The research protocol contains all elements except study results and their discussion that will also pro- vide the backbone of the ultimate research paper

1. Research Protocol Format

2. What is the focus of an experimental design?
o Propose a hypothesis
o Write down methods or procedures
o Stick to the procedures in the experiment
o Compare study group to a control group
o Compare results in both groups

3. Starting writing a research protocol does not begin
with its final structure, but:
Always start with what you know best!

4. Study description
a) Study question

5. Study question
The protocol should start with a clear and
precise formulation of the research question. It
is good practice to write this in the form of a
question, not a statement
Example:
Why is asthma among children in Istanbul
exceptionally frequent?

6. Study description
a) Study question
b) Rationale, previous studies on subject
g) References

7. Rationale, previous studies on the subject
How did the research question arise from current
subject knowledge? The sequence of
argumentation must be logical and concise; use key
references only.
o Discuss the importance of the topic
o Review relevant literature
o Describe results you have already obtained
o Indicate how the research question has emerged
o Outline how you intend to address the question
o State how your study contributes

8. References
This section will list references from all sections
discussed above and subsequently

9. Study description
a) Study question
b) Rationale, previous studies on subject
c) Aims and objectives
g) References

10. Objectives, hypotheses, and specific aims

11. Objectives
Even a precise study question is often too broad for
one study to answer, like “Why is asthma among
children in Istanbul exceptionally frequent?” You
must therefore break down the question into several
objectives.
Example:
The objectives of this study are to determine if the
excess asthma in Istanbul is related to a combination
of genetic disposition (estimated by atopic status) and
socioeconomic status and / or air pollution.

12. Hypotheses
To meet the objectives, comparisons may have to be
made. Hypotheses should be formulated, so that they
can be refuted (null hypotheses):
Examples:
1. Asthma prevalences are not different between
children from low versus high socioeconomic
groups
2. Asthma prevalences are not increased in children
living in homes with increased air pollution
3. The relationships between asthma prevalence
and socioeconomic status do not differ according
to the atopic status of the child

13. Specific Aims
The practical steps that need to be carried out
Example:
1. Identify the source for recruiting 200 cases
2. Identify and select suitable control subjects
3. Record characteristics of cases and controls
4. Perform allergy skin tests
5. Measure indoor particulate exposure (how, when)
6. Compare risk ratios according to exposure

14. 2. Study description
a) Study question
b) Rationale, previous studies on subject
c) Aims and objectives
d) Design and methods
f) Strengths and limitations
g) References
3. Ethical considerations
4. Significance (or expected impact)

15. d) Design and methods
f) Strengths and limitations
3. Ethical considerations
4. Significance (or expected impact)

16. Design and Methods
o Study design
o Study population
o Sample size and statistical power
o Subjects: selection and definitions
o Data collection methods: measurements,
definitions
o Data management and statistical analysis

17. Design and Methods
Study design
This should state the selected design of the
study. Keep in mind that the study design is
chosen in relation to study objectives.
Explain why the particular study design has
been chosen in preference to other possible
designs

18. Design and Methods
Study population
This section outlines the setting for which the
research has relevance
Example:
o Which children in Istanbul should we study?
o Can the study results be extrapolated?
o What is the definition of “child”?

19. Design and Methods
Sample size and statistical power
Specify assumptions and provide tables of
sample size and power calculation
Example:
o How many children will be recruited?
o What proportion of the population is included?
o Will the number of children be sufficient?
o ..., etc

20. Design and Methods
Subjects: selection and definitions
This section should provide:
o A detailed explanation of how many subjects in
each category will be recruited and why
o Definitions of eligibility, inclusion and exclusion
o Realistic estimates of the number eligible subjects
o Description of recruitment mechanism
o Discussion of recruitment feasibility

21. Design and Methods
Example:
o Will children with (without) asthma be included?
o Which children will be excluded?
o How will the children be approached?
o What will you do when they decline?
o How many children will be eligible and what
percentage do you expect will actually participate?

22. Design and Methods
Data collection methods: definitions and measurements
It is essential to state how the data will be collected
to determine both the health outcomes and the
determinants you are planning to study.
This means specifying exactly how these will be
measured or defined in the proposed study.
Quality control procedures should be specified.
If the procedure is a standard one that has been
described before, it should be referenced.

