I am writing to ask your professional opinion on the ethics of a medical study carried out at the University of Alberta in 1997. The purpose of the study was to measure pain responses in male infants undergoing circumcision.
I have been researching the subject of infant male circumcision for the past three years. I have found that circumcision is not required for an infant's mental or physical health. It is not recommended by the Canadian Paediatric Society, and is not an insured service under the Alberta Health Care Insurance Program (AHCIP). By the researchers' own account, circumcision of male newborns is not medically required.
Consequently, the study in question involved performing non-essential surgery on non-consenting persons. All of the subjects suffered pain; some were traumatized to the point of danger. The study was halted prematurely after one of the subjects vomited, went into shock and stopped breathing for more than 25 seconds.
My question is: in your view, did the study adhere to the principles governing research on humans? Specifically, did the study comply with the provisions of the following instruments:
- Nuremberg Code;
- Declaration of Helsinki;
- International Covenant on Civil and Political Rights;
- United Nations Convention on the Rights of the Child;
- Tri-Council Policy Statement on Ethical Standards for Research Involving Humans.
I have included relevant portions of these documents in an
Appendix.
I also enclose the following material:
- The
abstract of the study published in the Journal of the American Medical Association;
- A copy of the final report submitted by the researchers to Health Canada;
- A
collection of correspondence relating to the study, including letters from the Office of the Attorney General of Alberta, the Alberta Minister of Health, the Chair of the Research Ethics Board that approved the study, Health Canada, and the Chief Crown Prosecutor in Edmonton.
I would be most interested in hearing your professional opinion on this matter. I look forward to your reply.
Sincerely,
[signed]
D ennis H arrison
REPLIES
MS. CAROL BELLAMY
Executive Director, UNICEF
Awaiting reply.
DR. PAUL BYRNE
Co-Director
John Dossetor Health Ethics Centre
University of Alberta
May 30, 2000
Dear Mr. H arrison:
Thank you for your letter of May 5, 2000 and the binder of extensive correspondence relating to neonatal circumcision and the study of Lander et al. I do not have any ethical insights to assist you with your expressed concerns about these issues.
Sincerely,
[signed]
Edna Wiley
for Paul Byrne, MB, ChB, FRCPC
Associate Director/Clinical Ethicist
August 29, 2000
Dear Dr. Byrne:
In your letter of May 30th you stated that you had "no ethical insights" to offer in regard to a circumcision pain study undertaken at the University where you work. I assume that you wrote in good faith, and that you were motivated by a desire not to upset people who would be distressed to learn that neonatal circumcision is ethically and legally unacceptable.
I am sure you are among those individuals who respond to sound arguments and take steps to defend basic human rights. You might wish to review a paper entitled Infant Male Circumcision: A Violation of the Canadian Charter of Rights and Freedoms by Dr. Arif Bhimji. This paper was published recently in a new online journal
called HealthcareLaw.
I would be interested in hearing your views on Dr. Bhimji's paper. A copy is enclosed.
Sincerely,
[signed]
D ennis H arrison
SÉBASTIAN GRAMMOND
President, Canadian Lawyers Association for International Human Rights
Awaiting reply.
DR. GLENN GRIENER
Department of Philosophy, University of Alberta
Awaiting reply.
DR. MARIANNE LAMB
President, Canadian Bioethics Society
May 19, 2000
Dear D ennis H arrison:
I am writing in response to your letter in which you ask for my view, as President of the Canadian Bioethics Society, on a study conducted in 1997. I would like to acknowledge the work done and interest you have shown in this topic. However, the CBS does not review proposals or make decisions on research protocols and I am not in a position to do so on behalf of CBS.
Sincerely,
[signed]
Marianne Lamb
President, Canadian Bioethics Society
DR. JANET STORCH
President, National Council on Ethics in Human Research
Awaiting reply.
DR. MICHAEL McDONALD
Director, Centre for Applied Ethics, University of British Columbia
Awaiting reply.
MR. CAMPBELL MILLER
Chairman of the Board
Provincial Health Ethics Network
September 12, 2000
Dear Mr. H arrison:
Thank you for sending your research on infant male circumcision to Campbell Miller, Chair of the Board of Directors for the Provincial Health Ethics Network (PHEN) of Alberta. Mr. Miller passed your correspondence on to me for review.
I am very impressed by the thoroughness of your approach and agree that the issue you raise is an indeed an important one and deserving of attention. Our mandate as a Network has largely to do with referring Albertans interested in bioethical issues to resources that will assist them in their exploration, assist them in gathering resources for their work, and generally facilitate discussion of such issues. The Network is meant to take a philosophically neutral stance on most issues. Thus, it would be inappropriate for PHEN to take a position on the particular issue you raise.
I do know that my colleague, Mr. Al-Noor Nathoo, the Executive Director of the Network, does have a personal interest in this issue and so I have taken the liberty of passing your research his way.
I wish you the very best of luck with your work.
Sincerely,
[signed]
Bashir Jiwani
Coordinator, Northern Alberta
Provincial Health Ethics Network
September 18, 2000
Dear Mr. Jiwani:
Thank you for your letter of September 12th. I am writing to provide further information that might be of interest to you. I enclose a paper entitled Infant Male Circumcision: A Violation of the Canadian Charter of Rights and Freedoms, by Dr. Arif Bhimji. The paper was published recently in a new electronic journal
called HealthcareLaw.
