Investigators and research administrators will want to take note of two NIH guide notices that were published in August 2012.
NOT-OD-12-129, “Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval”
NIH approval is required prior to implementation of changes that increase risk to human subjects, including:
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:
- From non-human subjects research to human subjects research (exempt or non-exempt):
- From exempt to non-exempt human subjects research; or
- From “No Clinical Trial” to “Includes a Clinical Trial”; see NIH definition of “clinical trial”
2. The new inclusion of subject populations that are covered by additional regulatory protections under 45 CFR 46 subparts B, C or D (pregnant women, human fetuses, and neonates; prisoners; or children)
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. This could include the addition of a new study population that would be at higher risk from existing research procedures, the addition of new study procedures that are greater than minimal risk, any modification of existing study procedures that would increase overall risk, or the addition of a new clinical study or a new clinical trial intervention arm not originally proposed that is greater than minimal risk.
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 treatment.
NOT-OD-12-130 , “Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards)”
NIH uses the term “delayed onset human subjects research” to describe situations where intended human studies are not clearly defined at the time of the award. Typical delayed onset award scenarios include:
- Single project awards (research grants, career development awards or fellowships) in which results from initial pre-clinical research are needed before the human subjects research can be fully planned.
- Clinical research networks or consortia often funded as cooperative agreements or multi-project awards, that plan to add new protocols over the course of the award.
- Award mechanisms that include funds for small projects that will be selected and funded by the awardee. These are often referred to as pilot project programs and may be used to support new or junior faculty or to stimulate new research areas at the awardee institution and its collaborators.
This guide notice explains how to submit new protocols for NIH approval as part of a previously funded project.