Overview

1. Overview
2. Definitions
3. List of Subtopics
4. Literature Review
5. Assessment Criteria
6. Recommendations (Guidelines)
7. References
8. Minority Opinions

1. Overview [Top]
   
   As a matter of ethics and law there is an obligation, prior to examination and treatment, to disclose any material risk to the patient in order to obtain a valid informed consent. This legal duty has been established by case law and, in some provinces, by legislation.
   
   The need for full disclosure of material risk is an important new reality for all health care professionals. It is based on increased recognition by society and in the law that patients have the right to know about risks and their health care options before consenting to examination or treatment. It represents a rejection of the paternalistic approach of "the physician knows best" that has shaped attitudes and responsibilities in the past.
   
   The law of consent and informed consent varies from province to province and chiropractors should consult a lawyer for specific legal advice.
   
   
2. Definitions [Top]
   
   For definitions see the Glossary at the end of this publication.
   Consent
   Informed Consent
   Material Risks
   
   
3. List of Subtopics [Top]
   
   
   1. Disclosure
   2. Continued Care
   3. Form of Consent
   
   
   
4. Literature Review [Top]
   
   Doctors of chiropractic, as with all health care professionals, are required to obtain a patient's informed consent before commencing any examination, diagnostic procedure or treatment. The requirement of informed consent is recognized in ethics and at law. A chiropractor who fails to obtain a patient's informed consent may be held liable for battery (an unauthorized touching of the patient) or, more likely, for negligence (the negligent failure to make proper disclosure to the patient). Chiropractors may also face censure by their professional disciplinary body and be subject to penalties under provincial licensing legislation.
   
   The legal doctrine of informed consent is part of the general law of patient consent. Consent to treatment is often implied rather than expressed. However, where there is risk of significant harm from the treatment proposed, this risk must be disclosed, understood and accepted by the patient. It is clear from the case law, particularly the decisions of the Supreme Court of Canada in Hopp v. Lepp and Reibl v. Hughes, that the test of what amounts to a material risk is wide, and what needs to be disclosed is judged from the viewpoint of the reasonable patient not the chiropractor or other health professional.
   
   To quote Chief Justice Laskin in Reibl v. Hughes:
   
   "To allow expert medical evidence to determine what risks are material and, hence, should be disclosed and, correlatively, what risks are not material is to hand over to the medical profession the entire question of the scope of the duty of disclosure, including the question whether there has been a breach of that duty. ... The issue under consideration is a different issue from that involved where the question is whether the doctor carried out his professional activities by applicable professional standards. What is under consideration here is the patient's right to know what risks are involved in undergoing or foregoing certain surgery or other treatment (emphasis added)."
   
   The law as established in Hopp v. Lepp and Reibl v. Hughes was applied specifically to the chiropractic profession in Mason v. Forgie. The plaintiff patient, who was suffering from chiropractor. The patient claimed negligence in the manner of treatment and failure to inform him of the risk of stroke. The trial judge, Mr. Justice Jones, found there was no negligence in the delivery of treatment itself but that the chiropractor was negligent and liable for failure to disclose the risk of stroke. A duty of disclosure, as established in cases involving the medical profession, applied to chiropractors also: "I can see no distinction between surgical and non-surgical treatment if material risks are involved. ... I am satisfied that (Dr. Forgie) when he carries out a neck manipulation to another is of the class of persons who are obligated, if such treatment involves material risk, to obtain the informed consent of the patient."
   
   On appeal the Court of Appeal of New Brunswick agreed. On the issue of what amounts to a material risk it accepted this summary of the law in Reibl v. Hughes: "A risk which is a mere possibility ordinarily does not have to be disclosed, but if its occurrence may result in serious consequences, such as paralysis or even death, then it should be treated as a material risk and should be disclosed."
   
   This decision is a good illustration of how the perspective of the patient, and the patient's right to know, have become more dominant than professional evidence on the matter of what amounts to a material risk. A number of professional expert witnesses called on behalf of the chiropractor questioned the need to disclose such a remote risk. The Court accepted that the risk was very remote but, because the possible consequences included paralysis, it was by definition a material risk that should have been disclosed - whatever the professional views of chiropractors might be.
   
   For the chiropractic profession the doctrine of informed consent is of most practical significance, as in the Forgie v. Mason case, in connection with neck adjustment or manipulation and the risk of cerebrovascular accident. A chiropractor is obliged to explain the remote risk of serious consequences and, if the patient so desires, comment on the merits of alternative treatment or no treatment. The right to accept or reject treatment is that of the patient, not the chiropractor.
   
