Conflict of Interest on Wearing Two Hats: Clinician and Researcher
I have posted here (Jan 8 2005, Dec 23, 26, 13 2004) about situations where physicians play professionally two roles (wearing “two hats”) and the need to be concerned about the potential conflict of interest this raises. On the blog Respectful lnsolence Orac writes about his experience as a physician and also a scientist in the “two hat” role. The discussion centered about academic and financial issues. I added a comment about another possible conflict of interest between the role as a clinician and a clinical researcher with regard to the relationship to the patient-subject. Obviously, a physician who does purely laboratory research will not experience this conflict. I wrote:
..Maurice.
I may have missed it in reading all the text on this topic but isn't a discussion of the "two hat" conflict of interest of the physician/researcher with regard to the issue of the patient's informed understanding the research study yet to be considered here? By being a physician, even not the primary treating physician, doesn’t the patient expect a beneficial treatment from you and not an unknown or ambiguous treatment or no treatment at all within a study that both you and the patient participate?
Also are you not under a professional duty as a physician to provide care and avoiding maleficence. And yet as a researcher, your professional duties in clinical research do not require you to provide any treatment but to try to assure that the results of the study will be meaningful and worth the risks which are to be kept to a minimum. The responsibilities of each role, independently, might be understood by a patient-subject but can the role of those who are wearing "two hats" also be understood and accepted?
posted by Maurice Bernstein, M.D. @ 10:41:00 AM
2 comments
2 Comments:
Sorry I didn't respond to your comment. (I had meant to, and then forgot about it.) The conflict you mention doesn't yet apply to me, for the simple reason that none of my work has yet progressed to clinical trials. One day, I hope, it will.
Then, yes, such conflicts could be a problem. That is why IRBs were developed, because it was appreciated that these conflicts could exist and that researchers might be tempted to try to coerce patients to participate and/or remain in studies. In most institutions (mine included) they work well. In fact, in ours, we frequently complain that IRB restrictions are too onerous. Part of the solution is to strengthen the hand of IRBs.
My best wishes on your hopes for your future.
I think that besides a strong and educated IRB would be ongoing monitoring of the patients in the study by some independent resource. It is my understanding that IRBs simply approve the informed consent procedure and the manner in which the study is to be performed but don't continue to monitor each study as it is occurring. What would be important would be for independent survey of each patient to establish what each patient understands about what he or she is consenting and then perhaps an ombudsman-like followup where the independent resource can be available for contact by the patient throughout the course of the study and where the resource can learn of any problems which the patient might experience. ..Maurice.
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