How do I establish an IRB for reviewing clinical trials?

Question:

Can you provide insight on how to form an Institutional Review Board for the review of clinical trials in a teaching hospital environment?
- Researcher, teaching hospital

Response:

Putting new IRBs in place is complicated and people often underestimate the regulatory knowledge and amount of work needed to create a board that is efficient, effective and compliant with the applicable regulations. 

The first step would be figuring out what regulations one must follow.  The organization should also think about which regulations and ethical principles they may not technically need but may want to apply as a minimum standard, including whether they want to become AAHRPP accredited.  Then they need to develop processes; write SOPs, policies and any necessary worksheets/checklists; create application and other forms for researchers to use; hire or appoint staff; appoint the board; train the board; and register the IRB with US federal regulatory agencies (when US regulations apply).  Only then can an IRB actually start reviewing protocols. 

Because of the resources needed to maintain a review board that is in regulatory compliance, and the significant consequences if a board is not compliant (for example, closing studies or losing research funding), it is often recommended that organizations below a certain threshold of research volume form an agreement with another organization to provide review for them rather than creating or maintaining a small IRB.  This should always be a consideration when thinking about creating a new review board as well.

About the Author

Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG

Dr. Lindsay McNair has extensive experience in the pharmaceutical industry. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair teaches graduate-level courses on the scientific design of clinical research studies. She has been actively involved in IRB work for 18 years, and has a Master’s of Science in Bioethics with a concentration in research ethics.

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