Suz Redfearn at ClinPage recently posted an excellent article about IRB selection, and it’s valuable reading for sponsors or CROs who are struggling with their IRB.
“Choosing an IRB is an issue that doesn’t often get a lot of attention, but if poorly done it can cause a lot of delays for a sponsor and a CRO,” says Sue Hocker, a consultant who provides an in-depth look at the issues throughout the article.
Pointers include:
- Check the U.S. Dept. of Health & Human Services’ Office for Human Research Protection Institutional Review Board of Registry. Make sure the IRB you’re considering is listed and violation-free.
- Interview the IRB with an eye on the issues that can delay your study.
- Evaluate the IRB’s capacity and pay close attention to the number of high-risk trials they’re handling. “When a megatrial comes due for follow-up reviews—an all-hands-on-deck situation—the IRB’s smaller trials may be slighted,” Redfern writers.
- Make sure the IRB completely understands the protocol and is experienced in your therapeutic area.
- Understand the IRB’s regular meeting schedule, project management process, and document management system – surprises can pop up here and cause unexpected delays.
Check out the complete article (highly recommended) here.
