WRITING A HEALTH WRITING A HEALTH RESEARCH RESEARCH PROPOSALPROPOSAL

Presented by:Presented by:Dr. Soha Rashed Aref MostafaDr. Soha Rashed Aref Mostafa

Professor of Community MedicineProfessor of Community MedicineAlexandria Faculty of MedicineAlexandria Faculty of Medicine

EgyptEgypt

What is researchWhat is research??

Research is the systematic Research is the systematic collection, analysis and collection, analysis and interpretation of data to answer interpretation of data to answer a certain question or solve a a certain question or solve a problem.problem.

Characteristics of a Characteristics of a good researchgood research

It demands a clear statement of the problem. It demands a clear statement of the problem.

It requires clear objectives and a plan (it is not It requires clear objectives and a plan (it is not aimlessly looking for something in order to come aimlessly looking for something in order to come across a solution). across a solution).

It builds on existing data, using both positive and It builds on existing data, using both positive and negative findings. negative findings.

New data should be systematically collected and New data should be systematically collected and analyzed to answer the original research analyzed to answer the original research questions/objectives. questions/objectives.

The proposal is the detailed plan of the research The proposal is the detailed plan of the research studystudy

Why every research study should have a written Why every research study should have a written proposal?proposal?

The written proposal:The written proposal:

• • assists the investigators to clarify their thoughts and to assists the investigators to clarify their thoughts and to think about all aspects of the studythink about all aspects of the study

• • is a necessary guide if a team (not a single investigator) is is a necessary guide if a team (not a single investigator) is working on the researchworking on the research

• • is essential if the study involves research on human is essential if the study involves research on human subjects or is on experimental animals, in order to get the subjects or is on experimental animals, in order to get the institution’s ethical approvalinstitution’s ethical approval

• • is an essential component of a research proposal is an essential component of a research proposal submitted for fundingsubmitted for funding

A well-thought out and well-written proposal A well-thought out and well-written proposal can be judged according to three main can be judged according to three main criteria:criteria:

1.1. Is it adequate to answer the research Is it adequate to answer the research question(s), and achieve the study objective?question(s), and achieve the study objective?

2.2. Is it feasible in the particular set-up for the Is it feasible in the particular set-up for the study?study?

3.3. Does it provide enough detail (methodology) Does it provide enough detail (methodology) that can allow another investigator to do the that can allow another investigator to do the study and arrive at comparable conclusions?study and arrive at comparable conclusions?

Outlines of RP may vary according to Outlines of RP may vary according to the preference of each investigator. the preference of each investigator. However, the scientific community has However, the scientific community has agreed that all proposals should at least agreed that all proposals should at least contain: contain:

The The problem statement and justification for problem statement and justification for the research (the rationale for the studythe research (the rationale for the study), the ), the general and specific general and specific objectivesobjectives, , methodologymethodology, the , the plan of analysisplan of analysis, and the , and the timetable timetable and and budgetbudget. It should also highlight . It should also highlight how how ethical issuesethical issues will be considered. will be considered.

BASIC COMPONENTS OF A BASIC COMPONENTS OF A RESEARCH PROTOCOLRESEARCH PROTOCOL

Title of the Research ProjectTitle of the Research Project Project SummaryProject Summary Statement of the ProblemStatement of the Problem (scientific justification)(scientific justification) Applicability and Use of the ResultsApplicability and Use of the Results (type of knowledge expected to be (type of knowledge expected to be

obtained and the intended purpose of its application)= obtained and the intended purpose of its application)= Expected outcome of Expected outcome of the study, dissemination & publicationthe study, dissemination & publication

Theoretical FrameworkTheoretical Framework (argumentation, possible answers, hypothesis)(argumentation, possible answers, hypothesis) Research ObjectivesResearch Objectives (general and specific) (general and specific) MethodologyMethodology

− Operational Definitions (operationalization)Operational Definitions (operationalization)− Type of Study and General DesignType of Study and General Design− Study subjects, Sample Selection and Size, Unit of Analysis and Observation, Study subjects, Sample Selection and Size, Unit of Analysis and Observation,

Selection CriteriaSelection Criteria− Proposed Intervention (if applicable)Proposed Intervention (if applicable)− Data Collection Procedures, Instruments Used, and Methods for Data Quality Data Collection Procedures, Instruments Used, and Methods for Data Quality

ControlControl− Procedures to Ensure Ethical Considerations in Research with Human SubjectsProcedures to Ensure Ethical Considerations in Research with Human Subjects− Pretesting the methodology (Pilot study)Pretesting the methodology (Pilot study)

Plan for Analysis of ResultsPlan for Analysis of Results‒ Methods and Models of Data Analysis according to Types of VariablesMethods and Models of Data Analysis according to Types of Variables‒ Programs to be Used for Data AnalysisPrograms to be Used for Data Analysis

Bibliographic ReferencesBibliographic References Timetable (Work plan)Timetable (Work plan) BudgetBudget AnnexesAnnexes

Title of the Research Title of the Research ProjectProject

A good title should be short, accurate, and concise.A good title should be short, accurate, and concise.

It may need to be revised after completion of the It may need to be revised after completion of the proposal writing to reflect more closely the sense of the proposal writing to reflect more closely the sense of the study. study.

The title should be descriptive. It should make the The title should be descriptive. It should make the central objectives and variables of the study clear to the central objectives and variables of the study clear to the reader (reviewer). reader (reviewer).

The title provides the "key words" for the classification The title provides the "key words" for the classification and indexing of the project. and indexing of the project.

It is important to specify what population or universe will It is important to specify what population or universe will be investigated. be investigated.

Criticize the following Criticize the following research titles !!research titles !!

