Correspondence with Health Ethics Research Board, University of Alberta, re ethics of infant male circumcision

I've been troubled about a medical study undertaken by the University of Alberta for the purpose of measuring pain responses in male infants undergoing circumcision. The details were published in the Journal of the American Medical Association (December 24/31, 1997). Dr. Roderick Fraser, President and Vice-Chancellor of the University, has indicated that you might be able to assist me in coming to grips with the ethical issues raised by this study.

My concern stems from the apparent lack of justification for subjecting healthy infants to dangerous and irreversible surgery. In their final report, a copy of which I have obtained from Health Canada, the researchers themselves deny that the surgery they performed was medically necessary. Is medical necessity not an essential justification for removing functional body parts from persons incapable of giving voluntary informed consent?

The ethical framework set forth in the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans stipulates that "[r]esearchers and research ethics boards have a responsibility to make an independent assessment of the appropriateness of research participation for prospective participants who are incompetent or who are unable to act voluntarily." Since infants are neither competent nor able to act voluntarily, I assume an independent assessment of their appropriateness for research participation was made. I wonder if you could tell me what the results of this independent assessment were. On what basis was research participation by the infants deemed to be appropriate, given that the researchers themselves felt circumcision was not medically necessary?

I was also wondering how the surgical removal of specialized tissue from healthy infants could be reconciled with the need to protect persons with impaired or diminished autonomy.

All of the infants enrolled in the study were permanently deprived of an anatomical structure that may play an important role in sexual response [The prepuce: specialized mucosa of the penis and its loss to circumcision]. British Journal of Urology 1996;77:291-5. Some of the infants were traumatized to the point of danger.

I would appreciate it if you could explain what ethical justification existed for undertaking this project.

Sincerely,

[signed]

D ennis H arrison

September 10, 1998

Dear Mr. H arrison:

Thank you for your letter of August 28 regarding the study on circumcision of male infants conducted at the University of Alberta by Dr. J. Lander et al. I believe your concerns may arise from a misunderstanding of how the subjects were enrolled in the study. In the article it is stated that the newborns were "scheduled for circumcision" (Methods, p. 2158). These babies were already designated by their parents to be circumcised. They were not randomized to be circumcised; they were only randomized to receive analgesia or not during the procedure. Since no one had ever objectively studied if analgesia made a difference, it was justified to settle this question.

I quite agree with you that randomization of circumcision would be ethically questionable. However, this was not done. I hope this addresses your concerns.

Yours sincerely,

[signed]

Donald W. Morrish, M.D., Ph.D.
Chair, Research Ethics Board

cc: Dr. R. Fraser, President, University of Alberta

September 17, 1998

Dear Dr. Morrish:

NO REPLY Thank you for your letter of September 10, in which you explain that the infants enrolled in the circumcision pain study headed by Dr. Lander were selected from among those who had already been designated for circumcision by their parents.

I never doubted that all the infants participating in the study were circumcised with the assent of their parents. My concerns arise from the fact that parental assent is not by itself a sufficient justification for initiating medical treatment of an immature child. It seems to me that before initiating medical treatment of an immature child, a physician ought to show that the child needs medical treatment. Dr. Lander and colleagues subjected a group of infants to painful, dangerous, and irreversible surgery without ever showing that the infants needed medical treatment. In fact, in a report submitted to Health Canada, Dr. Lander and colleagues expressly denied that any of the surgical interventions undertaken in the study were medically necessary.

I thought that a society such as ours—which has managed to top the United Nations human development index for the fifth year in a row—would have safeguards in place to ensure that vulnerable, non-consenting people are not used as guinea pigs in experiments involving the performance of unadvised medical procedures. Yet the fifty-two newborn males enrolled in this study were traumatized—in some cases to the point of danger—as a result of surgery considered to be medically unnecessary by those who performed it. The researchers pleaded what amounts to the Nuremberg defense. That is, they said they felt obliged to follow orders.

It is my understanding that research on humans in Canada is governed by principles set out in the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans. This policy statement contains the following provision, designed specifically to protect the interests of immature children:

"Researchers and research ethics boards have a responsibility to make an independent assessment of the appropriateness of research participation for prospective participants who are unable to act voluntarily" (emphasis added).

