The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every protocol submitted for IRB review.
- When drafting the Research Plan, follow the format and use the section headings (i.e. A – I) provided below, refer to the bulleted items for section content.
- For each section, this guidance includes a description of why the information is important for IRB review (in italics).
H. Potential Benefits of the Research
In order to approve this research, the IRB must determine that the anticipated benefits to research participants and the knowledge researchers expect to gain are reasonable in relation to the potential risks.
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Describe any anticipated benefits that may result from the research. Consider the following:
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Direct benefits that may result from participation (e.g., psychological or emotional benefits, learning benefits, physical benefits, diagnostic or therapeutic benefits, etc.). If there are no direct benefits to participants, clearly state this.
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Benefits to the general participant population.
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General benefits of the research for society, science and humanity; potential generalizable knowledge.
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Compensation for participation is not a benefit and should not be included in this section.