sample of research proposal in health care

RESEARCH PROPOSAL – “Enhancing Quality in Patient Care”

1. relevant background of the proposed work:.

Patient care has gained immense importance in recent years due to the increased number of medical disorders and increasing awareness amongst people and patients. Increased demand in hospitals and healthcare centres to improve the patient’s health condition has become a formidable factor for all the health care professionals at every hierarchy level. Errors have become a part of the system, due to increase in the number of challenging issues that affect the deteriorating health condition of the patient. Improving the health condition by minimising system and human errors has become a crucial concern in the health industry. Health professionals have identified several causative factors for poor quality and implemented various measures to improve the quality of the situation. Unlike the old paradigm, the person approach, where the percentage of errors recorded was high, the system approach came into existence and is these days reducing the percentage of errors and increasing the complexity of the system (Warburton. 2005). In addition to the improvement of organisation, there are many other improvements underway, which include the public involvement in primary health research (Jonathan et al., 2010). According to the current situation, the health care team is also getting educated to reduce the risk of errors (Colin. 1995). Awareness of errors also created a significant impact on the safety of the patient and hence many resources were created and modified to reduce the risk (Warburton. 2005). These days, usage of health information technologies lead to improvement of the health. In the study by Connie and David (2010), through the innovative technology, the system can be advanced globally to reduce the socioeconomic barriers in various countries. Appropriate use of technology at the right time would cause miracles in the health sector (Connie et al., 2010). Many health care changes initiated in certain categories of patients decreased the risk of errors. Some of the measures included direct, personal supervision and decreased adverse reactions in case of paediatric and geriatric patients (Cambern. 2009). Another main implementation is an introduction of rapid assessment and initial patient treatment team (RAPT) in accident and emergency patients, reducing the risk to life (Cronin et al., 2005).

Summarising all the developments, quality in health care can be achieved by the academic and technical knowledge of the physician along with the communication of the health care assistants and public. In addition, appropriate utilisation of resources and tools is also essential to achieve the improvement of patient’s health condition as a target (Michelle. 1996).

2. HYPOTHESIS: Objective of the current project is to demonstrate new techniques based on studies done in previous years and to improve the quality of patient care, which is a considerable challenge for the health sector.

The tasks to accomplish include:

• To increase safety of patients by relevant initiatives. 12/16/2010 Research Proposal
• Team working within the health care sector and involvement of patients and public in primary research.
• Implementing innovations in patient care.

3. SCOPE: The following tasks would be undertaken as a part of proposed research:

• Task 1: To investigate the past studies on existing and improved health care system.
• Task 2: To appreciate the improvements in the health sector in the recent years.
• Task 3: To design research in order to increase quality in health care system and patient safety by reducing errors and implementing innovations.

4. METHODOLOGY AND APPROACH:

1. Patient Safety Initiatives: Although lots of experiments were done in patient safety in recent decades, it still remains a challenge for health professionals. These days, hospitals are spending enormous resources to reduce errors, which are appreciated. However, implementing all the proposals is not easy (Warburton. 2005). It is cost involving and depends on manpower to a greater extent, which is difficult to control.

The safety improvements cannot be implemented and always be accurate as it changes according to the situation. Improper design and rapid enforcement of safety measures would only cause meagre improvement to patients (Warburton. 2005).

There are several approaches and studies for obtaining maximum benefit out of the available resources. They are:

• Setting up a committee of professionals across the health sector to highlight vital safety measures in the hospital according to the patient conditions (Warburton. 2005). This method is time consuming and complicated. The results obtained were vague and could not improve the quality of patient.
• Another approach, which is my area of research interest, is setting up an Economic Evaluation Loop (EEL), based on the recommendation of Leape and others (1999) which would be based on utilising available evidence to establish priorities. In this approach, priorities would be set according to the analysis of available resources and outcomes of the changes (Warburton. 2005).

Accordingly, evaluation would be based on the benefits and resources available for research. Later, detailed research would be completed according to Warburton (2005), by which alternative assumptions could be identified and compiled. Finally, an additional research network would be framed to fulfil the requirements in the best possible way to reduce critical gaps (Warburton. 2005). This loop is a variant of Technology assessment iterate loop, called TAIL (Tugwell et al., 1986; Tugwell et al., 1995).

