10th Postgraduate Course for Training in Reproductive Medicine and Reproductive Biology
Research Protocol
M. Boulvain
This is only a suggested outline: most research agencies or ethics committees may have different guidelines, which should obviously be followed.
1. Introduction, summary:
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importance of the problem
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short summary of the current state of knowledge
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summary of the proposed research project, closing with your objectives and the rationale.
2. Literature review
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summary of the present knowledge on:
the exposure
the outcome
the relation between exposure and outcome: systematic review
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show how the project will improve the current knowledge:
is this the first study?
if not, how this study will correct biases present in previous studies, or their lack of precision
3. Objectives (some prefer to state them before the Literature review)
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Primary objective (or Main)
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Secondary objective (or Subsidiary)
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Hypothesis (optional, but it clarifies the purpose of the study to clearly state the hypothesis)
An alternative presentation could be:
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Overall goal
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Specific objectives
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Pertinent definitions (optional, but beware that the reader might not have the same as yours, thus be explicit)
4. Relevance
Justify the importance of the study (you should convince
the reader !). May be the put at the end, as a conclusion
5. Methodology
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Type of study design and a short justification for choosing this design, including limitations
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Study population (target population):
Inclusion criteria
Exclusion criteria -
Study procedures
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Outcome measures
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Statistical analysis
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Sample size (computed according to the primary outcome measure)
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Timetable
6. Feasibility
Often critical when submitting a research project for funding. Be realistic!
7. Ethics
Guidelines are available (CIOMS)
8. Conclusions/Relevance
This point is also very important, as the referee must be convinced at the
end of his reading of the relevance of the project.
9. References
You must support all your statements with relevant references, preferably
found in good and generally available journals. Don't miss "The" important
reference, as referees are expert in your field of research.
10. Budget
Generally the format is provided by the funding agency.
Edited by Aldo Campana,