September/October 2001 Table of Contents
In this Article
The Purpose of Informed Consent
The Nature of Informed Consent
by Sandra Hobson
The topic of informed consent affects every health care practitioner in Canada. Client-centred occupational therapists are ethically and morally obligated to obtain consent before beginning treatment, but according to the tenets of common law, we are also legally obligated to obtain informed consent. This article will provide a brief national overview on the purpose, nature, and documentation of informed consent with reference to occupational therapy treatment. Provincial and territorial jurisdictions differ around consent. Your regulatory body should be able to provide you with additional details unique to your location.
The Purpose of Informed Consent
Informed consent serves three main purposes. It is primarily intended to protect the individual's right to "security of the person" as outlined in the Canadian Charter of Rights and Freedoms (Rosovski, 1997). Any physical contact with a person without his/her consent constitutes battery (Morris, 1996). Informed consent also enhances communication and the special relationship of trust between caregiver and care recipient, legally called a fiduciary relationship (Rosovski, 1997). Informed consent can also be a risk management measure, a way to avoid litigation (Rosovski, 1997). Clients have the right to refuse treatment (Rosovski, 1997) or withdraw consent at any time after it has been given (Nelson, 1999).
The Nature of Informed Consent
For consent to be accepted as valid, it must meet 7 criteria (Rozovski, 1997).
1. The person must be legally competent to consent to treatment.
The presumption is always that the person, even a child (Rozovski, 1997), is competent. Many people mistakenly assume that the age of majority is the age of consent for treatment, but that is not true in Canada (Rozovski, 1997). Even individuals with a legally appointed guardian may be competent to consent to treatment, depending on the scope of the guardianship order and the legislation under which it was granted (Rozovski, 1997).
2. The person must possess the mental capacity to authorize care.
This refers to the "the intellectual ability to reach a reasoned choice about treatment"(Rozovski, 1997, p.6). This scope of capacity is NOT the same as the legal concept of capacity/competence to manage financial affairs. It refers strictly to the person's ability to make a treatment decision. Everyone is presumed mentally capable, unless there is some reason to question this. It is then the responsibility of the person obtaining the consent to assess the individual's capacity (Hoffman, 1995; Morris, 1996; Nelson, 1999). This means that occupational therapists may need to assess the client's capacity to consent to the treatment.
Some provinces have established ages above which consent from a child is binding, but even they may allow consent by younger children who are assessed as mentally capable of consenting to treatment (Gilmour, 1999). Problems may arise when the child and parent(s) disagree on treatment decisions (Rosovski, 1997), so details of the law in each jurisdiction should be checked carefully.
The other main area of misconception is the rights of clients with psychiatric illnesses or cognitive disabilities. Diagnosis alone is insufficient to presume incapacity (Kaiser, 1999). In most jurisdictions, even those involuntarily confined to a psychiatric treatment facility still have the right to give and withhold consent to treatment if they are mentally capable of doing so (Morris, 1996).
The test of capacity is the same for everyone and is based on the professional's opinion of whether the person has "the ability to understand the nature and effect of the treatment being proposed" (Nelson, 1999, p. 110). Ontario's Consent to Treatment Act (1992), considered a leader in the country (Rosovski, 1997), specifies that the person must be "able to understand the information that is relevant to making a decision concerning the treatment and able to appreciate the reasonably foreseeable consequences of a decision or a lack of decision" (Section 6(1)). This is further specified as including an ability to understand the condition for which treatment is proposed, the nature of the treatment, the risks and benefits of the treatment, and the alternatives to the treatment. This includes not having any treatment, as well as acknowledging that the condition for which treatment is proposed affects him/her and assessing how the proposed treatment could affect his/her life or quality of life (Hoffman, 1995).
Should the professional obtaining consent determine that the client is incapable of giving consent, a substitute decision maker must be identified and give proper informed consent for the treatment before it can begin (Kaiser, 1999). Substitutes are mandated to act in the best interests of the individual judged incapable (Rosovski, 1997) and in accordance with the individual's prior known wishes (Gilmour, 1999). In the case of a child, parent(s) are usually empowered to consent on the child's behalf (Gilmour, 1999), but disagreements between parents may cause difficulty (Rosovski, 1997). For incapable adults, a spouse or other family member is the usual substitute (Nelson, 1999). Some jurisdictions establish a strict hierarchy of substitutes, most notably Ontario, but courts in other jurisdictions usually act on similar principles (Morris, 1996). It is important to note that a judgement of incapacity is not a permanent verdict. Capacity is considered situational, and it can be influenced by fatigue, pain, medications, and so forth. All jurisdictions have some method to review capacity (Kaiser, 1999) for those formally deemed incapable of managing their own care. I would recommend that, before seeking a substitute decision maker, the occupational therapist revisit the client at least once, preferably when he or she is most rested and comfortable, to see if the client is capable under optimal conditions.
