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.
According to DHHS regulations 45 CFR 46.103, every institution engaged in human research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP). The FWA Signatory Official must be authorized to represent and commit the entire institution and all its components to a legally binding agreement. (See definition of engaged at http://www.hhs.gov/ohrp/policy/engage08.html.
The OHRP has also developed an IRB registration system. Registration of an IRB/Independent Ethics Committee (IEC) with the OHRP is voluntary; however, IRB/IEC registration is required for any institution or facility that receives federal funding. IRB registration is also mandatory for research that involves Food and Drug Administration articles that fall within its purview. The registration process is coordinated through the OHRP.
Both the Biomedical and Behavioral & Social Sciences IRBs at ECU are registered with OHRP/FDA. The registration numbers for those Committees are: