- Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017. Many of the Common Rule changes go into effect January 19, 2018.
- The changes to the Common Rule do not apply to FDA-regulated studies.
- ORIC is working to roll out these changes at ECU. The announcements section of the ORIC > UMCIRB webpage and the ePIRATE homepage will be your main source of information and updates about the revised Common Rule roll out.
- Studies submitted on or after January 19, 2018 will be reviewed under the revised Common Rule. We are currently evaluating whether the changes will apply to studies existing prior to January 19, 2018.
- The definition of "human subject" has been altered to now include identifiable biospecimens. Identifiable biospecimens and identifiable private data are treated the same in the final rule.
- Consent forms will need to include an introductory paragraph which provides a clear and easy to understand summary of the key information that will be helpful to a potential participant or their legally authorized representative in the understanding of reasons why they might or might not want to take part in the research.
- Overall, there are four new elements of informed consent; one new required element and three new optional (i.e."if applicable") elements. These new elements are generally related to the secondary use of data and samples and genomic research.
- The revisions to the Common Rule broaden the types of research that can be reviewed under the exempt categories. For example, secondary research involving identifiable private information that is protected by HIPAA can be reviewed under an exempt category; currently this type of research requires review under an expedited category. As has always been the case at ECU, only the IRB may determine what research may be reviewed under the exempt categories.
- Some minimal risk studies will no longer be required to undergo annual continuing review.
- Changes to the Common Rule mandate the use of a single IRB for multisite, cooperative studies. This requirement will be effective January 19, 2020.
- The revisions to the Common Rule go into effect January 19, 2018 and UMCIRB will begin reviewing new studies under the revised Common Rule on that date.
- New document templates will be posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new research studies submitted on or after 01.19.18.
- Revised SOPs will be posted on the UMCIRB website.
- For existing studies; ORIC is evaluating whether the changes will apply to these studies after the effective date.
- Keep our website and the ePIRATE homepage checked for continuing and updated information.
- Contact UMCIRB with any questions. You are welcome to email us at UMCIRB@ecu.edu.
- Remember, the revised Common Rule does not apply to FDA-regulated studies.
Federalwide Assurance Information
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.
- ECU’s FWA # is FWA00000658
- Vidant Medical Center’s FWA # is FWA00000652
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:
- IRB00000705 East Carolina U IRB #1 (Biomedical)
- IRB00003781 East Carolina U IRB #2 (Behavioral/SS)