if, then, therefore. Descriptions of hypothetical or alternative options in the future were sometimes included. The logic was linear. Such linear logic took the form of if–then constructions or chains of logic. Some used principles as logical reasons for actions.

Systematic stage performances were characterised by the ability to coordinate at least two logical relations into a system ( table 3 ); in other words, they demonstrated reasoning about complex causation and ability to understand a system of logical relationships. For example, one researcher described procedures for finding the “right people” by invoking a multivariate system that required the coordination of multiple variables. Systemic stage performances were characterised by more fluid reasoning than the linear, logical performances.

Comparing content and complexity

Few dissertations demonstrated abstract reasoning and systematic reasoning, four and six, respectively, but showed interesting patterns. The texts with abstract stage reasoning reported either one or two topics. All four mentioned approval; information and methodological issues were raised by only two. Texts with systematic reasoning introduced three to five ethical issues. Half of them discussed principles (as compared to merely citing a principle as the reason for an action), and the other three reported the rationale for the study, indicating that the topic and study could perhaps be viewed in a wider context. Among the majority of texts demonstrating formal reasoning, the topics varied from one to seven, meaning at least formal reasoning was needed to explain all conceivable aspects. Formal reasoning is required to report such tasks as fair selection of participants, rationale for the study and principles, ethics codes and laws.

Our study demonstrates that research ethics are insufficiently reported and inadequately described in many nursing dissertations. Few ethical topics are considered, and they are not discussed in a thorough way. While most note official approval and describe informed consent issues, other issues like the rationale for the study and how the participants were selected are infrequently reported. The level of complexity of reasoning was inadequate in most dissertations. The majority of the dissertations used formal reasoning, although by their nature, the ethical issues introduced in them require more complex reasoning to be satisfactorily addressed.

A methodological strength of our study is its inclusion of a large number of dissertations, which are likely representative of dissertations by Swedish nurses. A major advantage of our method is that the analytical approach permits assessments and comparisons of the coverage of ethical issues and the complexity of reasoning.

A methodological shortcoming is that the analysis was primarily focused on the section denoted “Ethical considerations/approval”, thus some ethics topics and reasoning might have passed undetected if they were treated in other parts of the dissertation. The analysis is thus limited to what the authors define as belonging to ethics sections. Our analysis identified the most complex stage of reasoning as a criterion for analysis because ethical considerations are complex matters. A more extensive analysis could have also analysed the entire low to high range of reasoning demonstrated in each ethics section. An implication of the language analyses is that we do not know which and how the ethical issues were applied in reality. Some issues could have been omitted from the dissertation text even though the issue was dealt with in practice and vice versa. The consistency between writing about ethics and ethical behaviour in the field—for example, in contact with research subjects and patients, should be investigated in future studies.

The first main finding is the incompleteness of the elaboration of topics and details in several dissertations, which is consistent with several studies in the domain of research ethics. A previous study showed a high level of errors in research ethics committee letters; that is, procedural violations, missing information, slip-ups and discrepancies. 8 Earlier research on Swedish nurses' dissertations demonstrate the questionable quality due to short length, few references and a narrow range of topics. 12

In our study, few topics were addressed. Emanuel et al argued for seven requirements to be considered and met in the conduct of ethical research: scientific value, validity, fair subject selection, favourable risk–benefit ratio, independent review, informed consent and respect for potential and enrolled subjects. 23 Applied to our findings, some requirements may be treated in other parts of a dissertation, but several dissertations leave out topics that are necessary for judging their ethical quality.

Informing potential participants and pursuing informed consent was reported in almost 90% of the dissertations' ethics sections. This frequency is higher than that reported in a study of Turkish nurses' dissertations where subjects were not informed about the study (72.7%) and the researchers had not obtained permission from the subjects (73.6%). 11

The second main finding is the insufficient level of complexity of reasoning, with which research ethics are handled. Findings from a discourse analysis of research ethics committee letters showed that there was “the lack of formal reasoning” (p 258) and ethical arguments—for example, informed consent are described as procedural norms rather than an ethics principle possible to dispute. 9 This is consistent with our findings, because a significant number invoked research ethics principles to justify procedures taken, rather than to use principles to support ethical arguments for and against certain procedures. However, our findings also showed that the great majority used at least some formal reasoning, as measured by hierarchical complexity.

Unfortunately, formal reasoning is necessary but not sufficient for adequacy in ethical matters. The analysis showed that formal reasoning and systematic reasoning were needed to elaborate on topics, and the comparison of complexity reasoning and content indicated that higher levels of reasoning involved more elaborated use of ethics principles. Very few used systematic reasoning, and none used metasystematic, which would be preferable because several of the research ethics concepts are metasystematic stage principles. For example, informed consent is a metasystematic stage concept because it coordinates the system of informing a research subject and the system of obtaining consent from the person. 24 This means that metasystematic reasoning is needed for a full understanding and use of these concepts.

What are possible explanations for the low levels of reasoning on research ethics? One possibility is that ethical issues are dealt with at a sufficiently high level of complexity in practice, whereas the text of the dissertation merely reflects a research tradition that discounts the importance of performing and explaining ethical reasoning. Disciplinary norms for terse writing styles are presumably promoted by supervisors and department guidelines. For example, nurses' dissertations in social science use more references to methods, ethics and philosophy of science than dissertation in the medical science tradition. 23 In addition, poor writing may occur because researchers mimic previous dissertations or regard ethical considerations as bureaucratic hurdles rather than moral requirements to protect participants. The supervisor role is an important factor since they sometimes acknowledge a considerable lack of knowledge about research ethics. 25 Another conceivable explanation is that the level of ethical reasoning corresponds rather accurately to the level of complexity the doctoral students and their supervisors use to handle complex issues in general. In other words, they are arguing on ethical issues at their highest complexity level. In that case, the scientists' (PhD students' and supervisors') ability to discuss at more complex levels must be improved for ethical issues to be sufficiently managed in the future. All these possibilities suggest further research is needed to account for our findings, since ethics have long been an important part of nurses' education and occupation.

There are several implications of insufficient ethical reasoning. Integrity of the research subjects and patients are at risk, and patients, if they participate, may be informed without understanding the implications. From the perspective of the readers of the scientific literature, it is impossible to assess how and why the authors dealt with various ethical issues. A crucial implication is the consequences of selection of research questions, methods and participants/sample. Scientists performing at abstract or formal stages are less likely to integrate relevant ethical aspects into their research aims than scientists at higher complexity levels. This is because such integration, by its nature, is multivariate at minimum. They will differ quite dramatically in the way they understand principles as principles, “risks” and “benefits”, rationale of the investigation, etc. Researchers with systemic or metasystematic stage reasoning are able to ask more complex questions, juggle ethics, research questions, and methods and design more complex research projects. 26

Our conclusion is that if the established praxis to include discussion of research ethics in Swedish nurses' dissertations is going to be valuable, and if its purpose is to indicate that the research complied with expected ethics, then the reporting must exhibit a certain quality, comprehensiveness and sufficiently significant treatment of ethics. Our study illustrates that factors that improve the quality include: appropriately thorough consideration of several ethical issues while avoiding minutiae; use of ethical principles in appropriate contexts to justify choices and reasons to support actions taken and use of at least formal and systematic reasoning. In addition, we would like to see more reflection and a critical stance to what has been done in the dissertation work.

In order to accomplish the intent of reporting research ethics, several improvements are needed. The most straightforward solution is to enhance the research ethics teaching in graduate education. Students must learn how to perform ethically sound research from the first steps of planning and performing to writing up the results and their potential and ability to report and reflect on ethical aspects of the research process must be enhanced. A more profound resolution is to emphasise metasystematic thinking in post-graduate studies and recruit senior researcher and post-graduate students who already have developed a systematic or metasystematic way of reasoning. This longer-term solution will also constitute the foundation for further development of complexity in handling ethics issues in the future.

Acknowledgments

We would like to thank professor Per Sjölander for valuable comments on the discussion.

• Emanuel EJ ,
• Wendler D ,
• Dixon-Woods M ,
• Ashcroft RE
• Finlay KA ,
• Fernandez CV
• Angell EL ,
• Jackson CJ ,
• Ashcroft RE ,
• Dixon-Woods M
• O'Reilly M ,
• Rowan-Legg A ,
• Ulusoy MF ,
• Kjellström S ,
• Creswell JW
• Commons ML ,
• Smith JEV ,
• Goodheart EA ,
• Dawson TL ,
• Swedish law
• Rodriguez JA ,
• Szirony TA ,
• Richards FA

Supplementary materials

Web only appendix.