I would appreciate it if you could tell me whether such an assessment was made. On what grounds was it deemed appropriate to enrol infants in a study that involved undertaking a non-therapeutic surgical intervention for non-medical reasons? I understand that at common law, non-therapeutic surgical interventions require the voluntary and informed consent of the person undergoing the intervention. Infants do not have the capacity to give such consent. For your information, I enclose a copy of a letter from Drs. Margaret Somerville and David Alwin to the New England Journal of Medicine, addressing these issues. The letter is in regard to a circumcision pain study conducted at the Hospital for Sick Children and Women's College Hospital in Toronto. On a point of accuracy, this study was published well in advance of the study undertaken by Dr. Lander; consequently your statement that "...no one had ever objectively studied if analgesia made a difference" does not seem to be correct.

It is my understanding that elections to undergo cosmetic surgery must be preceded by very full disclosure of the risks and harms known to be associated with such surgery. I was wondering if the parents of the infants enrolled in the study had been fully apprised of the risks and harms associated with neonatal circumcision. In particular,

Did the parents clearly understand that neonatal circumcision is non-therapeutic?
Were they aware that the Canadian Paediatric Society has recommended for over twenty years that neonatal circumcision should not be routinely performed? [1]
Did they realize that circumcision removes about half the skin from the penis, including specialized mucosa that may form an important component of the overall sensory mechanism of the penis? [2]
Did they know that the circumcised penis requires more care than the intact penis during the first three years of life, and that circumcised boys are significantly more likely to have common problems such as coronal adhesions, trapped epithelial debris, a reddened meatus, preputial stenosis (phimosis) and balanitis? [3]
Did they realize that neonatal circumcision performed without injected anesthesia is traumatic enough to induce heightened pain responses in infants months later? [4]
Did they know that babies have cried so hard during circumcision that they burst their lungs [5] or ruptured their stomachs? [6]
Were they aware of recent evidence suggesting that circumcision leaves males more susceptible to sexually transmitted diseases such as chlamydia? [7]
Did they know that the risk of complications associated with neonatal circumcision has been estimated at 2 to 10 percent, [8] and that these complications have ranged from hemorrhage and infection to total ablation of the penis and death?
Did they know that dorsal penile nerve block, one of the types of anesthesia administered in the study, is capable of having serious adverse consequences? [9]
Did they realize that infant circumcision may contravene current provisions of the Criminal Code of Canada?

Neonatal circumcision raises important ethical and legal issues that have been swept under the rug for too long. I hope to see these issues discussed more openly in the future. I look forward to your response.

Sincerely,

[signed]

D ennis H arrison

encl: Somerville MA, Alwin D. Lidocaine-Prilocaine Cream for Pain during Circumcision (letter). New England Journal of Medicine 1997: 337; 568.

cc: Dr. W. W. (Bill) Anderson, President, Alberta Medical Association

Dr. Henry Dinsdale, President, National Council on Ethics in Human Research

Dr. Roderick Fraser, President and Vice-Chancellor, University of Alberta

The Honourable Halvar Jonson, Minister of Health, Province of Alberta

Dr. Larry Ohlhauser, Registrar, College of Physicians and Surgeons of Alberta

Mr. Ian Potter, Assistant Deputy Minister, Health Canada

Dr. Margaret Somerville, McGill Centre for Medicine, Ethics and Law

Dr. Peter Venner, Chair, Ethics Committee, College of Physicians and Surgeons of Alberta

REFERENCES

1. Fetus and Newborn Committee, Canadian Paediatric Society. Neonatal Circumcision Revisited. Canadian Medical Association Journal 1996; 154(6): 769-80.

2. Taylor JR, Lockwood AP, Taylor AJ. The Prepuce: Specialized mucosa of the penis and its loss to circumcision. British Journal of Urology 1996; 77: 291-5.

3. Van Howe RS. Variability in penile appearance and penile findings: a prospective study. British Journal of Urology 1997; 80: 776- 82.

4. Taddio A, Katz J, Ilersich AL, Koren G. Effect of neonatal circumcision on pain response during subsequent routine vaccination. The Lancet 1997; 349: 599-603.

