Human Research Protection Program (HRPP) Coverage for Investigators Working on National Institute of Mental Health (NIMH) Protocols at the National Institutes Health

Authors

• CB Servis
• A Evans
• J Radcliffe
• S Rojas

Abstract

A researcher who is engaged in human subjects research working on a NIMH protocol at the NIH is covered by the NIH Federalwide Assurance (FWA); however, when former NIH employees or researchers, or non-NIH investigators, at non-NIH sites want to remain named on a NIH protocol after leaving the NIH, a special agreement may be needed depending on the specific protocol activities and if the protocol has an IND/IDE. Although there are official NIH policies governing this (SOPs:19, 20A & 20D), many Principal Investigators (PIs) are finding it confusing to navigate the various SOPs to determine if one or more of their investigators need special agreements to cover their research activities. The Clinical Monitoring Research Program (CMRP) Directorate of Leidos Biomedical Inc. provides protocol navigation, regulatory guidance support, clinical trials management support, and data and safety monitoring for protocols being conducted by the NIMH. The Protocol Navigation Team (PNT) works with the NIMH PIs to ensure that their protocols correctly address the agreement status of all investigators assigned to their protocols. To simplify the task of determining if agreements are needed for investigators assigned to NIMH protocols, the PNT has devised a decision tree which illustrates the human research protection policies that require special agreements for former NIMH staff or non-NIH investigators. The decision tree has been presented to Office of Human Subjects Research Protections for review, and the version provided with this abstract is currently in use at the NIMH.

Scientific Focus Area: Research Support Services

This page was last updated on Friday, March 26, 2021