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 (, 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


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”.

  1. SAFS Response to Tri-Council Draft Human Research Code: Some reactions to the original April (1996) draft
  2. First Tri-Council Reaction to 250 Letters Covering 1500 Pages of Comment (1996)
  3. Ethics-Code Changes May Dampen Research Efforts (1996 article in American Psychological Society Monitor, referring to an interview with JJF)
  4. Draft Research Code Raises Hackles (1996) article in Science, referring to the views of both a proponent (Director of a Canadian University Bioethics Program)and an opponent (president the Canadian Society of The Society for Academic Freedom and Schholarship) of the Canadian Code)
  5. Email exchange during 1996 concerning the Code between SAFS president and an experimental psychologist involved in the promulgation of the Code (Warning: this exchange is vitriolic, and may be offensive to some)

  6. Email (1996) from the chair of the Canadian Psychological Association's Scientific Affairs Committee to that committee regarding the Code. This email contains the critiques of various other organizations and individiuals. These critiques vary in severity and tone, but are all quite detailed

  7. SSHRC's president's 1997 apologia for Code written following a request from the Federal Ministry of Industry that he reply on the Ministry's behalf to a letter sent by SAFS to the ministry (for SAFS's letter, see #1 on this site)
  8. Evidence that details of some drafts of the revisions of the Code were not widely circulated among Canadian researchers, but were restricted to select individuals in a way that reminds one of the way in which Bishops get information that the Laiety do not (1997)
  9. Letter to John Furedy from Heather Munroe-Blum VP - Research and International Relations at the University of Toronto The Tri-council Code of Ethics and his prior contributions to Ethics Reviews before the rise of the Bioethics Industry (1997)
  10. Canadian Psychological Association's response to The Tri-council Code of Ethics (1997
  11. Hasty reply (March, 1997) by SAFS president to the revised version of the Code; the SAFS board had some objections to the style of this reply, but as it agreed with its basic content, it was sent in view of the narrow time window allowed by the Code writers for comments by reseearchers
  12. Reactions for Feburary, 1997 revisions of the Code by John Furedy and by Acting Chair of the UofT department following a March departmental meeing on the Code where about 80% of the faculty found no fault with the edict that subjects had the right to withdraw *their* data if they disapproved of the hypotheses that the researcher wished to investigate.
  13. John Furedy's March 1997 message (advocating ethical humility, but epistemological arrogance) to UofT faculty following its March departmental meeting (see #12 above). The degree to which the March message incfluenced the department's official response can be seen in #23 below.
  14. Doreen Kimura's individual statement (1997) regarding the revision of the Code, written at more leisure after the official SAFS letter (see #11) was sent. For Professor Kimura's scientific qualifications,