5. Auerbach MR, Scanlon JW. Recurrence of pneumothorax as a possible complication of elective circumcision. Am J Obstet Gynecol 1978; 132: 583.

6. Connelly KP, Shropshire LC, Salzberg A. Gastric rupture associated with prolonged crying in a newborn undergoing circumcision. Clinical Pediatrics 1992; 31: 560-1.

7. Laumann E, Masi C, Zukerman E. Circumcision in the United States: Prevalence, Prophylactic Effects, and Sexual Practice. JAMA 1997; 277: 1052-7.

8. Williams N, Kapila L. Complications of circumcision. Brit J. Surg 1993; 80: 1231-6.

9. Sara CA, Lowery CJ. A complication of circumcision and dorsal nerve block of the penis. Anaesth Intensive Care 1984; 13: 79-82.

November 13, 1998

Dear Dr. Morrish:

NO REPLY I wrote you on September 17 in regard to a circumcision pain study reviewed and approved by the research ethics board of which you are the chair. I asked the following questions:

Should a physician not establish that a child needs medical treatment before removing functional parts of the child's body?
Was an independent assessment made of the appropriateness of enrolling infants in a study that involved undertaking a non-therapeutic surgical intervention?
Were the parents of the infants enrolled in the study fully apprised of the risks and harms known to be associated with neonatal circumcision?

I am sure you will be replying in due course.

It is my understanding that non-therapeutic medical research which puts research subjects at risk, causes pain, and permanently alters the body cannot be conducted on children. Was the study in question an exception to the ethical and legal principles that normally govern such research?

Would it be possible for you to provide me with the report approving the study, and the names of the committee members who signed off on the protocol?

Sincerely,

[signed]

D ennis H arrison

Copies to:

Dr. Henry Dinsdale, President, National Council on Ethics in Human Research
Dr. Emmett Francoeur, President, Canadian Paediatric Society
Dr. Roderick Fraser, President and Vice-Chancellor, University of Alberta
The Honourable Halvar C. Jonson, Minister of Health
Dr. Rowland T. Nichol, President, Alberta Medical Association
Dr. Larry Ohlhauser, Registrar, College of Physicians and Surgeons of Alberta
Mr. Ian Potter, Assistant Deputy Minister, Health Promotion and Programs
Dr. Margaret A. Somerville, Founding Director, McGill Centre for Medicine, Ethics and Law
Dr. D. Lorne Tyrrell, Dean, Faculty of Medicine, University of Alberta
Dr. John Waters, Chief Medical Officer of Health, Province of Alberta
Dr. John R. Williams, Director of Ethics, Canadian Medical Association
Dr. Marilynn J. Wood, Dean, Faculty of Nursing, University of Alberta

May 21, 1999

Dear Dr. Morrish:

I wrote you on September 17, 1998 and November 13, 1998 in regard to a circumcision pain study reviewed and approved by the research ethics board of which you are the chair. I asked if it would be possible for you to provide me with the report approving the study and the names of the committee members who signed off on the protocol. So far, I have received no response.

It is my understanding that non-therapeutic medical research which puts research subjects at risk, causes pain, and permanently alters the body cannot be conducted on children. Was the study in question an exception to the ethical and legal principles that normally govern such research?

Sincerely,

[signed]

D ennis H arrison

June 8, 1999

Dear Mr. H arrison:

Thank you for your letter of May 21, 1999. I am puzzled as to why you are persisting in pursuing this matter. I would like to point out once again that your argument is based on a fundamental misunderstanding of Dr. Lander’s paper that invalidates your entire contention that the study was unethical. This error is your belief that babies were chosen to receive circumcision by the researchers. Circumcision was, in fact, chosen by the parents, as is their legal right. Dr. Lander only randomized the babies to receive or not to receive anaesthetic cream, a procedure that was not generally practised at the time. I should note that her paper and another similar study published in the same year have been instrumental in changing obstetric practice to recognize that babies did feel pain and should receive anaesthesia. Whether circumcision itself is correct has never been a subject of this research. There is therefore no basis for your objection to this study, which received appropriate ethical and scientific review.

I believe we have adequately dealt with your concerns and so I consider this matter closed and do not wish to discuss this matter further.

