Preparing the NIH Human Subjects Documents

Effective January 2018, all grants proposing human subjects research must include a Human Subjects and Clinical Trials Information form. A PDF copy of this form is included below (FORMS-F).


Required Human Subjects Documents

Beginning on/after May 25, 2020, grant applications to NIH must use FORMS-F application packages. The document list and templates below comply with the FORMS-F instructions.

Attachment Exemption 4 Non-Clinical Trials Clinical Trials
Inclusion of Individuals Across the Lifespan
Optional Yes Yes
Inclusion of Women and Minorities Optional Yes Yes
Recruitment and Retention Plan
Optional Yes Yes
Study Timeline
Optional Optional
Protection of Human Subjects Yes Yes
Single IRB Plan, if "Yes" to Q3.2* N/A N/A N/A
Data and Safety Monitoring Plan Optional Optional Yes
Overall Structure of the Study Team
Optional Optional Optional
Statistical Design and Power N/A N/A Yes
IND/IDE Status, if "Yes" to Q4.5 N/A N/A Yes
Dissemination Plan N/A N/A Yes
Other Clinical-trial Related Attachments N/A N/A Check FOA

*Note that beginning May 25, 2020, a Single IRB plan is no longer required for NIH applications. Single IRB plans are only required for applications to AHRQ.