By this EEL approach, critical gaps in the research area can be identified by discussions among the health professionals and these gaps, which are usually overlooked, would be considered to provide the best safety measures within the scope of resources.

Increasing research on safety implementation to patients often raises a question of how much safety is essential. Warburton (2005) describes that there is no upper bound for providing safety to patient as demands of improving safety measurements never drop. He explains this fact by the figure depicted in figure 2 of this paper.

The curve depicts total costs of errors to the society against the level of safeguards and clearly reveals that the safety measures are implemented based upon the cost effectiveness. When initial safety methods are employed it is initially cheap, and then with the increase of costs, negligible benefits are obtained due to less reduction of adverse effects when cost measures increases. This continues uphill, further reducing the benefits with increased cost (Warburton. 2005).

The curve depicts total costs of errors to the society against the level of safeguards and clearly reveals that the safety measures are implemented based upon the cost effectiveness. When initial safety methods are employed it is initially cheap, and then with increase of costs, negligible benefits are obtained due to a drop in the reduction of adverse effects when cost measures increases. This continues further reducing the benefits with increased cost (Warburton. 2005).

Figure 2: Cost to the society versus level of safeguards Figure adopted from Warburton (2005).

In my research project, EEL with regards to one of the patient safety will be studied in the clinical environment and conclusions would be compiled accordingly in the thesis work.

2. Patient and Public Involvement in Primary Research: Involvement of potential patients and the public is an import contribution to primary research.

According to Beresford’s argument, the research experiments tend to be more accurate when the distance between the potential patients and the investigator is minimal (Beresford. 2005).

Furthermore the public, the part owners for research as taxpayers, have an equal right to subscribe for the success of research, which would improve their lives directly (Boote et al., 2010).

Additionally, public involvement at all stages of research, especially the primary level, would reduce the initial value of resources by direct focus on potential treatment areas and thus contribute to the quality of care (Boote et al., 2002; Thompson et al., 2009).

One of the approaches by which quality of patient care would be enhanced is performing clinical trials in a particular diseased population. In these clinical trials, design of the study would be based on their relevant experiences. Questionnaires would be prepared accordingly to consider general experiences and needs in that category of patients. These questionnaires are then compiled together to establish a basic structure of description and would form the research theme. Initially consent forms would be taken from the patients, and research would be carried out by contacting them regularly for feedback. All the issues the public need to be addressed would be collected for better supervision and analysis would be carried on to ensure results favouring the potential patients. This attempt ensures that questions of the potential patients would be answered and treatment becomes patient friendly, reducing the stress on the investigator, and the patient.

In this project, clinical trial is closely observed on a class of patients. Later analysis would be done on how the involvement of public and potential patients influences quality of patient care.

3. Team Working Team working is essential for effective health care management, especially in critical conditions like chronic health disorders. To achieve quality team working amongst all the health care professionals, interaction among them in day-to-day service is necessary. To ensure team-working skills in hospitals and health care centres, educating the team would be required.

Education should be a dynamic process that is patient-centred (Coles et al., 1995). Education amongst the health professionals should be multidisciplinary rather than self-centred research.

Patients and their cares should get an education alongside to improve care and hygiene. Thus, quality in health care would be achieved by a patient-centred approach.

In addition, regular team meetings and interaction between the physicians, care takers and patients would improve the quality of patient care. Discussion among patients and physicians during the treatment would be useful to record the treatment procedure, which could be useful in future investigation of the same kind.

In this project, team-working skills within a selected hospital would be improved and quality of patient care would be compared.

4. Innovations in Delivering Patient Care Many advances have been introduced in the health sector in the recent years. Use of modern technology is one that simplified the administration of health sector. Health information technologies (HIT) include mobile phones, computers, self-administration equipment, health decision-making management devices, life style modification devices, monitoring chronic illness and patient education devices (Gustafson et al., 2002). Socioeconomic barriers cause slow penetration of HIT in developing countries (Connie et al., 2010).

Setting up an appropriate HIT within a health sector is a challenge for technologists as many factors would be taken into account while considering it, and to facilitate the system, a framework would be employed. By the use of this framework, approaches could be studied and the best HIT would be employed (Connie et al., 2010). Some factors that would be taken into consideration include situational factors like setting and clinical domain, technological factors and work force (Connie et al., 2010).

