WRITING A HEALTH RESEARCH PROPOSAL Presented by: Dr. Soha Rashed Aref Mostafa Professor of Community Medicine Alexandria Faculty of Medicine Egypt
What is research ?Research is the systematic collection,analysis and interpretation of data toanswer a certain question or solve aproblem.
Characteristics of a good research It demands a clear statement of the problem. It requires clear objectives and a plan (it is not aimlessly looking for something in order to come across a solution). It builds on existing data, using both positive and negative findings. New data should be systematically collected and analyzed to answer the original research questions/objectives.
The proposal is the detailed plan of the research studyWhy every research study should have a written proposal?The written proposal:• assists the investigators to clarify their thoughts and to think about all aspects of the study• is a necessary guide if a team (not a single investigator) is working on the research• is essential if the study involves research on human subjects or is on experimental animals, in order to get the institution’s ethical approval• is an essential component of a research proposal submitted for funding
A well-thought out and well-written proposal can be judged according to three main criteria:1. Is it adequate to answer the research question(s), and achieve the study objective?2. Is it feasible in the particular set-up for the study?3. Does it provide enough detail (methodology) that can allow another investigator to do the study and arrive at comparable conclusions?
Outlines of RP may vary according to thepreference of each investigator. However,the scientific community has agreed that allproposals should at least contain: The problem statement and justification for theresearch (the rationale for the study), the generaland specific objectives, methodology, the plan ofanalysis, and the timetable and budget. It shouldalso highlight how ethical issues will be considered.
BASIC COMPONENTS OF A RESEARCH PROTOCOL Title of the Research Project Project Summary Statement of the Problem (scientific justification) Applicability and Use of the Results (type of knowledge expected to be obtained and the intended purpose of its application)= Expected outcome of the study, dissemination & publication Theoretical Framework (argumentation, possible answers, hypothesis) Research Objectives (general and specific) Methodology − Operational Definitions (operationalization) − Type of Study and General Design − Study subjects, Sample Selection and Size, Unit of Analysis and Observation, Selection Criteria − Proposed Intervention (if applicable) − Data Collection Procedures, Instruments Used, and Methods for Data Quality Control − Procedures to Ensure Ethical Considerations in Research with Human Subjects − Pretesting the methodology (Pilot study) Plan for Analysis of Results ‒ Methods and Models of Data Analysis according to Types of Variables ‒ Programs to be Used for Data Analysis Bibliographic References Timetable (Work plan) Budget Annexes
Title of the Research Project A good title should be short, accurate, and concise. It may need to be revised after completion of the proposal writing to reflect more closely the sense of the study. The title should be descriptive. It should make the central objectives and variables of the study clear to the reader (reviewer). The title provides the "key words" for the classification and indexing of the project. It is important to specify what population or universe will be investigated.
Criticize the followingresearch titles !! Heart failure in diabetes Tuberculosis in HIV infected children Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy Cardiovascular comorbidities and blood pressure control in stroke survivors Prevalence and determinants of Protein Energy Malnutrition among under-fives in a semi-rural community in Alexandria, Egypt. Urinary incontinence among Alexandrian women: an outpatient study of prevalence, comorbidity, risk factors, and quality of life. Influence of interleukin-6 G-174C gene polymorphism on coronary artery disease, cardiovascular complications and mortality in dialysis patients
Project Summary Like the abstract of a research paper, the project summary, should be concise (no more than 300 words) and at the most a page long (font size 12, single spacing). Provided preferably on a separate page. It should summarize all the central elements of the protocol, for example the rationale, objectives, methods, populations, time frame, and expected outcomes. It should stand on its own, and not refer the reader to points in the project description.
Statement of the Problem This constitutes the scientific justification for the study; i.e., the basis of the need for research to generate further knowledge that will contribute to existing knowledge. The problem statement should make a convincing argument that there is not sufficient knowledge available to explain the problem and its possible alternative solutions , or it should make a convincing argument for the need to test what is known and taken as fact, if it is called into question by new findings or conditions. This section should show that the investigator has documented this problem and performed an exhaustive bibliographic review of the subject.
