- 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.
- Existing expedited studies approved prior to January 19, 2018 will continue to follow pre-2018 requirements including required renewal at least annually. Upon request by the investigator and after discussion with ORIC, an existing study may be revised to meet the new federal requirements. An amendment would need to be submitted and approved within the electronic IRB submission system to document this transition.
- 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.
Welcome to the ORIC - UMCIRB
This website contains the information you need to submit your human research for review and approval by the University & Medical Center Institutional Review Board (UMCIRB).
The primary function of the UMCIRB is to protect the rights and welfare of human participants in research at East Carolina University, Vidant Medical Center and its affiliates, and in research conducted elsewhere by faculty, students, staff or other representatives of the University in connection with their responsibilities or education. This mission is accomplished by an institutional commitment to education and establishment of a collaborative relationship with the researchers and key support staff.
The information you will find on this website includes, but is not limited to, the following:
- Access to the electronic IRB submission system known as ePIRATE;
- UMCIRB Standard Operating Practices;
- Institutional training requirements for persons involved in the conduct of human research;
- Links to CITI training, ePIRATE training and other training applicable to human research;
- FAQs related to human research, IRB oversight and ePIRATE;
- UMCIRB Rosters;
- UMCIRB forms, documents and templates, and
- Links to other websites such as FDA and OHRP