Other remarkable innovations include the establishment of RAPT, which is a rapid assessment and initial patient treatment team within accident and emergency, where the patient would be allocated 4 hr of comprehensive treatment in an emergency condition (Cronin et al., 2005).

Personal care within the department of paediatrics and geriatrics is one of the other innovations (Cambern et al., 2009). This would reduce the incidence of risk and errors causing adverse reactions in them.

My intention of study would be to try and implement some of the innovations in a hospital environment and examine the quality in terms of health care. 12/16/2010 Research Proposal.

5. FACILITIES TO BE USED: Many facilities would be used to perform the following objectives in accordance with available resources and these include:

• Discussion with various people across the health sector to set up the economic evaluation loop in order to set up priorities in patient safety.
• Seeking clearance to participate in some clinical trials which would enable to understand the association of public and patients in primary health research.
• Visiting hospitals and health care organisations to examine and record the facilities for a certain group of patients.
• Getting initial training in the system of control within the primary health sector to minimise the occurrence of errors.
• Many paper and poster articles analysing different approaches of patient education.
• Certain use of technology to study the improvement of quality with the use of innovation.

6. PROGRAM SCHEDULE AND DELIVERABLES: (A basic gnat chart without dates, client should set up dates appropriately)

7. FUNDS AVAILABLE: Client has to decide according to available funding

8. REFERENCES: Warburton, R.N. (2005) Patient safety-how much is enough? Health policy,71, pp.223-232.

Perrow, C. (1984) Normal accidents: living with high risk technologies. New York Basic Books.

Leape, L. L., Forward, I.N (1999). Error reduction in health care: a systems approach to improving patient safety. Jossey-Bass.

Tugwell, P.,Bennett, K.,Feeny, D.,Guyatt, G.,Haynes, R.B. (1986) A frame work for the evaluation of technology. Institute in research and public policy, pp.41-56.

Tugwell, P.,Sitthi-Amorn, C.,O’Connor, A.,Hatcher-Roberts ,J.,Bergevin, Y.,Wolfson, M (1995)

Technology assessment. Old, new and needs-based. International Journal of Technology Assesment in Health care, 11(4), 650-662.

Jonathan, B.,Wendy, B.,Claire.,B. (2010) Public involvement at the design stage of primary health research: A narrative review of case examples. Health policy, 95, pp.10-23.

Boote, J.,Telford, R., Cooper, C. (2002) Consumer involvement in health research: a review and research agenda. Health policy, 61(2), pp.213-236.

Beresford, P. (2005) Developing the theoretical basis for service user/survivor-led research and equal involvement in research. Epidemiologia e psichiatria Sociale, 14(1), pp.4-9.

Thompson, J.,Barber, R.,Ward, P.R.,Boote, J.D.,Cooper, C.L.,Armitage, C.J. (2009) Health Researchers’ attitudes towards public involvement in health research. Health expectations, 12(2), pp.209-220.

Coles, C. (1995) Educating the health care team. Patient Education and Counseling, 26, pp.239-244.

Connie, V.C.,David, R.K. (2010) A technology selection frame work for supporting delivery of patient-oriented health interventions in developing countries. Journal of Biomedical Informatics, 43, pp.300-306.

Cambern, K. (1952) A quality improvement program. Pediatrics and child health, pp.5172-5175.

Cronin, J.G.,Wright, J.RN. (2005) Rapid assessment and initial patient treatment team-a way forward for emergency care. Accident and Emergency Nursing, 13, pp.87-92.

Gustafson, D.H.,Hawkins, R.P.,Boberg, E.W.,Mc Tavish, F.,Owens, B.,Wise, M. (2003) 10 years of research and development in consumer health informatics for broad populations, including the underserved. Med inform, 65(3), pp.169-177.

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Writing a research proposal

The format of a research proposal varies depending on what or who it is required by. They can vary in length, ie. be very concise or quite long and detailed. Also the headings for the different sections can vary.  Therefore, this guide deals with the research proposal in its most generic form, which should be easily modifiable to fit the criteria for any research body.

The ultimate aim of any research proposal is to convince people that your research is important, has not been done before, is worthwhile and is feasible. Hence you have to make a strong argument for your research. The language used should be clear and easy to understand, as often non-experts will assess it.  Some funders may, and the Research Ethics Committee application form will, want a ‘lay’ summary in addition to your basic proposal document.  It is usually only in the background and methodology sections that writers tend to assume that the intended audience has a particular knowledge of their research area.

