Human Research Standard Operating Procedures
The UMCIRB provides human research standard operating procedures for researchers conducting research projects with human subjects. Learn more about the SOPs for each category below. For more information about the following SOPs, please contact the UMCIRB.
ECU’s Human Research Protection Program
- Application of Final Rule (PDF)
- ECU Regulation on the Use of Human Subjects in Research (PDF)
- Criteria for IRB Approval for Human Research
- Institutional Review Board Membership (PDF)
- Requirements for Human Research Protections Training (PDF)
- Primary/Secondary Reviewer System (PDF)
- Chairperson and Vice Chairperson Service on the Institutional Review Board (PDF)
- Expiration of IRB Approval (PDF)
- Expedited Studies Where Continuing Review Does Not Apply and the Expected End Date has Passed (PDF)
Institutional Roles and Responsibilities
- Ethical Principles and Regulatory Mandate to Protect Human Research Participants (PDF)
- Faculty Supervisor Responsibilities in Human Research (PDF)
- OHRP International Compilation of Human Research Standards
- Presidential Commission for the Study of Bioethical Issues (PDF)
- The Declaration of Helsinki (PDF)
- Nuremburg Code (PDF)
Human Research Activities
- Determining Whether an Activity Constitutes Human Research Requiring UMCIRB Review (PDF)
- Is an Activity Human Subject Research Requiring IRB Review and Approval? (PDF)
- Institutional Review Board (IRB) Reliance Agreements (PDF)
- Worksheet: Case Reports Using Existing Data (Word)
- Human Research Determination Worksheet (Word)
- Worksheet: Emergency Use (Word)
- IRB Guidance for Student Research and Class Projects
Food and Drug Administration Regulated Research
- Human Research Involving Drugs and Biologics (PDF)
- Use of Devices in Human Research Activities (PDF)
- Humanitarian Use Device (HUD) (PDF)
- Planned Emergency Research (PDF)
- Expanded Access Use of an Investigational Medical Product (Investigational Drug, Device, or Biologic) (PDF)
Informed Consent
- Essential Elements of Informed Consent (PDF)
- Informed Consent (PDF)
- Waiver or Alteration of Informed Consent (PDF)
- Waiver of Documentation of Informed Consent (PDF)
- Use of a Legally Authorized Representative (LAR) in Research Involving Vulnerable Adult Participants (PDF)
- Waiving Informed Consent for Emergency Medicine or During Emergency Use
Investigator Roles and Responsibilities
- Continuing Review (PDF)
- Unanticipated Problems Involving Risks to Participants and Others (PDF)
- Defining and Reporting Protocol Deviations (PDF)
- Noncompliance in Human Research Activities (PDF)
- Individual Investigator Agreement (Collaborating Investigators from Outside ECU and its Affiliates) (PDF)
- Amendments to Currently Approved Human Research (PDF)
- Suspension or Termination of IRB Approval (PDF)
- Conflict of Interest in Human Research (PDF)
- Biospecimen Banking (PDF)
- Emergency Use of a Test Article (PDF)
- Deception in Human Research (PDF)
- Recruiting for Human Research (PDF)
- Payment of Research Participants (PDF)
- Study Completion and Closure (PDF)
UMCIRB Roles and Responsibilities
- Certified Exempt Research (PDF)
- Expedited Review Procedures (PDF)
- Determination of Investigator and Research Personnel Qualifications to Conduct Human Research (PDF)
- Initial Review of Human Research Activities (PDF)
- Review by the Convened IRB (PDF)
ECU UMCIRB
Research Participants
- Research Involving Children (PDF)
- Research Involving Pregnant Women, Human Fetuses, and Neonates (PDF)
- Research Involving Prisoners (PDF)
- BSOM Research Related Injuries (PDF)
- Participants’ Rights and Responsibilities (PDF)
