CenterWatch has reported that just over half of the research institutions with their own IRBs rely on an independent IRB to review any research. And, for those who do work with an independent IRB, they typically do so for a small portion of their research. Quorum believes that setting up service agreements with two or more independent IRBs can help institutions succeed in industry-sponsored trials.
Roles Exist for Both Local and Central Review
One area where central review can work well is in industry-sponsored, multisite studies. Research institutions have much to offer these large studies, while sponsors and CROs are eager to attract research institutions for their expertise, patient populations, and facilities. A research institution which has standing agreements with multiple independent IRBs is in a good position to support many industry trials.
The transition to working with multiple independent IRBs may seem daunting, and the logistics challenging, but many institutions have done it successfully. Most independent IRBs have AAHRPP accreditation; they convene numerous board meetings each week; they have effective expedited review procedures and quality control practices in place; plus they utilize electronic tools to make communication easier.
We think this all adds up to potential advantages for research institutions, and that working with numerous independent IRBs will make it easier for an institution to join numerous industry trials.
Here are examples of how two universities and one research hospital have gone about expanding their roster of independent IRBs.
The University of North Carolina Chapel Hill: Testing a Hypothesis
In 2012, the University of North Carolina (UNC) Chapel Hill ran a six-month pilot study to compare how independent IRB processes and decisions compared with the university’s own IRBs.
Professor Daniel Nelson discussed the results in a Clinical Trials Transformation Initiative (CTTI) webinar. Nelson said that the independent IRB reviews of industry research saved up to 20 days of startup time, but that the decisions essentially matched those of the university’s IRBs. After assessing the results of the pilot, the university decided to expand beyond the one independent IRB it was working with. Under a new policy, UNC Chapel Hill agreed to work with whichever independent IRB served as the central IRB for an industry-sponsored study as long as it met three other criteria. The independent IRB had to:
- Be in good standing with OHRP and the FDA,
- Establish or already have a master services agreement with UNC Chapel Hill, and
- Be accredited.
Benaroya Research Institute: Diversifying the IRB Pool
After working with one independent IRB for many years, Seattle’s Benaroya Research Institute (BRI) decided to try working with a second. It is now adding a third. A representative of BRI’s IRB office said that one reason for the additions was to gain the efficiencies of central IRB review in more trials. Diversification was another. The IRB office representative said it was a safe move to “not have all of our eggs in one basket.”
For BRI, as at UNC Chapel Hill, accreditation was a key requirement for selecting an independent IRB. BRI’s evaluation process was less formal than UNC’s, but no less thorough. The IRB representative emphasized the importance of the process: “When you are at an institution you have to wonder who has your back. Who is watching out for the institution?”
University of Rochester: Moving Out of Its Comfort Zone
The University of Rochester has relied on one independent IRB to oversee industry studies for nearly 20 years. That long relationship meant that the university, its IRB office, and its investigators were very familiar with how to work with that IRB, but that reliance also meant a resistance to change. Over time, investigators started asking to work with independent IRBs on industry studies, and the university now is setting up agreements with two others. The university had a number of requirements for selecting its multiple IRBs, but accreditation was again a key element. “Accreditation has to be there for an independent IRB to be considered,” a representative said. “[It] allows us to avoid a more formal due diligence process…Without it, we won’t even start the discussion.”
Best Practices: What These Institutions Learned
Common threads run through the experiences of all these three institutions, including the importance of:
- Clear and consistent selection criteria,
- A consistent procedure for interacting with multiple independent IRBs,
- Master services agreements to define the relationships, and
- Monitoring capabilities for the institution’s own human subject protection program.
CTTI has created a set of helpful materials for an institution interested in working with an independent IRB. Its Single IRB toolkit includes:
- Recommendations for advancing the use of central IRBs in multisite trials
- A Central IRB Evaluation checklist
- An IRB Authorization Agreement Template
- A Considerations Document for issues to consider between an institution and central IRBs
Quorum also recently released a whitepaper, How Institutions Gain Research Opportunities, which explains the background and results of these three case studies in greater depth.