   For effective proof, informed consent should be obtained in writing. The written form must be specific in its reference to the material risk, and informed consent should not be obtained as part of a generalized form (Carey PF, Rozovsky FA). A consent prior to the first proposed cervical adjustment generally covers all further cervical adjustments. A new consent is only required if there is to be a significant change in the proposed care or there is some new reason to anticipate the patient has new or increased risk. Careful review is required when resuming treatment after a significant absence or for a new complaint (CCPA, Carey PF, Harrison JD and Rozovsky L). A patient who is given treatment without informed consent may claim compensation at law if the risk materializes. It is no defence that all other aspects of care were given with reasonable care and skill.
   
   In some provinces in Canada the law of consent and informed consent is now being codified in legislation. Thus for example the Consent to Treatment Act in Ontario (1992) deals comprehensively with capacity to consent (a mature minor may have capacity to give a valid consent) and the elements of consent and informed consent. Section 5(2) provides:
   
   "A consent is informed if, before giving it,
   a. the person received the information about the treatment, alternative courses of action, the material effects, risks and side effects in each case and the consequences of not having the treatment that a reasonable person in the same circumstances would require in order to make a decision; and
   b. the health practitioner responded to the person's requests for other information about the treatment, alternative courses of action, material effects, risks and side effects, and consequences of not having the treatment."
   
   A sample consent form is given as Figure 1. Because the law may vary from province to province, chiropractors are warned to take local legal advice on details of the process and content of a valid consent.
   
   Figure 1
   FORM OF CONSENT

   Doctors of chiropractic, medical doctors, and physical therapists using manual therapy treatments for patients with neck problems such as yours are required to explain that there have been rare cases of injury to a vertebral artery as a result of treatment. Such an injury has been known to cause stroke, sometimes with serious neurological injury. The chances of this happening are extremely remote, approximately 1 per 1 million treatments. Appropriate tests will be performed on you to help identify if you may be susceptible to that kind of injury. If you have any questions about this please do not hesitate to speak with Dr. Roe. I have read and understood the above statement, accept the risk mentioned, and hereby consent to treatment. Signed ___________________________ Date ___________________________ Witness ___________________________

   
   
   
   
5. Assessment Criteria [Top]
   
   Rating System 2 assessment criteria are used in this chapter. For an explanation of this system see the Introduction and Guide to Use (p. xxiii).
   
   
   
6. Recommendations (Guidelines) [Top]
   
   Disclosure:
   
   1.1 Chiropractors must disclose to the patient, or the guardian of a minor patient, the nature of the proposed treatment or procedure and any material risks including those that may be of a special or unusual nature.
   Rating: Necessary
   Evidence: Class I
   Consensus level: 1
   
   1.2 Even though a certain risk may be a very remote possibility, if it carries a risk of serious harm, it is a material risk and requires disclosure.
   Rating: Necessary
   Evidence: Class I
   Consensus level: 2
   
   1.3 Chiropractors must provide patients the opportunity to ask questions concerning risks that may be involved in the proposed treatment, alternative treatments, or no treatment, and should answer those questions to the patient's satisfaction.
   Rating: Necessary
   Evidence: Class I
   Consensus level: 1
   
   Continued Care:
   
   1.4 There is a continuing obligation to keep patients informed and to advise them of any new or changed material risk.
   Rating: Recommended
   Evidence: Class II & III
   Consensus level: 1
   
   Form of Consent:
   1.5 Consent may be given orally or in writing. The best record of consent is one that is objectively documented.
   Rating: Recommended
   Evidence: Class II & III
   Consensus level: 1
   
   
   
7. References [Top]
   
   Campbell LK, Ladenheim CJ, Sherman RP, Sportelli L. Risk management in chiropractic. Fincastle, Virginia: Health Services Publications Ltd, 1990: 107-111.
   
   Canadian Chiropractic Protective Association Risk Management Manual. J Canad Chiropr Assoc. 1989; 32:2.
   
   Carey PF. Informed cosent - the new reality. J Can Chiropr Assoc 1988; 32(2):91-94.
   
   Forgie v Mason. (1986); 38 CCLT 171 (NBCA), leave to appeal to SCC dismissed 76 NR 397n (SCC)
   
   Gotlib AC. The nature of the informed consent doctrine and the chiropractor. J Can Chiropr Assoc 1984; 28(2): 272-274.
   
   Harrison JD. Chiropractic practice liability, a practical guide to successful risk management. ICA Review. 1990; 123.
   
   Hopp v Lepp. 1980; 112 DLR (3d) 67 (SCC).
   
   Law Reform Commission of Victoria (Australia). Medicine science and the law. Discussion Paper #7. Informed consent to medical treatment. Oct. 1987.
   
   Nixdorf D. Current standards of material risk. J Can Chiropr Assoc 1990; 34(20): 87-89.
   
   Reibl v Hughes. [1980]; 14 CCLT (SCC).
   
   Robertson G. The Canadian Bar Review. 1991; 703(3): 423-447.
   
   Rozovsky L, Rozovsky FA. The Canadian law of consent to treatment. Toronto and Vancouver: Butterworths, 1990; 119-122.
   
   
   
8. Minority Opinions [Top]
   
   None