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  • 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. 
The following UMCIRB informed consent templates have been revised:
Consent Letter Template for Expedited Survey Research v. 1.21.19
Consent for More than Minimal Risk Research v. 1.21.19
Consent for No More than Minimal Risk Research v. 1.21.19
Genetic Testing Consent Template v. 1.21.19
Language for Use in a Sponsor's Consent Template v. 10.1.18
Parent Permission Form Template: No More than Minimal Risk Research v. 1.21.19

Please begin using these templates immediately and discard any old templates you may have stored on your desktop. 

The revisions primarily involve changes to consent elements that will be required under the revised regulations, effective January 21, 2019. These revised templates can be found on our website as well as in ePIRATE. 

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.

Effective October 1, 2017, the NIH began automatically issuing CoCs to all ongoing or new research funded by the NIH as of December 13, 2016 that is collecting or using identifiable, sensitive information. NIH awardees no longer have to apply for a CoC. Language to include in consent documents have been added to the consent templates on the UMCIRB's website. More information about CoCs can be found on the NIH website.

 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. 

University & Medical Center Institutional Review Board

Standard Operating Practices for Human Research Activities

  1. ECU's Human Research Protection Program
  2. Application of the Final Rule
    Institutional Review Board Membership
    Requirements for Human Research Protections Training
    Primary/Secondary Reviewer System
    Chairperson and Vice Chairperson Service on the Institutional Review Board
  3. Institutional Roles and Responsibilities
  4. Ethical Principles and Regulatory Mandate to Protect Human Research Participants
    Faculty Supervisor Responsibilities in Human Research
  5. Human Research Activities
  6. Determining Whether an Activity Constitutes Human Research Requiring UMCIRB Review
    Reliance on Other Institutional Review Boards
  7. Food and Drug Administration Regulated Research
  8. Use of Devices in Human Research Activities
    Humanitarian Use Device (HUD)
    Planned Emergency Research
    Human Research Involving Drugs and Biologics
  9. Informed Consent
  10. 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
  11. Investigator Roles and Responsibilities
  12. 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
  13. Institutional Review Board (IRB) Roles and Responsibilities
  14. 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
  15. ECU Office of Research Integrity & Compliance
  16. 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
  17. Research Participants
  18. Research Involving Children 
    Research Involving Pregnant Women, Human Fetuses, and Neonates
    Research Involving Prisoners 
    Research Related Injuries
    Participants' Rights and Responsibilities
  19. HIPAA Policies Related to Human Research 
  20. ECU HIPAA Privacy Policy: Limited Data Set
    Vidant Health Policy & Procedure: Disclosure of a Limited Data Set