Heart failure in diabetesHeart failure in diabetes Tuberculosis in HIV infected childrenTuberculosis in HIV infected children Predicting mortality in patients with bleeding peptic ulcers after Predicting mortality in patients with bleeding peptic ulcers after

therapeutic endoscopytherapeutic endoscopy Cardiovascular comorbidities and blood pressure control in stroke Cardiovascular comorbidities and blood pressure control in stroke

survivorssurvivors Prevalence and determinants of Protein Energy Malnutrition Prevalence and determinants of Protein Energy Malnutrition

among under-fives in a semi-rural community in Alexandria, among under-fives in a semi-rural community in Alexandria, Egypt.Egypt.

Urinary incontinence among Alexandrian women: an outpatient Urinary incontinence among Alexandrian women: an outpatient study of prevalence, comorbidity, risk factors, and quality of life.study of prevalence, comorbidity, risk factors, and quality of life.

Influence of interleukin-6 G-174C gene polymorphism on Influence of interleukin-6 G-174C gene polymorphism on coronary artery disease, cardiovascular complications and coronary artery disease, cardiovascular complications and mortality in dialysis patientsmortality in dialysis patients

Project SummaryProject Summary

Like the abstract of a research paper, the Like the abstract of a research paper, the project summary, should be concise (no more project summary, should be concise (no more than 300 words) and at the most a page long than 300 words) and at the most a page long (font size 12, single spacing). Provided (font size 12, single spacing). Provided preferably on a separate page.preferably on a separate page.

It should summarize all the It should summarize all the central elementscentral elements of the protocol, for example the of the protocol, for example the rationale, rationale, objectives, methods, populations, time frame, objectives, methods, populations, time frame, and expected outcomes.and expected outcomes.

It should stand on its own, and not refer the It should stand on its own, and not refer the reader to points in the project description. reader to points in the project description.

Statement of the ProblemStatement of the Problem

This constitutes the scientific justification for the This constitutes the scientific justification for the study; i.e., the basis of the need for research to study; i.e., the basis of the need for research to generate further knowledge that will contribute to generate further knowledge that will contribute to existing knowledge. existing knowledge.

The problem statement should make a The problem statement should make a convincing convincing argumentargument that that there is not sufficient knowledge there is not sufficient knowledge available to explain the problem and its possible available to explain the problem and its possible alternative solutionsalternative solutions, or it should make a , or it should make a convincing convincing argumentargument for the for the need to test what is known and need to test what is known and taken as facttaken as fact, if it is called into question by new , if it is called into question by new findings or conditions.findings or conditions.

This section should show that the investigator has This section should show that the investigator has documented this problem and performed documented this problem and performed an an exhaustive bibliographic reviewexhaustive bibliographic review of the subject. of the subject.

Literature reviewLiterature review

It It prevents the duplicationprevents the duplication of work that has of work that has been done before.been done before.

It helps the researchers to find out It helps the researchers to find out what what others have foundothers have found and reported on the and reported on the problem.problem.

It helps the researcher to become more It helps the researcher to become more familiar with the various types of familiar with the various types of methodologymethodology that could be used in the study. that could be used in the study.

It should provide It should provide convincing argumentsconvincing arguments why why this particular research project is needed.this particular research project is needed.

A logical sequence for A logical sequence for presenting the statement would presenting the statement would be:be:

Magnitude, frequency, and distribution.Magnitude, frequency, and distribution. Affected geographical Affected geographical areas and population groups affected by the problem.areas and population groups affected by the problem. Ethnic and Ethnic and gender considerations.gender considerations.

Probable causes of the problem:Probable causes of the problem: What is the current knowledge What is the current knowledge of the problem and its causes? Is there consensus? Is there of the problem and its causes? Is there consensus? Is there controversy? Is there conclusive evidence?controversy? Is there conclusive evidence?

Possible solutions:Possible solutions: In what ways have solutions to the problem In what ways have solutions to the problem been attempted? What has been proposed? What are the results?been attempted? What has been proposed? What are the results?

Unanswered questions:Unanswered questions: What remains to be answered? What What remains to be answered? What areas have not been possible to understand, determine, verify, or areas have not been possible to understand, determine, verify, or test?test?

Applicability and Use of Applicability and Use of the Resultsthe Results

This section describes the type of knowledge expected to be obtained This section describes the type of knowledge expected to be obtained and the intended purpose of its application. and the intended purpose of its application.

It should indicate the strategy for disseminating and using the research It should indicate the strategy for disseminating and using the research findings according to the potential users of the knowledge findings according to the potential users of the knowledge generated. generated.

The justification should answer the following:The justification should answer the following: How does the research relate to the priorities of the Region and the How does the research relate to the priorities of the Region and the

country?country? What knowledge and information will be obtained?What knowledge and information will be obtained? What is the ultimate purpose that the knowledge obtained from the What is the ultimate purpose that the knowledge obtained from the

study will serve?study will serve? How will the results be disseminated?How will the results be disseminated? How will the results be used, and who will be the beneficiaries?How will the results be used, and who will be the beneficiaries?

The justification, which can be included as part of the The justification, which can be included as part of the statement of the problem or in a separate section, statement of the problem or in a separate section, should make a should make a convincing argumentconvincing argument that the that the knowledge generated will be useful and generally knowledge generated will be useful and generally applicable within the regional context. applicable within the regional context.

Expected Outcomes of the StudyExpected Outcomes of the Study The protocol should indicate how the study will contribute to The protocol should indicate how the study will contribute to

advancement of knowledge, how the results will be utilized, advancement of knowledge, how the results will be utilized, not only in publications but also how they will likely affect not only in publications but also how they will likely affect health care, health systems, or health policies. health care, health systems, or health policies.

