Conflict of Interest?: The Researcher has the Disease under Study
I have a simple question to put to my visitors: should a researcher who has the very disease under investigation regarding therapy be a major or significant investigator in the study or should the researcher recuse him/herself and simply become a patient subject of the study?
There is past and current concern in the medical literature about the conflict of interest which may be held by an investigator who is working for or in any way given financial or other support by a pharmaceutical company who will produce the drug under investigation. The concern is that there may be actual bias involved in the design or the carrying out of the study toward the benefit of the pharmaceutical company with lesser concern for the science involved. If there is no intentional bias, perhaps to others it may appear as a possibility and will affect how others look at the results of the research study.
Now with regard to the investigator, him or herself, if the investigator was a patient with the disease, regardless of the financial support of the study, would conflict of interest exist as a patient that might affect the study and its results? If so, how would the conflict manifest itself? An analogous question might be why are patients as subjects of a drug study not given an opportunity to make suggestions in the design and development of the study?
I would welcome comments from my visitors on this aspect of conflict of interest in research. By the way, for those who want to read about another kind of conflict of interest, specifically where the investigators in the study of the cause of autism are or appear to be associated with activist organizations or organizations holding a particular point of view? I posted that thread on November 21, 2007. ..Maurice.
posted by Maurice Bernstein, M.D. @ 10:10:00 PM
5 comments
5 Comments:
I would like to extend the discussion of conflict of interest in medical research, perhaps to introduce the possiblity that if a researcher has mixed interests, it may be wrong to assume that those intersts will always be to the detriment of the patient. I also pose the question whether with similar mixed interests as may occur when medical schools, medical students and physicians interact with drug or medical device companies whether one can assume they all are potential conflicts of interest which only harm the professional goal of doing the best for patients. I haven't settled yet on an answer, though I would say there are definite nuances to what people may consider "conflict of interests".
I wrote the following today to a bioethics listserv to get the opinion of ethicists. ..Maurice.
I think that there is a whole lot of nuances in the definition and application of the concept of “conflict of interest” with regard to medical research and medical education when considering medical researcher/academic institutions, medical instructors and physicians vs industry as one looks at the basic and final goal to benefit the patient. The reason I bring up nuances is because in all the discussions about COI, there is always a negative or unethical connotation. Is there something else? An example of something else might be considered if an individual has two or more interests, when should they be considered in conflict? What if both diverse interests when investigated are shown to work synergistically to accomplish the accepted goal, yet on first examination they appear to be in conflict? Therefore, accepting a negative view based on only the appearance of conflict of interest would be an unfair judgment.
An example I posted on my bioethics blog is the medical researcher who is responsible for devising the study regarding a treatment for a disease and running it. One problem(?).. the researcher is ill with that very disease (or, if not, a very close relative has it.) Now what? Does the fact this researcher has the disease suggests that he or she has a conflict of interest? Yes, the conflict might involve the possibility that while others might rightly assume equipoise [starting a study without bias that one arm of a study will give better results than the other] regarding the treatment and lets say a placebo or a standard treatment, the researcher may have personal emotional reasons to hope otherwise and perhaps would have designed the study with that in mind, essentially faulting the investigation. On the other hand, the need to benefit the researcher’s personal medical illness but also with intention to benefit other patients, the researcher may instead take extra pains to attempt to devise and carry out a study that is would be considered by others as faultless. In this case, the two interests of the researcher, his own illness and the illnesses of others would really not be in conflict. But would those, on first examination, make the appropriate judgment regarding any COI? There could be even nuances in the appearance of COI between medical academia and the drug or device industry.
Yes do get yourself involved. You never know just how helpful your personal research maybe into the investigation.
I find Dr. Bernstein's comments very interesting. It's true, we do have a tendency to assume COI must have a negative effect. But maybe if we mull it over a bit more, we could find some positive effects, or even mixed effects. I mean, isn't that what is so tantalizing about medical ethics as a thought problem: just how complicated and difficult all of the issues are to sort out?
I spent two years working as a research assistant for a hospitalist who focused his research mostly on prostate cancer in the African American community. This particular physician was interested in the disease because he himself was African American and at a heightened risk for prostate cancer because of that. Is that a conflict of interest? It's hard to say. I do think many times drug companies have too much influence in medical schools, in the research process. I saw lots of examples of it in even my two short years working at a teaching hospital. But I do think Dr. Bernstein is right to caution us to look at the nuances.
Immediately the COI I identified was probably the same one that is the gut reactions of others - mainly, the researcher with the disease is using others to experiment on potential cures without having to take any of the personal risks involved with studying. But after this gut reaction I generated a surprising number possible COIs - some positive and some negative:
#1 - see above
#2 - the researcher will be overly optimistic when reviewing data because they will "see what they want to see"
#3 - the researcher will overlook positive results that are not up to the level of cure that the researcher wants to cure their own disease state
#4 - the researcher could be overly invested in the research and miss a crucial step of discovery (versus #3 where they see a positive result but it isn't "good enough")
#5 - the researcher could actually distance themselves from the research when it isn't very promising so they don't have to deal with personal feelings of failing themselves
#6 – the researcher could be so personally invested in the study that they reject others ideas for improving the study (i.e. tunnel vision).
These are just a few a came up with in under 3 minutes and I am sure there are a variety of other possible COIs. The real question though is knowing that all these possibilities exist can there be a blanket rule prohibiting researchers with a disease from studying that disease. From a practical standpoint I don’t think there can be a blanket rule. Some researchers will be able to handle the situation appropriately and others will not – that's the way things work in all segments/jobs/positions in society. However, I do think there should be safeguards in place – primarily placing the personally invested person as "second in command" or having a "Co-PI" who isn't personally as invested but must be consulted with for certain aspects of the study. Such a system would help minimize the negative conflicts that could arise while allowing the researcher who is passionate about finding a cure for a disease for personal reasons to harness that energy.
Yes, davei, all your possible COIs are certainly realistic. That the primary investigator with the disease related to the study be monitored by an investigator without the disease is a reasonable mitigating action, however this would depend on the ego of the primary investigator. Often those who have conflicts of interests are either not aware or deny any COI and there are investigators who cannot give up their professional power, control and assumed intellectual expertise to a theoretical concern by others.
Another aspect of this discussion must be consideration of the incidence or frequency of the primary investigator or someone in his family having the disease. This discussion may be more theoretical itself than a reasonably common occurance. Finally, would the investigator disclose to others the personal nature of the study? Nevertheless, it is still worth considering since it always is a possibility. ..Maurice.
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