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Correspondent: NATIONAL COUNCIL September 18, 1998 Dr. Henry B. Dinsdale, President
Dear Dr. Dinsdale: I would like to raise questions in regard to a medical study undertaken by the University of Alberta for the purpose of measuring pain responses in infants undergoing circumcision. The study was halted prematurely after two of the infants were traumatized so severely that they became ill. I enclose a copy of the abstract for your convenience. As I have outlined in a letter to Dr. Donald Morrish, chair of the ethics committee that reviewed and approved the study, I am concerned about the fact that researchers subjected infants to surgery which the researchers themselves considered to be medically unnecessary. It seems to me that such conduct on the part of medical professionals contravenes basic ethical principles governing research on human subjects. I would appreciate hearing your comments on this matter. For your information, I enclose a copy of my correspondence with Dr. Morrish. Sincerely,
Enclosures
October 23, 1998 Dear Mr. H arrison: Thank you for your letter dealing with information regarding a research project undertaken at the University of Alberta. As you may be aware, individual research projects are assessed by local research ethics boards (REBs). It is not in our mandate to comment on individual research, although we work directly with REBs and advise them, upon request, on process issues. I am sure that Dr. Morrish will be in touch with you in due time. Regards,
November 13, 1998 Dear Dr. Dinsdale: Thank you for your letter of October 23 in response to my concerns about a circumcision pain study undertaken by researchers at the University of Alberta. You write that the mandate of the National Council on Ethics in Human Research (NCEHR) does not include commenting on individual research. However, I understand that the mandate of the NCEHR does include "fostering education, dialogue and understanding" with the public. Moreover, you yourself have called attention to the need for public trust if guidelines are to survive (NCEHR Communiqué, 1998; Vol. 8 No. 2: Winter/Spring 97/98, page 3). As a member of the public, I am concerned about the medical study in question because it involved subjecting vulnerable persons to a surgical intervention that was not deemed medically necessary by those who performed it. The need to protect vulnerable persons from unnecessary interventions is not a contentious new issue; it is a well-established principle that has informed the practice of medicine since the days of Hippocrates. As the Tri-Council document puts it, "[a] principle directly related to harms-benefits analysis is non-maleficence, or the duty to avoid, prevent or minimize harms to others. Research subjects must not be subjected to unnecessary risks of harm..." By their own account, researchers at the University of Alberta put infants at risk to measure the effects of unnecessary surgery. How could such an undertaking be defended? Sincerely,
October 7, 1999 REGISTERED MAIL Dear Dr. Dinsdale: I wrote you on November 13, 1998, in connection with a circumcision pain study undertaken by researchers at the University of Alberta. So far I have received no response. By their own account, researchers at the University of Alberta put vulnerable persons at risk to measure the effects of surgery that was not medically required. I find this unusual and disturbing. To comply with its own terms of reference, the National Council on Ethics in Human Research must: Foster education, dialogue and understanding in and among institutions, REBs, researchers, professional personnel, organizations that fund research and the public, on the ethical aspects of research involving human subjects and the implementation of appropriate guidelines.I seek your assistance in understanding the ethical aspects of the research conducted at the University of Alberta. In your view, was this medical study an exception to the rules that normally govern research on humans? Sincerely,
encl.
September 22, 2000 Dr. Janet Storch, President
Dear Dr. Storch: I have written to the National Council on Ethics in Human Research (NCEHR) on several occasions over the past two years in connection with a medical study undertaken at the University of Alberta. The study, which involved measuring pain responses in male infants undergoing circumcision, was terminated early after one of the infants vomited, went into shock, and stopped breathing for more than 25 seconds. By the researchers' own account, infant male circumcision is not medically required. I have received no reply to letters I wrote to the NCEHR on November 13, 1998, October 7, 1999, and May 5, 2000. According to its own terms of reference, the NCEHR shall: Foster education, dialogue and understanding in and among institutions, REBs, researchers, professional personnel, organizations that fund research and the public, on the ethical aspects of research involving human subjects and the implementation of appropriate guidelines. [Emphasis added.]Consequently I believe you have an obligation to comment on the ethical aspects of the study in question. All I want to know is this: Are there any circumstances under which medical researchers may traumatize non-consenting persons who are in good health? If so, please explain.The NCEHR reports annually to Health Canada, the Medical Research Council of Canada, the Natural Sciences and Engineering Research Council of Canada, the Royal College of Physicians and Surgeons Council, and the Social Sciences and Humanities Research Council of Canada, as well as the boards of various participating organizations. If I have not received an answer to my question by October 31, 2000, then I intend to pursue this matter further with the public bodies and professional associations to which the NCEHR is accountable. Sincerely,
October 28, 2000 Dear Dennis, I am responding to your letter of September 22, 2000. While NCEHR is responsible for fostering education, dialogue and understanding on ethical aspects of research involving human subjects, our ability to do so has been hindered by a lack of clarity and direction amongst the Granting Councils about who is to be responsible for establishing appropriate guidelines. That authority has, to date, been vested with the Tri-Council Advisory Group (TAG), a committee made up of representatives from the Medical Research Council, now the Canadian Institute of Health Research, the Social Sciences and Humanities Research Council, and the Natural Sciences and Engineering Research Council (NSERC). I therefore suggest that you seek guidance and interpretation on the implementation of the Tri-Council Policy Statement where the authority to do so currently resides, that is, with the TAG. The contact person is Anne-Marie Monteith [address supplied]. Sincerely,
November 7, 2000 Anne-Marie Monteith