I have also sent a copy to Mr. Al-Noor Nathoo. Thanks again for your encouragement.
Sincerely,
[signed]
D ennis H arrison
MR. ALEX NEVE
Secretary General, Amnesty International
(Canadian Section, English-speaking)
July 18, 2000
Dear Mr. H arrison,
Thank you for your letter of May 5 and enclosed materials regarding the medical study carried out at the University of Alberta in 1997. I apologize for the delay in responding.
I have reviewed the documents. Unfortunately, the issues you raise are outside the mandate of Amnesty International and also outside my own professional experience and expertise. I am, therefore, returning them to you in case they can be of use to you in other approaches or discussions.
I wish you all the best in your efforts to have this study reviewed.
Sincerely,
[signed]
Alex Neve
Secretary General
August 8, 2000
Dear Mr. Neve,
Thank you for your letter of July 18th and for your return of the information package I sent you.
The information package documents the use of non-consenting minors as guinea pigs in a medical experiment involving the surgical removal of normal tissue. None of the researchers suggested that the subjects would benefit from such surgery; the operation was performed solely to satisfy parents or other third parties. The researchers terminated their study early after some of the subjects were traumatized to the point of danger. A government department funded the study to the amount of $135,966.
Perhaps you could explain in more detail why a critical review of such research falls "outside the mandate of Amnesty International." What are the characteristics of a human rights violation? What criteria must be met before Amnesty will investigate a complaint? Which of those criteria are not satisfied by the medical study in question?
I would be grateful if you would answer the above questions. I also seek your permission to distribute copies of your letter of July 18th to interested parties, including the media.
Sincerely,
[signed]
D ennis H arrison
August 28, 2000
REGISTERED MAIL
Dear Mr. Neve,
You stated in a letter dated July 18th that certain issues I had raised in regard to a Canadian medical study were "outside the mandate of Amnesty International." I am writing to seek clarification of this point.
The study in question involved measuring pain responses in male infants undergoing routine circumcision. The researchers freely admitted that they had inflicted needless pain and suffering on healthy children. They justified their actions by stating that they were merely following orders issued by the children's caregivers.
Amnesty International (AI) is committed to upholding the right of every person to physical and mental integrity.
The London Declaration, adopted by AI on May 21, 1995, calls for the abolition of "cruel, inhuman or degrading treatment or punishment" and urges professional associations "to investigate and act upon all reports of human rights abuses by health professionals."
The AI Health Professionals Network Online says it "regularly issues appeals for action" on cases involving "infliction of human rights violations with the assistance of medical personnel."
Under these circumstances, I have difficulty understanding why the issues I have raised fall outside AI's mandate. Does the infliction of unnecessary pain and suffering on vulnerable persons not constitute a human rights violation, regardless of the context in which it occurs?
To turn to another matter, I would be interested in hearing your views on a paper entitled "Infant Male Circumcision: A Violation of the Canadian Charter of Rights and Freedoms." The paper was published recently in a new online journal
called HealthcareLaw. The author is Dr. Arif Bhimji, a physician in Newmarket, Ontario. A copy of the paper is enclosed.
Thank you for considering this matter. I look forward to your reply.
Sincerely,
[signed]
D ennis H arrison
MRS. MARY ROBINSON
United Nations High Commissioner for Human Rights
Awaiting reply.
DR. DAVID ROY
Directeur du Centre de bioéthique
Institut de recherches cliniques de Montréal
(Director, Centre for Bioethics
Clinical Research Institute of Montreal)
May 17, 2000
Dear Mr. H arrison:
Thank you for asking for my comments on the Alberta study on neonatal circumcision. Regretfully, I must decline. I am already far behind a number of deadlines for completion of research papers. I would be irresponsible were I to take on additional assignments now.
With every best wish.
[signed]
David J. Roy
Director
DR. PETER VENNER
Chair, Research Ethics Committee
Alberta College of Physicians & Surgeons
May 19, 2000
Dear Mr. H arrison:
|
Subject: |
Comparison of Ring Block, Dorsal Penile Nerve Block and Topical Anesthesia for Neonatal Circumcision
|
I have reviewed the multiple correspondence you enclosed, including responses from the Registrar of the College of Physicians and Surgeons of Alberta and the Research Ethics Board of the University of Alberta.
I do not believe that I have anything further to add that would be useful to you.
Sincerely,
[signed]
Peter Venner, MD
Chair, Research Ethics Review Committee
DR. CHARLES E. WEIJER
Department of Bioethics
Dalhousie University
May 18, 2000
Dear Mr. H arrison:
Thank you for your most
recent correspondence regarding my professional opinion on the ethics of a medical study carried out at the University of Alberta. Unfortunately, at this time I don't provide free consultation outside the university. My rate for such a consultation would be $200/hour. If you are still interested in my opinion, feel free to contact me. Thanks.
Sincerely,
[signed]
Charles Weijer, MD, PhD
Assistant Professor
Department of Bioethics
DR. JOHN R. WILLIAMS
Director of Ethics
Canadian Medical Association
May 23, 2000
Dear Mr. H arrison:
I am in receipt of your
letter dated May 5, 2000 and its supporting documentation, outlining some of your concerns regarding infant male circumcision.
I am reviewing your concerns and will forward a more formal response shortly.
Thank you for your interest.