• Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017. Many of the Common Rule changes went into effect January 21, 2019. 
• The changes to the Common Rule do not apply to FDA-regulated studies. 
• UMCIRB SOPs, templates, and the ePIRATE electronic IRB submission system have been revised accordingly. 
• Click on the tab labeled Common Rule Changes in the UMCIRB website for more information about the changes.  
• Studies submitted on or after January 21, 2019 will be reviewed under the revised Common Rule. Studies approved prior to January 21, 2019 will continue to fall under the pre-2018 Common Rule requirements. 

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 umcirb@ecu.edu.

• The revisions to the Common Rule go into effect January 21, 2019 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 01.21.19. 
• Revised SOPs will be posted on the UMCIRB website. 
• Existing expedited studies approved prior to January 21, 2019 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.