Files in this Data Supplement:

• web only appendix

Competing interests None.

Provenance and peer review Not commissioned; externally peer reviewed.

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Guide to ethical approval

• Related content
• Peer review
• Justin Nowell , specialist registrar, London Deanery
• 1 Department of Cardiothoracic Surgery, St George’s Hospital, London SW17 0QT
• justin.nowell{at}stgeorges.nhs.uk

For research involving patients, whether directly or indirectly, or involving NHS facilities, the ethical review process is mandatory. Justin Nowell takes you through it

Why read about ethics?

During their career journey many health professionals do a formal period of research. You may wish to improve your personal portfolio or raise the profile of a new department. Or are you thinking about pursuing research in the NHS? If so, you need to think carefully about ethics. As a chief investigator, whether you are a general practitioner or a nurse, a physiotherapist or a professor of medicine, the process is identical. It would be wise to plan your ethics application early, well before your proposed start date. The requirement for ethical approval applies not only to interventions like clinical trials but also to a range of other activities such as questionnaires, case note reviews, telephone surveys, and collecting samples or data. Many people find the process of applying for NHS ethical approval intimidating. A galaxy of red tape is guaranteed to dampen enthusiasm even in the most ardent researchers, however brilliant their ideas. Some knowledge of the application and review process can help ease this burden. Advance preparation may also save you a lot of wasted time.

Do I need ethical approval?

Traditionally, medical students are taught that the cornerstones of good ethics comprise beneficence, non-maleficence, autonomy, justice, dignity, and truthfulness. Therefore activities that damage these six principles undermine ethics. It is not always clear how to translate such lofty ideals into improving research. The General Medical Council advises that research involving people directly or indirectly is vital in improving care and reducing uncertainty for patients now and in the future, and for improving the health of the population as a whole. GMC guidance 1 requires that if you are involved in designing, organising, or doing research you must:

Put the protection of the participants’ interests first

Act with honesty and integrity

Follow the appropriate national research governance guidelines and the guidance in Research: The role and responsibilities of doctors . 2

Ethical review from the appropriate NHS research ethics committee is required for any research involving:

Patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient’s or user’s past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions

Individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above

Access to data, organs, or other bodily material of past and present NHS patients

Fetal material and in vitro fertilisation involving NHS patients

Those who have died recently in NHS premises

The use of, or potential access to, NHS premises or facilities

NHS staff recruited as research participants by virtue of their professional role

Healthy volunteers, if done on NHS premises.

Application form

Obtaining ethical approval is divided into national and local stages. The first task is to complete an application form. This has recently changed from the National Research Ethics Service form to a new Integrated Research Application System. 3 This is much more than just a form; it is an integrated dataset designed to fulfil the requirements of a number of review bodies. Detailed guidance notes are included in the form, but completion is time consuming, so save completed sections as you go and return later.

The aim of the ethics review process is to protect participants and promote good quality research. With this in mind, there are some searching questions to answer. There are four parts A-D and some additional forms. Part A comprises the generic and core information. Answers to part A automatically generate appropriate header sections and datasets for the remainder of the application. Part A has 78 questions, although not all questions will need to be answered and the form sieve will automatically reflect this. Resist the temptation to cut and paste large sections of your protocol—it will be obvious at the review meeting if you do. You are asked to write a comprehensive lay summary and it is worth paying special attention to this task. Since 1 May 2008 lay summaries have been published, and this will soon be extended to include summary ethical opinions. 4

Part B, comprising 25 questions, asks specifically about the product or device to be tested, tissue collection, and information security measures. Part C contains an overview of all research sites. Part D is the declarations section. There are also Research Tissue Bank and Medicines and Healthcare products Regulatory Agency forms to complete if relevant.

Applicant’s checklist

After completing the application form you must complete an applicant’s checklist. The checklist specifies supporting documents to be attached, including patient information sheets, consent forms, sometimes a letter from a statistician, and investigator and subinvestigator CVs. Online guidance is available on the format of protocols and other documents, but if you are unsure ask someone experienced; patient advisory groups are helpful in drafting documents designed to inform patients.

There is no prohibition on asking individual members of your local research ethics committee for advice; several of them are likely to be local health professionals. Probably the most valuable advice is to remember to identify all documents with a date and version number.

Where to apply

If you are unsure, the National Research Ethics Service website 4 contains a list of all local research ethics office contacts, which will be able to advise where to submit and how to book a review slot. Usually this will be via your local research ethics committee. The website also contains the standard operating procedures for ethics committees.

Provided the applicant’s checklist is complete, a reference number is issued, and the forms are locked, printed, and signed. If you do make a mistake you can ring the National Research Ethics Service helpline and they can unlock the form. Deliver signed hard copy forms with supporting documents to the designated research ethics committee office. Local research ethics committees consider around five to 10 studies a month. If they are fully booked you may be asked to return for submission the following month. There is no waiting list system for the research ethics committee —it is first come, first served. If time is tight, you could opt at this stage to submit to another research ethics committee within the same domain (area served by the same strategic health authority). Check local arrangements for submission carefully, because procedures may vary slightly. In some NHS trusts the research and development department wants to scrutinise the application before submission.

Once the application form and checklist have been approved you will receive a letter from the research ethics committee stating that the application is validated and giving a date for review. Ethics committees must provide an opinion within 60 days of validating an application.

Site specific information

The final online forms are the site specific information forms, which are submitted once the application is validated. The form has two purposes: one is to obtain NHS permission (a universal requirement) and the other is to request site specific assessment. Some types of study, such as questionnaires and surveys, are designated site specific assessment exempt. For most studies, however, once ethical approval is obtained local site specific assessment approval is required using the form. This is designed to ensure that individual sites have appropriate local resources to support the study safely.

The committee has a maximum of 18 members and one third of these are lay members. The investigator will receive an invitation to the meeting, and although attendance is not compulsory, it is advisable. The committee will consider the application for up to half an hour and then call in the investigator to answer questions. If you do attend, it will expedite the process as you may be able to clarify points raised by individual research ethics committee members.

Notification of decision

After the review meeting you will be informed of the committee’s provisional opinion, subject to certain conditions or any further information that is required. If the committee has serious concerns, complete resubmission may be requested. The committee will confirm their decision in writing within 10 days.

Request for further information

The committee may request further information or revision of documents before granting a final favourable ethical opinion. You will also be reminded that further consents may be required (site specific approval for other sites, research and development, Medicines and Healthcare products Regulatory Agency) before the study can begin.

Final approval and beyond

The research ethics committee will confirm the final ethical opinion in writing. Subsequent amendments to the study protocol must be formally notified to the committee. You are obliged to start your research within 12 months of a favourable ethical review. You must provide safety and progress reports as specified. You should also notify the committee when your study ends.

Complete the online application form

Complete the applicant’s checklist

Decide where to apply and book a review slot

Make your submission

Validation and review date

Complete site specific information form

Review meeting and provisional ethical opinion

Request for further written information

Final ethical opinion

After approval

Competing interests: None declared.

• ↵ General Medical Council. Good medical practice . London: GMC, 2006 .
• ↵ General Medical Council. Research: The role and responsibilities of doctors. London: GMC, 2002 .
• ↵ Integrated Research Application System. www.myresearchproject.org.uk .
• ↵ National Research Ethics Service. www.nres.npsa.nhs.uk .

Student intranet

Ethical approval

Student research occasionally raises ethical issues.

If you are undertaking research for a course unit, dissertation, thesis or project that involves collecting data on or from human participants, it will involve ethical considerations and University requirements for research ethics.

For coursework involving limited data collection such as evaluations, market research or working with professionals (note: students are not classed as professionals) ethical approval is not normally required but this is subject to local requirements and the decision is made by your course leader. Therefore, it is important to verify this with your course leader before you start your research.

Ethical approval of coursework is required if:

• topics are sensitive or contentious;
• vulnerable groups are included such as NHS patients, children under 18, adults with learning difficulties, adults with a terminal illness, mental illness or dementia, adults in care homes, adults or children in emergency situations (eg refugees, asylum seekers, prisoners or criminals, young offenders, users of illegal drugs or illegal substances);
• unless otherwise exempt, the data collected will form the basis of a publication or similar.

