Addendum to On-Site Research Collaborators (RC) Policies: On-Site RC Conducting Human Subjects Research at NIH

On-site Research Collaborators (RC) may conduct human subjects research in partnership with intramural researchers. However, their activities may not automatically fall under the NIH Federal-wide Assurance (FWA) or be overseen by the NIH Institutional Review Board (IRB). Therefore, depending on the nature of the RCs activities and the appointment mechanism, used a written agreement may be required to provide IRB oversight. The Office of Human Subjects Research Protections should be contacted at the earliest opportunity to determine how IRB oversight will be handled. The RC must not participate in any human subjects research until IRB oversight for the RC has been established and any protocols have received the required IRB approvals.