Correspondent:

BOARD OF GOVERNORS
University of Alberta

I would like to ask questions about a medical study¹ approved some years ago by the Research Ethics Board of the University of Alberta. I believe this study raises important issues related to the duties of physicians and the rights of children.

Below is some background information:

1. The study was undertaken during the period 1993 - 1996 for the purpose of measuring pain responses in male infants undergoing circumcision. It was terminated early after several infants were severely traumatized. One infant vomited, went into shock, and stopped breathing for more than 25 seconds.
    
2. Circumcision is not required to protect a newborn's mental or physical health. The official position of the Canadian Paediatric Society since 1975 has been that circumcision of newborns is not medically justified. The Alberta Health Care Insurance Plan dropped newborn circumcision from its list of insured services in 1987.
    
3. The foreskin is a normal body part having specific functions. The law of the land does not allow physicians to remove normal body parts from vulnerable people who have nothing wrong with them. Dr. Margaret Somerville, Director of the Centre for Medicine, Ethics and Law at McGill University, sums up the legal status of infant male 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.²

4. In a landmark 1986 decision called Re Eve,³ the Supreme Court of Canada affirmed that parents can legally consent to surgery on their child if and only if the surgery is therapeutically required. Routine infant circumcision is by definition non-therapeutic, since it is performed on healthy newborns.
    
5. 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 was illustrated in a case involving the Jewish General Hospital in Montreal.⁴ 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 from circumcision have been reported in the medical literature. If one of the infants enrolled in the University of Alberta 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 University's Research Ethics Board, then the University could be vulnerable to lawsuits.
    
6. Other people besides myself have expressed concern about this study. For instance, Mr. Bob Rechner, Alberta Children's Advocate, said in a letter dated April 16, 1998 that he found the material I sent him "most interesting and disturbing." Mr. Alex Neve, Secretary General of Amnesty International Canada, indicated in a letter dated July 18, 2000 that he thought the study should be reviewed.
    
7. I have written to the following people at the University of Alberta in connection with this matter: Dr. Janice Lander, principal author of the study; Dr. Donald Morrish, Chair of the Research Ethics Board that approved the study; and Dr. Roderick Fraser, President of the University. Dr. Lander did not reply to any of the letters I sent her. Dr. Morrish responded to only two letters of the seven I sent him. He did not answer my questions and ignored requests for further information. Dr. Fraser decided that Dr. Morrish had responded to my letters appropriately and declared the matter closed in a letter dated December 15, 2000.

I enclose further background material:

1. A CNN news report from December 1997 describing the study.
    
2. Copies of my correspondence with people at the University of Alberta, as well as with Mr. Bob Rechner, Alberta Children's Advocate, and Mr. Alex Neve, Secretary General, Amnesty International Canada.
    
3. Complications of Newborn Circumcision.
    
4. A news release describing the filing of a lawsuit on December 19, 2000 by an 18-year-old in the United States against the physician who circumcised him in infancy and the hospital where he was circumcised. The plaintiff alleges that since his circumcision was not medically required, his parents' consent to the operation was legally ineffective.

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

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

References:
1.	Lander J, Brady-Freyer B, Metcalfe JB, et al. Comparison of ring block, dorsal penile nerve block, and topical anesthesia for neonatal circumcision. JAMA 1997;278:2158-2162.
2.	Margaret A. Somerville, The Ethical Canary: Science, Society and the Human Spirit (Toronto: Penguin, 2000), p. 211.
3.	E. (Mrs.) v. Eve, [1986] 2 S.C.R. 388.
4.	Weiss v. Solomon, [1989] 48 C.C.L.T. 280 (C.S. Qué.).

cc:	Dr. Roderick Fraser, President, University of Alberta
	Dr. Janice Lander, Faculty of Nursing, University of Alberta
	Dr. Donald Morrish, Faculty of Medicine & Dentistry, University of Alberta
	Dr. Janet Storch, President, National Council on Ethics in Human Research