Please note that even if your project does not require formal ethical approval you must adhere to the best practice guidelines:

• a  GDPR Compliant participant information sheet and content form/script must be used, normally your course leader will have copies available for you to use;
• ethical consent must be obtained and you must provide the signed copies to your course leader (in their role as the data custodian);
• any audio transcripts must be anonymised and the original recordings deleted;
• all data protection expectations regarding storage, confidentiality and retention must be followed.

 If, after speaking to your course leader, you need further advice please contact the General Reviewer for your area.

Projects, dissertations and thesis

Before you begin your ethics application, you should complete the Ethics Decision Tool . The tool will advise whether ethical clearance is needed for your project. Ideally, you will complete the Ethics Decision Tool with your supervisor but if this is not possible, take a screengrab of the outcome and share it with your supervisor for discussion. 

If the tool and your supervisor agree that ethical approval is not required, your supervisor will email the screengrab to your Programme Administrator so that this is recorded and you can proceed with your project or research.

If the tool determined that you require ethical approval then you need to log on to the online  Ethical Review Manager (ERM)  to create a new ethics application and have it reviewed and approved so you can start your project or research, without receiving formal ethical approval by email you cannot start your research.

You may view the School of Social Sciences guidance  and the health, safety and risk information online, there is also ethics guidance for staff members.

All ethics applications are submitted via the Ethical Review Manager (ERM), please read our guidance on completing the ERM form  or read our frequently asked questions (FAQs)  document.

Further information on good research conduct, misconduct and policies and guidelines can be found on our research governance, ethics and integrity webpage on the central University website.

The application

Students and supervisors are advised to complete the application together. There are two main routes for obtaining ethical approval for your research project. The first set of questions, as well as the School of Social Sciences (SoSS) guidance notes, will determine which route you need to follow via the Ethical Review Manager (ERM).

• The SoSS Research Ethics Template (do not take this route if your data collection does not comply with the template in the SoSS guidance notes).
• The University Research Ethics Committee (UREC) reviews projects that fall outside of the scope of the SoSS template and/or require full ethical review.
• Projects involving NHS patients/users typically require review by an NHS REC.

Completing the application

When completing your application, consult with the help of bubbles beside each question as they contain lots of vital information and links to documentation such as templates for participant information sheets and consent forms.

Do not submit your application without checking that it is fully completed and all the necessary documentation is attached (consent forms, recruitment adverts etc). Applications that are not fully considered or are incomplete will be returned to you and this will significantly delay the process.

Submitting the application

Once you have completed your application (including the risk assessment) and you have signed it, you then request your supervisor signature by pressing the blue "sign" button. Once it has been signed by both of you, it will automatically be submitted. You will receive an email confirmation that it has been submitted, if you do not receive this, check with your supervisor or read our Frequently Asked Questions guidance . 

Health and safety

The health and safety of you and your participants is very important. For this reason, all students embarking on fieldwork must complete a risk assessment with their supervisor and attach it to the ethics application. These can be found on our Health and Safety intranet , you will also need to ensure that you have adequate insurance in place.

How long does the ethical review process take?

This will depend on whether you are seeking review via the University Research Ethics Committee (UREC) or at the School level.

On average, the process can take:

• 8-12 weeks for full UREC.
• 6-8 weeks for Proportionate UREC.
• 4-6 weeks for Division/School Review although we endeavour to process applications that are fully completed within 2 weeks.
• NHS approval can take a very long time, for example, a year.

It is therefore very important that you submit your application in good time and when entering the dates of your proposed data collection that they are far enough in the future for your application to be considered. Often applications are returned to applicants to amend those dates as they are not far enough in the future. Approval cannot be given retrospectively.

School template review and approval

When your application is submitted, it will be assigned to a General Receiver and to a Chair Reviewer for their consideration. You will receive an email following their consideration. The outcome of this will either be "approved" or "revisions needed".

If approved

• You and your supervisor will receive email notification of this and you can embark on your research. It is very important that you read the contents of the approval letter.

If revisions needed

• You and your supervisor will receive an email advising you that the application has been returned for further amendments or clarifications.
• You and your supervisor will consider the feedback, make the amends in the Ethical Review Manager (ERM) and resign the application, you will both need to sign this again.
• Check you have received your confirmation email.
• Your application will then be sent back for consideration and you will be informed of the outcome. 

UREC review and approval

If your research project needs ethical review and approval from the University Research Ethics Committee (UREC), read our research ethics guidance . 

The UREC application is submitted via the Ethics Review Manager (ERM), the process is:

• Complete the application online and upload documents and appendices (eg participant information sheets, consent forms and recruitment advertisements). Templates for participant information sheets and consent forms are available on the research ethics guidance webpage.
• The completed form will be pre-screened by a research ethics signatory authorised on behalf of the School. The purpose of pre-screening is to check if the project necessitates UREC approval and ensure that all applications are completed appropriately. The school signatory will aim to review your application within 10 working days.
• Once completed, the signatory will submit it directly via the ERM (applicants will be copied into the email confirmation) for subsequent review at the next available UREC meeting. Dates of UREC meetings and potential outcomes can also be found on the research ethics guidance webpage.

The Research Ethics Office will email you to confirm the details of your review. You cannot proceed with your research until you have received an email confirming you have received ethical approval.

Disclosure and Barring Service (DBS)

Do you require a dbs check.

• This depends on various factors such as the environments, the activity being completed, the duration and the subjects involved, read our DBS webpage for more information.
• If you do need a DBS check, please contact Susan Rowe in the Faculty of Humanities. 

If you already have a DBS certificate from The University of Manchester

• You may upload this certificate when completing your online ethical application.

If you already have a DBS certificate but it is not from The University of Manchester

• If you signed up for the update service at the time your certificate was produced, you can contact your Programme Administrator who will check the update service to verify that there have been no changes since your check was completed. You can upload a copy of the certificate when completing your online ethical application.
• If you did not sign up for the update service, you may require a new check to be completed by The University of Manchester.

Data protection

It is imperative that data is handled confidentially and securely to protect research participants and to preserve the reputation of students, staff and the University.

Data protection and processing personal data guidance has been issued by the University and should be followed in all research studies.

Please ensure the guidance is read carefully and issues of data security are explicitly addressed in applications for ethical approval.

Training on research ethics, practice and integrity

Training related to research ethics, practice and integrity that you should take depends on the nature of your research and may include:

• research integrity;
• clinical trials;
• human tissue;
• DBS check; and
• data protection.

Some of these may be required by the research ethics reviewer/committee. Please see the research governance, ethics and integrity website for more information.

Research integrity training for PhDs

PhD students within the School of Social Sciences can view our research ethics policies in the PGR handbook. 

Dissertations - Skills Guide

• Where to start
• Research Proposal

Ethics Form

• Primary Research
• Literature Review
• Methodology
• Downloadable Resources
• Further Reading

What is it?

An ethics form is a document that prompts you to provide information about your research to ensure you are meeting set standards. Readers usually expect to see ethics in a research proposal, or mentioned in your writing, even if there doesn't appear to be any problematic ethical issues to be addressed. 

Why do I need to do it?

When someone embarks on a piece of research there is a chance of doing harm, even if harm isn't intended. Setting ethical guidelines ensures there are set standards for conducting research to ensure the research will not harm people physically or emotionally. 

How do I do it?

You can find more information about completing your ethics form from the research ethics page of the university website ( click here ).

Ethics Further Reading

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• Last Updated: Oct 18, 2023 9:32 AM
• URL: https://libguides.derby.ac.uk/c.php?g=690330

Ethical review application

If your research involves human participants, their data or samples, then ethical review and approval is mandatory and must be obtained  before  starting your research. This page describes how to submit an application for ethical review and what to expect along the way. 

Researchers should consult the guidance on ethical issues  for more on what to consider when planning research and completing an application form.

There are ethical review application form - exemplars (PDF) available for reference when completing the free-text fields in the application form and there is also  training (online and face to face) available for applicants. 

Those making the following types of applications should follow the link for additional information:

• collaborative application  (if you are collaborating with another School or organisation)
• amendment and extension applications  (if you already have ethical approval but your plans have changed or you need to extend the approval period)
• teaching module application  (if you are a module coordinator)
• human tissue and cell line related application (if your research uses human tissue or cell lines)

Applications for ethics review can only be for a specific research project or study and applications for 'umbrella', 'blanket' or generic approval (aside from teaching module approval) will not be reviewed.

