The University of Pennsylvania in Philadelphia has developed an IRB of record relying site division of responsibility form that outlines what each IRB involved in the collaboration and authorization agreement will do.
The following are some sample items from the spreadsheet form:
• Responsibilities of IRB of record for initial review:
- Determination that approval criteria are met or required revisions to meet approval criteria.
- Informed consent form is assessed for required elements, necessary optional elements, and any revisions needed to improve subject understanding or remove inappropriate language.
• Responsibilities of relying IRB for initial review:
- Receives the approved version of the application/protocol; facilitated review may occur as needed.
- Receives approved version of the consent form(s) with revisions as needed per the local site (i.e. contact information, voluntary participation language, HIPAA, injury language, etc.).
• Responsibilities of local investigator/research team for initial review:
- Verifies that the research team is suitable to conduct the research.
- Receives approved consent form from the cIRB and uses this version for consenting subjects.
• Responsibilities of IRB of record for continuing review:
- Conducted on the required annual basis with a request to the local IRB of record’s research team to provide an annual progress report and self-assessment related to conduct of the research from each of the relying sites.
• Responsibilities of relying IRB for continuing review:
- Can be notified by local PI/research team that continuing review application is underway and be notified when approval is granted or if additional information is needed (sites can decide if they want this information shared).
• Responsibilities of local investigator/research team for continuing review:
- Provides annual progress report (template will be provided) and completes self-assessment for inclusion with continuing review application to the cIRB.