Correspondent:

THE HOSPITAL FOR SICK CHILDREN
TORONTO

I am writing to inquire about the ethics of a medical study undertaken at the Hospital for Sick Children.¹ The study involved measuring pain responses in healthy male infants undergoing circumcision. My concern stems from two considerations:

1. Research on children is ethical only if the potential benefits significantly outweigh the potential harms.² Neonatal circumcision fails this test. The world’s paediatric organizations all agree that the potential benefits of neonatal circumcision do not significantly outweigh the potential harms.^3,4,5,6 The Canadian Paediatric Society recommends that "circumcision of newborns should not be routinely performed."⁷
   
   
2. Persons incapable of giving informed consent cannot legally be forced to undergo invasive, irreversible non-therapeutic surgical interventions.⁸

I asked Ms. Margo Farren, Research Ethics Board (REB) Coordinator, if it would be possible to obtain copies of the study protocol and the REB approval. Ms. Farren has informed me that these documents are confidential and cannot be made public. Can you tell me why this confidentiality is necessary?

I would also like to review the consent form signed by the infants’ parents. Would it be possible for you to send me a sample?

Sincerely,
 
[signed]
 
D ennis H arrison
 

1	Taddio A, Pollock N, Gilbert-MacLeod C, Ohlsson K, Koren G. Combined analgesia and local anesthesia to minimize pain during circumcision. Arch Pediatr Adolesc Med 2000 June;154:620-3.
2	Research Ethics Board, The Hospital for Sick Children. Four Steps toward Ethical Approval for Research Involving Humans. May, 1997 (revised March, 1999).
3	Task Force on Circumcision, American Academy of Pediatrics. Circumcision Policy Statement. Pediatrics 1999;103(3):686-693.
4	British Medical Association. Circumcision of Male Infants. September, 1996.
5	Australian College of Paediatrics. Position Statement: Routine Circumcision of Normal Male Infants and Boys. Parkville, Victoria: 1996.
6	Fetus and Newborn Committee, Canadian Paediatric Society. Neonatal Circumcision Revisited. Canadian Medical Association Journal 1996;154(6):769-80.
7	Ibid., p. 769.
8	E. (Mrs.) v. Eve [1986] 2 S.C.R. 388.

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September 14, 2000

Ms. Cyndy DeGiusti
Chief, Public Affairs
The Hospital for Sick Children

Dear Ms. DeGiusti:

As you are aware, I have been trying to obtain information about a medical study that was approved by the hospital’s Research Ethics Board (REB). The study, which was published in the July, 2000 issue of Archives of Pediatrics and Adolescent Medicine, was entitled Combined Analgesia and Local Anesthesia to Minimize Pain During Circumcision.

I wrote to Dr. Max Perlman, Chair of the Research Ethics Board, and asked him for copies of the experimental protocol and the REB approval. Dr. Perlman forwarded my request to Public Affairs. Ms. Helen Simeon of Public Affairs informed me that the documents I had requested were confidential.

I would appreciate it if you could explain why the documents I requested are confidential. I would also appreciate it if you could send me blank copies of the forms that were used to obtain parental consent. I understand two separate forms were used: one for authorizing participation in the study, and another for authorizing surgery.

Sincerely,
 
[signed]
 
D ennis H arrison
 

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October 12, 2000

REGISTERED MAIL

Dear Ms. DeGiusti:

I wrote to you four weeks ago, on September 14th, in connection with a medical study approved by the Research Ethics Board. To date I have received no reply.

I believe that my letter was reasonable and that it touched on an important issue. Consequently I think it was worthy of a reasonable response. If I have received no reply by October 31st, then I intend to pursue this matter further with the Honourable Elizabeth Witmer, Minister of Health and Long-Term Care, and with the Board of Directors of The Hospital for Sick Children. I enclose a copy of my letter of September 14th for your ease of reference.

I would also appreciate it if you could tell me whether or not the study in question was supported by public funds.