For research involving the NHS

If your research involves the NHS you should also visit the Research involving the NHS page .

For research involving children

You should seek the advice of the Child Panel Representative before submitting your application - please email Dr Barbara Dritschel ( [email protected] ). There are template participant documents for children and letters to schools/parents and guardians . You may require PVG/DBS approval, check the guidance on the additional documents page.

What projects require ethical review and approval

All research involving human participants, their data or samples, requires ethical review and approval before the research starts. This includes observation-based research and research using social media . 

The term 'research' refers to a process of investigation leading to new insights.

Applications for ethics approval must be for a specific study or project that is time-limited, clearly defined in scope or aims, and where the data, participants and methods used are specified. The only exception to this is teaching module approval. 

Exemptions from ethical approval

The following types of work do not require ethical approval:

• Service evaluation . This is work to monitor, improve or test a service being delivered, where a 'service provider' (or someone acting on their behalf) collects information from a 'service user'. For example, a module coordinator seeking feedback on a module from their students, or an employer seeking feedback on its support activities from its staff.
• Audit . This is work to ascertain whether an activity was undertaken as it should have been.
• Research involving only deceased subjects. If the subjects are deceased, and the information collected will not contain sensitive information about the living, then ethical approval is not normally required. However, research involving the use of health and census information that is less than 100 years old does require ethical approval. 
• The review includes analysis of the underpinning raw data or of a dataset attached to a publication (for which researchers should follow the guidance on using secondary data ).
• The review will raise ethical issues such as around social profiling, data management issues such as managing sensitive personal data, or access issues that are best addressed by completion of the ethical review process.  

If you are unsure whether your project is research or one of the above, contact your School ethics committee  for guidance.

Other application scenarios

Blanket or generic applications.

Applications for the following will not be accepted:

• ‘Blanket or ‘umbrella’ approval to cover several projects or studies, a lab or research group’s activities, or an ongoing programme of research.
• Generic approval where researchers will pick from several potential methods, topics, or participant groups, including where these are vague or not specified.
• Approval to cover only the use of a specific research method, technique, or piece of equipment.
• Open-ended iterative sequences of experiments or similar

This does not preclude applications for a single project with multiple experimental arms, participant groups, or methods if:

• The project has a well-defined focus such as a specific research question or aim.
• The ethical issues associated with each element of the study are accounted for.
• The study’s elements, their timing, and their relationship to each other and the overall study end point and outcomes are clearly specified, defined, and justified.

Keep these points in mind when amending an existing ethical approval - your SEC may require you to submit a full application. All approvals must be renewed with a full application after five years. See the guidance on amendments and extensions .

Multi-phase, long-term and open-ended research

In large studies with multiple phases or long-term/open-ended research programmes each phase or ‘chunk’ of activity should be submitted for review as a separate application. This ensures the application’s records and documents, including any subsequent amendments, are clear and manageable. Applications can be made as each phase or activity arises (sequentially) or at the same time (in parallel).

Student researchers and student projects

Students sometimes assist on a project or study led by a member of staff which already has ethics approval, using the data or outcomes in an assessed piece of work – in these cases the staff research lead must ensure:

• The project is, or remains, in line with the guidance on this page
• Students are included in, or added to, the ethics approval
• Research participants, if any, are aware of how their data will be used.

PhD (and often Honours and Masters dissertation) research, as a piece of ‘independent research’, will normally require its own ethics approval.

Autonomous student projects

Students undertaking an autonomous research project (an independent self-led project which is not carried out as part of a course, assessed work, or University-affiliated programme such as a Laidlaw Scholarship) may wish to seek advice or obtain an ethics opinion from a University ethics committee.

To request this, the student must identify an academic member of staff to voluntarily ‘sponsor’ the ethics application.

The sponsor should:

• Provide advice on the application and project.
• Check that adequate processes are in place to ensure the ethical conduct of the project.
• Determine if their School’s SEC has capacity to review the application.

If appropriate, an ethics application can then be submitted to the sponsor’s SEC.

The SEC may, at their discretion, review the application and provide feedback, recommendations, and issue an opinion on the ethics of the project, such as reporting a favourable outcome.

This does not constitute University ‘ethics approval’, endorsement or affiliation and should not be represented as such, for example in participant information or by using University branding.

Student researchers in this scenario should also ensure they are familiar with data protection legislation and how this applies to their project, given it does not come under the remit of the University.

Why ethical review and approval is required

Ethical review is a peer-review process to help researchers fulfil their personal responsibility to act in accordance with the University’s Principles of Good Research Conduct (Policy)  and fully account for ethical issues related to research involving humans . This minimises risk to the project, the researcher, the participants and the University.

Failure to obtain and adhere to ethical approvals is defined as research misconduct .

Who should complete the application

The lead researcher, whether that is a member of staff or student, should complete the ethical review application form (Word) . For student projects, supervisors must check and countersign the application form. Failure to do so may delay approval.

The form should name all researchers associated with the project so that ethical approval covers everyone involved.

The same applies to an ethical amendment application.

Which documents to complete

More detail is available on the template documents  page.

All applications should normally include:

• ethical review application form (Word)
• participant information sheet (PIS) (Word)
• consent form (Word) .

You may also need to include copies or drafts of:

• participant advertisement (Word) : when an advert (electronic or hardcopy) will be used to recruit participants 
• participant debrief (Word) : when participants may need referral to support services or additional information about the purpose of a project following completion
• surveys or questionnaires: when using surveys or questionnaires to collect data, append copies to the application - for online surveys or questionnaires , append screenshots of the initial and final pages, and the list of questions. 
• interview or focus group schedules or topic guides: when using interviews or focus groups to collect data, append copies to the application

Depending on the nature of your research project, there are other additional documents related to policies and procedures outwith the ethical approval process, which may need to be obtained prior to research commencing and might need to be appended to your application.

Some School ethics committees (SECs) require their own forms to be submitted alongside the ethical application form. For more information, contact your  SEC . 

Research involving child participants

If the research involves child participants or is taking place in educational establishments (schools) you should include the appropriate documents:

• Letter to schools: when research is within an educational establishment. There is an initial letter to school - agreement in principle (Word) and a follow-up letter to school - study commencing (Word)
• letter to parent or guardian (Word) : when research is with child participants
• Age-appropriate documents : when research is with child participants. There are age-appropriate versions of the template PIS and consent forms (on the templates page under 'PIS and consent for child participants').

Where to submit your application

Following the completion of the form, most Schools require that you email it to your School ethics committee  (SEC), however you should check with your SEC if they have specific instructions for submission.

You should submit your application as far in advance of needing to start research as possible to ensure it can be reviewed in time for your project.

Take care in completing your application form - application forms which are poorly completed, incomplete or unsigned will be returned and may delay approval. Student applications should be checked and countersigned by their supervisor.

If your research will involve child participants you should seek guidance from the Child Panel Representative (Dr Barbara Dritschel, email  [email protected] ) before submitting the application to your SEC.  

Researchers from the Schools of Geography and Sustainable Development, Medicine and Psychology and Neuroscience may send their applications directly to their SEC as usual.

The review process

After you submit your fully completed and signed ethical review application, it is reviewed by your  School ethics committee (SEC). You can be invited to attend a meeting.  

Standard and proportionate review

• Proportionate review - this means that it can be reviewed and approved by a single SEC member without being taken to a full SEC meeting
• Standard review - this means that it will be reviewed by three SEC members or taken to a full SEC meeting 

Filter criteria and why they are used

The criteria are detailed in the filter form at the start of the  ethical review application form (Word)

Research which is complex or that brings more substantial ethical considerations can be valuable and rewarding. However, it is important to consider whether the research is appropriate given the potential participants, nature of the project, experience of the researcher, and circumstances. Projects meeting the filter criteria undergo standard review processes to ensure these aspects are fully considered, while more straightforward projects can often undergo a 'lighter touch' proportionate review. 

If an application reviewed under the proportionate review route is found to involve substantial ethical considerations it may be escalated into the standard review route for consideration by the SEC in full. 

Developing a standardised protocol for research that is complex or which brings substantial ethical considerations

Researchers, research groups or Schools that frequently conduct research projects that would normally come under the standard review route can choose to develop a proposal with a protocol or 'standard operating procedure' (SOP) that puts in place a standardised approach that mitigates the ethical issues. 

