NCCIH Policy: Protocol Amendments
Guidance on Changes in Clinical Studies in Active Awards –
When Is Prior NCCIH Approval Required?
Current National Institutes of Health (NIH) policy requires prior approval from the NIH awarding institute/center for a change in scope (NIH Grants Policy Statement (GPS) 220.127.116.11). One of the potential indicators of a change in scope is a change from the approved involvement of human subjects (grants.nih.gov/grants/guide/notice-files/NOT-OD-12-129.html).
Protocol changes that do not meet the criteria below of editorial or administrative updates should be considered amendments and therefore must be submitted and approved by NCCIH prior to implementation. To add further clarity, the following protocol changes are considered amendments and therefore require prior NCCIH approval:
- Any change that may affect patient safety (e.g., change in eligibility criteria; change in risk, regardless of whether risk is increased or decreased)
- Any change that changes scientific intent or study design, or affects human subject protection
- Addition/deletion of a site
- Addition/deletion of key study personnel
- A change of institution for key study personnel
- A change in enrollment targets.
Examples of protocol changes that NCCIH considers editorial or administrative updates to approved protocols and does not need to approve are:
- Typographical correction, unless the change results in a change in patient risk
- Rephrasing a sentence or section to add clarity as long as the change does not affect the scientific intent, study design, patient risk, or human subject protection
- Reformatting the document as long as the change does not affect the scientific intent, study design, patient risk, or human subject protection
- Address, telephone, or e-mail changes
- Addition/deletion of non-key personnel
- Standardization of protocol language inconsistencies, as long as the change does not affect the scientific intent, study design, patient risk, or human subject protection.