Dissemination of Results and Publication PolicyDissemination of Results and Publication Policy The protocol should specify not only dissemination of results The protocol should specify not only dissemination of results

in the scientific media, but also to the community and/ or in the scientific media, but also to the community and/ or the participants, and consider dissemination to the policy the participants, and consider dissemination to the policy makers where relevant. makers where relevant.

Publication policy should be clearly discussed- for example Publication policy should be clearly discussed- for example who will take the lead in publication and who will be who will take the lead in publication and who will be acknowledged in publications, etc.acknowledged in publications, etc.

Theoretical Framework = BackgroundTheoretical Framework = Background(argumentation, possible answers, (argumentation, possible answers,

hypothesis)hypothesis)

This is derived from the statement of the problem. It also requires This is derived from the statement of the problem. It also requires an an exhaustive bibliographic reviewexhaustive bibliographic review..

The theoretical framework, considered the "grounds“/”basis” that The theoretical framework, considered the "grounds“/”basis” that support the central question of the study, support the central question of the study, states the states the investigator's reasoning and arguments for the attempt to find investigator's reasoning and arguments for the attempt to find the evidence that will offer an answer to the question and/or the evidence that will offer an answer to the question and/or hypothesishypothesis. .

Establishment of relationships (identification of the Establishment of relationships (identification of the relationships between the independent variable and the relationships between the independent variable and the response variables). What is known, and how has it been response variables). What is known, and how has it been explained? Are the results conclusive? What are the bases of explained? Are the results conclusive? What are the bases of the question?the question?

How are the possible answers to the question explained and How are the possible answers to the question explained and defended? What are the assumptions? What are the defended? What are the assumptions? What are the relationships? What are the working hypotheses?relationships? What are the working hypotheses?

Research hypothesisResearch hypothesis

Study hypotheses serve to direct and guide the research. Study hypotheses serve to direct and guide the research. They indicate the major They indicate the major independent independent (PREDISPOSING/ (PREDISPOSING/ RISK FACTORS)RISK FACTORS) and and dependant variables dependant variables (OUTCOME/ (OUTCOME/ CONDITION/ DISEASE)CONDITION/ DISEASE) of interest. of interest.

They suggest the type of data that must be collected and They suggest the type of data that must be collected and the type of analysis that must be conducted in order to the type of analysis that must be conducted in order to measure the relationship among the variables. measure the relationship among the variables.

Why should research Why should research hypotheses be hypotheses be developed?developed? Study hypotheses serve to direct and guide the research. Study hypotheses serve to direct and guide the research.

They indicate the major independent and dependant variables of They indicate the major independent and dependant variables of interest. interest.

They suggest the type of data that must be collected and the type They suggest the type of data that must be collected and the type of analysis that must be conducted in order to measure the of analysis that must be conducted in order to measure the relationship among the variables. relationship among the variables.

A single hypothesis might state that variable A is associated A single hypothesis might state that variable A is associated with variable B, or that variable A causes variable B.with variable B, or that variable A causes variable B.

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.

Intervening/Control variables

Direct relationship

Indirect relationship

Research objectivesResearch objectives

Why should research objectives be Why should research objectives be developed?developed?

The formulation of objectives will help you The formulation of objectives will help you to:to:

1.1. Focus Focus the study (narrowing it down to the study (narrowing it down to essentials)essentials)

2.2. Avoid Avoid the collection of data which are the collection of data which are not strictly necessary for not strictly necessary for understanding and solving the problem understanding and solving the problem you have identified; and you have identified; and

3.3. OrganizeOrganize the study in clearly defined the study in clearly defined parts or phases. parts or phases.

Properly formulated, specific objectivesProperly formulated, specific objectives will will facilitate the development of your facilitate the development of your research research methodologymethodology and will help to and will help to orient the orient the collectioncollection, , analysisanalysis, , interpretationinterpretation and and utilizationutilization of data. of data.

What are the characteristics What are the characteristics of well-constructed of well-constructed objectives?objectives?

Objectives should be:Objectives should be:

Logical and coherentLogical and coherent FeasibleFeasible Realistic, considering local conditionsRealistic, considering local conditions Defined in operational terms that can Defined in operational terms that can

be measuredbe measured Phrased to clearly meet the purpose of Phrased to clearly meet the purpose of

the study (relevant)the study (relevant)

How should objectives be How should objectives be stated?stated?

Objectives should be stated using Objectives should be stated using “action verbs”“action verbs” that are specific enough that are specific enough to be measured:to be measured:

e.g.e.g. To determine …, To compare…, To determine …, To compare…, To verify…, To calculate…, To To verify…, To calculate…, To describe…, etc.describe…, etc.

Do not use vague non-action verbsDo not use vague non-action verbs such as: Tsuch as: To appreciate … To o appreciate … To understand… To believeunderstand… To believe

Research ObjectivesResearch Objectives (General and Specific) (General and Specific)

These should be defined after the theoretical framework has been These should be defined after the theoretical framework has been developed, and the sequence is clear between the central developed, and the sequence is clear between the central question and possible responses to the questions and/or question and possible responses to the questions and/or working hypotheses. working hypotheses.

General ObjectiveGeneral Objective:: This should specify what kind of knowledge This should specify what kind of knowledge the study is expected to obtain. It should give a clear notion of the study is expected to obtain. It should give a clear notion of what is to be described, determined, identified, compared, and, what is to be described, determined, identified, compared, and, in the cases of studies with working hypotheses, confirmed.in the cases of studies with working hypotheses, confirmed.

Specific ObjectivesSpecific Objectives: : These disaggregate and follow logically These disaggregate and follow logically fromfrom the general objective. They are a preliminary view of the the general objective. They are a preliminary view of the research design.research design.

