Douglas Kinsella*, University of Calgary: We have focussed on private and public interests, conflicts of interest, and research ethics boards (REBs). Another jurisdiction has been ignored, except by private REBs. It is the constituency of practicing physicians who, because some element of the economic climate has limited their standard of living, are supplementing their income by becoming involved in various types of clinical trials, e.g., Phase IV trials. That traffic has gravitated towards private REBs, because most institutions, e.g. medical schools, for liability reasons, cannot touch them, since they are unable to monitor or accredit the physicians.
The Alberta College of Physicians and Surgeons now has a duty to ensure competence in the area of research practice as well as clinical practice. To that end, the College will run an REB, based on the code. It is in the process of implementing this plan. I am privileged to serve as Chair of the Implementation Committee.
There are implications for private REBs and institutions, who must find some way of interfacing with this regulatory body, which has more authority over Alberta physicians participating in research trials. One question that I have asked the board to address is whether we should require, on the informed consent form, a statement that makes it clear to patients that the physician is gaining personal income or profit from participating in the research project. The furor that has emerged from the clinical community over this question is a disappointment.
Frederick Lowy: Many practicing physicians are part-time clinical investigators. The extent of their investigation is rather limited, i.e., they usually enroll patients in Phase IV trials and may have a remote connection with the actual research. They are concerned how this statement will affect the doctor/patient relationship, which is an important component of good health care. They are concerned that this statement may imply that they are compromising the best possible care for their patients and that, somehow, patients will lose trust. Although this view is not necessarily valid, it may be the motivation for the reluctance to accept the statement.
Michael McDonald, University of British Columbia: It is a bad, short-term strategy not to have clear standards of accountability. Strict standards of accountability set us free and give us a lot more latitude than the absence of standards. We are asking for trouble in the near future if we do not have those standards. I am puzzled as to how people can think that the absence of accountability will make it any easier. It is a downward race. Private industry has realized the importance of strict accountability and standards as a way of showing to interested shareholders, other stakeholders, employees, and others that they are on the level. I do not understand why the public sector does not grasp the importance of this issue.
Trudo Lemmens, Clarke Institute of Psychiatry and Joint Centre for Bioethics: I have argued that conflicts of interest are everywhere. The question is how to deal with them and how to create trust in the institutions. I have also argued that the difference between commercial and academic review is that academic review occurs in an environment that promotes critical reflection. At least two speakers in this discussion serve on REBs. In an academic setting, REBs constantly reflect upon issues of conflicts of interest and how to deal with them. I fear that the increasing commercial involvement in academia may affect this possibility or increase the pressure on suppressing or limiting critical reflection.
Frederick Lowy: I agree. The academic setting offers a considerable degree of protection, particularly for tenured professors, who can say what they want, even if it displeases the administration. Of course, anyone who works in a hospital or university knows that no monolithic approach exists for anything. In fact, it is a debating society, which is why decisions are often slow and cumbersome. That may be an advantage. Little that happens in an academic institution that is not publically known, if not immediately, then shortly thereafter. There is a certain protection in that.
Kathleen Glass: While protection may exist within the academic environment, there is still the consideration: "Can I lose my corporate sponsor by what I say?" or "Can I cause my university to lose their corporate sponsors by what I say?".
Patricia Kosseim: Dr. Glass, you talked about your son’s reaction to finding out that his teachers were paid. It was not unlike what I felt when I discovered that doctors were paid for their research. The fact that they were paid did not surprised me; it was their secrecy. I have worked in hospitals for all of my life and was an REB member for two years before I discovered that fact. Whenever the subject is raised, it creates emotions. That, in itself, is symptomatic.