If approved, this means any subsequent research projects which strictly follow that protocol or procedure can be reviewed through the proportionate review route.

Protocols or SOPs should be submitted to the  School ethics committee  for approval in principle. The SEC will then seek final sign off from the  University Teaching and Research Ethics Committee . 

Review process and outcomes

All SECs aim to give their decision on applications as soon as possible, though exact timings vary.

The SEC can make three decisions following review:

• Immediate approval : the SEC decides that your application meets the requisite standard and is approved. This is rare because, as a peer-review process, revisions (even if minor) are often requested. 
• Requires revisions : the SEC has identified a need for you to make revisions to your application. Make the required revisions, explicitly highlighting them in the application form, and resubmit the application as instructed by your SEC. Substantial revisions may need to be reviewed at a SEC meeting. 
• Escalation to the University Teaching and Research Ethics committee (UTREC) : sensitive or complex ethical applications may need to be referred to UTREC for further guidance and approval. For most SECs, applications involving child participants must be escalated to UTREC.

If the SEC escalates your application to UTREC review and approval might take longer. If you anticipate that your project will require review by UTREC, please make sure that you submit your application to the SEC in good time so as not to delay the start of your project. Once reviewed at UTREC (at a meeting of the committee), you should be informed within three days of their decision. For information on UTREC and their meetings, refer to the UTREC web page .

How to complain 

If you have evidence that your application has not been properly processed by the SEC, please refer to the guidance on concerns and complaints .

Addressing a request for revisions

If the outcome of your ethical application has been a request for revisions, the SEC may be concerned with two areas:

• Statutory : the committee cannot approve anything that does not meet statutory requirements. For example, if the proposed project fails to comply with data protection legislation. 
• Discretionary : the committee exercises judgment over ethical issues. For example, it may judge that the project entails risk out of proportion to the benefits it may bring or that the researcher has not adequately considered (or detailed in the application form) the ethical issues arising from the proposed research.

Using the committee’s comments, you should revise your application and address any issues. There is guidance available on the ethical issues to consider when planning your research or completing the application form. 

When resubmitting your application, make sure to explicitly highlight where you have dealt with the committee’s concerns. 

If you are unsure about how to revise or resubmit your application, contact your SEC .

Once your application is approved

You must wait for confirmation of approval from your SEC before you can start your research. This is normally in the form of an approval code, issued in a formal letter. Approval is valid for five years.

Once you have received approval, if your research changes and no longer reflects that which you described in your original application then you should submit an  amendment application . 

If you need to extend your approval then you should submit an extension application . Ensure you apply or an extension in good time, before your current approval is due to expire. 

If any adverse events occur during your research you should contact your SEC  and any other relevant contacts. 

Institute of Archaeology

Applying for ethical clearance for human participant research

Guidelines for Students and Staff undertaking Research Involving Human Participants 

Any student or staff member who is considering undertaking research that involves collecting data from human participants must first get formal clearance for their project.

This guidance covers student dissertations, essays, portfolios and other assessed work, and staff and postdoctoral research.

• What type of research does this include?
• Why is ethical clearance necessary?
• How to Apply
• Application deadlines

1. What type of research does this include?

Any research involving direct interaction with other people, or that uses data that have been collected from individuals, is considered ‘human participant research’. This might include:

• Questionnaires or surveys
• Focus groups
• Visitor survey data
• Personal records, including medical or biometric data
• Observations of people's behaviour
• Activities involving research subjects

Ethical approval is required whether you collect this data yourself, or are using secondary datasets collected by other researchers. If you are uncertain about whether your research requires ethical approval, please contact the Chair of the Ethics Committee, currently Julia Shaw ( [email protected] ) to discuss this further.

2. Why is ethical clearance necessary?

It is important to ensure the way you collect your data is ethically sound. All human participant research should be designed to minimise the risk of harm to those who take part in it, while being fully compliant with UK law. 

By gaining proper ethical clearance you will have protection from the UCL legal team should any problems arise during the course of your work.

The process of gaining ethical approval will also help you develop a robust methodology and avoid some of the potential pitfalls of this type of research.

3. How to Apply

• Establish your topic, research aims and methods
• Complete the ethics checklist to determine which committee to apply to
• Submit a Risk Assessment
• Register with the UCL Data Protection Office (if collecting personal data)
• Complete and submit your Ethics Application (LREC or REC)
• Obtain confirmation of ethics approval
• Obtain external permissions and checks (if required)
• Renewal of ethics approval (for research lasting more than 12 months)

3.1. Establish your topic, research aims and methods

Students should first discuss their proposed research with their dissertation supervisor to develop a clear idea of their research aims and methods. You may wish to consult the ethics checklist below  while working out your research strategy.

Once you have determined your course of action, you should begin the application process. This should be done as soon as you are ready ; do not leave it till the last moment.

  3.2. Complete the ethics checklist

There are two routes to apply for ethical approval for your research at UCL, depending on the risks associated with your proposal. Use this 12-point checklist to find out which route is appropriate for your project.

Go to risk checklist

If you identify your project as low risk , you should apply to your Local Research Ethics Committee (LREC) for review by the Institute of Archaeology Ethics Committee.

If you identify your project as high risk , you will need to apply to the Research Ethics Committee (REC). Before doing this, consult with your supervisor and Julia Shaw, Chair of the IoA Ethics Committee ( [email protected] ) to ensure your assessment is correct.

We recommend you consult this checklist as early as possible, so you are aware of the potential risks of your proposed research, and the amount of time needed to gain ethics approval.

  3.3. Submit a Risk Assessment

This is required for all research, and must be completed before you can apply for ethics approval. Risk Assessment Applications usually take around 10 working days to process.

• Download a Fieldwork Risk Assessment form (Undergraduate and Masters students)
• Apply via RiskNet (PhD students and Staff)

Please send your forms to Sandra Bond , the Institute's Departmental Safety Officer.

3.4 Register with the UCL Data Protection Office

If you collect any any personal data from your research subjects you must comply with UK Data Protection Regulations. These state that you should:

• Only collect the personal data needed for your research
• Keep this data secure at all times
• Delete the data when it is no longer required for the stated purpose

Personal data includes information such as names, addresses, phone numbers, email addresses, images that allow the subject to be identified, audio or video recordings.

To proceed:

• Undergraduates must complete a UCL training course in Data Protection .
• Postgraduate researchers and staff must register their research with the UCL Data Protection Office .

Training or Registration must be completed before you can apply for ethics approval.

Data Protection Applications usually take around 10 working days to process.

• Data Protection guidance

3.5. Complete and submit your Ethics Application

If the Ethics Checklist shows that your application is considered low risk, you may apply to the Local Research Ethics Committee (LREC) for internal review by the Institute of Archaeology Ethics Committee.

Begin IoA ethics application

• Download a LREC Application Guide
• Download the LREC Application Flowchart

If the checklist shows your application to be high risk, you should apply to the UCl Research Ethics Committee (REC).

Go to REC website

Note that research involving NHS patients and carers must be approved by a national body; Please refer to the  NHS Health Research Authority (HRA) checklist  and  the HRA's decision tool . We do not recommend this route for Undergraduate or Master student dissertations, because of the length of time required to get ethical approval in place.

For research involving live animals,  you should apply to the Animal Welfare Ethics Review Board (AWERB) .

Whatever route you take to gain ethics approval, you may need to attach supporting documents to your application, depending on the methods employed. These may include:

• Information Sheet
• Consent form
• Sample interview or survey questions
• Evidence that you have, or will be applying for, any external permissions needed to conduct your research

3.6. Obtain confirmation of ethics approval

You will be informed of the outcome of your ethics application by letter or email. Once approval has been granted, you may proceed to advertise your project, recruit participants, and collect your data.

  3.7. Obtain external permissions and checks

You may also need to gain the permission from other organisations in order to recruit research subjects or collect data from them.

For example, if you intend to observe visitors to a museum, you should formally request that museum's permission to do this. They may have their own requirements for how this research should be conducted.

Similarly, you should get permission from the owners of discussion groups on social media before posting recruitment adverts or links to online questionnaires.

DBS checks may also be required if your research would place you in close, regular contact with children or vulnerable adults. Click here for further guidance.

If you would like advice on whether you require this, student researchers should email [email protected] . For enquiries from staff researchers, please email [email protected] .

You will also be expected to follow accepted procedures for gaining informed consent from  participants, and if conducting research abroad, make sure you have the appropriate visas and travel insurance in place.

