Section 8: Informed consent and medico-legal framework

International Framework for Examination of the Cervical Region

Informed consent

Informed consent is comprised of both ethical and legal components. Patient consent to treatment is a standard of physical therapy practice. The specific requirements of informed consent will vary from country to country according to local laws, customs and norms. This section provides physical therapists with information on this process based on the literature and current generally accepted ethical and legal standards.

Application to individual Member Organisations:
  • Given the international audience of this document, Member Organisations are advised to check local laws and health regulations affecting the informed consent process.
  • Please consult your MO for any local information or requirements. Member Organisations are encouraged to add any local requirements as an addendum to this document to facilitate use of the document in their local context.

In seeking informed consent, the physical therapist should be confident that the patient will benefit from treatment and that the risk is minimal. Informed consent can be defined as “the voluntary and revocable agreement of a competent individual to participate in a therapeutic or research procedure, based on an adequate understanding of its nature, purpose and implications”[1]. The process of informed consent includes the following components: the types of consent, the requirements of disclosure of information by the therapist, how it is obtained, and the requirements of record keeping of the informed consent process. It is important to note that informed consent is part of the process of clinical reasoning. This acknowledges the importance of dialogue between the physical therapist and patient about treatment alternatives, in combination with the patient’s preferences, so that mutually agreed choices of care can be made[2][3]. Further, it infers the importance of the patient’s autonomy and that their right to make decisions throughout the treatment process is ongoing and not a one-off event[4].

Types of consent

Express consent is given explicitly either in writing or verbally[5] (e.g. the patient expressly states that they agree, or signs a form indicating agreement). This is recommended when initially seeking informed consent for a treatment intervention e.g. cervical manipulation, as it provides the clearest form of consent and often fulfills legal obligations.

Implied consent is not specifically indicated as in express consent, but is implied by some action which suggests consent[5](e.g. after having a discussion with the physical therapist regarding treatment, the patient lays down on the treatment bed signaling that they are a willing participant). This form of consent is open to interpretation and is therefore less reliable upon legal scrutiny.

Tacit consent is failure of the patient to disagree or dissent[5]. This form of consent is open to interpretation and is therefore less reliable upon legal scrutiny.

Embodied consent is assessment of the patient’s body language for consent to treatment, prior to and during treatment[6]. Since express consent is initially recommended for treatment interventions e.g. cervical manipulation, embodied consent becomes important during the treatment. The body language of the patient should be observed specifically during the pre-manipulative hold and assessed for indications that they may be reconsidering the initial express consent that was given. If the therapist observes body language that may indicate the patient is uncomfortable with proceeding, the therapist should stop the procedure and ask the patient if it is acceptable to continue.

Whatever the form of the consent, it should be given voluntarily and without undue influence from the therapist, and once the patient has given consent they can withdraw their consent at any time during treatment.

Disclosure of Information

It is recommended that physical therapists provide patients with information about the proposed assessment and treatment procedures. The information provided can be communicated verbally or by written material, such as an information brochure. The most prudent approach is to use both verbal and written communication[7].

Once again, Member Organisations are advised to check local laws and health regulations affecting the informed consent process as the legal requirements may vary from country to country.

Provision of a brochure is optional, but allows patients time to consider the recommendations, ask questions, and make an informed choice overall. It can be given to the patient to read prior to treatment while they are in the waiting room or in the clinic. If the patient requires further time before making a decision, a brochure can be taken home for consideration. Provision of a brochure ensures that the information is standardised and allows for easy record keeping of the informed consent process by indicating that the brochure was given.

It is recommended that the information provided to the patient cover the following points[8][9]. It is important to note that the points apply to any physical therapy intervention:

  • It must be specific to the proposed treatment.
  • It must cover alternative treatment options.
  • It must cover benefits and risks of the proposed treatment and alternatives.

Note: It is important to remember that an analysis of risk is based upon a physical therapist’s analysis of the situation i.e. the interaction of the patient, therapist and planned intervention to inform the level of risk.

Omission of any of the above information may invalidate the consent of the patient. It is the responsibility of the physical therapist to ensure that the patient fully understands all of the information that has been provided. It is also the responsibility of the physical therapist to provide further information requested by the patient and to answer all questions asked by the patient in a manner that the patient considers satisfactory[9].

Once again, Member Organisations are advised to check local laws and health regulations affecting the informed consent process as the legal requirements may vary from country to country.

Obtaining informed consent

Informed consent is obtained when a patient explicitly indicates either verbally or in writing, following adequate disclosure of information about the proposed procedure, their consent to proceed with the treatment. Consent must be obtained before treatment begins. Asking the patient for consent while treatment is in progress may adversely influence the patient’s decision-making and is not recommended[10].

For changes in treatment (introducing a different type of technique), the full process of informed consent must be undertaken and consent explicitly obtained verbally or in writing.

e.g. You have been treating a patient using intervention A. The patient has not responded as you had hoped and you would like to now try intervention B. Intervention B is considered to be a new or different treatment to intervention A. Therefore, if the initial process of obtaining informed consent did not include information pertaining specifically to intervention B, the physical therapist must specifically gain informed consent for the use of intervention B prior to its application. For continuation of the same treatment (e.g. intervention A), it is recommended that consent be obtained each time it is used. This does not necessarily entail the full disclosure of information that was required the first time. Agreement by the patient verbally to the ongoing use of intervention A in most cases would be sufficient. If however, in follow up discussion with the patient, you perceive that there is a lack of understanding of the previously disclosed information, it is recommended that the full process of disclosure of information be revisited.

Recording of informed consent

It is recommended that the disclosure of information and the obtaining of informed consent be recorded in a standardised manner in the patient’s clinical record. For each treatment, it is recommended that the obtaining of informed consent be recorded each time. The use of stickers (one for the initial informed consent process and one for follow up visits) is suggested to standardise and facilitate ease of recording. Stickers can be designed with a series of bullet points that can be ticked. Similar strategies can be used in an electronic medical record system.

References

  1. Sim J (1986). Informed consent: ethical implications for physiotherapy. Physiotherapy 72:584-7.
  2. Charles C, Gafni A, Whelan T (1997). Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Social Science and Medicine 44(5):681-92.
  3. Jones MA, Rivett DA (2004). Introduction to clinical reasoning. In M.A. Jones and D.A. Rivett (eds.), Clinical Reasoning for Manual Therapists. Butterworth-Heinemann: Edinburgh 3-24.
  4. Delany C (2005). Respecting patient autonomy and obtaining their informed consent: ethical theory - missing in action. Physiotherapy 91:197-203.
  5. 5.0 5.1 5.2 Sim J (1997). Ethical decision-making in therapy practice. Oxford, Reed, pp 59-75, (chapter 4).
  6. Fenety A, Harman K, Hoens A, et al (2009). Informed consent practices of physiotherapists in the treatment of low back pain. Manual Therapy 14(6):654-60.
  7. Purtillo RB (1984). Applying the principles of informed consent to patient care: legal and ethical consideration for physical therapy. Physical Therapy 64:934-7.
  8. Appelbaum PS, Lidz CW, Meisel A (1987). Informed Consent: Legal theory and clinical practice. Oxford University Press, New York.
  9. 9.0 9.1 Wear S (1998). Informed consent: Patient autonomy and clinician beneficence within healthcare. Second edition. Georgetown University Press. Washinton, DC.
  10. Jensen AB (1990). Informed consent. Historical perspective and current problems. Ugeskr Laeger, Nov 26;152(48):3591-3.