N.B.N.B. It is recognized that not all research requires the It is recognized that not all research requires the formulation of a hypothesis for subsequent empirical formulation of a hypothesis for subsequent empirical verification. However, all research should explain its general verification. However, all research should explain its general and specific objectives.and specific objectives.

Example: A study looking into factors Example: A study looking into factors influencing utilization of maternal health care influencing utilization of maternal health care services in X District has the following services in X District has the following objectives:objectives:

General objective:General objective: To assess factors influencing utilization To assess factors influencing utilization of maternal healthcare services in District X.of maternal healthcare services in District X.

Specific Objectives:Specific Objectives:1. To assess the knowledge, attitude and practice of 1. To assess the knowledge, attitude and practice of

pregnant women regarding antenatal care, and TT pregnant women regarding antenatal care, and TT vaccination,vaccination,

2. To identify factors that influence women’s attendance at 2. To identify factors that influence women’s attendance at antenatal care (ANC) and institutional delivery care antenatal care (ANC) and institutional delivery care services,services,

3. To identify the sources of delivery service and mothers’ 3. To identify the sources of delivery service and mothers’ preference of place of delivery,preference of place of delivery,

4. To determine coverage with ANC and TT vaccination 4. To determine coverage with ANC and TT vaccination among mothers.among mothers.

MethodologyMethodology The methodology section has to be thought out carefully and The methodology section has to be thought out carefully and

written in full detail.written in full detail. It is the most important part of the protocol.It is the most important part of the protocol.

The methodology explains the procedures that will be used to The methodology explains the procedures that will be used to achieve the objectives. achieve the objectives.

In this section the operational definition for the variables used In this section the operational definition for the variables used should be specified in detail, along with the type of variables should be specified in detail, along with the type of variables and the ways to measure them. and the ways to measure them.

In addition, the methodology should consider the study design In addition, the methodology should consider the study design and the techniques and procedures used to achieve the and the techniques and procedures used to achieve the proposed objectives. proposed objectives.

A description is given below of what the investigator is expected A description is given below of what the investigator is expected to specify in the methodology:to specify in the methodology:

Operational Definition of Operational Definition of VariablesVariables

Based on the concepts that may be made explicit in Based on the concepts that may be made explicit in the theoretical framework, the theoretical framework, the variables should be the variables should be made operative;made operative; i.e. the investigator should clearly i.e. the investigator should clearly describe describe what is understood by each variablewhat is understood by each variable, what , what type of variabletype of variable is being considered, and the is being considered, and the way its way its values are to be reportedvalues are to be reported ( (quantitativelyquantitatively, when the , when the variable is numerical and variable is numerical and qualitativelyqualitatively, when the , when the variables do not have numerical values).variables do not have numerical values).

Operationalization is a process that will vary in Operationalization is a process that will vary in accordance with the type of research and research accordance with the type of research and research design. However, the variables should be clearly design. However, the variables should be clearly defined and appropriately operationalized.defined and appropriately operationalized.

Protocols will be considered incomplete if their Protocols will be considered incomplete if their operational aspects are vaguely formulated: operational aspects are vaguely formulated:

e.g.,e.g.,"The pertinent and relevant variables will be "The pertinent and relevant variables will be

studied" studied"

"demographic and social variables will be "demographic and social variables will be considered" considered"

or when the statement is so or when the statement is so impreciseimprecise that it does that it does not allow the relevance of the variables and their not allow the relevance of the variables and their use to be appraised.use to be appraised.

Examples of variables with different options for Examples of variables with different options for

indicatorsindicators

Type of Study and Type of Study and General DesignGeneral Design

The type of study and its design should be decided on The type of study and its design should be decided on the basis of its proposed the basis of its proposed objectivesobjectives and the availability and the availability of of resourcesresources, in addition to , in addition to ethical considerationsethical considerations. .

The investigator should clearly state the type of study The investigator should clearly state the type of study that will be conducted and provide a detailed that will be conducted and provide a detailed explanation of its design. explanation of its design.

On this point, the investigator should also state the On this point, the investigator should also state the strategies and mechanisms that will be used to reduce strategies and mechanisms that will be used to reduce or eliminate or eliminate threats to the validitythreats to the validity of the results, i.e. of the results, i.e. the so-called the so-called confounding factorsconfounding factors (in the selection and (in the selection and assignment of subjects, the loss of cases, and the assignment of subjects, the loss of cases, and the control of instruments and observers, etc.). control of instruments and observers, etc.).

Ideal study designs according to purpose of

study

Summary of research fields and recommended study designs

Study subjects or participants, Study subjects or participants,

Selection Criteria,Selection Criteria,

Sample Selection and Size, Sample Selection and Size,

Unit of Analysis and Unit of Analysis and ObservationObservation

Research subjects or Research subjects or participants (cont.)participants (cont.)

Depending on the type of the study, Depending on the type of the study, the following questions should be the following questions should be answered:answered:

– – What are the criteria for inclusion or What are the criteria for inclusion or

selection?selection?– – What are the criteria for exclusion?What are the criteria for exclusion?– – In intervention studies, how will subjects In intervention studies, how will subjects

be allocated to index and comparison be allocated to index and comparison groups?groups?

– – What are the criteria for discontinuation?What are the criteria for discontinuation?

ObservationsObservations

Information should be provided on the observations to be Information should be provided on the observations to be made, how they will be made, and how frequently will made, how they will be made, and how frequently will they be made. they be made.

If the observation is made by a If the observation is made by a questionnairequestionnaire, this should , this should be appended to the protocol. be appended to the protocol. Laboratory or other Laboratory or other diagnostic and investigative proceduresdiagnostic and investigative procedures should be should be described. described.

