CTTI) has information and resources for any research institution that is wondering whether a central institutional review board (IRB) can help its human research subject protection program. CTTI is a collaborative effort of private and public research organizations that seeks to improve the process of clinical research. CTTI has identified four categories of projects based on stages of the clinical trial process: Investigational Plan, Study Startup, Study Conduct, and Analysis and Dissemination. In the second of these categories, Study Startup, CTTI is looking at how the research community could improve IRB review. In particular, since 2012 a working group has considered the pros and cons of relying on an external IRB for review of all or some types of human participant research.
Federal Regulators Encourage the Use of Central IRBs
Of course, CTTI is neither the first nor the only organization considering whether an external IRB can streamline clinical research and still protect research participants. In 2006, the Food and Drug Administration (FDA) released a guidance document that encouraged using central IRBs to prevent “duplicative review” in multi-site studies. The Department of Health and Human Services (HHS) added to the conversation when its Office of Human Research (OHRP) released draft regulatory guidance mentioning central IRB review in 2009, posted a letter about the issue in 2010, and announced additional draft guidance in 2011. In 2011, a National Heart, Lung, and Blood Institute (NHLBI) statement said that greater use of central IRBs could improve the NHLBI’s study processes. A speaker at a November 2013 IRB conference described the increasing calls for central IRB review as an “approaching tornado.”
While some organizations are moving towards greater use of external IRBs, many others have concerns about making that kind of step. They want to know:
- Can it really save time? Would a non-local IRB ensure the same protection of our study participants?
- What about the other institutional reviews and requirements that our review board handles now?
- How do we know this external IRB will remain compliant with the regulations?
- How should we even start to consider this kind of change?
If any of these questions sound familiar, you should check out CTTI’s web site on Central IRBs. CTTI pulled together academics, IRB professionals and researchers to look closely at what might work and what might go wrong when a central IRB reviews research for institutions. To date,this working group has put together a thorough guidance document for using external IRBs and produced two useful webinars .
Look for more about those webinars in upcoming blog entries, but here’s a spoiler: a pilot program by Professor Daniel Nelson at the University of North Carolina Chapel Hill showed that external IRBs could save up to twenty days’ processing time during study startup.
Join the Discussion
Are you excited, concerned, intrigued, or do you simply have questions about the use of Central IRBs by institutions? If so, please share your thoughts and questions with us in the comments below. Or email us, if you’d like to be contacted directly.This blog is the first in a four part series discussing the use of Central IRBs in Multicenter Clinical Trials.