WRITING A RESEARCH WRITING A RESEARCH PROTOCOL PROTOCOL Dr.B.Unnikrishnan, Dr.B.Unnikrishnan, Professor & Head, Professor & Head, Dept of Community Medicine, Dept of Community Medicine, Kasturba Medical College , Mangalore. Kasturba Medical College , Mangalore.
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Study questionStudy question The protocol should start with a clear and The protocol should start with a clear andprecise formulation of the researchprecise formulation of the research
question. It is good practice to write thisquestion. It is good practice to write thisin the form of a question, not a statementin the form of a question, not a statement
Example: Example:
W hy is asthma among children in W hy is asthma among children in
How much the same or similar research problemHow much the same or similar research problem
has been studied previously has been studied previously
To understand the limitations in those studies To understand the limitations in those studies To critically assess the required modifications To critically assess the required modifications
which could provide some new knowledge which could provide some new knowledge
Provide logical & Scientific justificationProvide logical & Scientific justification
Describe precisely the magnitude and quantumDescribe precisely the magnitude and quantum
of knowledge available regarding the problemof knowledge available regarding the problem Identify the gaps & controversies in the existing Identify the gaps & controversies in the existing
knowledgeknowledge
Should be as brief as possibleShould be as brief as possible
Even a precise study question is often tooEven a precise study question is often toobroad for one study to answer, like ´broad for one study to answer, like ´Why is Why is
a sth ma among chi ldren i n M angalore ex c epti onall y a sth ma among chi ldren i n M angalore ex c epti onall y
f requen t? f requen t? µ You must therefore break down theµ You must therefore break down thequestion into several objectivesquestion into several objectives..
Example: Example:
The objectives of this study are to determine if the excess The objectives of this study are to determine if the excessasthma in Mangalore is related to a combination of geneticasthma in Mangalore is related to a combination of geneticdisposition ( estimated by atopic status) and socioeconomicdisposition ( estimated by atopic status) and socioeconomicstatus and / or air pollution.status and / or air pollution.
One should be able to achieve it within aOne should be able to achieve it within a
reasonable time.reasonable time.
Should be simple, clear, specific and measurableShould be simple, clear, specific and measurable Number of objectives should be limitedNumber of objectives should be limited
oo Will children with (without) asthma be included? Will children with (without) asthma be included?
oo Which children will be excluded? Which children will be excluded?oo How will the children be approached?How will the children be approached?
oo What will you do when they decline? What will you do when they decline?
oo How many children will be eligible and whatHow many children will be eligible and what percentage do you expect will actually participate? percentage do you expect will actually participate?
Data collection methods: definitions and measurementsData collection methods: definitions and measurements
It is essential to state how the data will be collected toIt is essential to state how the data will be collected to
determine both the health outcomes and thedetermine both the health outcomes and the
determinants you are planning to study.determinants you are planning to study.
This means specifying exactly how these will be This means specifying exactly how these will be
measured or definedmeasured or defined i n th e propos ed st ud y i n th e propos ed st ud y ..
Quality control procedures should be specified.Quality control procedures should be specified.If the procedure is a standard one that has beenIf the procedure is a standard one that has been
described before, it should be referenced.described before, it should be referenced.
Ethical ConsiderationsEthical Considerations This section must explicitly state that the study This section must explicitly state that the study
takes the principles of the Helsinki declarationtakes the principles of the Helsinki declaration
into account. It indicates:into account. It indicates:
oo How the quality of technical aspects is ensuredHow the quality of technical aspects is ensured
oo The expected hazards and benefits The expected hazards and benefitsoo The rational and justification for the research The rational and justification for the research
oo The priority of participants· interest The priority of participants· interest
oo Responsibility for liability for injuryResponsibility for liability for injury
oo How participants are informed about studyHow participants are informed about study
oo How participants give consent for enrolmentHow participants give consent for enrolment
Investigators: role of each andInvestigators: role of each andc urr ic ulum vit ae c urr ic ulum vit ae Define here the role each investigator plays in the studyDefine here the role each investigator plays in the study
and state responsibilities.and state responsibilities.
Determine best here authorship of any publicationsDetermine best here authorship of any publications
The CV should provide description of qualification The CV should provide description of qualification
Each item of expenditure must be specifiedEach item of expenditure must be specified
Expenditures should, to the extent possible, be given inExpenditures should, to the extent possible, be given inunits (such as salarial costs per hour, day, week)units (such as salarial costs per hour, day, week)
A written budget justification is usually required if the A written budget justification is usually required if the
study has external sponsorsstudy has external sponsors
Statement of facts quoted in the protocol mustStatement of facts quoted in the protocol must
be referencedbe referenced
Accepted style of writing references is the Accepted style of writing references is the Vancouver style ´Uniform requirements for Vancouver style ´Uniform requirements formanuscript submitted to biomedical journalsµmanuscript submitted to biomedical journalsµ
´International Committee of Medical Journal´International Committee of Medical JournalEditors ( ICM JE)µ accepted by more than 400Editors ( ICM JE)µ accepted by more than 400
International medical journalsInternational medical journals