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).
- Human Subjects and Clinical Trials Information Form
- Study Record: Human Subjects and Clinical Trials Information Form
- Annotated Human Subjects Form
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
|Inclusion of Women and Minorities||Optional||Yes||Yes|
|Recruitment and Retention Plan
|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
|Statistical Design and Power||N/A||N/A||Yes
|IND/IDE Status, if "Yes" to Q4.5||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.
Human Subjects Document Templates:
- Non-Human Subjects Research Justification
- Delayed Onset Study Justification
- Inclusion of Individuals Across the Lifespan
- Inclusion of Women and Minorities
- Recruitment and Retention Plan
- Study Timeline
- Protection of Human Subjects
- Data and Safety Monitoring Plan
- Overall Structure of the Study Team
- Statistical Design and Power
- IND/IDE Status
- Dissemination Plan
If you have questions or comments, please contact the SRDO via email at email@example.com.