  15. SAFS president's (1997) email to SAFS members informing them of recent critiques of the revised Code, and urging them to submit their own individual reactions (along the lines of statements like #14 above)
  16. Process of Evaluation and Dissemination of the Code of Ethiocal Conduct for Reseasrch Inovling Humans Email (1997) from SAFS Board of Directors to presidents of the Canadian MRC, NSERC, and SSHRC. Includes particulars of a complaint concerning how the deputy chair of the Code's working committee, Prof. M. McDonald, handled the dissemination of the revisions of the Code (see also #8 above and #18 & #19 below) for other evidence that this dissemination to the research community, in my and some others' opinion, was inadequate, and even unethical)
  17. SAFS and the Proposed Canadian Tri-Council Code of Ethical Conduct for Research Involving Humans: Ethical Humility but Epistemological Arrogance SAFS president's 1997 email to SAFS members
  18. Your oral charges made to Prof. Vincent Di Lollo (President of CSBBCS and Professor of Psycholgy, UBC) that my behavior has been "improper" and "reprehensible" SAFS president's 1997 email to Deputy Chair of the Code's working Committee, and Director, Center for Applied Ethics, UBC
  19. The Deputy Chair and Director's reply to the email #18 above (1997)
  20. Email to SAFS president (1997) from Code revision committee (The "Working Group" regarding dissemination of revisions), praising individuals who served on the Working Group "without renumeration", and still assuming that the Tricouncil document should be a code rather than a set of guidelines.
  21. SAFS's president's (1997) reply to #20 arguing that while Hammurabi and Moses can be said to have codes, the Tri-Council should follow the American example of having only guidelines
  22. Email (1997) to Humanities and Social Sciences Federation of Canada (HSSFC) from Professor Richard C. Tees, Department of Psychology, University of British Columbia and President, Canadian Society for Brain, Behaviour and Cognitive Science, regarding the Working Groups first revision of the Code
  23. Department of Psychology, University of Toronto's official response to Working Committee's first revision of the Code
  24. A reaction to the July, 1997 version (2nd revision) of the Ethics Code Email from John Furedy Vice Provost, Research, University of Toronto (September, 1997). Includes recommendation to shift from Mosaic Code to American Guidelines, echoed and detailed by some University of Western Ontario research administrators
  25. Handout for " SAFS and the Proposed Canadian Tri-Council Code of Ethical Conduct for Research Involving Humans: Ethical Humility but Epistemological Arrogance Presented by John Furedy in symposium on "Social Policy Masked as Ethics Hurts Science: Some Perspectives from Working Scientists", at the Annual Meeting of the Society for Neuroscience, October, 1997, New Orleans. This file contains documents that inform American neuroscientific researchers who use human subjects about the 1996-7 Canadian "code" scene
  26. From "Code" to "Guidelines" Email (1997) from President Social Sciences and Humanities Research Council of Canada to SAFS president regarding projected 3rd revision of the Working Group. The chief signficacne of this email is the implicit acceptance of guildlines language, and acceptance that, as will be seen from files # , below was modified in the actual ambiguous terminology of later versions that referred to "statements" which, however, if not kept to, we mandated to be followed by punishment (i.e., it walks and quacks like a rule, so probably is a rule).
  27. SAFS president's email (1997) to SAFS members copying emails of a SAFS member and human-subjects researcher (who, for understandable reasons, wished to remain anonymous) to the the Code's (now termed "guidelines") Working Group, and the Working Group's reply (that still referred to "guidelines" rather than "rules" or "statements")
  28. From "code" through "guidelines" to "statement" SAFS's president's (1998) email to SAFS members on learning of the title of 3rd revision (to be circulated January, 1998) of the Tricouncil "statement". This email contains the critique of this 3rd revision by Professor Rhoda Howard
  29. John Furedy's handout to MRC Educational Visitors concerning Implementation of Tri-Council Policy "Statement" and UofT Responders to MRC's Questionnaire on REB Issues at 2-hour session on Jan. 21, 1999, at UofT). This document includes remarks by other individual UofT researchers at a time when the Tricouncil "Statement" had been accepted by Canadian universities, and the time for implementation had arrived
  30. John Furedy's recollections of the January 21 (1999) Meeting of MRC Educational Visit Team with rsponders to MRC's questionnaire on REB issues connected with Tri-Council Policy Statement Visit (see also #29 above)
  31. Research Ethics Boards: A Waste Of Time? (2001) This file contains a paper submitted to the Canadian Psychologist (essentially a newsletter of the Canadian Psychological Association), and the Rejection letter from Victor Catano (Web site: accompanied by the remarks of two anonymous referees . A revision sent to the American equivalent of the Canadian Psychologist was published in the same year. See Mueller, J.H., & Furedy, J.J. (2001). Reviewing the Risk: What.s the Evidence that IRBs work? Part 1 and Part 2 Two-part article in American Psychological Society Observer, September and October issues.
  32. IRBs: Ethics, Yes-Epistemology, No Letter to American Psychological Society Observer (2002)
  33. Some apparent breaches of elementary ethical and accountability principles by apopologists for the Bioethics Industry in the U.S.A. Letter re "ABCs of IRBs" (2002)
  34. Questioning some of the mantras of the American Bioethics Industry Letter re "Coping with IRBs: A Guide for the Bureaucratically Challenged" (2003)
  35. Taxonomic Chaos in the Confused Canadian Bioethics Industry: Apres Moi la Deluge (2005 writeup of 2004 paper to APA symposium at annual meeting in Hawaii; 2006 journal-article version of the 2004 paper)
  36. May, 2005 letter from Society for Academic Freedom and Scholarship to (Canadian) National Council on Ethics in Human Research opposing research ethics accreditation proposal. this proposal, in my view, represents the further expansion of the Biothics Industry into areas where it has no competence, and where its "product" is not evaluated even to the extent that Consumer Reports evaluates the products of other industries















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