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 email@example.com.
- 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 July 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 July 19, 2018 will be reviewed under the revised Common Rule. Currently approved studies will continue to fall under the pre-2018 Common Rule requirements.
- The revisions to the Common Rule go into effect July 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 07.19.18.
- 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.
University & Medical Center Institutional Review Board
Standard Operating Practices for Human Research Activities
- ECU's Human Research Protection Program
- Institutional Review Board Membership
- Requirements for Human Research Protections Training
- Primary/Secondary Reviewer System
Chairperson and Vice Chairperson Service on the Institutional Review Board
- Institutional Roles and Responsibilities
- Ethical Principles and Regulatory Mandate to Protect Human Research Participants
Faculty Supervisor Responsibilities in Human Research
- Human Research Activities
- Determining Whether an Activity Constitutes Human Research Requiring UMCIRB Review
- Reliance on Other Institutional Review Boards
- Food and Drug Administration Regulated Research
- Use of Devices in Human Research Activities
- Humanitarian Use Device (HUD)
- Planned Emergency Research
Human Research Involving Drugs and Biologics
- Informed Consent
- Use of a Legally Authorized Representative (LAR) in Research Involving Vulnerable Adult Participants
- Informed Consent
- Waiver or Alteration of Informed Consent
- Waiver of Documentation of Informed Consent
- Investigator Roles and Responsibilities
- Continuing Review
- Unanticipated Problems Involving Risks to Participants and Others
- Defining and Reporting Protocol Deviations
- Noncompliance in Human Research Activities
- Individual Investigator Agreement (Collaborating Investigators from Outside East Carolina University (ECU) and its Affiliates)
- Amendments to Currently Approved Human Research
- Suspension or Termination of IRB Approval
- Conflict of Interest in Human Research
- Biospecimen Banking
- Emergency Use of a Test Article
- Deception in Human Research
- Recruiting for Human Research
- Study Completion and Closure
- Institutional Review Board (IRB) Roles and Responsibilities
- Certified Exempt Research
- Expedited Review Procedures
- Determination of Investigator & Research Personnel Qualifications to Conduct Research
- Initial Review of Human Research Activities
- Review by the Convened IRB
- ECU Office of Research Integrity & Compliance
- Fees--Standard Operating Procedures
*If a sponsor needs an invoice for IRB fees, please contact the ORIC*
- UMCIRB Correspondence: Electronic Signatures
- ORIC Quality Assessment Program
- Meeting Minutes
- Research Participants
- Research Involving Children
- Research Involving Pregnant Women, Human Fetuses, and Neonates
- Research Involving Prisoners
- Research Related Injuries
- Participants' Rights and Responsibilities
- HIPAA Policies Related to Human Research
- Vidant Health Policy & Procedure: Disclosure of a Limited Data Set