For For established proceduresestablished procedures, reference to appropriate , reference to appropriate published work is enough. published work is enough.

For For new or modified proceduresnew or modified procedures, an adequate description , an adequate description is needed, with a justification for their use.is needed, with a justification for their use.

Sample sizeSample size

The protocol should provide information and justification about The protocol should provide information and justification about samplesample

size. size.

A larger sample sizeA larger sample size than needed to test the research hypothesis than needed to test the research hypothesis increases the increases the costcost and and durationduration of the study, and will be of the study, and will be unethicalunethical if it exposes human subjects to any potential if it exposes human subjects to any potential unnecessary risk without additional benefit. unnecessary risk without additional benefit.

A smaller sample sizeA smaller sample size than needed can also be unethical if it than needed can also be unethical if it exposes human subjects to risk with no benefit to scientific exposes human subjects to risk with no benefit to scientific knowledge. knowledge.

The basis on which sample size is calculatedThe basis on which sample size is calculated should be explained should be explained in the methodology section of the protocol. in the methodology section of the protocol.

Calculation of sample sizeCalculation of sample size has been made easy by computer has been made easy by computer software programs. But the principles underlying the estimation software programs. But the principles underlying the estimation should be well understood.should be well understood.

Proposed InterventionProposed Intervention (if (if applicable)applicable)

This section should be prepared when This section should be prepared when the research objectives and design the research objectives and design provide for an evaluation of the results provide for an evaluation of the results of an intervention (educational of an intervention (educational program, vaccine, treatment, etc.). program, vaccine, treatment, etc.).

Generally, these are comparative Generally, these are comparative studies with experimental or quasi-studies with experimental or quasi-experimental designs, before and experimental designs, before and after, where assessment is made of after, where assessment is made of results attributable to the intervention. results attributable to the intervention.

There should be a full description provided of the There should be a full description provided of the intervention and an explanation given of the activities in intervention and an explanation given of the activities in their order of occurrencetheir order of occurrence

It is essential that the description of the intervention It is essential that the description of the intervention answer three fundamental questions:answer three fundamental questions:

1.1. Who will be responsible for the intervention? Who will be responsible for the intervention? 2.2. Where will it take place? Where will it take place? 3.3. What activities will be performed, and with what frequency What activities will be performed, and with what frequency

and intensity?and intensity?

Many research efforts that include interventions involving Many research efforts that include interventions involving human subjects require an ethical review. In these cases, human subjects require an ethical review. In these cases, the investigator will be required to include a section in the investigator will be required to include a section in reference to this area.reference to this area.

Data Collection Procedures, Data Collection Procedures, Instruments Used, and Methods Instruments Used, and Methods for Data Quality Controlfor Data Quality Control The investigator should write up:The investigator should write up:

- the the proceduresprocedures that will be used (population survey, in- that will be used (population survey, in-depth interviews, non-participant observation, focus group depth interviews, non-participant observation, focus group dynamics, content analysis, etc.), dynamics, content analysis, etc.),

- how and when the how and when the proceduresprocedures will be used, and the will be used, and the instrumentsinstruments that will be used to collect information that will be used to collect information (questionnaire, interview guide, observation recording form, (questionnaire, interview guide, observation recording form, guide for a focus group moderator, content analysis guide, guide for a focus group moderator, content analysis guide, etc.). etc.).

- Procedures or techniques that are Procedures or techniques that are standardized and/or standardized and/or documented in the literaturedocumented in the literature should be described briefly, should be described briefly, and bibliographic references should be given to sources and bibliographic references should be given to sources where the details of these procedures and techniques can where the details of these procedures and techniques can be found.be found.

This section must describe in detail the This section must describe in detail the procedures to be used procedures to be used to control the factors that undermine the validity or reliabilityto control the factors that undermine the validity or reliability of of the results (controls for observers or persons responsible for the results (controls for observers or persons responsible for compiling the information, and controls for the instruments).compiling the information, and controls for the instruments).

If the use of If the use of secondary datasecondary data is required, the investigator will is required, the investigator will describe their sources, content, and quality so that it will be describe their sources, content, and quality so that it will be clear that the information required for the study is available. If clear that the information required for the study is available. If use is made of historical, journalistic, or other similar types of use is made of historical, journalistic, or other similar types of documentary sources, indication should be provided of the documentary sources, indication should be provided of the sources and techniques that will be used to collect and analyze sources and techniques that will be used to collect and analyze the information.the information.

The protocol should have an annex containing the The protocol should have an annex containing the instruments that will be used (questionnaires, interview instruments that will be used (questionnaires, interview guides, moderator guides, registration forms, etc.),guides, moderator guides, registration forms, etc.), and and it should indicate their stage of preparation.it should indicate their stage of preparation.

Procedures to Ensure Ethical Procedures to Ensure Ethical Considerations in Research with Considerations in Research with Human SubjectsHuman Subjects

When the research involves human subjects, this section should When the research involves human subjects, this section should explicitly provide for the following aspects:explicitly provide for the following aspects:

The known benefits and risks or disadvantages for the subjects in the The known benefits and risks or disadvantages for the subjects in the study.study.

Exact description of the information to be delivered to the subjects of Exact description of the information to be delivered to the subjects of the study and when it will be communicated orally or in writing. the study and when it will be communicated orally or in writing.