Yours sincerely,

[signed]

Donald W. Morrish, MD
Chair
Health Research Ethics Board (Biomedical)

cc:
Dr. R. Fraser, President, University of Alberta
Dr. H. Dinsdale, President, National Council on Ethics in Human Research

June 17, 1999

Dr. Donald Morrish
Chair, Research Ethics Board
University of Alberta

Dear Dr. Morrish:

NO REPLY Re: Circumcision pain study

Thank you for your letter of June 8th. Though I understand your desire to have done with this matter, you have made statements that cannot go unanswered. You wrote, “Circumcision was...chosen by the parents, as is their legal right.”

The lawfulness of routine infant circumcision has been brought into question by legal experts from every corner of the English-speaking world. As evidence of this, I enclose copies of letters from Dr. Margaret Somerville, Founding Director of the McGill Centre for Medicine, Ethics and Law, to Dr. Robin Walker, member of the Fetus and Newborn Committee of the Canadian Paediatric Society and co-author of that society’s 1996 position statement on neonatal circumcision. On page 2 of the letter dated November 10, 1997, Dr. Somerville writes: “The present law would prohibit circumcision on a child unless the persons consenting to this and the physician carrying it out can show that it is justified.” On page 1 of the letter dated January 28, 1998, Dr. Somerville writes: “The only possible justification for non-religious infant male circumcision is medical justification.”

Your views on the legality of neonatal circumcision seem to differ from those of Dr. Somerville. You appear to believe that medical professionals can legally operate on the sex organs of infant males even when medical justification is not present. Can you provide any supporting evidence for this view?

You also wrote, “whether circumcision itself is correct has never been a subject of this research.” I don’t understand the logic behind this statement. An essential part of any ethical review is to make sure the interests of vulnerable subjects are protected. The interests of vulnerable subjects are protected only so long as the proposed course of treatment is correct and medically appropriate.

It is irrefutable that vulnerable persons were severely traumatized in the course of a medical experiment, and that this traumatization occurred for the sake of a surgical intervention deemed to be medically unnecessary by the professionals who carried it out. So far you have not assisted me to understand how such an undertaking can be reconciled with basic ethical and legal principles governing research on humans.

I ask once again if you would be kind enough to provide me with a copy of the report approving the study, and the names of the individuals who signed off on the protocol.

Sincerely,

[signed]

D ennis H arrison

encl.

cc:
Dr. R. Fraser, President, University of Alberta
Dr. H. Dinsdale, President, National Council on Ethics in Human Research

September 27, 1999

REGISTERED MAIL

Dear Dr. Morrish:

NO REPLY I have written to you on several occasions to express my concerns in regard to a circumcision pain study reviewed and approved by the research ethics board of which you were the chair. My concerns arise from the simple fact that non-therapeutic medical research which puts research subjects at risk, causes pain, and permanently alters the body cannot be conducted on children. I have written to a number of individuals about this study, including Mr. Bob Rechner, the Alberta Children's Advocate. Mr. Rechner said he found the background material I sent him "most interesting and disturbing." I enclose a copy of Mr. Rechner's letter for your information.

In a letter dated June 8, 1999, you stated that the study "received appropriate ethical and scientific review." Could you please furnish supporting evidence for this statement? I would appreciate a copy of the report approving the study and the names of the committee members who signed off on the protocol.

Yours sincerely,

[signed]

D ennis H arrison

cc:
Dr. Henry Dinsdale, President, National Council on Ethics in Human Research
Dr. Roderick Fraser, President and Vice-Chancellor, University of Alberta
Mr. Bob Rechner, Children's Advocate, Province of Alberta

November 6, 2000

Dear Dr. Morrish:

NO REPLY I have had some correspondence with you regarding a medical study approved several years ago by the research ethics board of which you were the chair. I have received no responses to letters I sent you on June 17, 1999 and September 27, 1999. I enclose copies of these letters for your information.

My reason for writing today is that I would like to review a blank copy of the form used to obtain parental consent. I would like to see exactly what the parents consented to. I don't want to see any signatures—just a blank form.

I believe my request is reasonable. If I have received no response by November 30th, then I intend to pursue this matter further with Dr. Roderick Fraser, President of the University.