When Will My IRB Approve My CAM Study?

So far I've submitted to IRBs that seem to understand clinical research involving complementary and alternative medical (CAM) therapies and apply the same rigorous standards (not higher ones) as they do to studies involving conventional care. But this sense of efficiency and fairness apparently has evolved over time--not without stops and starts. I've heard horror stories at other institutions about IRB's taking a year or more to review a protocol simply because it involves chiropractic, acupuncture, or homeopathy.

This situation needs work, but it's not always entirely the IRB's fault--that's my opinion. Issues of bias are, for now, endemic to evaluation and current scientific discussion of CAM therapies, and thus structural, not only personality-driven. That situation may change as scientific research accumulates over time, either validating specific CAM therapies or not, or perhaps giving new insights into mechanism of action that complement such notions as, for instance, acupuncture's concept of chi.

Research into safety, efficacy, and mechanism of CAM therapies raises several challenges, including typical lack of familiarity by IRB personnel with such studies; difficulty in evaluating risks and benefits, qualifying CAM co-investigators, and/or meeting protocol requirements; and lack of sufficient scientific information regarding safety and efficacy of dietary supplements. These are real challenges, and IRB members are located in time and space within a culture that has adopted certain models of truth-finding and presumptions about what is acceptable.

Ironically, however, these very challenges argue for increased approval of CAM investigations, because research can only help resolve the quagmire of knowledge around what therapies are safe or effective. In Cohen MH, Schacter S, Facilitating IRB consideration of protocols involving complementary and alternative medical therapies, Clin Researcher 2004;4:3:2-6, my colleague Steven Schacter, M.D. (a neurologist and HMS faculty member affiliated with Beth Israel Hospital in Boston) offer some policy recommendations to facilitate IRB consideration of such proposed studies.