Examples of this information include:Examples of this information include: - the objectives and purposes of the study, the objectives and purposes of the study, - any experimental procedures, any experimental procedures, - any known short- or long-term risks, possible discomforts, any known short- or long-term risks, possible discomforts, - expected benefits of the procedures used, expected benefits of the procedures used, - duration of the studies, duration of the studies, - alternative methods for treatment if the study is a clinical trial, 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 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 there is sufficient evidence of positive effects that do not justify continuing with the study, and continuing with the study, and

- the freedom of subjects to withdraw from the study whenever they the freedom of subjects to withdraw from the study whenever they want.want.

When appropriate, indicate When appropriate, indicate any special incentiveany special incentive or or treatment that subjects will receive through their treatment that subjects will receive through their participation in the study. If there is any type of participation in the study. If there is any type of payment/reward, specify the amount, method of payment/reward, specify the amount, method of delivery, time, and reason why payment is required.delivery, time, and reason why payment is required.

Indicate how the information obtained from Indicate how the information obtained from participants in the study will be kept participants in the study will be kept confidentialconfidential..

List the drugs, vaccines, diagnoses, procedures, or List the drugs, vaccines, diagnoses, procedures, or instruments to be used, whether they are registered, instruments to be used, whether they are registered, unregistered, new, or currently in use in the country.unregistered, new, or currently in use in the country.

Moreover, responses are required for other ethical aspects, Moreover, responses are required for other ethical aspects, such as:such as:

In studies where personal information will be obtained from the In studies where personal information will be obtained from the subjects, indicate how the information will be kept confidential.subjects, indicate how the information will be kept confidential.

For studies involving the participation of subjects in an For studies involving the participation of subjects in an experiment (experimental or quasi-experimental trials, studies of experiment (experimental or quasi-experimental trials, studies of interventions, etc.), information should be provided on the interventions, etc.), information should be provided on the free free and informed consentand informed consent of the participants and the strategy that of the participants and the strategy that will be used to obtain it.will be used to obtain it.

Brief synopsis of how the research findings will be reported and Brief synopsis of how the research findings will be reported and delivered to the subjects involved in the study or to other delivered to the subjects involved in the study or to other interested parties.interested parties.

Indicate and justify the inclusion, as appropriate, of children, the Indicate and justify the inclusion, as appropriate, of children, the elderly, physical challenged, and pregnant women. Justify the elderly, physical challenged, and pregnant women. Justify the non-inclusion in the study group, if appropriate, of women (of any non-inclusion in the study group, if appropriate, of women (of any age), an ethnic minority, racial group, etc.age), an ethnic minority, racial group, etc.

When appropriate, indicate how the appropriate balance of the When appropriate, indicate how the appropriate balance of the two sexes will be ensured in the study groups. In addition, two sexes will be ensured in the study groups. In addition, indicate, when appropriate, how gender inequities and indicate, when appropriate, how gender inequities and discrimination and disadvantages can affect women's discrimination and disadvantages can affect women's involvement in the research.involvement in the research.

Ethical considerationsEthical considerations

All research protocols in the biomedical field, particularly if it All research protocols in the biomedical field, particularly if it involves human subjects, must include a section addressing involves human subjects, must include a section addressing ethical considerations. ethical considerations.

This includes two components: This includes two components:

1.1. The first is a written approval of the appropriate ethics The first is a written approval of the appropriate ethics review committee, together with a written form for informed review committee, together with a written form for informed consent, where appropriate. consent, where appropriate.

2.2. The second is a special section, preferably in the format of a The second is a special section, preferably in the format of a checklist, to address all possible ethical concerns. Simply checklist, to address all possible ethical concerns. Simply getting the ethical approval is not enough.getting the ethical approval is not enough.

1. Approval by ethics review committees1. Approval by ethics review committees

For studies in humans (or involving human biological For studies in humans (or involving human biological materials), the protocol must be approved by the materials), the protocol must be approved by the local, institutional or equivalent ethics committee local, institutional or equivalent ethics committee and/or national ethics committee.and/or national ethics committee.

For animal studies approval is required from the animal For animal studies approval is required from the animal welfare committee of the institute or its equivalent. welfare committee of the institute or its equivalent.

If no such committee exists, a statement signed by the If no such committee exists, a statement signed by the principal investigator(s) should indicate that the principal investigator(s) should indicate that the research will be carried out in accordance with the research will be carried out in accordance with the International Guiding Principles for Biomedical International Guiding Principles for Biomedical Research involving Animals.Research involving Animals.

2. Informed decision-making2. Informed decision-making

A consent form, where appropriate, must be developed and A consent form, where appropriate, must be developed and attached to the protocol.attached to the protocol.

It should be written in the prospective subjects’ mother tongue. It should be written in the prospective subjects’ mother tongue.

The consent form has two parts: The consent form has two parts: a) a statement describing the study and the nature of the a) a statement describing the study and the nature of the

subject’s involvement in it; and subject’s involvement in it; and b) a certificate of consent attesting to the subject’s consent. b) a certificate of consent attesting to the subject’s consent.

Both parts should be written in Both parts should be written in simple languagesimple language so that the so that the subject can easily understand the contents. As much as subject can easily understand the contents. As much as possible, possible, the use of medical terminology in writing up the the use of medical terminology in writing up the consent form should be avoidedconsent form should be avoided. Special care is needed when . Special care is needed when subjects are illiterate.subjects are illiterate.

3. Ethics checklist3. Ethics checklist

A checklist must address ethical A checklist must address ethical concerns that could be raised concerns that could be raised about the methodology, including about the methodology, including the research design, selection of the research design, selection of subjects, the interventions subjects, the interventions introduced and the observations introduced and the observations to be made.to be made.

Ethics checklist (cont.)Ethics checklist (cont.)

• • Is the research design adequate to provide answers to the research Is the research design adequate to provide answers to the research question? It is unethical to expose subjects to research that will have question? It is unethical to expose subjects to research that will have no value.no value.

