Tuesday, December 20, 2011

IRB Thinks Overweight People Are Less Capable of Giving Informed Consent

Since it concerns a medical study, this is a little off-topic for this blog, but a recent essay tells us something about the paternalist mindset of IRBs and their reliance on guesswork.

[Jerry Rabow, "An IRB Public Member’s Education," Journal of Clinical Research Best Practices 7 (December 2011). h/t Roberto Veloso]

Writing in the Journal of Clinical Research Best Practices, Jerry Rabow--a retired lawyer and non-affiliated, non-scientist member of the IRB at the Cedars-Sinai Medical Center in Beverly Hills--boasts of persuading his IRB to reject "a clinical study to evaluate the effectiveness of a new procedure for bariatric (weight loss) surgery."

Rabow believes that overweight people are more vulnerable to disappointment and less capable of making informed decisions than are other adults considering experimental surgery:

Participants would be drawn from a psychologically vulnerable population (seriously overweight individuals who had tried and failed other methods of weight loss, such as diet, exercise and counseling). Assuming that the placebo effect and eating regimen would not secure long-term weight loss for the control group, individuals randomized to the sham surgery might experience stress and disillusionment from yet another personal "failure" — the inability once again to lose weight despite attempting to adhere to the prescribed eating regimen.

Low self-esteem of the participants could also make them especially vulnerable during the consent process, due to societal views that are often openly critical of people who are seriously overweight (based, I believe, on the erroneous view that all obesity is a consequence of ignorance or lack of willpower). Taken together with the participants' past failed attempts to lose weight, these special vulnerabilities to psychological pressure to solve their obesity problems raise the question as to whether their signature on any ICF [Informed Consent Form] could be relied upon as signifying truly voluntary informed consent, at least in the absence of special consent procedures.

Rabow does not explain how he arrived at his understanding of overweight adults' capacity to make decisions or what "special consent procedures" he thinks necessary when recruiting them to a study.

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