The issue of informed consent

Finding

The evidence suggests that the parents of the children involved in these cases were not as fully informed as they were entitled to be when asked to give consent to surgery on their children.

Patients and family members granting consent on behalf of a patient are entitled to know the risks involved, before they give their consent to surgery. However, there was clear disagreement over the sort of information that must be shared.

The experience of the surgeon and the team

A number of the medical witnesses felt that declaring one's medical experience is not a requirement for informed consent, while many of the parents felt strongly that they should have been provided with more information about the program and about the surgeon's experience.

Many hospital staff seemed to feel that it was appropriate to describe the surgeon as highly trained, or 'one of the best', and to state that the Winnipeg program was 'as capable as anywhere else'. Yet they also felt it would have been inappropriate to tell the families that Odim had not performed any of the procedures he proposed in 1994 without supervision. How one could feel free to do the former while not feeling obligated to do the latter is a matter of some concern.

Some witnesses felt that the patient or parent is owed the truth if a question about previous experience is asked, but that a doctor can remain silent on the same point if the patient or parent does not ask. While the obligation to tell the truth is obvious, it seems illogical that some would see the obligation to be truthful as not encompassing an obligation to disclose a relevant fact.

While it might not be necessary to disclose a surgeon's abundant experience at performing a particular procedure, a surgeon's lack of experience is clearly a fact that is relevant to the question of whether or not someone would be willing to entrust his life, or the life of his or her child, to that surgeon. For that reason alone, such information ought to have been disclosed without prompting.

Information about surgical risk

Furthermore, the risk factors that were cited to parents for the procedures undertaken by Odim in 1994 were not based on the facts of the situations that the children actually faced in Winnipeg.

In many cases the indications of risk that were given to the parents were reflective of profession-wide risk, rather than the level of risk for the procedure at the HSC. Information such as the relative inexperience of the surgeon, and the fact that he would be performing the procedure in an unsupervised setting for the first time in his career, was not factored into the risk assessment shared with the families. This information should have been included when determining what risk level to advise the parents was associated with the operation on their child.

All the available data clearly suggest that there is a risk factor attached to a surgeon's experience. While that risk factor diminishes with experience, the fact that it is clearly higher with inexperience ought to have been disclosed to the parents, along with an indication as to what was applicable with Odim. Additionally, the state of experience and level of functioning of the surgical team was not, as it ought to have been, factored into the assessment of risk.

Information about the May 17 withdrawal of services by the anaesthetists

All parents whose children underwent operations after May 17, 1994, should have been informed about the anaesthetists' withdrawal of service on that date. As well, parents were entitled to be informed of the decision to perform only low-risk procedures thereafter, and the decision to resume full service in September 1994.

Information about the Williams and Roy Report and the February 1995 suspension of the program

Parents also should have been made aware of the Williams and Roy report and should have been allowed to read it. Additionally, parents should have been contacted and informed of the decision to suspend the program in February 1995, before that decision was made public.

Recommendation

It is recommended that: The Department of Health of the Manitoba Government prepare a patient's rights handbook that, among other things, deals with the issue of informed consent. That handbook should clearly set out that a patient and a parent acting on behalf of a minor have a number of rights, including, but not limited to:

• The right to be fully informed before giving consent to medical treatment;

• The right to information about a surgeon's experience in performing a particular procedure, as well as the experience of the hospital and/or surgical team;

• The right to a second opinion;

• The right to an out-of-province referral in certain circumstances, including where the patient or parent chooses to have a procedure performed by a surgeon or institution with more appropriate experience and where the surgeon or institution in Manitoba lacks the same experience; and

• The right to have an out-of-province surgeon perform the procedure in Manitoba, provided that there is a surgeon willing and able to do the procedure here.

It is recommended that: The Department of Health direct Manitoba hospitals to require that, as part of their obligation to obtain informed consent from a patient, hospitals have a positive obligation to provide to a patient, or a parent on behalf of a minor, information about:

• The right to information about a surgeon's experience in performing a particular procedure as well as the experience of the hospital and/or surgical team;

• The right to a second opinion;

• The right to an out-of-province referral in certain circumstances, including where the patient or parent chooses to have a procedure performed by a surgeon or institution with more appropriate experience and where the surgeon or institution in Manitoba lacks the same experience; and

• The right to have an out-of-province surgeon perform the procedure in Manitoba, provided that there is a surgeon willing and able to do the procedure here.

It is recommended that: The HSC review its policies on consent and communication with families. All information that is germane to a child's care or to decisions that must be made about a child's care should be provided to those from whom consent is being obtained. In particular, the policy on consent must make it clear that the medical staff treating a patient must be forthright and truthful in disclosing all relevant information to the patient or representative before the procedure in question. The fact that a surgeon has not performed a particular surgical procedure on his or her own in an unsupervised setting in the past must be disclosed.