NHGRI Institutional Review Board
Forms, Templates and Guides
- Guide to Completing Form 1195
* - NHGRI Protocol Template

- Targeted/Planned Enrollment Table

(For Initial Review Only) - Inclusion Enrollment Form

(For continuing studies only) - Consent Form Template
- Watermarked Assent Form Template

- NHGRI Dual Signature Page Consent Template

- Examples of Protocol Deviations and Violations

- Template Memo for Reporting Protocol Deviations and Violations to the NHGRI IRB

- Previously Collected Human Biological Materials and Data Amendment Form

- Serious Adverse Event Report Form
(See PTMS) - Designation of Reimbursement for Travel and Subsistence (DRTS) Form (NIH-2868) **
- Clinical Center Resource Assessment Tool Form
* TIP: NIH Form 1195 (for Initial Reviews) and NIH Form 1195-1 (for Continuing Reviews) need to be e-signed in the Protocol Tracking and Management System (PTMS).
Be sure to have all NIH investigators initial next to their names on the hard copy version of the 1195 or 1195-1 form or on the front page of the protocol. Or have them send an e-mail stating that they acknowledge that they have been added to the protocol and if they are not NHGRI employees, then we need an acknowledgement from their Clinical Director.
** TIP: The Designation of Reimbursement for Travel and Subsistence (DTRS) Form should be filled out in the PTMS. It only needs to be filled out ounce unless something changes in reimbursement.
To view the
files on this page, you will need Adobe Acrobat Reader. ![]()
To view the
files on this page, you will need MS Word. A copy of Word Viewer can be downloaded for free.
Last Updated: March 21, 2013






