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Research from the subject perspective

Does the average informed consent process adequately describe a research subject’s available options? Regulations require any “alternatives that might be advantageous to the subject” to be addressed. But can the few words in a consent form, which are sometimes limited to “ask your doctor about the other treatments available”, fully explain what the options are?

A recent post on PRIM&R’s blog, Ampersand, highlights the confusion subjects may face when considering joining a clinical trial, and the difficulties IRBs may have in understanding the subject point of view. The author was given the opportunity to enroll in a clinical trial after a serious cancer diagnosis, but declined, after figuring out that the trial may delay her treatment and would prevent her accessing a newly approved drug. This author’s background is noteworthy — she has worked as a bioethicist for decades, and has been involved in research ethics throughout her career. In other words, she’s highly educated and has a solid grasp of the ethical underpinnings of research, and is therefore not the typical research subject. How about our patients? How should information be presented to them so they fully understand their options before saying yes or no to study enrollment? How can we consider their perspective in reviewing and approving research?

Please click on the link above to read more. Note that this author has a new book available about subject participation in research ethics discussions. If we can find a local source that has this title available for borrowing, we’ll let you know.