Literature review It prevents the duplication of work that has been done before. It helps the researchers to find out what others have found and reported on the problem. It helps the researcher to become more familiar with the various types of methodology that could be used in the study. It should provide convincing arguments why
A logical sequence for presentingthe statement would be: Magnitude, frequency, and distribution. Affected geographical areas and population groups affected by the problem. Ethnic and gender considerations. Probable causes of the problem: What is the current knowledge of the problem and its causes? Is there consensus? Is there controversy? Is there conclusive evidence? Possible solutions: In what ways have solutions to the problem been attempted? What has been proposed? What are the results? Unanswered questions: What remains to be answered? What areas have not been possible to understand, determine, verify, or test?
Applicability and Use of theResultsThis section describes the type of knowledge expected to be obtained and the intended purpose of its application.It should indicate the strategy for disseminating and using the research findings according to the potential users of the knowledge generated.The justification should answer the following: How does the research relate to the priorities of the Region and the country? What knowledge and information will be obtained? What is the ultimate purpose that the knowledge obtained from the study will serve? How will the results be disseminated? How will the results be used, and who will be the beneficiaries?The justification, which can be included as part of the statement of the problem or in a separate section, should make a convincing argument that the knowledge generated will be useful and generally applicable within the regional context.
Expected Outcomes of the Study The protocol should indicate how the study will contribute to advancement of knowledge, how the results will be utilized, not only in publications but also how they will likely affect health care, health systems, or health policies.Dissemination of Results and Publication Policy The protocol should specify not only dissemination of results in the scientific media, but also to the community and/ or the participants, and consider dissemination to the policy makers where relevant. Publication policy should be clearly discussed- for example who will take the lead in publication and who will be acknowledged in publications, etc.
Theoretical Framework = Background (argumentation, possible answers, hypothesis)This is derived from the statement of the problem. It also requires an exhaustive bibliographic review.The theoretical framework, considered the "grounds“/”basis” that support the central question of the study, states the investigators reasoning and arguments for the attempt to find the evidence that will offer an answer to the question and/or hypothesis. Establishment of relationships (identification of the relationships between the independent variable and the response variables). What is known, and how has it been explained? Are the results conclusive? What are the bases of the question? How are the possible answers to the question explained and defended? What are the assumptions? What are the relationships? What are the working hypotheses?
Research hypothesis Study hypotheses serve to direct and guide the research. Theyindicate the major independent (PREDISPOSING/ RISKFACTORS) and dependant variables (OUTCOME/CONDITION/ DISEASE) of interest.They suggest the type of data that must be collected and the typeof analysis that must be conducted in order to measure therelationship among the variables.
Why should research hypotheses be developed? Study hypotheses serve to direct and guide the research. They indicate the major independent and dependant variables of interest. They suggest the type of data that must be collected and the type of analysis that must be conducted in order to measure the relationship among the variables. A single hypothesis might state that variable A is associated with variable B, or that variable A causes variable B. Directrelationship Sometimes a hypothesis will specify that, under condition X, Y and Z, variable A is associated with variable B. A well-written hypothesis focuses the attention of the researcher on specific variables. Indirectrelationship Intervening/Control variables
Research objectivesWhy should research objectives be developed?The formulation of objectives will help you to:1. Focus the study (narrowing it down to essentials)2. Avoid the collection of data which are not strictly necessary for understanding and solving the problem you have identified; and3. Organize the study in clearly defined parts or phases.Properly formulated, specific objectives will facilitate the development of your research methodology and will help to orient the collection , analysis , interpretation and utilization of data.
What are the characteristics ofwell-constructed objectives?Objectives should be: Logical and coherent Feasible Realistic, considering local conditions Defined in operational terms that can be measured Phrased to clearly meet the purpose of the study (relevant)
How should objectives bestated? Objectives should be stated using “action verbs” that are specific enough to be measured: e.g. To determine …, To compare…, To verify…, To calculate…, To describe…, etc. Do not use vague non-action verbs such as: T o appreciate … To understand… To believe
Research Objectives(General and Specific)These should be defined after the theoretical framework has been developed, and the sequence is clear between the central question and possible responses to the questions and/or working hypotheses. General Objective : This should specify what kind of knowledge the study is expected to obtain. It should give a clear notion of what is to be described, determined, identified, compared, and, in the cases of studies with working hypotheses, confirmed. Specific Objectives : These disaggregate and follow logically from the general objective. They are a preliminary view of the research design. N.B. It is recognized that not all research requires the formulation of a hypothesis for subsequent empirical verification. However, all research should explain its general and specific objectives.
