NIH Grant Recipients: A new NIH Human Subjects System (HSS) will replace the current NIH Inclusion Management System (IMS) for the reporting of data about human subjects and clinical trials. NIH will launch this new system on June 9, 2018 and it will be available within the eRA Commons site. More information can be found here.
The National Institutes of Health (NIH) Policy on the use of a single Institutional Review Board (sIRB) of record for multi-site research became effective January 25, 2018. This policy establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects. This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.
This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.
Investigators are encouraged to consult with the Office of Research Integrity and Compliance (ORIC) prior to including an sIRB plan in their application if they have questions about whether or not ECU should cede IRB review to another IRB or assume the responsibility of being the IRB of record (Reviewing IRB).
You may review the NIH posting regarding sIRB review by clicking here.
If you have additional questions about the sIRB review process or IRB reliance agreements, please call the ORIC at 252-744-2914, or email your question to firstname.lastname@example.org.
CIRB (The Central Institutional Review Board for the National Cancer Institute)
East Carolina University (ECU) has been approved as an institution that may rely on the CIRB for review and approval of NCI sponsored clinical trials. The link below directs you to the CIRB website where you can find more information about CIRB including; access to CIRB standard operating procedures, quick guides for information about activities associated with relying on CIRB and access to IRBManager (the CIRB electronic submission platform).
WIRB (Western Institutional Review Board)
ECU has entered into an agreement permitting reliance on WIRB for review and approval of sponsored clinical trials. For the purpose of relying on WIRB, a sponsored clinical trial is one that is funded by an industry sponsor AND the sponsor has selected WIRB to serve as the IRB of record for review and approval of their clinical trial. The documents below provide the reader with the information needed regarding this agreement and the process for relying on WIRB for review and approval of a sponsored clinical trial.
East Carolina University is now a participating institution with SMART IRB. (To visit the SMART IRB website click on their logo above)
SMART IRB is a platform designed to ease common challenges associated with initiating multi-site research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy. Freely available for institutions and investigators, SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multi-site studies across the nation, regardless of funding status.