23. Design and Methods
Data collection methods: definitions and measurements
This includes:
o Precise definitions of all terms
o Consideration of pilot testing for methods and
instruments
o Discussing the validity and reliability of the
definitions proposed
o Discussing the limitations of the measurement tools
and definitions proposed

24. Design and Methods
Example:
o How will the presence of asthma be determined?
o What will happen if someone who doesn’t have
asthma is said to have it?
o What is the definition of indoor pollution?
o Which components of indoor pollution will be
evaluated?
o How will socio-economic status be determined?

25. Design and Methods
Study design
Data: management and analysis
o Procedures for coding and data entry
o Measures to ensure completeness and accuracy
o Examples of data presentation and comparisons
o Formal hypothesis testing

26. Design and Methods
Study design
Data: management and analysis
Structure follows best research questions,
objectives, and hypotheses
Include appropriate references for formal
hypothesis testing (books, papers, or software)

27. Design and Methods
Study design
Example:
o How will patient records be abstracted?
o How will correct coding be ensured?
o What types of graphs, tables will be used to
display the results?
o What statistical tests will be used to test the
study hypotheses?

28. Strengths and Limitations
Issues
o Compromises have to be made in design
o There is no “perfect protocol”: provide a section
discussing areas open to criticism; provide
reasoning for accepting limitations.
Provide a section on particular strengths of the
study design.

29. Ethical Considerations
This section must explicitly state that the study takes
the principles of the Helsinki declaration into
account. It indicates:
o How the quality of technical aspects is ensured
o The expected hazards and benefits
o The rational and justification for the research
o The priority of participants’ interest
o Responsibility for liability for injury
o How participants are informed about study
o How participants give consent for enrolment

30. Ethical Considerations
Example:
o Will any child be at risk from a reaction to the
allergy skin tests?
o Who will provide consent for the child to
participate?
o Who will know about the results of the
examinations?
o What will be done if disease is found?

31. Significance (expected impact)
This section restates the justification for the study in
terms of the anticipated results. It will specify:
o The implications of the potential results
o How the results of the study may be used by
your own research team in the future, by other
researchers, by policy makers, by the community

32. 2. Study description
a) Study question
b) Rationale, previous studies on subject
c) Aims and objectives
d) Design and methods
e) Project management
f) Strengths and limitations
g) References
3. Ethical considerations
4. Significance (or expected impact)
6. Investigators: role of each and curriculum vitae

33. Overall Project Management
Personnel required and timeline including:
o Pilot testing
o Recruiting of subjects
o Preparation of forms and questionnaires
o Data collection
o Follow-up procedures
o Data checking an statistical analyses
o Reporting – to participants, community,
academic community

34. Investigators: role of each and
curriculum vitae
Define here the role each investigator plays in the
study and state responsibilities.
Determine best here authorship of any publications
The CV should provide description of qualification
and expertise, training, degrees, scientific
publications

35. 2. Study description
a) Study question
b) Rationale, previous studies on subject
c) Aims and objectives
d) Design and methods
e) Project management
f) Strengths and limitations
g) References
3. Ethical considerations
4. Significance (or expected impact)
5. Budget
6. Investigators: role of each and curriculum vitae

36. Budget
Each item of expenditure must be specified
Expenditures should, to the extent possible, be given
in units (such as salarial costs per hour, day, week)
A written budget justification is usually required if the
study has external sponsors

37. 1. Abstract
2. Study description
a) Study question
b) Rationale, previous studies on subject
c) Aims and objectives
d) Design and methods
e) Project management
f) Strengths and limitations
g) References
3. Ethical considerations
4. Significance (or expected impact)
5. Budget
6. Investigators: role of each and curriculum vitae

38. Questions that the Study Description must answer
Why? Sets out the study question and the
relevant background information

39. Questions that the Study Description must answer
Why? Sets out the study question and the
relevant background information
How? Describes the study design and the
rationale for choosing it

40. Questions that the Study Description must answer
Why? Sets out the study question and the
relevant background information
How? Describes the study design and the
rationale for choosing it
Who? Defines the target and study populations
and sample size

41. Questions that the Study Description must answer
Why? Sets out the study question and the
relevant background information
How? Describes the study design and the
rationale for choosing it
Who? Defines the target and study populations
and sample size
What? Identifies the variables to be measured,
instruments to use and outcomes to be
analyzed

42. Questions that the Study Description must answer
Why? Sets out the study question and the
relevant background information
How? Describes the study design and the
rationale for choosing it
Who? Defines the target and study populations
and sample size
What? Identifies the variables to be measured,
instruments to use and outcomes to be
analyzed
So what? Comments on the expected significance
of results and contribution to knowledge

43. The research protocol contains all elements except
study results and their discussion that will also pro-
vide the backbone of the ultimate research paper