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.
Belmont Report (also in Spanish)
OHRP's Online Training Opportunities
OHRP offers an assortment of educational videos developed by the Division of Education and Development. These videos provide information on a variety of topics regarding the Department of Health and Human Services (HHS) regulations for the protection of human participants of research described at 45 CFR part 46. Each video is approximately 20-25 minutes in length. Click on the following link: HHS YouTube channel to view the selection of educational videos. A sample of video titles available includes:
The Office of Research Integrity (ORI) and the Office for Human Research Protections (OHRP) present The Research Clinic. The interactive training video educates clinical and social researchers on the importance of appropriately protecting research subjects and avoiding research misconduct. The Research Clinic allows the viewer to assume the role of one of four characters and determines the outcome of the storyline by selecting decision-making choices for each “playable” character. Click on the following link to view “The Research Clinic”
National Institutes of Health
Fundamental Information for New Investigators and Key Research Personnel
Presidential Commission for the Study of Bioethical Issues – Research Primer: Incidental and Secondary Findings
NIH FAQs: HIPAA Privacy Rule for Researchers
Expedited & Exempt Categories
Criteria for IRB Approval of Research