 Additionally, it is crucial that different sections of your research proposal should link or follow on from each other, eg. the research question should link with the methodology.  This may sound obvious, but revisions of one section can lead to mis-matches. Check this before submitting your proposal! 

Typical stages in a research proposal

1. The purpose of a research proposal is:

• To help to focus on a relevant and current topic.
• To identify a gap or inadequacy in the research literature.
• To make sure that these are your ideas, and to help you to focus and crystallise your ideas.
• To help you to focus on what the actual stages involved in the research process will be, eg. the exact methodology and data analysis that will be adopted.
• To justify a proposed research project to a particular audience, eg. supervisor, departmental or faculty committee, external funding body etc.

2. Some strategies before you start:

• Search through literature for topic related articles and books, ie. search through databases/catalogues/journals etc.
• Look at what is already being done in the area i.e. existing data and research.
• Read critically, ie. look for interesting and suitable gaps – areas for research.
• Talk to your employer for approval – there is no point in starting research that you will not be allowed to complete.
• Talk to your local research and development teams.  They will be able to tell you the specific criteria for any research proposal and may highlight some issues that you have overlooked.
• Talk to experts or supervisors in the field – in person, phone, letters, e-mail.
• If it is helpful, use concept maps to link ideas, and or formulate questions that the literature review should address. 

3. Identifying your research question:

Any research proposal needs to have a clear research question for it to succeed.  Without a clear question research will become confused and lack direction. Subsequent analysis will be difficult because the research question is key to forming your hypothesis or aims, and later analysis.

Do start by writing a question, not a statement.  This will help clarify exactly what the issue is that you are trying to find a solution to.  Hypotheses, aims etc can then follow from this.

Your research question should:

• Be as clear and concise as you can make it.  Don’t use multi-barrelled questions if you can avoid them.
• Be informative – state your population of interest, locality etc.
• Avoid technical jargon – this is the golden rule in most areas of research proposals.  Remember that your research question is what will capture the interest of the reader / assessor.
• Relate to the proposal title – often the research question is quoted as the title of the proposal.
• Relate to the aim of the research – again, the research question is often quoted as the research aim.

It should be obvious from your question alone what the project will aim to do, and on who.

4. Project title:

The title should be brief but informative. It is important that it is clear and easy to understand, and describes what your proposed research is.  As previously stated, this is often the research question.

5. Abstract or summary:

This is a very important section which bears a disproportionate share of responsibility for success or failure of a proposal, as it may act as the initial ‘hook’.

It needs to be written for a wider audience, so technical vocabulary has to be limited. The abstract also needs to come quickly to the proposed research. Abstracts for grant proposals usually begin with the objective or purpose of the study, move on to methodology (procedures and design), and close with a modest but precise statement of the projects’ significance.

The significance should:

• Be about one paragraph – if it needs any longer it is advisable to rethink your research or break it down into more manageable chunks.
• Explain to the reader why the study is “significant”, in the sense of advancing general knowledge.
• Explain what the benefits to the patient / health community are.
• Encourage funding.

Although you present this first in the document, write it last so that its content accurately reflects the whole proposal.

6. Introduction:

The introduction is also written so that a more general audience can easily obtain a general idea of what the project is about, and the major concepts involved. It will also typically begin with the purpose of the proposed research.  The introduction will typically be quite short, leaving the detail to the background and methodology sections.

7. Background:

It is only in the background and methodology sections that writers tend to assume that their intended audience is a specialist in their research area, and so use more technical language.

This section will include the literature review.

The purpose of a literature review is as follows:

• To become familiar with the research area and keep up to date with the current research in your area of interest.
• Identify an appropriate research question.
• Establish a theoretical framework for the research.
• Justify the need for the research.

Through the actual process of writing the literature review you, the researcher, can explore the relevant literature, formulate a problem, defend the value of the research, and compare the findings and ideas with your own. The literature review establishes a context and orientates the reader to your research topic.

The common structure of the literature review is likened to a “funnel effect”, which goes from general to more specific studies etc directly relating your intended project, ending with your research question, problem or objective.

In summary the stages of a literature review are as follows:

• General statement(s) about the field of research – the setting.
• More specific statements about the previous research.
• Statements that indicate the need for more investigation.
• Very specific statement(s) of the research question, problem or objective.

