Research
Interests

THE NORTH AMERICAN
BIOETHICS INDUSTRY

IRBs meet Good Samaritan

More Resources to Review Social Science Proposals

*This header emailed by Prof. John Mueller of the University of Calgary (see also some articles by him in this section) a few days after the arrest of the UK terrorist suspects who are "persons of interest" in the matter of the plots to blow up 'planes carrying innocent civilians (these are terrorists, as they target innocent civilians in contrast to those whose violent actions against terrorists resulted in the deaths of some innocent civilians) in August, 2006. The Bioethics Industry's opposition to profiling is based not only on political correctness, but also on a conceptually primitive ignorance of the basic principles of risk assessment through cost-benefit analysis (cartoon found by John Mueller).

A Guide to Papers in this Section

1. Ethics in human research before the rise of the bioethics industry: A personal perspective

When I began my tenure-stream faculty position (assistant professor of psychology) at the University of Toronto in 1967, where research was an important part of my job description, there was a clear distinction between my ethical obligations to my (human) subjects and my epistemological obligations to my discipline.

My ethical obligations were monitored by an ethics committee to which I had to submit a protocol of each new research project. The ethics committee comprised four faculty (both from my department and from other departments), and had to judge whether my treatment of the subjects in my research was ethical. This included such treatment details as the strength of the aversive stimuli (electric shocks) I was delivering to the subjects, and, most importantly, whether the consent form signed by the subject was clearly understood by her or him on such matters as the nature of the stimuli to be presented, and the freedom to discontinue the experiment at any time without any penalty.

I do not want to suggest that the decisions of these ethics committees were always wise. I recall, in particular, a near-retired professor of physiology who was obviously not interested in research, opining that if the electric shock I used to provide an aversive stimulus to my subjects could be detected by those subjects, then the shock was too strong to be used in human research. But at least the old gentleman was arguing on ethical and not epistemological grounds: he did not criticize the design of my experiments. And I was able to convince the ethics committee that a shock not strong enough to be detected could not serve as an aversive stimulus to allow researchers to decide whether signaling an aversive event reduced the felt aversiveness of that event.

I in turn served on these ethics committees to monitor the ethical obligations of other researchers at my university from the early seventies until late nineties, when what are known in Canada as the Research Ethics Boards (REBs) were formed. In those pre-REB days, each member of the committee was sent a written proposal of a research project that involved humans as subjects. Each committee member submitted a written report. If the report contained criticisms of the way in which the researcher proposed to treat the subjects, the researcher was notified and submitted a revision, which was considered by each individual ethics committee member. Only after a revision was approved by all committee members was the proposal approved. If the researcher considered that one of more members of the ethics committee was mistaken in their appraisal, a physical meeting of the committee with the researcher could be called to resolve this disputes.

Over the 20 odd years that I served as an ethics committee member, I criticized, in writing, about 40% of these proposals. Many of the proposals were from clinical researchers who wished to test the efficacy of some drug or other treatment. In many of these proposals, my most frequent criticism was lack of full information provided in the consent forms. I felt more pressure to formulate these written criticisms accurately, because they were going not only to the applicant, but also to fellow committee members. Writing something stupid which can be criticized in writing and at leisure is more dangerous than saying something stupid at a committee meeting, where the applicant, in particular, is under some pressure not to alienate people who hold the applicant’s fate in their hands.

On the other hand although, as a researcher myself who has a special interest in research methodology, I thought that at times the proposed research design was not optimal, I kept these epistemological opinions to myself. And during those twenty some years of commenting on several hundred proposals, I once never had to attend a single face-to-face meeting of any committee and the applicant.

My epistemological obligations to my discipline included such matters as whether my experimental designs were methodologically sound, whether the issues I was investigating were scientifically significant. I cannot say that I agreed always with my peers’ evaluations of these epistemological obligations, but I could count on their being formally qualified in terms of their expertise not only my discipline, but also in such sub-areas of my discipline as human Pavlovian autonomic conditioning. And, of course, as with the ethics committees, I rendered epistemological judgments over the journal articles and grant applications of my peers. I am sure that there were many of these judgments that my peers thought were unsound, and perhaps even biased. However, they, like I, could rest assured that these judgments were made by individuals who were formally qualified as experts in the relevant disciplines to make those judgments.

2. The slow American and dramatic Canadian development of the North American bioethics industry.

In this section my treatment of the American story will be brief, if only because my involvement with the American details was rather cursory. The more dramatic Canadian story will be more detailed because not only was I an observer from a research-oriented Canadian university, but I was also president of the Society for Academic Freedom and Scholarship (www.safs.ca), which was the academic organization whose opposition to the bioethics industry was most marked among Canadian academic organizations.

In my opinion, the following factors played role in the rise of the bioethics industry in both Canada and the U.S.A.

A. An increased concern with the harm done to human research subjects in the light of various obviously unethical medical treatments, and some dubious psychological treatments, such as the sensory-isolation experiments. This concern, for the most part, was a legitimate one having to do with the treatment of human subjects.

B. The practice, required by most primary Psychological journals, of having to refer to subjects as “research participants”. The latter term, in my view, should be reserved for those who make an epistemological contribution to the research such undergraduate students, masters and doctoral students, post-doctoral fellows, other faculty member, and even, at times, technical staff and academically unqualified friends who nevertheless contribute, intellectually, to the design and interpretation of the research (my spouse, who has not done more than one year of undergraduate psychology, being my prime example). Subjects, on the other hand, whether they are animal or human, make no epistemological contribution. There is only the ethical requirement that the research does them no unnecessary harm (in medical research that evaluates a treatment, there may be a risk of some harm, but that must be justified, on ethical grounds, to be less important than the benefits to the subject).

C. The increased acceptance of the view that expertise in the ethical issue of the treatment of subjects can extend to expertise in the epistemological issue of the methodology of research designs. This confusion of ethics with epistemology is reinforced by the creation of a new branch of ethics, namely “bioethics”.

D. The acceptance of the view that the criterion for resolving ethical questions, and even epistemological questions, is the comfort of the adjudicators, rather than consistency with certain fundamental principles. Of course these principles are open to question, and are sometimes in conflict. But the move from using logic and evidence to using (subjective) comfort has promoted the spread of the Bioethics Industry.

NOTE ON THE PAPERS IN THIS SECTION

The papers below are organized only by year rather than scheme. Still, the earlier papers (from 1996) are mostly focused on the Bioethics Industry’s burgeoning influence on Canadian research with human subjects, whereas the later papers are more general, and apply to both the USA and Canada. In these later papers, one of important and unanswered questions that are raised concerns the cost/benefits problem and the lacunae of evidence that the increased restrictions brought about by the “bioethics” boards actually have reduced harm done to subjects, especially in psychological research. It is ironic that an organization like Consumer Reports insists on evidence for evaluating items like motor cars, but the scientific research community is largely silent and passive when it comes to requiring the Bioethics Industry to provide evidence that its strictures have, in fact, led to harm-reduction among human so-called “research participants”.

DANIEL BERLYNE
(1924-76):
BIBLIOGRAPHICAL ANALYSIS

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