Sincerely,
 
[signed]
 
D ennis H arrison
 

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November 10, 2000

Dear Mr. H arrison:

I acknowledge receipt of your letter dated October 12, 2000 and the copy of your letter to the Minister dated November 1, 2000. I did not receive your letter dated September 14, 2000.

As we have indicated to you in the past, the Research Ethics Board (REB) does not provide access to the protocols and other information submitted to it by researchers seeking approval for research projects. This material is treated as confidential as it may contain proprietary or other sensitive information. Researchers expect that the REB will maintain this long-standing practice.

In conclusion, let me assure you that the research protocol/methodology used by Dr. Anna Taddio is set out in the publication of her paper in the July 2000 issue of the ‘Archives of Pediatrics and Adolescent Medicine’.

Sincerely,
 
[signed]
 
Cyndy DeGiusti
Chief, Public Affairs
 

cc:	Mr. Alexander R. Aird, Chairman, Board of Trustees
	Dr. Christine Harrison, Director, Department of Bioethics
	Hon. Elizabeth Witmer, Minister of Health and Long-Term Care

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November 17, 2000

Dear Ms. DeGiusti:

Thank you for your letter of November 10th. I can appreciate the need to maintain confidentiality with respect to proprietary or sensitive information. Therefore I will stop asking for the experimental protocol. However, I also requested information that is neither proprietary nor sensitive. As you have not made reference to these requests, I am resubmitting them to you for a response:

1. Can you send me blank copies of the forms used to obtain parental consent? I understand two separate forms were used: one for authorizing surgery, and another for authorizing participation in medical research.
    
2. Can you tell me if this study was supported by public funds?

Thank you for your assistance.

Sincerely,
 
[signed]
 
D ennis H arrison
 

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December 11, 2000

Mr. Alexander R. Aird
Chairman, Board of Trustees
The Hospital for Sick Children
Toronto  M5G 1X8

Dear Mr. Aird:

I am writing to inquire about a medical study on neonatal circumcision¹ approved by the Research Ethics Board of The Hospital for Sick Children. I believe the Research Ethics Board may have acted negligently in approving this study.

I am concerned about this matter because I think important principles are at stake. The notion that parental consent can serve as a justification for removing part of a healthy organ from a non-consenting minor is completely contrary to medical ethics.

Below is some background information:

1. The Hospital’s research ethics guidelines² stipulate that research on children can be ethically justified “only when the potential benefit significantly outweighs the potential for harm.” Neonatal circumcision does not meet this condition; it is not recommended by the Canadian Paediatric Society and it is not an insured service under the Ontario Health Insurance Plan (OHIP). By approving research on a paediatric surgical intervention whose potential benefit does not significantly outweigh the potential for harm, the Research Ethics Board appears to have violated its own guidelines.
    
2. Neonatal circumcision performed outside a religious context is technically illegal. In a new book entitled The Ethical Canary: Science, Society, and the Human Spirit, Dr. Margaret Somerville, Director of McGill University’s Centre for Medicine, Ethics and Law explains the legal status of neonatal circumcision in these terms:
   
   

   Physicians who undertake infant male circumcision could be legally liable for medical malpractice (civil liability in battery or negligence), which can result in an award of damages simply for carrying out the circumcision even if it was competently performed. They could also, as explained, be charged with criminal liability for assault. In both ethics and law, a physician has a primary obligation of personal care to the patient. This obligation requires the physician both to place the patient first and to first do no harm. Physicians who undertake surgery on patients must prove that it is justified.³

3. The Research Ethics Board may not have a good understanding of the legal limits to parental consent. The current chair of the Research Ethics Board, Dr. Max Perlman, indicated to me in a telephone conversation that he thought the study in question was ethically acceptable because the infants’ parents had given consent for circumcision. But parental consent is not a kind of legal password that medical professionals obtain so they can conduct research on infants and children without fear of legal harassment. Physicians have a primary duty of personal care to their patients.⁴ Before performing a painful, invasive and irreversible operation on a non-consenting minor, a physician must show that the operation is medically justified. Parents do not have the legal authority to consent to invasive, irreversible surgical operations being performed on their children for non-medical reasons.⁵
    