Dear Anne-Marie Monteith: I have been in correspondence with the National Council on Ethics in Human Research (NCEHR) in regard to a medical study undertaken several years ago at the University of Alberta. I have been trying to find out whether or not this study, which received international media coverage in December 1997, conformed to the ethical principles governing research on humans. Dr. Janet Storch, President of the NCEHR, has indicated that responsibility for interpreting the Tri-Council Policy Statement currently rests with the Tri-Council Advisory Group, and that you are the contact person for this group. Accordingly, I am directing my inquiry to you. The study in question involved measuring pain responses in male infants undergoing circumcision. This procedure is not required to protect an infant's mental or physical health. In fact, the Canadian Paediatric Society recommends that circumcision of newborns should not be routinely performed. The study was halted prematurely after one of the infants vomited, went into shock, and stopped breathing for over 25 seconds. By their own account, the researchers put vulnerable persons at risk to measure the effects of surgery that was not medically required. I find this unusual and disturbing. How can non-consenting persons be used as guinea pigs in non-therapeutic medical research that puts subjects at risk, causes pain, and permanently alters the body? I would be interested in hearing your professional opinion on the ethics of this study. Specifically, I would like to know whether or not the study adhered to the principles enunciated in the Tri-Council Policy Statement on Ethical Standards for Research Involving Humans. I enclose the following material:
Sincerely,
November 22, 2000 Dear Mr. H arrison: Thank you for your letter of November 7, 2000 concerning a University of Alberta research project involving the measurement of pain responses in male infants undergoing circumcision. Under the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (and the previous MRC Guidelines on Research Involving Humans, which would have been in effect at the time the study was conducted), individual research projects must be assessed by local research ethics boards. I understand that the University of Alberta Research Ethics Board reviewed and approved this project. I regret to inform you that the three granting Councils cannot comment on the ethics of individual research projects. Sincerely,
November 28, 2000 Dear Anne-Marie Monteith: Thank you for your letter of November 22nd. If the Councils cannot comment on the ethics of specific research projects, then perhaps you would be kind enough to answer a question of a more general nature: In your professional opinion, are the principles laid down in either the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, or the earlier MRC Guidelines on Research Involving Humans, consistent with the use of unwilling subjects in painful and dangerous medical experiments undertaken for non-therapeutic purposes? I would appreciate a reply at your earliest convenience. For your information, I enclose a copy of an article entitled "The Ethics of Circumcision" that appeared recently in the Globe and Mail. Sincerely,
December 22, 2000 Dear Mr. H arrison: Thank you for your letter of November 28, 2000, in which you request the granting Councils' views on the ethics of medical experiments undertaken for non-therapeutic purposes. As indicated in my letter of November 22, 2000, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans requires, as a condition for funding, that all proposed research involving human subjects be reviewed by and obtain the approval of local research ethics boards. This ethical review is guided by the principles described in the Tri-Council Policy Statement, and takes into account the nature of the research and the ethical norms and practices of the relevant research discipline. The Councils, therefore, do not directly assess or comment on the ethical acceptability of individual projects or types of projects, but rely on the judgement and discretion of research ethics boards in accordance with the principles of the Tri-Council Policy Statement. Sincerely,
January 2, 2001 Dear Ms. Monteith: Thank you for your letter of December 22nd, in which you state that the Councils "do not directly assess or comment on the ethical acceptability of individual projects or types of projects." Can you clarify, then, who has the authority to assist local research ethics boards with interpretation and implementation of the Tri-Council Policy Statement? Dr. Janet Storch, President of the National Council on Ethics in Human Research, believes that this authority is vested in the Tri-Council Advisory Group, and that you are the contact person for this group. Sincerely,
January 29, 2001 Dear Mr. H arrison: Thank you for your letter of January 2, 2001, in which you request clarification of the role of the Tri-Council Advisory Group in assisting research ethics boards in interpreting and implementing the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Since the Tri-Council Policy Statement was published in 1998, the three granting agencies have relied on the National Council on Ethics in Human Research (NCEHR) to provide education and guidance to research ethics boards in implementing the policy. This support is being offered mainly in the form of site visits to institutions, and regional and national workshops. NCEHR also provides technical support for an REB listserve to facilitate the sharing of views and experience on matters of ethics review. While NCEHR provides general advice to members of the university-based research community on ethical matters, it refers questions requiring clarification or interpretation of the Tri-Council Policy Statement to the Tri-Council Advisory Group, of which it is also a member. The Tri-Council Advisory Group was created to advise the Presidents of the three granting agencies on the further development and evolution of the Tri-Council Policy Statement. As part of its mandate, it reviews and provides advice on questions that require further clarification or development of the Tri-Council Policy Statement. However, as stated in my letter of December 22, 2000, it does not assess or comment on the ethical acceptability of individual projects. This is done by local research ethics boards, in accordance with the principles and procedures outlined in the Tri-Council Policy Statement. The roles of the NCEHR and the Tri-Council Advisory Group are currently under review. The three granting agencies are planning to centralise their resources and create a Tri-Council Ethics Panel and Tri-Council Ethics Secretariat to coordinate better the further development of the Tri-Council Policy Statement, and offer more consistent support and advice to the community on matters of ethical review. Even under this new structure, which should become operational in early summer 2001, the responsibility to assess individual projects would remain with local research ethics boards. Sincerely,
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