• • Is the method of selection of research subjects justified? The use of Is the method of selection of research subjects justified? The use of vulnerable subjects as research participants needs special justification. vulnerable subjects as research participants needs special justification. Vulnerable subjects include those in prison, minors and persons with Vulnerable subjects include those in prison, minors and persons with mental disability. Particularly in international research, it is important mental disability. Particularly in international research, it is important to ensure that the population in which the study is conducted will to ensure that the population in which the study is conducted will benefit from any potential outcome of the research. They should not be benefit from any potential outcome of the research. They should not be doing it to the benefit of another population. Justification is needed for doing it to the benefit of another population. Justification is needed for any inducement, financial or otherwise, for participants to be enrolled any inducement, financial or otherwise, for participants to be enrolled in the study.in the study.

• • Are interventions justified, in terms of risks/benefits ratio? Risks are not Are interventions justified, in terms of risks/benefits ratio? Risks are not limited to physical harm. Psychological and social risks must also be limited to physical harm. Psychological and social risks must also be considered.considered.

• • For observations made, have measures been taken to ensure For observations made, have measures been taken to ensure confidentiality?confidentiality?

Data management and Data management and analysisanalysis

The protocol should provide The protocol should provide information on how the data will information on how the data will be managed, including data be managed, including data coding for computer analysis, coding for computer analysis, monitoring and verification. monitoring and verification.

Plan for Analysis of ResultsPlan for Analysis of Results

Although this item is considered under the methodology, it is Although this item is considered under the methodology, it is suggested that the investigator treat it as a separate section.suggested that the investigator treat it as a separate section.

What is expected from a plan of analysis:What is expected from a plan of analysis:

Methods and Models of Data Analysis according to Types Methods and Models of Data Analysis according to Types of Variablesof Variables

In accordance with the proposed In accordance with the proposed objectivesobjectives and based on the and based on the types types of variablesof variables, the investigator should specify how the variables , the investigator should specify how the variables will be measured and how they will be presented (quantitative will be measured and how they will be presented (quantitative and/or qualitative), indicating the analytical models and and/or qualitative), indicating the analytical models and techniques (statistical, non-statistical, or analytical techniques techniques (statistical, non-statistical, or analytical techniques for non-numeric data, etc.). for non-numeric data, etc.).

The investigator should provide a preliminary scheme for tabulating The investigator should provide a preliminary scheme for tabulating the data (especially for variables that are presented the data (especially for variables that are presented numerically). numerically).

It is recommended that special attention be given to the It is recommended that special attention be given to the key key variablesvariables that will be used in the statistical models. that will be used in the statistical models.

Programs to Be Used for Data Analysis:Programs to Be Used for Data Analysis: Briefly describe the Briefly describe the software packagessoftware packages that that

will be used and their anticipated applications.will be used and their anticipated applications.

Power of the study, level of significance to be Power of the study, level of significance to be used, procedures for accounting for any used, procedures for accounting for any missing or spurious data, etc.missing or spurious data, etc.

For projects involving qualitative approaches, For projects involving qualitative approaches, specify in sufficient detail how the data will be specify in sufficient detail how the data will be analyzed.analyzed.

Pretesting the Pretesting the methodology methodology (Pilot study)(Pilot study) It may be possible to pre-test:It may be possible to pre-test:

• The The reactions of respondentsreactions of respondents to the research procedures and to to the research procedures and to questions related to sensitive issues. questions related to sensitive issues.

• The appropriateness of The appropriateness of study type and research toolsstudy type and research tools selected selected for the purpose of the study. for the purpose of the study.

• The appropriateness of The appropriateness of format and wording of questionnairesformat and wording of questionnaires

and interview schedules and the accuracy of the translations. and interview schedules and the accuracy of the translations.

• The The time neededtime needed to carry out interviews, observations or to carry out interviews, observations or measurements.measurements.

• The feasibility of the designed The feasibility of the designed samplingsampling procedures.procedures.

• The feasibility of the designed The feasibility of the designed procedures for data processing procedures for data processing and analysis.and analysis.

ReferencesReferences

References should be written in References should be written in Vancouver style.Vancouver style.

Citing References Citing References 1.1. Number references consecutivelyNumber references consecutively throughout the throughout the

body of the text in the order in which they are body of the text in the order in which they are first mentioned. first mentioned.

2.2. DO NOT include references in your abstract.DO NOT include references in your abstract. Identify references in text, tables and legends by Identify references in text, tables and legends by numerals in parenthesis e.g. (1), (2,3) or (3-6). numerals in parenthesis e.g. (1), (2,3) or (3-6).

3.3. Some journals require references to be indicated Some journals require references to be indicated in in superscript superscript which makes typing more difficult.which makes typing more difficult.

ReferencesReferences

4.4. DO NOT use abstracts as your source of DO NOT use abstracts as your source of information,information, you must consult the full text of you must consult the full text of the article before using it as a cited reference. the article before using it as a cited reference.

5.5. When citing When citing authorsauthors in the text, acknowledge in the text, acknowledge only the first author where there are three or only the first author where there are three or more authors, e.g. Williams more authors, e.g. Williams et al.et al.(1994) stated (1994) stated that .....(1). Where there are two authors cite that .....(1). Where there are two authors cite both, e.g. Jones and Smith (1997) reported both, e.g. Jones and Smith (1997) reported that ....(2). Note that a reference at the end of that ....(2). Note that a reference at the end of a sentence is included before the period. a sentence is included before the period.

6.6. The list of references must begin on a The list of references must begin on a new new pagepage and they are cited by and they are cited by number and number and sequencedsequenced by order of citation. Include by order of citation. Include all all authorsauthors in the list of references. in the list of references.