4. The courts have ruled that when obtaining consent for non-therapeutic medical research, investigators must disclose the risks fully and completely. Failure to disclose even remote risks can result in legal liability, as illustrated in a case involving the Jewish General Hospital in Montreal.⁶ In that case, the hospital’s research ethics review committee was held to have been negligent in its review of a research protocol after one of the subjects died from a rare complication. The remote risk that this complication could occur and cause death had not been disclosed in the informed consent form which the research ethics review committee had approved. As is evident from the enclosed document entitled Complications of Newborn Circumcision, a wide range of serious complications can ensue from circumcision. If one of the infants enrolled in the study develops or has already developed a serious complication, and the possibility that this complication could occur was not disclosed in the consent form approved by the Research Ethics Board of The Hospital for Sick Children, then the Hospital could be vulnerable to lawsuits.

In light of the above, I would like to ask the following questions:

1. Was the Board of Trustees aware that this medical study was being conducted?
    
2. Does the Board of Trustees consider this study to be ethically and legally acceptable? If so, on what basis?
    
3. Does the Board of Trustees believe that this study should have been undertaken?

Thank you for considering this matter. I would appreciate a reply at your earliest convenience.

Sincerely,
 
[signed]
 
D ennis H arrison
 

cc:	Dr. Christine Harrison, Director, Department of Bioethics
	Dr. Max Perlman, Chair, Research Ethics Board
	Dr. Anna Taddio, Coordinator, Therapeutic Drug Monitoring, Department of Pharmacy (principal author of the study)

References:
 

1	Taddio A, Pollock P, et al. Combined Analgesia and Local Anesthesia to Minimize Pain During Circumcision. Archives of Pediatrics and Adolescent Medicine 2000 June;154:620-623.
2	The Hospital for Sick Children, Research Ethics Board. Four Steps Toward Ethical Approval for Research Involving Humans. May 1997, revised March 1999.
3	Margaret A. Somerville, The Ethical Canary: Science, Society and the Human Spirit (Toronto: Penguin, 2000), pp. 211-212.
4	Code of Ethics of the Canadian Medical Association. Approved by the CMA Board of Directors, October 15, 1996.
5	E. (Mrs.) v. Eve, [1986] 2 S.C.R. 388.
6	Weiss v. Solomon, [1989] 48 C.C.L.T. 280 (C.S. Qué.).

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December 21, 2000

Dear Mr. H arrison:

I am replying to your letter dated December 11, 2000.

I understand that you have been in communication with Dr. Max Perlman, the Chair of the Research Ethics Board, in respect to the concerns outlined in your letter. The framework for the management of research is the responsibility of the Research Ethics Board which operates in accordance with generally accepted guidelines at arm's-length from the Hospital. It is not within the purview of the Board of Trustees.

Sincerely,
 
[signed]
 
Alexander R. Aird
Chairman of the Board
 

c.c.	Dr. Christine Harrison, Director, Department of Bioethics
	Dr. Max Perlman, Chair, Research Ethics Board
	Dr. Anna Taddio, Coordinator of Therapeutic Drug Monitoring, Dept. of Pharmacy

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December 27, 2000

Anna Taddio, Ph.D.
Division of Clinical Pharmacology and Toxicology
The Hospital for Sick Children

Dear Dr. Taddio:

I have seen your letter in the December, 2000 issue of the Archives of Pediatrics & Adolescent Medicine and wish to comment. You state that

The debate over the ethics of circumcision has not prevented some parents from choosing to have their sons circumcised.

It is equally true that the debate over the ethics of circumcision has not prevented some physicians from choosing to circumcise newborns. Physicians also have a choice in the matter, although those who decide to remove normal anatomy from non-consenting people who have no medical need for surgery could be legally liable for medical malpractice.

Should you care to write to me, I would be interested in hearing why you drew attention to the choices made by parents but not to those made by physicians.

Sincerely,
 
[signed]
 
D ennis H arrison