Click here for more information on gaining informed consent .

3.8. Renewal of Ethics Approval

Ethics approval is granted for up to one year at a time. If your research is continuing beyond this point, you must apply for an extension before your current approval expires. This is done using the same online application portal, selecting the ‘previously approved’ option in the form.

Apply for an LREC Ethics Approval Extension

4. Application deadlines

You should allow a minimum of 4-6 weeks for your ethics application to be processed. 

The earlier you apply, the better. This is to ensure you have sufficient time for data collection, analysis and writing up - or for amending your research plans should your application be declined and/or require resubmission.

4.1. Applications for BA/BSc Dissertations

Second year undergraduates planning to collect data over the summer should:

• Complete Data Protection training and submit your ethics application by 26 June 2024 at the latest.

Third year undergraduates planning to collect data over the Christmas break should:

• Complete Data Protection training and submit your ethics application by 23 October 2024 at the latest. This is the last opportunity to submit an ethics application for dissertations due in May 2025.

4.2. Applications by MA/MSc students, PhD students, staff and postdoctoral researchers

4.2.1. Local Research Ethics Committee (LREC) Applications

Students can submit a LREC application for consideration at any time. You are advised to submit your application as soon as you are able to do so.

Please note that there is a cut-off point for LREC applications from students doing Undergraduate and Masters dissertations in the 2023-24 academic session, after which it will NOT be possible to apply.

• MA/MSc students should apply for Data Protection (if needed) by  24 May 2024  and submit their LREC application by  10 June 2024  at the latest.
• PhD, staff or postdoctoral ethics applications may be made at any time.

LREC Applications to the Institute of Archaeology Ethics Committee usually take up to 20 working days to process. This depends on you replying promptly to any queries we send you; incomplete or problematic applications may take longer.

4.2.2. UCL Research Ethics Committee (REC) Applications

REC applications can be made at any time. You are advised to submit your application as soon as you are able to do so.

Following the criteria in our 12-point ethics checklist above, all REC applications are automatically categorised as ‘High Risk’ and will require full committee review.

Deadlines and meeting dates for REC applications are listed below. The application process will take one month or more to complete.

Please note that there is a cut-off point for REC applications from students doing Undergraduate and Masters Dissertations in the 2023-24 academic session, after which it will NOT be possible to apply.

• MA/MSc students should apply for Data Protection (if needed) by 15 May 2024 and submit their REC application by 29 May 2024 at the latest.
• PhD students and staff may apply at any time. However note that the REC does not meet in August or September.

Applicants are usually notified of the Committee decision within 1–2 weeks after the scheduled REC meeting.

As with LREC approval, REC ethics approval will be granted for a period of up to one year. If your research continues past this point, you must apply to request an extension of your existing approval.

Similarly, if you change your research plans - which might include changing your target groups or research methods - you should apply for an amendment to your existing ethics approval.

• Apply for renewal or amendment of REC ethics approval
• Sample information sheet
• Sample consent form
• UCL Letterhead 

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The School of Literatures, Languages and Cultures attaches great importance to research ethics and integrity and has developed rigorous procedures for ensuring proper ethical review and accountability.

Research ethics

The University is committed to maintaining the highest standards of research integrity .

The research ethics review process is designed to support researchers in managing risks associated with their research, and to ensure the highest professional standards in designing, conducting and disseminating research. The University of Edinburgh adheres to the  UK Research Integrity Office (UKRIO) Code of Practice for Research  and the Universities UK (UUK) Concordat to Support Research Integrity . 

In line with the principles outlined in these documents, the University of Edinburgh has published the University Research Ethics Policy and the College of Arts, Humanities and Social Sciences (CAHSS) has developed the  College Research Ethics Framework (CREF) and the College Research Integrity Framework (CRIF) .

Staff and students in LLC should familiarise themselves with these policies before completing the LLC Research Ethics Checklist and, if required, the online Research Ethics, Integrity & Governance Application , which serves as the vehicle for formal research ethics review.

Why do we need ethics review?

Research ethics are “the moral principles that govern how researchers should carry out their work” (Wellcome Trust, 2014). The aim of the ethics review process in LLC is to facilitate high quality ethical research by ensuring that research comes in line with University research ethics principles. The LLC Research Ethics Committee (REC) is committed to working with staff and student researchers in a collaborative way and aims to help researchers think through any ethical issues associated with their research and to find appropriate solutions and/or mitigations. The REC plays an important role in the research process by ensuring that research is planned appropriately, safely and ethically. It is therefore of prime importance that applicants set out any ethical issues clearly and explain the reasoning behind their decisions, as well as describing in detail the processes they have put in place to ensure that the research is conducted in an ethically viable way. Applicants should bear in mind that the ultimate responsibility for research being carried out in an ethical manner lies with them.

Applicants should note that although the LLC REC will consider how the research will keep data secure and obtain informed consent (where needed), a favourable opinion given by the REC does not mean that the research is compliant with data privacy and UK GDPR requirements for processing personal data. It is ultimately the applicant’s responsibility to ensure that their research is compliant.

When should research ethics review be conducted?

This depends on the type of research being conducted.

In line with University policy, all staff and student researchers should:

explicitly self-evaluate the ethical implications of all their research. Where the research might reasonably be considered to raise ethical questions, then research ethics review will be required before the research commences. Ethical consideration is not solely the preserve of research on humans and animals. Many other fields have ethical considerations (e.g. ranging from physics, the environment, energy, to the arts). It is the responsibility of the researchers to consider, and where appropriate, seek ethical review prior to instigating any project. University Research Ethics Policy, p.2

The LLC Research Ethics Checklist is an aid to helping staff and student researchers "self-evaluate" whether or not their research requires formal ethics review via the LLC Research Ethics Committee by submitting a Research Ethics, Integrity & Governance Application .

It is the responsibility of all researchers – staff and students – to ensure that their research project undergoes ethics review via the LLC Research Ethics Committee, if required.

Supervisors of undergraduate, postgraduate taught, MScR and PhD projects should ensure to the best of their ability that student research under their supervision goes through the formal ethical review process where required. In addition, "supervisors of student research have an ongoing responsibility throughout the research to make students aware of the ethical issues and requirements associated with their research" (University Research Ethics Policy, p.8).

Any new ethical issues which arise during the carrying out of the research should be addressed via further ethics review in a timely manner.

For Research Ethics, Integrity & Governance Applications, please ensure that you adhere to the LLC submission deadlines of a minimum of:  ​​

• 8 weeks before the commencement of any project or  submission of a funding application

This will  allow sufficient time for proper research ethics review of the proposed research to be conducted. Please note that for projects which involve complex ethical issues, it may be necessary to seek advice from the College Research Ethics Committee or specialists in other schools within the University.

For student research projects , the following deadlines apply:

Undergraduate dissertations: &nbsp;If a dissertation project requires formal ethics review, it is expected that Research Ethics, Integrity & Governance Applications will be submitted no later than the end of the first week of December in the academic year in which the dissertation will be submitted. Such dissertation projects should secure a favourable opinion (“approval”) no later than three months before the submission deadline. No data gathering or analysis should take place before a favourable opinion is secured.

If a favourable opinion is not secured by the deadline, the student will have to change their research project plan to a low-risk project which does not require ethics review. This means that they should not conduct research which is not defined as low-risk according to the LLC Research Ethics Checklist (ie, answers to all questions are ‘No’).

Taught postgraduate dissertations:

If a dissertation project requires formal ethics review (via a Research Ethics, Integrity & Governance Application), such dissertation projects should secure a favourable opinion (“approval”) no later than three months before the submission deadline. No data gathering or analysis should take place before a favourable opinion is secured.

If a favourable opinion is not secured by the deadline, the student will have to change their research project plan to a low-risk project which does not require ethics review. This means that they should not conduct research which is not defined as low-risk according to the LLC Research Ethics Checklist (i.e., answers to all questions are ‘No’).

MScR dissertations:

15,000 word dissertations: If a dissertation project requires formal ethics review (via a Research Ethics, Integrity & Governance Application), such dissertation projects should secure a favourable opinion (“approval”) no later than three months before the submission deadline. No data gathering or analysis should take place before a favourable opinion is secured.

30,000 word dissertations: If a dissertation project requires formal ethics review (via a Research Ethics, Integrity & Governance Application), such dissertation projects should secure a favourable opinion (“approval”) no later than six months before the submission deadline. No data gathering or analysis should take place before a favourable opinion is secured.