How to format various How to format various reference sources?reference sources? JournalsJournals

Harrison KL, Forster TH. Instruction to Harrison KL, Forster TH. Instruction to authors. authors. Aust J Med SciAust J Med Sci 1996; 17: 45- 1996; 17: 45-47.47.

Author(s) of a bookAuthor(s) of a book

Murray-Smith S. Right Words: A guide to Murray-Smith S. Right Words: A guide to English usage in Australia. 2nd ed. English usage in Australia. 2nd ed. Melbourne: Penguin Books; 1990. Melbourne: Penguin Books; 1990.

How to format various How to format various reference sources?reference sources? Author(s) of a chapter in a bookAuthor(s) of a chapter in a book

    Bogduk N. Spinal pain: backache Bogduk N. Spinal pain: backache and neck pain. In: Gandevia SC, and neck pain. In: Gandevia SC, Burke D, Anthony M, editors. Burke D, Anthony M, editors. Science and practice in clinical Science and practice in clinical neurology. Melbourne: Cambridge neurology. Melbourne: Cambridge University Press; 1993; 39-57. University Press; 1993; 39-57.

How to format various How to format various reference sources?reference sources? Internet referencingInternet referencing

1.1. Document/Individual WorkDocument/Individual Work

Tyner R. Sink or Swim: Internet Tyner R. Sink or Swim: Internet search tools and techniques (version search tools and techniques (version 3) [WWW document]. Okanagan 3) [WWW document]. Okanagan University College, 7 July 1998. University College, 7 July 1998. http://oksw01.okanagan.bc.ca/libr/cohttp://oksw01.okanagan.bc.ca/libr/connect96/search.htm [accessed 19 nnect96/search.htm [accessed 19 July 2008]. July 2008].

How to format various How to format various reference sources?reference sources?

2.2. JournalsJournals Zorn P, Emanoil M, Marshall L, Zorn P, Emanoil M, Marshall L, Panek M. Advanced searching: Panek M. Advanced searching: Tricks of the trade. Tricks of the trade. OnlineOnline [WWW]. 1996 May; 9 pages. [WWW]. 1996 May; 9 pages. http://www.onlineinc.com/onlinehttp://www.onlineinc.com/onlinemag/MayOL/zorn5.html mag/MayOL/zorn5.html [accessed 19 July 1998].  [accessed 19 July 1998]. 

Duration of the ProjectDuration of the Project

The protocol should specify the The protocol should specify the time that each phase of the time that each phase of the project is likely to take, along with project is likely to take, along with a detailed month by month a detailed month by month timeline for each activity to be timeline for each activity to be undertaken.undertaken.

Timetable (Work plan)Timetable (Work plan) A work plan is a schedule that A work plan is a schedule that

summarizes, in a clear fashion, summarizes, in a clear fashion, various components of a research various components of a research project and how they fit together.project and how they fit together.

It should include:It should include:1.1. The various The various taskstasks to be performed to be performed

2.2. WhenWhen the tasks will be performed the tasks will be performed

3.3. WhoWho will perform the tasks will perform the tasks

BudgetBudget

The budget section should The budget section should contain a detailed item-wise contain a detailed item-wise breakdown of the funds breakdown of the funds requested for, along with a requested for, along with a justification for each item.justification for each item.

A HYPOTHETICAL PROPOSAL BUDGETA HYPOTHETICAL PROPOSAL BUDGET

Annexes (Annexes (Appendices)Appendices)

Include in the appendices of your proposal Include in the appendices of your proposal any additional information you think might any additional information you think might be helpful to a proposal reviewer. be helpful to a proposal reviewer.

Biographical data on the principal Biographical data on the principal investigatorinvestigator

The study questionnaire (and/or other data The study questionnaire (and/or other data collection tools)collection tools)

The informed consent formThe informed consent form A copy of the approval from the A copy of the approval from the

Institutional Review Board.Institutional Review Board.

Will the project be funded?Will the project be funded?

Funding organizations receive many more proposals than what Funding organizations receive many more proposals than what they can fund. The selection process is very competitive. they can fund. The selection process is very competitive.

The following factors are generally taken into The following factors are generally taken into consideration in deciding whether the proposal is to consideration in deciding whether the proposal is to be funded:be funded:

• • importance and relevance of the research question to the importance and relevance of the research question to the declared interests of the agency; success in obtaining a declared interests of the agency; success in obtaining a grant depends on matching the proposal with the interests grant depends on matching the proposal with the interests of a granting agencyof a granting agency

• • quality of the research designquality of the research design

• • ability of the investigators to carry out the projectability of the investigators to carry out the project

Will the project be Will the project be funded? (cont.)funded? (cont.)

• • capacity of the research facility to carry out capacity of the research facility to carry out the project, ability of the institution to handle the project, ability of the institution to handle the administrative and financial proceduresthe administrative and financial procedures

•• satisfactory ethical considerationssatisfactory ethical considerations

• • realistic and justifiable budget, within the realistic and justifiable budget, within the limits set by the agency, and normally with limits set by the agency, and normally with no expectations for continued funding after no expectations for continued funding after the completion of the projectthe completion of the project

Will the project be Will the project be funded? (cont.)funded? (cont.)

• • reasonable time-frame for completion of the reasonable time-frame for completion of the projectproject

• • understanding of anticipated problemsunderstanding of anticipated problems

• • clarity and style of the written proposal.clarity and style of the written proposal.

Writing with enthusiasm is a good idea, but Writing with enthusiasm is a good idea, but overstatements should be avoided. overstatements should be avoided.

The applicant should be realistic about the The applicant should be realistic about the limitations of the study.limitations of the study.

Thank youThank you