This is the third of four posts with information from CTTI (the Clinical Trials Transformation Initiative) about using a central IRB (Institutional Review Board). This post summarizes a presentation by Cynthia Hahn, Vice President for Clinical Research and Regulatory Affairs from the North Shore – LIJ Health System in New York. Ms. Hahn’s presentation starts at minute 28 in the CTTI Webinar, Research Institution Perspectives on Advancing the Use of Central IRBs for Multicenter Clinical Trials in the United States. (A presentation by Professor Daniel Nelson from the University of North Carolina Chapel Hill precedes it.)
The challenges of introducing something new must be familiar to anyone who has proposed using a different resource for an existing task. Implementing something that is potentially disruptive can be daunting, especially when stakeholders are uncertain about (or explicitly oppose) the idea.
In clinical research, these challenges can be on full display whenever a university, hospital, or other academic medical center (AMC) considers using a central IRB. Although the FDA and OHRP have endorsed using central IRBs in multi-site studies, many AMCs have yet to try taking that step. In her presentation, Ms. Hahn from the North Shore-LIJ Health System helped explain some of the reasons why.
In looking at what kept AMCs from turning to central IRBs, Ms. Hahn identified two central barriers:
- Within an AMC, “IRB” review frequently includes other procedural reviews and approvals that are beyond the scope of protecting human participants in research. Bringing in a central IRB would disrupt that established process.
- In addition, unfamiliarity with IRBs outside of the system can foster a reluctance to work with them.
(Note: Ms. Hahn emphasized that the phrase “central IRB” can encompass several types of IRB. It can refer to an independent IRB [such as Quorum Review]; a federally-funded IRB; or an IRB from another AMC. The common threads are that the IRB operates outside of the AMC in question and serves across multiple sites in a study)
The North Shore-LIJ Health System and Central IRBs
Ms. Hahn shared how the North Shore-LIJ Health System introduced central IRB reviews and offered practical advice for any AMC interested in traveling the same route. North Shore-LIJ is a network of hospitals in New York, with 16 hospitals and 2500 doctors. Each year this healthcare network manages over 2,000 projects that require human research subject protection (i.e., IRB review or oversight). North Shore-LIJ first used central IRBs only for minimal risk studies. Over time, the organization’s experience increased, so did the comfort level with central IRBs. Ms. Hahn said that expanding the use of external IRBs enabled her office to concentrate on other functions of North Shore-LIJ’s human research participant protection program.
CTTI Considerations Document: Clear Responsibilities, Clear Communication
If an AMC is interested in starting work with a central IRB, Ms. Hahn said that CTTI’s Considerations Document is an excellent place to start. The Considerations Document offers important guidance, such as delineating responsibilities clearly. Central IRBs, for example, should oversee the conduct of research for a particular protocol. The AMC’s human research participant protection program, meanwhile, has responsibilities outside of the protocol, such as appropriate training of its research personnel. Both parties share duties such as documenting their relationship and defining their methods of communication.
Ms. Hahn acknowledged that changes of this magnitude can be difficult. She shared advice about planning, implementing, and communicating change. Include everyone, she said, and be aware early of complaints or developing problems. One specific suggestion was to perfect an ‘elevator pitch’ for informal opportunities to discuss a proposal.
LIJ-North Shore’s experience with central IRBs provides practical lessons for any organization considering a similar move. Check out all of Ms. Hahn’s presentation at the CTTI website, and let us know what you think. Or contact us to learn more about using Quorum for your external IRB.
Tags: academic medical center, Central IRB, CTTI, Cynthia Hahn, Daniel Nelson, FDA, Institutional Review Board, minimal risk studies, Multicenter Clinical Trials, New York, North Shore – LIJ Health System, OHRP, Quorum Review IRB, University of North Carolina Chapel Hill, webinar