Proposals with Exemption 4
NIH describes human subject research as “research involving a living individual about whom data is obtained through interaction/intervention or identifiable, private information.” However, NIH also recognizes three (3) situations where human subjects research can be exempt from federal regulations. The latest formsets set offers eight (8) exemptions. See NIH’s Exempt Human Subjects Research infographic.
eCat includes several questions and attachments that are optional for human subjects proposal that fit the definition of -only- Exemption 4.
1. All of “Section 2 – Study Population Characteristics” is optional
2. The Recruitment and Retention Plan is optional
3. The “Recruitment Status” question is optional
4. The “Enrollment of First Subject” question is optional
5. An Inclusion Enrollment Report is optional
6. A Data and Safety Monitoring Plan is optional
7. The “Data Safety Monitoring Board” question is optional
8. The Overall Structure of the Study Team is optional
3.1 Protection of Human Subjects attachment
If you are claiming that your human subjects research falls under any exemptions, justify why the research meets the criteria for the exemption(s) that you have claimed. This justification should explain how the proposed research meets the criteria for the exemption claimed. Do not merely repeat the criteria or definitions themselves.
3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?
Select “N/A” for studies that fit the definition of Exemption 4
Sections 4 and 5 of the Human Subjects and Clinical Trial Information form should NOT be completed for projects that do not fit the definition of Clinical Trial.