Your Trust librarians will be able to help with appropriate literature searching techniques if required.

8. Methodology:

The method or methodology section describes the steps you will follow in conducting your research. It is a very important section as assessors will scrutinise it to evaluate the feasibility and likelihood of successful completion of your proposed research.

Examine methodology sections of research articles in your research area. Arrange to discuss your research with a statistical and/or methodological specialist (Trust and other local research clinics / groups). Discuss with other researchers in your discipline the methodologies they have adopted. Consult methodology texts and statistical packages.

Overview of research:

Population/sample to be studied, including:

• How you have arrived at the sample size.
• How they will be recruited.
• Location of the research.
• Restrictions/limiting conditions.
• Sampling technique.
• Procedures.
• Analysis tools and methods.

9. Timescale:

10. Budget:

11. Ethical considerations:

• Benefits vs risks of the involvement in the project.
• Receipt of informed consent.
• Protection of participants (including data protection and storage issues).
• Privacy, minimising discomfort etc.
• Community values.

12. Dissemination strategy:

• The targets of your research eg. staff, patients, service users or carers,
• services locally and/or nationally,
• policies that drive the above services.

13. Bibliography and references:

Good luck with your project!

Useful reading: Bowling A (2002),  Research Methods in Health: Investigating Health and Health Services  2Rev Ed edition, Open University Press Polgar S and Thomas SA. (4 th   Edition 2004)   Introduction to Research in the Health Sciences.  Churchill Livingstone. MRC Good Research Practice Guidance

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Writing Research Proposals in the Health Sciences A Step-by-step Guide

• Zevia Schneider
• Jeffrey Fuller
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Well written, comprehensive and easy to use - definitely one I will recommend.

excellent book for healthcare students

Goes through the stages of a research proposal guiding students on the expected content for each section

lovely clear text, concepts clearly set out, an excellent introductory book for health science students

A useful resource to help level 3 students to develop their academic writing. This step by step guide provides clear guidance. Students have found this very useful

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How to prepare a Research Proposal

Health research, medical education and clinical practice form the three pillars of modern day medical practice. As one authority rightly put it: ‘Health research is not a luxury, but an essential need that no nation can afford to ignore’. Health research can and should be pursued by a broad range of people. Even if they do not conduct research themselves, they need to grasp the principles of the scientific method to understand the value and limitations of science and to be able to assess and evaluate results of research before applying them. This review paper aims to highlight the essential concepts to the students and beginning researchers and sensitize and motivate the readers to access the vast literature available on research methodologies.

Most students and beginning researchers do not fully understand what a research proposal means, nor do they understand its importance. 1 A research proposal is a detailed description of a proposed study designed to investigate a given problem. 2

A research proposal is intended to convince others that you have a worthwhile research project and that you have the competence and the work-plan to complete it. Broadly the research proposal must address the following questions regardless of your research area and the methodology you choose: What you plan to accomplish, why do you want to do it and how are you going to do it. 1 The aim of this article is to highlight the essential concepts and not to provide extensive details about this topic.

The elements of a research proposal are highlighted below:

1. Title: It should be concise and descriptive. It must be informative and catchy. An effective title not only prick’s the readers interest, but also predisposes him/her favorably towards the proposal. Often titles are stated in terms of a functional relationship, because such titles clearly indicate the independent and dependent variables. 1 The title may need to be revised after completion of writing of the protocol to reflect more closely the sense of the study. 3

2. Abstract: It is a brief summary of approximately 300 words. It should include the main research question, the rationale for the study, the hypothesis (if any) and the method. Descriptions of the method may include the design, procedures, the sample and any instruments that will be used. 1 It should stand on its own, and not refer the reader to points in the project description. 3

3. Introduction: The introduction provides the readers with the background information. Its purpose is to establish a framework for the research, so that readers can understand how it relates to other research. 4 It should answer the question of why the research needs to be done and what will be its relevance. It puts the proposal in context. 3

The introduction typically begins with a statement of the research problem in precise and clear terms. 1

The importance of the statement of the research problem 5 : The statement of the problem is the essential basis for the construction of a research proposal (research objectives, hypotheses, methodology, work plan and budget etc). It is an integral part of selecting a research topic. It will guide and put into sharper focus the research design being considered for solving the problem. It allows the investigator to describe the problem systematically, to reflect on its importance, its priority in the country and region and to point out why the proposed research on the problem should be undertaken. It also facilitates peer review of the research proposal by the funding agencies.