Example: A study looking into factors influencing utilization of maternal health care services in X District has the following objectives:General objective: To assess factors influencing utilization of maternal healthcare services in District X.Specific Objectives:1. To assess the knowledge, attitude and practice of pregnant women regarding antenatal care, and TT vaccination,2. To identify factors that influence women’s attendance at antenatal care (ANC) and institutional delivery care services,3. To identify the sources of delivery service and mothers’ preference of place of delivery,4. To determine coverage with ANC and TT vaccination among mothers.
Methodology The methodology section has to be thought out carefully and written in full detail. It is the most important part of the protocol. The methodology explains the procedures that will be used to achieve the objectives. In this section the operational definition for the variables used should be specified in detail, along with the type of variables and the ways to measure them. In addition, the methodology should consider the study design and the techniques and procedures used to achieve the proposed objectives.A description is given below of what the investigator is expected to specify in the methodology:
Operational Definition of Variables Based on the concepts that may be made explicit in the theoretical framework, the variables should be made operative; i.e. the investigator should clearly describe what is understood by each variable, what type of variable is being considered, and the way its values are to be reported (quantitatively, when the variable is numerical and qualitatively, when the variables do not have numerical values). Operationalization is a process that will vary in accordance with the type of research and research design. However, the variables should be clearly defined and appropriately operationalized.
Protocols will be considered incomplete if their operational aspects are vaguely formulated:e.g.,"The pertinent and relevant variables will be studied""demographic and social variables will be considered"or when the statement is so imprecise that it does not allow the relevance of the variables and their use to be appraised.
Examples of variables with different options for indicators
Type of Study and GeneralDesign The type of study and its design should be decided on the basis of its proposed objectives and the availability of resources, in addition to ethical considerations. The investigator should clearly state the type of study that will be conducted and provide a detailed explanation of its design. On this point, the investigator should also state the strategies and mechanisms that will be used to reduce or eliminate threats to the validity of the results, i.e. the so-called confounding factors (in the selection and assignment of subjects, the loss of cases, and the control of instruments and observers, etc.).
Ideal study designsaccording to purpose of study
Summary of research fields and recommended study designs
Study subjects or participants, Selection Criteria, Sample Selection and Size,Unit of Analysis and Observation
Research subjects or participants (cont.)Depending on the type of the study, the following questions should be answered:– What are the criteria for inclusion or selection?– What are the criteria for exclusion?– In intervention studies, how will subjects be allocated to index and comparison groups?– What are the criteria for discontinuation?
ObservationsInformation should be provided on the observations to be made, how they will be made, and how frequently will they be made.If the observation is made by a questionnaire, this should be appended to the protocol. Laboratory or other diagnostic and investigative procedures should be described.For established procedures, reference to appropriate published work is enough.For new or modified procedures, an adequate description is needed, with a justification for their use.
Sample sizeThe protocol should provide information and justification about samplesize.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 if it exposes human subjects to risk with no benefit to scientific knowledge.The basis on which sample size is calculated should be explained in the methodology section of the protocol.Calculation of sample size has been made easy by computer software programs. But the principles underlying the estimation should be well understood.
Proposed Intervention (if applicable) This section should be prepared when the research objectives and design provide for an evaluation of the results of an intervention (educational program, vaccine, treatment, etc.). Generally, these are comparative studies with experimental or quasi-experimental designs, before and after, where assessment is made of results attributable to the intervention.
There should be a full description provided of the intervention and an explanation given of the activities in their order of occurrence It is essential that the description of the intervention answer three fundamental questions:1. Who will be responsible for the intervention?2. Where will it take place?3. What activities will be performed, and with what frequency and intensity? Many research efforts that include interventions involving human subjects require an ethical review. In these cases, the investigator will be required to include a section in reference to this area.
Data Collection Procedures,Instruments Used, and Methods forData Quality Control The investigator should write up:- the procedures that will be used (population survey, in-depth interviews, non-participant observation, focus group dynamics, content analysis, etc.),- how and when the procedures will be used, and the instruments that will be used to collect information (questionnaire, interview guide, observation recording form, guide for a focus group moderator, content analysis guide, etc.).- Procedures or techniques that are standardized and/or documented in the literature should be described briefly, and bibliographic references should be given to sources where the details of these procedures and techniques can be found.
This section must describe in detail the procedures to be used to control the factors that undermine the validity or reliability of the results (controls for observers or persons responsible for compiling the information, and controls for the instruments). If the use of secondary data is required, the investigator will describe their sources, content, and quality so that it will be clear that the information required for the study is available. If use is made of historical, journalistic, or other similar types of documentary sources, indication should be provided of the sources and techniques that will be used to collect and analyze the information. The protocol should have an annex containing the instruments that will be used (questionnaires, interview guides, moderator guides, registration forms, etc.), and it should indicate their stage of preparation.