3. The person must receive proper disclosure of information from the professional.
The Supreme Court of Canada has clearly indicated that the information provided must be what a "reasonable person in the client's position" would want to know to make the decision (Dickens, 1999). This includes the anticipated benefits and the "material" risks (Dickens, 1999, p. 119) of the treatment. Such risks include those probable, even if not serious, as well as those that are unlikely, but serious (Dickens, 1999). Rosovski (1997) also cautioned that the risks described must be those specific to the particular client, not merely general risks of the treatment. Most occupational therapy is not considered very risky but, for example, transfer training does carry a possibility of falls, and this may be particularly serious for a client on blood thinners.
4. Consent must be specific to the treatment to be given.
Consent need not be obtained for every single step of a treatment plan (Nelson, 1999), but the blanket consent signed at admission to hospital is not adequate (Rosovski, 1997). The consent can be for a course of treatment (Hoffman, 1995), but that course should be discussed and main elements identified for the consent to be valid.
Also included under this criterion is identification of who will administer the treatment (Dickens, 1999). If assistants and/or students are to implement parts of the treatment plan, this should be included in the information given the client as part of the consent process (Nelson, 1999). A survey by Lynöe, Sandlund, Westberg, and Duchek (1998) found that 80% of clients felt aggrieved if they were treated by medical students without being informed, although 88% were, in principle, willing to participate in student training.
The law is not clear on whether informed consent must be obtained for assessment. Most literature on consent ignores the concept of assessment, except in the case of invasive diagnostic tests.
owever, Ontario's Consent to Treatment Act (1992) defines treatment as "anything that is done for a therapeutic, preventative, palliative, diagnostic, cosmetic, or other health-related purpose ... " (Section 1). It would therefore seem prudent to obtain consent for assessment as well as treatment. The issue of documenting consent will be discussed later.
5. The person must have the opportunity to ask questions and receive understandable answers.
This criterion emphasizes that clients are entitled to receive information in the language that they can understand. The professional is obligated to explain the information in lay terms (Dickens, 1999) and, should the client speak another language, translation must be made available (Rosovski, 1997).
6. The consent must be voluntary.
That is, it must be freely given and not obtained through undue influence or coercion (Nelson, 1999). Although this seems clear, subtle influences, like the inherent power imbalance between client and practitioner, may lead clients to do as the practitioner seems to wish, despite personal preference.
7. The consent must not be obtained by misrepresentation of information.
The professional may not slant the information presented to lead the client to any one decision, even if the professional thinks it in the client's best interest (Dickens, 1999). This is not to say that the practitioner may not express an opinion as to the best course of action (Rosovski, 1997), but accurate and impartial information on all treatment alternatives must be provided.
Documentation of Consent
Consent to treatment may be implicit (e.g., holding out a limb for examination) or explicit, and the latter may be verbal or written (Nelson, 1999). All are legally acceptable, but should questions arise later, some are more difficult to prove. Written consent is more typical for invasive procedures (Nelson, 1999), and this may be mandated in legislation (Rosovski, 1997), but the mere fact of a signed consent form is not adequate proof that the consent process was valid (Rosovski, 1997). Most consent litigation challenges the validity of the consent based on whether the client received adequate information to make the decision (Rosovski, 1997). Careful documentation of the consent process can provide evidence of the process followed (Nelson, 1999).
Rosovski (1997) suggested developing policies and procedures for both the consent process and documenting it. He recommended that a consent note be written, rather than using a form, because the forms are often poorly designed. Bottrell, Alpert, Fischbach, and Emanuel (2000) found that only 26% of 540 forms they studied met their criteria for valid consent. Rosovski (1997) also feared that consent forms might lull busy practitioners into merely getting the signature on the form, rather than actually securing a valid consent.