Then it is necessary to provide the context and set the stage for the research question in such a way as to show its necessity and importance. 1 This step is necessary for the investigators to familiarize themselves with existing knowledge about the research problem and to find out whether or not others have investigated the same or similar problems. This step is accomplished by a thorough and critical review of the literature and by personal communication with experts. 5 It helps further understanding of the problem proposed for research and may lead to refining the statement of the problem, to identify the study variables and conceptualize their relationships, and in formulation and selection of a research hypothesis. 5 It ensures that you are not "re-inventing the wheel" and demonstrates your understanding of the research problem. It gives due credit to those who have laid the groundwork for your proposed research. 1 In a proposal, the literature review is generally brief and to the point. The literature selected should be pertinent and relevant. 6

Against this background, you then present the rationale of the proposed study and clearly indicate why it is worth doing.

4. Objectives: Research objectives are the goals to be achieved by conducting the research. 5 They may be stated as ‘general’ and ‘specific’.

The general objective of the research is what is to be accomplished by the research project, for example, to determine whether or not a new vaccine should be incorporated in a public health program.

The specific objectives relate to the specific research questions the investigator wants to answer through the proposed study and may be presented as primary and secondary objectives, for example, primary: To determine the degree of protection that is attributable to the new vaccine in a study population by comparing the vaccinated and unvaccinated groups. 5 Secondary: To study the cost-effectiveness of this programme.

Young investigators are advised to resist the temptation to put too many objectives or over-ambitious objectives that cannot be adequately achieved by the implementation of the protocol. 3

5. Variables: During the planning stage, it is necessary to identify the key variables of the study and their method of measurement and unit of measurement must be clearly indicated. Four types of variables are important in research 5 :

a. Independent variables: variables that are manipulated or treated in a study in order to see what effect differences in them will have on those variables proposed as being dependent on them. The different synonyms for the term ‘independent variable’ which are used in literature are: cause, input, predisposing factor, risk factor, determinant, antecedent, characteristic and attribute.

b. Dependent variables: variables in which changes are results of the level or amount of the independent variable or variables.

Synonyms: effect, outcome, consequence, result, condition, disease.

c. Confounding or intervening variables: variables that should be studied because they may influence or ‘mix’ the effect of the independent variables. For instance, in a study of the effect of measles (independent variable) on child mortality (dependent variable), the nutritional status of the child may play an intervening (confounding) role.

d. Background variables: variables that are so often of relevance in investigations of groups or populations that they should be considered for possible inclusion in the study. For example sex, age, ethnic origin, education, marital status, social status etc.

The objective of research is usually to determine the effect of changes in one or more independent variables on one or more dependent variables. For example, a study may ask "Will alcohol intake (independent variable) have an effect on development of gastric ulcer (dependent variable)?"

Certain variables may not be easy to identify. The characteristics that define these variables must be clearly identified for the purpose of the study.

6. Questions and/ or hypotheses: If you as a researcher know enough to make prediction concerning what you are studying, then the hypothesis may be formulated. A hypothesis can be defined as a tentative prediction or explanation of the relationship between two or more variables. In other words, the hypothesis translates the problem statement into a precise, unambiguous prediction of expected outcomes. Hypotheses are not meant to be haphazard guesses, but should reflect the depth of knowledge, imagination and experience of the investigator. 5 In the process of formulating the hypotheses, all variables relevant to the study must be identified. For example: "Health education involving active participation by mothers will produce more positive changes in child feeding than health education based on lectures". Here the independent variable is types of health education and the dependent variable is changes in child feeding.

A research question poses a relationship between two or more variables but phrases the relationship as a question; a hypothesis represents a declarative statement of the relations between two or more variables. 7

For exploratory or phenomenological research, you may not have any hypothesis (please do not confuse the hypothesis with the statistical null hypothesis). 1 Questions are relevant to normative or census type research (How many of them are there? Is there a relationship between them?). Deciding whether to use questions or hypotheses depends on factors such as the purpose of the study, the nature of the design and methodology, and the audience of the research (at times even the outlook and preference of the committee members, particularly the Chair). 6

7. Methodology: The method section is very important because it tells your research Committee how you plan to tackle your research problem. The guiding principle for writing the Methods section is that it should contain sufficient information for the reader to determine whether the methodology is sound. Some even argue that a good proposal should contain sufficient details for another qualified researcher to implement the study. 1 Indicate the methodological steps you will take to answer every question or to test every hypothesis illustrated in the Questions/hypotheses section. 6 It is vital that you consult a biostatistician during the planning stage of your study, 8 to resolve the methodological issues before submitting the proposal.