Denis Cournoyer, Montreal General Hospital: At McGill University, when the joint ethics committee, which is comprised of the Chairs of different ethics committees of McGill-affiliated institutions, it was felt that the wording of an initial draft of the tri-council guidelines was too strong in banning any form of physician compensation. That being said, I’m very surprised to hear – and I realize that there are different standards – that physicians receive personal compensation and that this practice seems so widespread. At Montreal General Hospital and the MGH research institute, it is extremely rare. The institution has been very uncomfortable in allowing physicians to receive compensation for their work. Their grants-per-patient are funnelled into research accounts that are administered in the same manner as the institution’s research accounts. Governing policies prevent physicians from using that fund for personal benefit. It is generally restricted to R&D.
Despite decreasing health-care resources, there will be a need to compensate physicians fairly for their work. In my opinion, that need will extend to REB committee members. I do not think that the increasing workload will be possible to manage or of the best quality, if these individuals are not fairly compensated for their work.
Kathleen Glass: More institutions are regulating this problem. Such regulations can eliminate potential conflicts of interest. There are still some potential conflicts, and there is wide variability among policies of various institutions. Not all are multiple health-care establishments under a single academic unit with one policy.
Douglas Kinsella: Variations in policy exist across the country. Different institutions have devised different ways of handling this problem. Our institution has essentially the same rule. A physician who is engaged in a clinical trial is not permitted to use the income derived from that clinical trial for personal expenditures. Some trials pay $16,000-$32,000 per patient. It is difficult to relay that information to the patient. Regardless how the initial contract is configured, at the end of the trial, some physicians have a habit of moving leftover funds into other accounts, where they can be used for other purposes. So, we have to be careful about casting this information into a framework of purity, where physicians do not personally benefit from their involvement in clinical trials. We try not to have it happen, but there are ways in which it can.
Trudo Lemmens: If the committee feels that the grant-per-patient is unduly large, that is a different issue. Our trials are scrutinized to identify additional, unnecessary costs. In the research context, if we ask pharmaceutical companies to pay for blood counts, chest x-rays, CT scans, and MRIs, then we should ask them to pay for professional fees that health-care providers are no longer willing to pay.
(unidentified): As a working group, we are not mandated to look at commercial REBs, but I would like to know how you would deal with the inherent, blatant conflicts of interest in commercial REBs.
Kathleen Glass: Perhaps some sort of mandatory regulation could establish an official committee to oversee commercial REBs.
(unidentified): As we have heard today, potential conflicts of interest exist in institutional REBs, so it seems that such regulations should cover all REBs.
Kathleen Glass: Yes, except the institution and funding agency are separate. Unlike public REBs, private REBs do not exist on different levels, so a similar oversight mechanism is needed.
Gordon Crelinsten, Royal Victoria Hospital and NCBHR: Physicians do not want to disclose the fact that they are compensated for Phase IV surveillance studies, because of difficulties with the doctor/patient trust relationship. Most Phase IV surveillance studies are veiled research. They are marketing tools to improve the market shares of various drugs.
How physicians who do this kind of research explain to patients why they are putting them on drug "a" as opposed to drug "b"? The answer to that question is: "I’m taking you off drug "b" and putting you on drug "a", because someone is paying me to do it". That is a difficult answer to give to their patients.
People intimately involved in research evaluation often have no idea that physicians receive this compensation. To go further, some patients view physician compensation as an inducement to get involved in research. They are so thankful to physicians and health-care providers that they will support them in this way. They cannot give them a turkey from their farm or a discount at their general store, but they will participate in a study, which they are assured has very little risk. Compensation, when disclosed to some patients, is viewed as an inducement to be involved in Phase IV surveillance studies.
Patricia Kosseim: I spoke about individual bias in institutional or hospital REBs, but we also have to deal with the biases of factions within the committee. On one occasion, the chair and people at one institution felt a lot of pressure to present a unanimous document to the board of directors for their own reasons. Individual committee members must deal with that unavoidable bias, whether acceptable or not from a legal standpoint. As members not linked to the institution, we have to ensure that we are not tainted by the same pressure that may compel others to render a decision.
* Dr. Douglas Kinsella passed away June 15, 2004.