Procedures to Ensure Ethical Considerations in Research with Human SubjectsWhen the research involves human subjects, this section should explicitly provide for the following aspects: The known benefits and risks or disadvantages for the subjects in the study. Exact description of the information to be delivered to the subjects of the study and when it will be communicated orally or in writing.Examples of this information include:- the objectives and purposes of the study,- any experimental procedures,- any known short- or long-term risks, possible discomforts,- expected benefits of the procedures used,- duration of the studies,- alternative methods for treatment if the study is a clinical trial,- suspension of the study if a finding is made of negative effects or if there is sufficient evidence of positive effects that do not justify continuing with the study, and- the freedom of subjects to withdraw from the study whenever they want.
When appropriate, indicate any special incentive or treatment that subjects will receive through their participation in the study. If there is any type of payment/reward, specify the amount, method of delivery, time, and reason why payment is required. Indicate how the information obtained from participants in the study will be kept confidential. List the drugs, vaccines, diagnoses, procedures, or instruments to be used, whether they are registered, unregistered, new, or currently in use in the country.
Moreover, responses are required for other ethical aspects, such as: In studies where personal information will be obtained from the subjects, indicate how the information will be kept confidential. For studies involving the participation of subjects in an experiment (experimental or quasi-experimental trials, studies of interventions, etc.), information should be provided on the free and informed consent of the participants and the strategy that will be used to obtain it. Brief synopsis of how the research findings will be reported and delivered to the subjects involved in the study or to other interested parties. Indicate and justify the inclusion, as appropriate, of children, the elderly, physical challenged, and pregnant women. Justify the non-inclusion in the study group, if appropriate, of women (of any age), an ethnic minority, racial group, etc. When appropriate, indicate how the appropriate balance of the two sexes will be ensured in the study groups. In addition, indicate, when appropriate, how gender inequities and discrimination and disadvantages can affect womens involvement in the research.
Ethical considerationsAll research protocols in the biomedical field, particularly if it involves human subjects, must include a section addressing ethical considerations.This includes two components:1. The first is a written approval of the appropriate ethics review committee, together with a written form for informed consent, where appropriate.2. The second is a special section, preferably in the format of a checklist, to address all possible ethical concerns. Simply getting the ethical approval is not enough.
1. Approval by ethics review committeesFor studies in humans (or involving human biological materials), the protocol must be approved by the local, institutional or equivalent ethics committee and/or national ethics committee.For animal studies approval is required from the animal welfare committee of the institute or its equivalent.If no such committee exists, a statement signed by the principal investigator(s) should indicate that the research will be carried out in accordance with the International Guiding Principles for Biomedical Research involving Animals.
2. Informed decision-makingA consent form, where appropriate, must be developed and attached to the protocol.It should be written in the prospective subjects’ mother tongue.The consent form has two parts:a) a statement describing the study and the nature of the subject’s involvement in it; andb) a certificate of consent attesting to the subject’s consent.Both parts should be written in simple language so that the subject can easily understand the contents. As much as possible, the use of medical terminology in writing up the consent form should be avoided. Special care is needed when subjects are illiterate.
3. Ethics checklistA checklist must address ethical concerns that could be raised about the methodology, including the research design, selection of subjects, the interventions introduced and the observations to be made.
Ethics checklist (cont.)• 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. Particularly in international research, it is important to ensure that the population in which the study is conducted will benefit from any potential outcome of the research. They should not be doing it to the benefit of another population. Justification is needed for any inducement, financial or otherwise, for participants to be enrolled in the study.• Are interventions justified, in terms of risks/benefits 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?
Data management andanalysis The protocol should provide information on how the data will be managed, including data coding for computer analysis, monitoring and verification.
Plan for Analysis of ResultsAlthough this item is considered under the methodology, it is suggested that the investigator treat it as a separate section.What is expected from a plan of analysis: Methods and Models of Data Analysis according to Types of VariablesIn accordance with the proposed objectives and based on the types of variables, the investigator should specify how the variables will be measured and how they will be presented (quantitative and/or qualitative), indicating the analytical models and techniques (statistical, non-statistical, or analytical techniques for non-numeric data, etc.).The investigator should provide a preliminary scheme for tabulating the data (especially for variables that are presented numerically).It is recommended that special attention be given to the key variables that will be used in the statistical models.
