In the Human Subjects Research section of the Research Plan, you must provide sufficient information for reviewers to determine that the proposed research meets (1) the requirements of the HHS regulations to protect human subjects from research risks (45 CFR Part 46), (2) the requirements of NIH policies for data and safety monitoring of clinical trials, and (3) the requirements of NIH policies on inclusion of women, minorities, and children. See Instructions Pertaining to Non-Exempt Human Subjects Research.
If the research is exempt from the requirements in the Federal regulations, you must provide a justification for the exemption with sufficient information about the involvement of the human subjects to allow a determination by peer reviewers and NIH staff that claimed exemption(s) is/are appropriate. See Exempt Human Subjects Research.
Applications must comply with this requirement; if not, application processing may be delayed or the application may be returned to the applicant without review.
For all research involving human subjects, a part of the peer review process will include careful consideration of protections from research risks, as well as the appropriate inclusion of women, minorities, and children. The Scientific Review Group (SRG) will assess the adequacy of safeguards of the rights and welfare of research participants, and the appropriate inclusion of women, minorities, and children, based on the information in the application.
To assist you in completing Item E. of the Research Plan (Human Subjects Research), we have provided six possible scenarios. All research will fall into one of these six scenarios. Determining which scenario best matches your proposed research depends on your answers to the following five questions:
Question 3: Does your proposed research meet the definition of clinical research?
Question 4: Does your proposed research include a Clinical Trial?
Question 5: Does your proposed research meet criteria for an NIH-Defined Phase III Clinical Trial?
Click on the questions and when you can answer the five questions, select the scenario that best matches your responses, and then follow the instructions provided for the scenario you choose.