IRB mergers can be smooth with planning
IRB mergers can be smooth with planning
By Paul W. Goebel Jr.
Vice President
Chesapeake Research Review
Columbia, MD
Question: Our institution’s IRB is merging with another IRB. What can we do to make the transition efficient? (In other words, what can go wrong and how can we minimize the possibility?)
Answer: The question presents a situation where two hospitals or medical centers wish to merge the two IRBs into one.
Mergers of this type can be done relatively smoothly if you keep in mind the following:
- The terms of the merger must be outlined in writing and agreed to by the decision makers for each institution.
- If either of the institutions conducts federally funded research, the assurance that it has filed with the Office for Human Research Protections must be amended.
- The populations from which each institution draws study subjects should be examined for dissimilar cultures. The IRB membership and the IRB staff should be sensitive to minority populations that are likely to participate in studies reviewed by the new IRB.
- If the institutions are in different states, the merged IRB must be aware of each state’s requirements for IRB review and informed consent and assure the new/transitioning IRB procedures are in compliance.
- Each institution is likely to have different operational policies, constraints, and commitments. The IRB administrator, in concert with the administration of each institution, must develop a policy and procedure manual that represents the expectations of the new entity.
- The examination of processes should extend to such areas as control and accountability for the investigational test articles including receipt at the institution, secure storage and records of distribution or disposition.
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