This section should include:

Research design: The selection of the research strategy is the core of research design and is probably the single most important decision the investigator has to make. The choice of the strategy, whether descriptive, analytical, experimental, operational or a combination of these depend on a number of considerations, 5 but this choice must be explained in relation to the study objectives. 3

Research subjects or participants: Depending on the type of your study, the following questions should be answered 3 , 5

• - What are the criteria for inclusion or selection?
• - What are the criteria for exclusion?
• - What is the sampling procedure you will use so as to ensure representativeness and reliability of the sample and to minimize sampling errors? The key reason for being concerned with sampling is the issue of validity-both internal and external of the study results. 9
• - Will there be use of controls in your study? Controls or comparison groups are used in scientific research in order to increase the validity of the conclusions. Control groups are necessary in all analytical epidemiological studies, in experimental studies of drug trials, in research on effects of intervention programmes and disease control measures and in many other investigations. Some descriptive studies (studies of existing data, surveys) may not require control groups.
• - What are the criteria for discontinuation?

Sample size: The proposal should provide information and justification (basis on which the sample size is calculated) about sample size in the methodology section. 3 A larger sample size than needed to test the research hypothesis increases the cost and duration of the study and will be unethical if it exposes human subjects to any potential unnecessary risk without additional benefit. A smaller sample size than needed can also be unethical as it exposes human subjects to risk with no benefit to scientific knowledge. Calculation of sample size has been made easy by computer software programmes, but the principles underlying the estimation should be well understood.

Interventions: If an intervention is introduced, a description must be given of the drugs or devices (proprietary names, manufacturer, chemical composition, dose, frequency of administration) if they are already commercially available. If they are in phases of experimentation or are already commercially available but used for other indications, information must be provided on available pre-clinical investigations in animals and/or results of studies already conducted in humans (in such cases, approval of the drug regulatory agency in the country is needed before the study). 3

Ethical issues 3 : Ethical considerations apply to all types of health research. Before the proposal is submitted to the Ethics Committee for approval, two important documents mentioned below (where appropriate) must be appended to the proposal. In additions, there is another vital issue of Conflict of Interest, wherein the researchers should furnish a statement regarding the same.

The Informed consent form (informed decision-making): A consent form, where appropriate, must be developed and attached to the proposal. It should be written in the prospective subjects’ mother tongue and in simple language which can be easily understood by the subject. The use of medical terminology should be avoided as far as possible. Special care is needed when subjects are illiterate. It should explain why the study is being done and why the subject has been asked to participate. It should describe, in sequence, what will happen in the course of the study, giving enough detail for the subject to gain a clear idea of what to expect. It should clarify whether or not the study procedures offer any benefits to the subject or to others, and explain the nature, likelihood and treatment of anticipated discomfort or adverse effects, including psychological and social risks, if any. Where relevant, a comparison with risks posed by standard drugs or treatment must be included. If the risks are unknown or a comparative risk cannot be given it should be so stated. It should indicate that the subject has the right to withdraw from the study at any time without, in any way, affecting his/her further medical care. It should assure the participant of confidentiality of the findings.

Ethics checklist: The proposal must describe the measures that will be undertaken to ensure that the proposed research is carried out in accordance with the World Medical Association Declaration of Helsinki on Ethical Principles for Medical research involving Human Subjects. 10 It must answer the following questions:

• • Is the research design adequate to provide answers to the research question? It is unethical to expose subjects to research that will have no value.
• • Is the method of selection of research subjects justified? The use of vulnerable subjects as research participants needs special justification. Vulnerable subjects include those in prison, minors and persons with mental disability. In international research it is important to mention that the population in which the study is conducted will benefit from any potential outcome of the research and the research is not being conducted solely for the benefit of some other population. Justification is needed for any inducement, financial or otherwise, for the participants to be enrolled in the study.
• • Are the interventions justified, in terms of risk/benefit ratio? Risks are not limited to physical harm. Psychological and social risks must also be considered.
• • For observations made, have measures been taken to ensure confidentiality?

