NIH has indicated that if NIH is the Reviewing IRB, it will report noncompliance or unanticipated problems to the Office of Human Subjects Protections (OHRP) and/or the Food & Drug Administration (FDA), as applicable. If reports are required to the funding agency or sponsor or any other oversight authority, those will be the responsibility of the Relying Institution. NIH intends to accomplish this by triggering Section 5.13 of the Agreement only as to a Relying Institution’s reporting obligations to a sponsor, funding agency, and other oversight authority. This clarification is included here to specify the process by which NIH will implement reporting to agencies.
Articles in this section
- Background on SMART IRB Agreement v2.0
- Background: Why are the revisions to the SMART IRB Agreement reflected in SMART IRB Agreement v2.0 necessary?
- Background: How will SMART IRB Agreement v2.0 allow NIH to collaborate with extramural organizations?
- Admninistrative Issues: If my institution has already joined SMART IRB Agreement v1.0, can my institution continue to use that Version 1.0?
- Administrative Issues: My institution is not serving as a Reviewing IRB for the NIH nor is it ceding IRB review to the NIH Intramural Research Program IRB. Does my institution need to sign SMART IRB Agreement v2.0?
- Administrative Issues: If my institution serves as a Reviewing IRB for the NIH engaged and for other institutions engaged in the Research, would all of the institutions engaged in that Research need to sign SMART IRB Agreement v2.0?
- Administrative Issues: Does my institution need to re-execute a Joinder Agreement to sign Version 2.0 of the SMART IRB Agreement?
- Administrative Issues: Re-execution of a Joinder Agreement to sign Agreement v2.0 & satisfaction of Section 1.2, HRPP Quality
- Administrative Issues: Does my institution need to document which version of the SMART IRB Agreement covers each of our reliance arrangements in effect?
- Reporting: How will reporting of noncompliance and unanticipated problems be handled by NIH?