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Small change in recruitment pool: Back to the IRB?

Reader question: I’m in the midst of the recruitment process for a clinical trial, and I have to widen the pool of acceptable applicants. To do this, I must extend the age limit by one year, which would require a change to the recruitment Web site. That will take at least two weeks. Must I notify the IRB and/or seek its approval for the one-year change?

Expert comments:

Yes, you need to go back to the IRB and get its approval for a modified procedure, such as an age change for your proposed study group. Most IRBs have a procedure for minor revisions of previously approved studies, and you likely will have to file the relevant form. You should clearly explain the change to the IRB on the available form and do not make any change in project implementation without prior board approval.

IRBs may grant such approvals through an “expedited” review process. For example, the Indiana University of Pennsylvania IRB states that it will grant this type of review for “minor modifications or additions to existing approved studies.” And you request an expedited review on your IRB protocol review form.

These reviews follow the same standard of practice as a “Full Board” review and bear the same significance, but are conducted by a board-designated person(s). If the reviewer deems revisions necessary, he will work with you until the project can be approved. In general, federal guidelines outline a project’s eligibility for expedited review, and these will be a part of local IRB procedures. At our institution, the process is much faster than the monthly review by the full board, often taking less than a week. One such situation that allows an expedited review is a case like the one noted above — minor modifications to an already approved studies. If the PI failed to seek such a review at my institution, he would risk academic misconduct accusations and probably have some liability exposure. Another question arises from this situation: Would a PI have to submit more than one Request for Modification if there’s a change not only to the recruitment process, but also to the Web site, for example?

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All of the changes can be a part of the same Request for Modification and approval. Any place in the protocol where the age range was reflected would be relevant, including the project Web site, handouts, letters to physicians, etc. The PI would request permission to add a year to the age range for potential participants and list the places they were adding it.

Expert comments by John A. Mills, PhD, ABPP, Professor of Psychology, Chairperson, Institutional Review Board, Indiana University of Pennsylvania, Indiana, PA.