Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval

Guidance on Changes That Involve Human Subjects in Active Awards and
That Will Require Prior NIH Approval


Important Points: This notice provides guidance on the types of changes
in human subjects research awards that will require NIH approval and the
process to seek approval of these requests.

Any change in research procedures in an active award that would result
in an increased risk to human subjects will require NIH approval before
implementation. This would include the following:

1. An addition or change to the study design/protocol that would result
in the need to change the overall human subjects designation or clinical
trial designation of the grant: (a) From non-human subjects research to
human subjects research (exempt or non-exempt) (b) From exempt to
non-exempt human subjects research; or (c) From “No Clinical Trial” to
“Includes a Clinical Trial”; see NIH definition of “clinical trial”

2. The new inclusion of subject populations such as pregnant women,
human fetuses, and neonates; prisoners; or children that are covered by
additional regulatory protections

3. Any change to the study protocol that would result in an overall
increase in risk level for subjects, including physical, psychological,
financial, legal or other risks.

4. New information that comes to light after a study is underway which
indicates a higher level of risk to participants than previously
recognized for a study intervention, procedure, or pharmacological

Process for Submitting Prior Approval Requests: NIH strongly encourages
PD/PI’s to discuss any potential changes in human subjects research
under consideration with their Program Officer. Prior approval requests
must be submitted in writing (including submission by e-mail) by the
Authorized Organization Representative (AOR) to the GMO of the funding
IC no later than 30 days before the proposed change. Please refer to the
Notice for the required documentation. Although proposed changes may be
addressed in the annual progress report, the formal prior approval
request must be submitted as a separate request.

Should you have any questions regarding this Notice, please contact your
Contract and Grant Officer .

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