Description
The Institutional Review Board Amendment service allows principal investigators (PIs) and research teams to submit proposed changes to a previously approved Institutional Review Board research project. Federal regulations and GRCC institutional policy require that any changes to approved human subject research—including protocol modifications, key personnel updates, consent document revisions, or changes in recruitment strategies—be reviewed and approved by the IRB prior to implementation, except when necessary to eliminate immediate hazards to subjects.
Key Features
- Protocol & Methodology Revisions: Submit modifications to study design, data collection instruments, surveys, or participant intervention procedures.
- Personnel Updates: Add or remove principal investigators, co-investigators, faculty advisors, or student researchers from an active protocol.
- Consent & Recruitment Material Updates: Submit revised informed consent forms, assent forms, flyers, emails, or advertisements for approval.
- Sample Size & Population Adjustments: Request changes to total participant counts or criteria for participant inclusion/exclusion.
Eligibility
- GRCC Faculty, Staff, and Administrators serving as Principal Investigators
- External Researchers with an active, GRCC IRB-approved protocol
- Student Researchers submitting amendments under the supervision of a GRCC Faculty Advisor
Requirements
Hold for approvers
- Original GRCC IRB Protocol / Tracking Number
- Detailed description and justification for all proposed changes
- Tracked-changes versions of updated documents (e.g., protocol narrative, consent forms, survey tools)
- Updated Human Subjects Research Training (CITI) certificates for any newly added personnel