- 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.
Users will now select "Final Report" on the left side of each study's workspace to close a research study. This option was added to help users navigate to the correct application more easily when they are ready to close a study. Brief tutorials have also been added to the website.
The short form consent (both the English and Spanish versions) has been updated. The new version date for the short form is 10/09/2017. In addition, an attestation of translation has been obtained for the Spanish translated version of the short form and is available on the UMCIRB website under "Forms, Docs & Templates". Please be sure to use this new template when submitting a short form for IRB review and approval.
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