Rosovski (1997) suggested that a consent note be brief, but that it include the nature and purpose of the proposed treatment, the probable risks and benefits, the reasonable alternatives, and the fact that the criteria for valid consent were met. In his words, "the fact that a caregiver took the time to write the note lends far more credibility to the documentation of consent than is the case with checklists and forms" (p.119). This may appear onerous at first glance, but slight re-wording of the chart note typically written after assessment and outlining the treatment goals may be sufficient. See the appendix for a sample note.
Equally important to document would be refusal of consent, withdrawal of consent, or a decision by the practitioner that a particular client was not capable of giving consent, including the basis of that judgement. For example, you may decide that your new client who had a stroke three weeks ago lacks insight and memory sufficient to recognize that he had a stroke, and that he is currently unable to dress or transfer safely and needs treatment for this.
Particular care must be taken in obtaining consent where the client may not speak the same language as the professional. The name and qualifications of the translator need to be documented (often a family member, in my clinical experience), and a signed statement by the translator may be prudent (Rosovski, 1997), especially for more invasive or risky procedures.
Can you delegate the act of obtaining consent, for example to a student or assistant? Yes, as long as you remember that you are accountable, as the professional directing the treatment, for ensuring that the client gave informed consent for the treatment before it was initiated. It is a question of trust - how sure are you that the person to whom you have delegated this responsibility knows the criteria for valid consent, is able to assess the client's capacity to give it, and will document it appropriately? You can delegate responsibility for the task but you retain legal accountability for it.
Conclusion
It is the responsibility of the professional who will be implementing a treatment to obtain informed consent for it (Morris, 1996; Nelson, 1999). Failure to obtain consent before initiating treatment constitutes battery, leaving the health professional open to civil litigation and/or professional disciplinary proceedings (Morris, 1996). Treatment given on the basis of consent that is invalid, because it was not voluntary, was obtained by misrepresentation, or was obtained from a person mentally incapable of granting it, also constitutes battery (Rosovski, 1997). All that must be proven in a battery case is that the treatment occurred in the absence of a valid consent (Nelson, 1999). The onus of proof that valid consent was obtained rests on the professional and damages may be awarded even if no physical injury was caused (Nelson, 1999).
The more common route for consent litigation in Canada now is under negligence law (Dickens, 1999; Rosovski, 1997). In this case liability would only arise if the client could prove that harm had been done as a result of the negligent behaviour (Nelson, 1999). Most cases of negligence are lost because, although the clients can prove that they were improperly or incompletely advised, they are not able to prove that this resulted in injury (Rosovski, 1997). Nonetheless, negligence may be grounds for professional misconduct proceedings. It is, therefore, wise and prudent for occupational therapists to be aware of the unique requirements for consent in their jurisdiction, to obtain informed consent for treatment, and to document that consent in such a way that its validity is clear and defensible.
Abut the author
Sandra Hobson, MAEd, O.T. Reg. (Ont.), OT(C) is an Associate Professor in the School of Occupational Therapy at The University of Western Ontario. She also practices as a Capacity Assessor under the Ontario Ministry of the Attorney General.
Bottrell, M.M., Alpert, H., Fischbach, R.L., & Emanuel, L.L. (2000). Hospital informed consent for procedure forms: Facilitating quality patient-physician interaction. Archives of Surgery, 135, 26-33.
Consent to Treatment Act, Chapter 31, Statutes of Ontario (1992).
Dickens, B.M. (1999).Informed consent. In J. Downie & T. Caulfield (Eds.), Canadian health law and policy (pp. 117-141). Toronto: Butterworths.
Gilmour, J.M. (1999). Minors. In J. Downie & T. Caulfield (Eds.), Canadian health law and policy (pp. 179-215). Toronto: Butterworths.
Hoffman, B.F. (1995). The law of consent to treatment in Ontario. Toronto: Butterworths.
Kaiser, H.A. (1999). Mental disability law. In J. Downie & T. Caulfield (Eds.), Canadian health law and policy (pp. 217-274). Toronto: Butterworths.
Linöe, N., Sandlund, M., Westberg, K., & Duchek, M. (1998). Informed consent in clinical training - Patient experiences and motives for participating. Medical Education, 32, 465-471.
Morris, J.J. (1996). Law for Canadian health care administrators. Toronto: Butterworths.
Nelson, E. (1999). The fundamentals of consent. In J. Downie & T. Caulfield (Eds.), Canadian health law and policy (pp. 101-116). Toronto: Butterworths.
Rosovski, L.E. (1997). The Canadian law of consent to treatment. Toronto: Butterworths.
September/October 2001 Table of Contents
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