Guidance Documents When WVU Principal Investigator Relies on External IRB
Step-by-Step Process when WVU PI Relies on External IRB
Step 1:
WVU PI (or researcher) completes a reliance request form that will be sent to:
reliance@mail.wvu.edu. The reliance request form provides the WVU
OHRP with a summary of the information necessary to determine whether or not a
reliance agreement is appropriate for the project and which IRB should act as the
Reviewing IRB of Record. The WVU OHRP will respond to the request form via email
within 3 business days to communicate next appropriate steps.
Step 2:
Once the WVU researcher has received instructions to proceed with the reliance
submission from the OHRP, the WVU researcher creates a registration (“shell study”)
in WVU+kc for tracking purposes. The CIRB submission type should be used for
reliance submissions.
The following information is required to be included in a
WVU+kc CIRB Submission when WVU is NOT the IRB of Record/WVU is relying on
another IRB:
- Completed
Reliance Request Form
- IRB of Record Approval Letter
-
Reviewing IRB-Approved Protocol
-
Reviewing IRB-Approved Informed Consent Form with approved WVU language
-
Ancillary Review Approvals as needed from WVU (COI, PRMC, IBC, Tissue Banking,
etc.)
-
Letter of Permission (may be required in some cases)
-
Site specific local context questionnaire (if required by the reviewing IRB)
-
Reliance agreement document/IAA (if available when submitting)
The WVU investigator is responsible for:
- Assisting with obtaining necessary documentation/information from the reviewing
IRB
- Following the IRB approved protocol
- Ensuring all WVU personnel are qualified and meet WVU education/training requirements
- Not modifying the protocol or materials without first obtaining review and approval
from the Reviewing IRB
- Accepting responsibility for the conduct of the study at WVU, the ethical performance
of the project, and the protection of the rights and welfare of the human participants
who are directly involved with WVU personnel
- Obtaining any required WVU ancillary approvals before commencing the research (including
Conflict of Interest (COI) disclosures, Radiation/Biological Safety approvals,
Data Use Agreements, and Data Protection certificate).
- Notifying the WVU OHRP of applicable events that occur at WVU in WVU+kc (See WVU OHRP SOP-010 Single IRB Reliance for guidance)
- Notifying the WVU OHRP if the Principal Investigator changes via an amendment in WVU+kc
Step 3:
WVU OHRP staff completes administrative review of reliance request/shell study
WVU does not complete an additional IRB review; instead, the OHRP staff completes
an administrative review of the application/submission that includes the following:
- Notifying WVU researcher of any information needed, or modifications required
- Negotiating and executing the IRB reliance agreement (if necessary)
- Confirming that the necessary documentation from the reviewing IRB is included
- Confirming WVU personnel have completed required human subjects protection training
- Verifying that consent documents include any required local language
- Identifying necessary local ancillary reviews (e.g., conflict of interest, radiation
safety) and ensuring that appropriate approvals/plans are in place.
The OHRP staff will issue an “Acknowledgement” notice when the OHRP administrative
review is complete and the reliance agreement document has been signed by all approving
officials. This signifies that WVU human subjects protection requirements have
been met and that the WVU researcher’s role in the research can begin. If a separate
reliance agreement document has been signed to document the agreement, a copy of
the signed agreement will be included in WVU+kc.