PhD theses: &nbsp;If a PhD project requires formal ethics review (via a Research Ethics, Integrity & Governance Application), such projects should secure a favourable opinion (“approval”) no later than three months after the First Year Review. No data gathering or analysis should take place before a favourable opinion is secured.

Please note that for projects which involve complex ethical issues, it may be necessary to seek advice from the College Research Ethics Committee or specialists in other schools within the University.

If required to submit a Research Ethics, Integrity and Governance (REIG) Application, when should I submit my application?

There is a wide range of approaches to designing and conducting research. It is not always clear exactly when a research project begins and ends. You will need to take some preparatory steps in order to identify things such as your topic, possible research questions, primary materials, secondary literature, theoretical approach, etc. You should submit your research ethics application for review when you have a clear idea of what your project is about (topic and research question/s) and what your approach will be (your methods or methodology). You should not begin analysing primary materials or generating new data before securing a favourable ethical opinion (sometimes referred to as “ethics approval”).

If, having completed the LLC Research Ethics Checklist, I am required to complete a Research Ethics, Integrity & Governance (REIG) Application, what are some of the elements of research that I could do before submitting my REIG application?

It is generally fine to identify primary materials or potential sources of primary data; for example, audio-visual materials such as audio recordings, videos, films; texts such as novels, poems, diaries; visual materials such as photographs, murals, propaganda posters; interview participants; performances; archival materials; online discussion forums or online communities; policy or legal documents.

If, having completed the LLC Research Ethics Checklist, I am required to complete a Research Ethics, Integrity & Governance (REIG) Application, what are some of the elements of research that I should NOT do before submitting my REIG application?

While it is fine to identify primary materials or potential sources of primary data before submitting your research ethics application, you should not generate (“collect”) primary data or conduct systematic analysis of primary materials. For example, you should not analyse audio-visual or textual materials (in cases where you have identified ethical issues with the use of these materials), or conduct surveys, interviews or participant observation.

Can I apply for research ethics review after I have started my research?

No. Retrospective research ethics review refers to ethics review which is conducted after a research project has commenced or after a research project has been completed. Retrospective research ethics review is not permitted under any circumstances for projects which have already been completed, without exception. In the case of projects which have already commenced (or where data has been collected or generated) retrospective ethics review is only permitted in exceptional circumstances, and usually only where changes have been made to a previously reviewed Research Ethics, Integrity & Governance Application. In cases where a researcher seeks retrospective research ethics review, there MUST be a clear and justifiable reason for doing so. For the sake of clarity, retrospective ethics review would be permitted in the following scenarios:

• In circumstances where a researcher comes across or is given access to materials or a setting which later have the potential to serve as data for a research project.
• In circumstances where, in the course of an existing research project which has already been through the research ethics review process, the researcher comes across or is given access to materials or a setting which was not anticipated at the outset of the project.

In either of these circumstances, further research using this data should not proceed without formal research ethics review. This should be done in a timely manner.

It should be stressed that if the generation or collection of any data does not meet the research ethics and GDPR criteria set out in these pages, then it may not be possible for the researcher to utilise the research data in any output, including dissertations and publications.

Whose research is subject to ethical review procedures?

All research carried out by members of the School, including academics, emeritus staff, teaching staff, undergraduate students, postgraduate students (Masters and PhD), visiting scholars and fellows, and research assistants, are subject to the procedures outlined in these pages.

The review process

Undergraduate and taught postgraduate students:

Applications will go to the Supervisor (or Course Organiser for in-class projects other than dissertations) for ethics review and sign-off/escalation. The application will then go to the LLC Research Ethics Committee (REC) for review. In the majority of cases, the REC will provide an ethical opinion. However, if the LLC REC determines that an application needs further scrutiny then it will be escalated to College for additional review. 

MScR and PhD students:

Applications will go to the Supervisor (or Course Organiser for in-class projects other than dissertations) for ethics review and sign-off/escalation. Applications will then go to the LLC Research Ethics Committee (REC) for review. They will be reviewed independently by two REC members. In the majority of cases, the REC will provide an ethical opinion. However, if the LLC REC determines that an application needs further scrutiny then it will be escalated to College for additional review. 

Applications will go to the LLC Research Ethics Committee (REC) for review where they will be reviewed independently by two REC members. In the majority of cases, the REC will provide an ethical opinion. However, if the LLC REC determines that an application needs further scrutiny then it will be escalated to College for additional review.

‘Legacy’ Research Projects and Ethics Review Guidance

An increasing number of journals are requesting evidence of formal ethics review for the research upon which outputs are based. While it seems to be the case that journals in the Arts and Humanities are less likely to request this, the situation is changing, and there have been several cases in LLC where scholars have been asked for proof of ethics review after an article has been accepted for publication. In cases where formal ethics review has been carried out, this is not a problem. However, in situations where scholars have been working on a research project which started before the introduction of ethics review processes in the School, the situation is more complicated since we do not conduct retrospective ethics review in LLC. In such situations, we suggest that colleagues try the following:

• Consider to what extent the research adheres to either University or external ethics guidelines/policies (or both – this will very much depend on the field). Assuming that the research does adhere to the University (or external) ethics guidelines/policies, put together a ‘defence’ of the research, explaining how it adheres to the guidelines/policies. 
• Use this ‘defence’ to try to negotiate with the publisher (assuming that ethics review processes were not in place at the time the research was conducted (in LLC, this would be prior to 2013).

NB: LLC does not conduct retrospective review and the LLC REC should not be approached to provide a cover letter or other documentation where ethics review has not been conducted.

What are the consequences of conducting research that requires ethics review without first securing a favourable opinion from the relevant Research Ethics Committee?

If you conduct research which requires formal ethics review and you do so without a favourable (or conditional favourable) opinion, you are in violation of the University of Edinburgh’s University Research Ethics Policy.

In such cases, the REC may recommend the deletion of data or the halting of the research project. In addition, the University has put in place processes for dealing with misconduct in relation to research ethics.

“Failure to meet research ethical obligations can constitute research misconduct, and as such may lead to the implementation of a research misconduct investigation, following the Research Misconduct Policy ” (University Research Ethics Policy, pp. 8-9).

For students:

“Failure to meet research ethical obligations may constitute research misconduct. This failure may lead to a referral to the relevant Academic Misconduct Officer and implementation of academic misconduct procedures, and could lead to referral of the case for disciplinary action under the Code of Student Conduct ” (University Research Ethics Policy, p.10).

School of Social and Political Science

Research ethics, ethical practice in sps.

In the School of Social and Political Science (SPS) we recognise that good ethical practice is a cornerstone of all our research and a mark of our commitment to professionalism, including our care for our research participants, our colleagues, collaborators, and research partners, as well as the data produced in our research.

SPS attaches great importance to research ethics, and is developing extensive procedures for supporting staff and ensuring proper ethical review and accountability.

Please use the links below to find out more and complete the online ethical review.

To improve information security around the Research Ethics and Overseas Travel and Field Work Risk Assessment forms staff and students must now connect to the University VPN (Virtual Private Network), before logging in and working on their submissions. Instructions on how to connect to the VPN are available online.

University of Edinburgh - webpage with information on how to connect to the VPN

If you are experiencing any problems configuring your VPN please contact [email protected] .

Good practice guidance is available from various sources including:

• College of Humanities and Social Science - Research Ethics and Integrity
• The University of Edinburgh - Policy on Conflict of Interest (PDF)
• ESRC - Framework for research ethics
• UKRIO - UK Research Integrity Office
• UKRI - Research Integrity
• European Commission - Ethics for Researchers (PDF)

All research carried out by members of the School is are subject to ethical review. The ethical review process is designed to support researchers in managing risks associated with their research, ensuring the highest professional standards in designing, conducting and disseminating research.

PLEASE NOTE: The staff ethics form and associated material has now been moved onto the Research Office intranet. This section of the (public) webpage is only updated on student ethics processes. To view information related to staff ethics processes, please visit the  SPS Ethics Intranet webpages .

Further information on ethics processes can be found on the  CAHSS Research Ethics site .

All research carried out by members of the School, including undergraduate and post-graduate dissertation projects, needs to go through an ethical review process. The ethical review process is designed to support researchers and students in managing risks associated with their research, and to ensure the highest professional standards in designing, conducting and disseminating research.