Research setting 5 : The research setting includes all the pertinent facets of the study, such as the population to be studied (sampling frame), the place and time of study.

Study instruments 3 , 5 : Instruments are the tools by which the data are collected. For validated questionnaires/interview schedules, reference to published work should be given and the instrument appended to the proposal. For new a questionnaire which is being designed specifically for your study the details about preparing, precoding and pretesting of questionnaire should be furnished and the document appended to the proposal. Descriptions of other methods of observations like medical examination, laboratory tests and screening procedures is necessary- for established procedures, reference of published work cited but for new or modified procedure, an adequate description is necessary with justification for the same.

Collection of data: A short description of the protocol of data collection. For example, in a study on blood pressure measurement: time of participant arrival, rest for 5p. 10 minutes, which apparatus (standard calibrated) to be used, in which room to take measurement, measurement in sitting or lying down position, how many measurements, measurement in which arm first (whether this is going to be randomized), details of cuff and its placement, who will take the measurement. This minimizes the possibility of confusion, delays and errors.

Data analysis: The description should include the design of the analysis form, plans for processing and coding the data and the choice of the statistical method to be applied to each data. What will be the procedures for accounting for missing, unused or spurious data?

Monitoring, supervision and quality control: Detailed statement about the all logistical issues to satisfy the requirements of Good Clinical Practices (GCP), protocol procedures, responsibilities of each member of the research team, training of study investigators, steps taken to assure quality control (laboratory procedures, equipment calibration etc)

Gantt chart: A Gantt chart is an overview of tasks/proposed activities and a time frame for the same. You put weeks, days or months at one side, and the tasks at the other. You draw fat lines to indicate the period the task will be performed to give a timeline for your research study (take help of tutorial on youtube). 11

Significance of the study: Indicate how your research will refine, revise or extend existing knowledge in the area under investigation. How will it benefit the concerned stakeholders? What could be the larger implications of your research study?

Dissemination of the study results: How do you propose to share the findings of your study with professional peers, practitioners, participants and the funding agency?

Budget: A proposal budget with item wise/activity wise breakdown and justification for the same. Indicate how will the study be financed.

References: The proposal should end with relevant references on the subject. For web based search include the date of access for the cited website, for example: add the sentence "accessed on June 10, 2008".

Appendixes: Include the appropriate appendixes in the proposal. For example: Interview protocols, sample of informed consent forms, cover letters sent to appropriate stakeholders, official letters for permission to conduct research. Regarding original scales or questionnaires, if the instrument is copyrighted then permission in writing to reproduce the instrument from the copyright holder or proof of purchase of the instrument must be submitted.

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Writing a Global Health Proposal

A guide to how to begin the writing process

When writing a proposal, you must be motivated and passionate about your idea. After you have narrowed your idea into a concise purpose, you can begin the writing process.

If you need help on turning an idea into a proposal, click  here  for writing prof Penny Hirsch's advice.

One step that should not be skipped is creating an outline to organize your thoughts. Check out  this article on making outlines .

Here is the backbone for how your proposal should be structured. 

Introduction: Define the issue or problem with a statement of purpose

          1)     What is the purpose of the study?

          2)    Why should this issue be addressed/researched?

          3)    How will you contribute as a researcher?

          1)     Who has been studying this area and what are their conclusions?

          2)     What gaps need to be filled in their research? Are you aiming to fill those gaps?

          3)     How have you prepared to tackle this project?

Methodology: Here you will define a hypothesis or research question

          1)    How are variables related to one another?

          2)    What is the procedure for collecting data?

          3)    What is the overall design of the study? What are the time estimates?

          4)    How will you analyze data? What techniques or measurements?

Results and Conclusions: Discuss the possible findings and conclusions that will be gathered

          1)     What are the probable conclusions of your research?

          2)     Is this topic related to other topics? Can this topic be generalized? What is the larger picture?

          3)     Are there any implications for your study?

          4)     What are the possible limitations?

          5)     How will this research help you in your personal pursuits/future goals?

You must also be aware of citation, style and sentence level concerns

           Citation resources

          Gender Sensitive Language

          Passive voice

          Should I use "I"?

For examples of winning Global Health proposals cli ck  here .

Check out these other resources :

Check out the  FAQS  and  Checklist  (pdf).

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