IRB Mythbusters – External Reliance
The VCU Human Research Protection Program presents IRB Mythbusters — a periodic newsletter clarifying common misconceptions about conducting human research and the IRB!
In this issue, “myths” surrounding External IRB Reliance (i.e.: when an external IRB, such as WCG, Advarra, or another academic institution reviews a VCU study) are addressed. View the attachment to see the newsletter, or read through the same content below. Access previous editions of IRB Mythbusters by visiting the “mythbusters” tag on our blog.
MYTH #1:
Reliance is always faster and easier than getting local (VCU) IRB review
FACT: Implementing reliance agreements to cede review of research to an external IRB is a multi-step process, and there is variability in processes across institutions. This can create additional work for study teams, especially on the front end of study. Negotiating a reliance agreement, obtaining and communicating local context information, and ensuring that all VCU institutional requirements are met must happen in ADDITION TO obtaining IRB approval for the VCU site at the reviewing IRB. While this creates extra work on the front end, the process can simplify IRB review over the life of the study. Typically, reliance arrangements create the most efficiency for large, complex, multi-site studies.
TIP: While the reliance SmartForm in RAMS-IRB is shorter than the form you would see for full-board/expedited/exempt studies submitted to the VCU IRB, please remember that the screening process remains very similar. You can generally expect at least one round of revision between the initial submission and finalization of a screening. After screening is complete and a reliance agreement has been executed, you are still responsible for ensuring that IRB approval FOR THE VCU SITE is obtained prior to initiating the research. When relying on another academic IRB, this may mean that you are communicating with the reviewing IRB through an intermediary, usually the lead study site’s team, and are thus subject to their availability and timelines. Please remember that if you’re unsure about the requirements and what reliance may look like for your study, we are always here to consult with you. To schedule a time to consult with the IRB Reliance team specifically, please reach out to us at [email protected], or schedule an appointment with our team through appointlet.
MYTH #2:
Once I have completed the VCU reliance screening and there is an agreement in place, I can begin my research.
FACT: While the screening and negotiation of a reliance agreement are crucial to ensure that the VCU IRB is meeting its regulatory duties to rely on an external IRB, the ultimate determination for the research is up to that external IRB. Just like when research is reviewed by a local IRB, research cannot begin until the reviewing IRB has issued a determination of approval (or conditional approval) for the proposed study, and for the engagement of the VCU site specifically. This means if you submit a reliance request for a study that has already been reviewed and approved by another IRB, you must still wait for that IRB to review for and approve the VCU site.
TIP: Once the study has been approved by the external IRB, please remember that it is the VCU study team’s responsibility to ensure that the RAMS-IRB study submission remains up-to-date. Changes can be made to the approved study submission by submitting amendments. For more details on submitting amendments, please see the ‘Creating an Amendment’ section in the RAMS-IRB for Researchers Guide.
MYTH #3:
If using an external IRB, I don’t have to submit anything to VCU
FACT: The VCU IRB needs to know about any and all instances where VCU employees or agents are involved in human subjects research projects, including research that has been determined to be exempt by another institution. The VCU IRB must grant authorization for review to be ceded to an external institution prior to the beginning of any research activities at the VCU site. In order for the VCU IRB to assess the appropriateness of each reliance request, PIs and study coordinators must request a reliance arrangement through the RAMS-IRB system. Even after a reliance request has been submitted, screened and approved, an agreement is in place, and you have IRB approval from the reviewing IRB, there are still certain things that MUST be submitted to the VCU HRPP. These include ANY study amendment that may impact institutional requirements or prompt an ancillary committee review (i.e., changes in use of PHI, addition of a new investigational drug, or a change in PI would all trigger institutional requirements; a new potential conflict, or the addition of DXA scan to study procedures would prompt ancillary committee reviews), an annual update, and a closure notice when the study has been closed by the reviewing IRB. You also MUST submit ANY determinations of Serious or Continuing Non-Compliance, or Unanticipated Problem by the reviewing IRB. This last piece is particularly important, because VCU may be subject to reporting requirements that other institutions or IRBs are NOT subject to.
TIP: Despite its shorter length, PIs and study coordinators should be prepared to answer the questions and prompts as thoroughly as possible—-just as with any other IRB submission. Due to the scope of VCU’s institutional requirements regarding human subjects research, the IRB reliance team will review most facets of a research proposal. Study teams should be prepared to submit key documents pertaining to their study, such as Informed Consent Forms (ICFs), the study proposal, ancillary committee approvals, etc. The requirements for ongoing submissions to the VCU HRPP are described in your VCU “Reliance Accepted” notice, as well as in the VCU HRPP WPPs and the VCU Reliance Website. If you are ever unsure about submitting something, or have any other questions about studies involving reliance arrangements, please reach out to us at [email protected].
If you have questions about a potential or ongoing reliance study, don’t hesitate to reach out to the IRB Reliance team ([email protected]). Additionally, be on the lookout for a fresh update to the VCU HRPP’s dedicated webpage on IRB reliance, which will soon include frequently asked reliance questions. Roll out to be announced on the VCU HRPP blog.
