Reporting: How will reporting of noncompliance and unanticipated problems be handled by NIH?

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.