Programs to Be Used for Data Analysis: Briefly describe the software packages that will be used and their anticipated applications. Power of the study, level of significance to be used, procedures for accounting for any missing or spurious data, etc. For projects involving qualitative approaches, specify in sufficient detail how the data will be analyzed.
Pretesting the methodology(Pilot study) It may be possible to pre-test: • The reactions of respondents to the research procedures and to questions related to sensitive issues. • The appropriateness of study type and research tools selected for the purpose of the study. • The appropriateness of format and wording of questionnaires and interview schedules and the accuracy of the translations. • The time needed to carry out interviews, observations or measurements. • The feasibility of the designed sampling procedures. • The feasibility of the designed procedures for data processing and analysis.
References References should be written in Vancouver style. Citing References1. Number references consecutively throughout the body of the text in the order in which they are first mentioned.2. DO NOT include references in your abstract. Identify references in text, tables and legends by numerals in parenthesis e.g. (1), (2,3) or (3-6).3. Some journals require references to be indicated in superscript which makes typing more difficult.
References4. DO NOT use abstracts as your source of information, you must consult the full text of the article before using it as a cited reference.5. When citing authors in the text, acknowledge only the first author where there are three or more authors, e.g. Williams et al. (1994) stated that ..... (1). Where there are two authors cite both, e.g. Jones and Smith (1997) reported that ....(2). Note that a reference at the end of a sentence is included before the period.6. The list of references must begin on a new page and they are cited by number and sequenced by order of citation. Include all authors in the list of references.
How to format variousreference sources?JournalsHarrison KL, Forster TH. Instruction to authors. Aust J Med Sci 1996; 17: 45- 47.Author(s) of a bookMurray-Smith S. Right Words: A guide to English usage in Australia. 2nd ed. Melbourne: Penguin Books; 1990.
How to format variousreference sources? Author(s) of a chapter in a book Bogduk N. Spinal pain: backache and neck pain. In: Gandevia SC, Burke D, Anthony M, editors. Science and practice in clinical neurology. Melbourne: Cambridge University Press; 1993; 39-57.
How to format variousreference sources? Internet referencing1. Document/Individual Work Tyner R. Sink or Swim: Internet search tools and techniques (version 3) [WWW document]. Okanagan University College, 7 July 1998. http://oksw01.okanagan.bc.ca/libr/connect 96/search.htm [accessed 19 July 2008].
How to format variousreference sources?2. Journals Zorn P, Emanoil M, Marshall L, Panek M. Advanced searching: Tricks of the trade. Online [WWW]. 1996 May; 9 pages. http://www.onlineinc.com/onlinemag/ MayOL/zorn5.html [accessed 19 July 1998].
Duration of the Project The protocol should specify the time that each phase of the project is likely to take, along with a detailed month by month timeline for each activity to be undertaken.
Timetable (Work plan) A work plan is a schedule that summarizes, in a clear fashion, various components of a research project and how they fit together. It should include: 1. The various tasks to be performed 2. When the tasks will be performed 3. Who will perform the tasks
Budget The budget section should contain a detailed item-wise breakdown of the funds requested for, along with a justification for each item.
A HYPOTHETICAL PROPOSAL BUDGET
Annexes (Appendices) Include in the appendices of your proposal any additional information you think might be helpful to a proposal reviewer. Biographical data on the principal investigator The study questionnaire (and/or other data collection tools) The informed consent form A copy of the approval from the Institutional Review Board.
Will the project be funded?Funding organizations receive many more proposals than what they can fund. The selection process is very competitive.The following factors are generally taken into consideration in deciding whether the proposal is to be funded:• importance and relevance of the research question to the declared interests of the agency; success in obtaining a grant depends on matching the proposal with the interests of a granting agency• quality of the research design• ability of the investigators to carry out the project
Will the project be funded?(cont.)• capacity of the research facility to carry out the project, ability of the institution to handle the administrative and financial procedures• satisfactory ethical considerations• realistic and justifiable budget, within the limits set by the agency, and normally with no expectations for continued funding after the completion of the project
Will the project be funded?(cont.)• reasonable time-frame for completion of the project• understanding of anticipated problems• clarity and style of the written proposal.Writing with enthusiasm is a good idea, but overstatements should be avoided.The applicant should be realistic about the limitations of the study.