Before starting any empirical research, all students need to complete ethical review through using the support form on the SPS intranet. This will involve a series of prompts about issues which might arise during research. Completed forms will be reviewed by the student’s supervisor or relevant course organiser. Please review the important information below.

Ethics, Data and Research Integrity Online Support Form

On page 1 of the form, students will be asked to specify their supervisor and/or course organiser. For PhD students or MSc students submitting their dissertation, it is important that they list their dissertation or PhD supervisor here and must leave the course organiser box  BLANK. Otherwise the form will be sent to the wrong person and will not be processed. If their supervisor does not appear in the drop down list, please select specify someone not in the list and add in their details.

All of the questions asked on the form are directly related to the type of research to be undertaken and so it should be a straightforward form to complete. The form can be saved and returned to at a later point, so students can clarify any issues with their supervisors as they complete the process.

View a listing of current in-progress and submitted applications

Note that if you are uploading more than one document into a form field, this must be uploaded in a single file eg a zip file.

If the research involves  human participants , students must complete the checklist for either on campus or off campus research, and include it as an attachment with the ethics application.

Research activity - COVID-checklist

Once submitted, the supervisor will be in touch via email to request further information or with the outcome. Students should check their Clutter and Junk folders on their student email account in case any of the communications are sent there.

If for any reason students need to update, revise, or check the status of their form, this can be done by logging in and viewing your submissions .

MSc students must carefully read section 6 of the Dissertation Handbook for guidance on dissertation ethics review.

MSc Dissertation Handbook 2023-24.docx (live.com)

In case of any queries on the process or the status of an application please contact your supervision or course organiser in the first instance. You may also contact:

• for MSc Dissertation Research Ethics submissions:  [email protected]
• for PhD and MScR Research Ethics submissions:  [email protected]

Supervisors are the first point of contact for students reflecting on the ethical implications of their planned research. They play a key role in guiding students through the ethics review process, conducting initial reviews of the ethics form, and ensuring that research carried out by their students adheres with ethical standards. The role of supervisors and other staff in ethics review differs depending on the level of study with differing processes at PGR, PGT and UGT. Supervisors must consult the relevant guidance on the Supervisor Resources intranet page: Supervisor Resources (sharepoint.com) .

We have prepared a template consent form and a template information sheet for colleagues in the School to adapt for projects as appropriate for the research.

Use of these templates is not compulsory. You can create your own versions, tailored to your own research context. Even if you do not use these templates, working through them may help you clarify appropriate practice for your own project.

For collaborative projects, or projects using oral consent, creating a list of key commitments and intentions around participant information and consent based on these templates may still be useful for sharing with team members, or documenting practice when oral consent is being used.

Participant Information Sheet Template

Informed Consent Form Template

What are SARELS?

This is a new role created to expand capacity across the School for dealing with ethical and related data management issues.

These new roles are intended to increase capacity for dealing with:

• ethical review
• to provide more integration and oversight of staff and student ethics processes
• to contribute to promoting good practice in research ethics across the School
• to contribute to the development of strategy around ethics

The appointees will work closely with the Deputy Director of Research Ethics (DDoR Ethics).

These roles are appointed by the Head of School in consultation with the DDoR Ethics. The appointments are normally for a period of three years. Appointees will normally be active in research and not solely desk-based research.

Areas of responsibility

Strategy and development.

• To work together with DDoR (Ethics), the DDoR (Data Management), the Director of Research, as well as the Research Support Office and other members of the Research Management Team as necessary, in order to promote best practice around ethics and data management in the School
• To contribute to the development of School strategy around ethics and data management

Research ethics: staff

• To review and provide an opinion on Level 1 applications (from across the School; not all in own subject area)
• To work with Deputy Director of Research Ethics & Integrity for review and provide an opinion on Level 2 applications (from across the School; not all in own subject area)
• To act as the lead to coordinate the review and provide an opinion on Level 3 reviews (from across the School; not all in own subject area) and to be available to sit on the panel for other Level 3 reviews if appropriate.
• To act as a point of contact for ethics queries at subject area level

Research Ethics: PhD students

• To provide guidance on SSPS research ethics processes and requirements for PhD students.
• To provide advice on level 2 ethics applications to Subject Area supervisors.
• To act as the lead to coordinate the review and sign-off of level 3 reviews for students and to be available to sit on the panel for other level 3 reviews, or project set-up meetings, if appropriate, in conjunction with DDoR (Ethics)
• To participate in planning for support for PhD student projects at level 2 and level 3
• Supervisor Resources for Ethics, including details of the PGR Ethics process, can be found here: SPS Sharepoint - Ethics Supervisor Resources - VPN access required .
• To participate in induction and training for the role
• To participate in an ethics and data management committee meeting, approximately monthly in term time (may be virtual or face-to-face)
• To contribute to the ongoing development of ethical practice in the School, including around data management, identifying emerging issues, addressing gaps in provision, proposing solutions etc
• To manage the ethics email box, where ethics applications will be forwarded from the RSO
• To carry out other emerging tasks related to ethics and data management as appropriate

Current SARELS (last update: February 2024)

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Example Documents

Each project is different and so the documentation required for different projects is different too.  Below you will find some examples of study documentation, which you may use as a guide when producing your own.

General Tips

• Use simple words and sentences.
• Ensure the information is easy to follow - consider how you format the text and whether to use flowcharts/diagrams.
• Ask rather than demand.  
• Avoid using jargon.  
• Use the active (not passive) voice, e.g. 'We invite you...' instead of 'You are invited to...'
• Tailor your material to the audience, e.g. consent forms for preschool children will be different to those for young adults.
• For guidance on writing a good lay summary, see VoiceNorth's short video:  Bitesize Training - How to Write a Good Lay Summar y. 

Ethics Application Forms

At Newcastle University, researchers must complete an ethics application form, before any research commences, either by:

• completing the University Online Ethics Form  or
• by completing the HRA IRAS form  (if NHS/HSC Research Ethics Committee approval required)*

*Note, if you are unsure whether your study requires NHS/HSC REC approval, you should complete the University Online Ethics Form first, which will notify you accordingly if NHS/HSC REC approval is needed.

Ethics application forms will ask the researcher for key information about the research project, including:

• Principal Investigator contact details
• Project description
• Proposed project start and end dates
• Details of the risks associated with the research
• Proposed measures to prevent/minimise the risks
• Additional details, as applicable  

The information provided should be written for a lay audience, and supporting documentation should be attached with the application form (e.g. information sheets, consent forms, data management plans and other relevant research materials, including for example research questionnaires, recruitment materials). 

Below are examples of ethics application forms:

1.  Example Ethics Form - Cyber Bullying [PDF: 122KB]

2.  Example Ethics Form - Student Project [WORD: 50KB]

3.  Example Ethics Form - Food & Nutrition [PDF: 496KB]

4.  Example Ethics Form - Sexual Health [PDF: 201KB]

Participant Information Sheets (PIS)

The Participant Information Sheet (PIS) provides participants with sufficient information about the research study to allow them to make an appropriate (fully informed) decision about taking part. For further information, please see the Human Participation - Informing Participants section.

‌ Example Information Sheet

Consent Forms

On receiving the information about the research study (typically through a Participant Information Sheet), the participant should be allowed time to consider whether or not to take part.  If they wish to take part, typically participants will sign a Consent Form.  For further information, please refer to the section on Human Participation - Acquiring Voluntary Consent  and the University's Informed Consent Guidelines .

The University has also developed an Example Consent Form that can be downloaded and adapted to the research project.

Data Management Plans

A research data management plan outlines how a researcher will collect, use and store data, during and after the research study.  For further information, please see the Data - Governance considerations for research data .

DMPOnline provides access to example Data Management Plans.  The online tool can also be used to develop Data Management Plans that meet different funder requirements.   

Further guidance is available through the University's  Research Data Service (RDS) .

Privacy Notice

A Privacy Notice sets out how personal information will be processed in accordance with the UK General Data Protection Regulation (GDPR).  Participants in a research project should be provided with a Privacy Notice alongside a Participant Information Sheet (PIS), and have the opportunity to ask questions before they sign a Consent Form.  

To support researchers, the University has created a template form that can be downloaded and adapted to the project.

Template Form

Privacy Notice Template for Research

If you wish to recommend any changes to the information above, or have any example documents that may help other researchers, please contact  [email protected] .