The rights of an individual that are protected under the constitution, though not explicitly stated in the Fourteenth Amendment of the United States Constitution, were enumerated as follows by Justice William Douglas during the Supreme Court Roe v. Wade decision, 410 U.S. 113 (1973). This amendment allows the autonomous decision-making ability of each individual to protect one's right or zone of privacy in making decisions related to one's body.
Informed consent is a legal contract, between the patient and the healthcare practitioner, applicable to every jurisdiction in the United States.4 It is an agreement-perhaps in written form for best practices' sake-based on the premise that self-determination and individual autonomy must be upheld at all stages of health care treatment, trials, discussions and contemplations.
Furthermore, the ability of the competent patient to make his or her own health care decisions is ensured under the Patient Self-Determination Act (PSDA). The PSDA is a Federal law enacted in 1990 that requires health care organizations to provide the patient with a summary of their rights which include being able to make their own health care decisions.4 Informed consent seeks to empower patients to become an active participant in the care planning in matters that affect their overall well-being with the health care practitioner helping them chart the right course.
Thus, this goal cannot be achieved by having the patient fill out a form or sign on the dotted lines at one visit. Rather, it is obtained after the individual or patient has participated in honest and straightforward discussions with their health care provider, the aim of the discussion is to enhance their understanding of what is involved and enable their ability to make rational choices about their health care procedure or treatment. In other words, informed consent is part of a comprehensive patient education process in clinical practice. In physical therapy, patient education is sometimes used as a treatment tool on its own or as part of care plan to ensure compliance with home program.
Ethical and Legal Responsibilities
The ability of a patient to make an educated choice and fulfill the predetermined societal expectations makes informed consent a process that is only fulfilled by ensuring that certain parameters are included.4-6 These parameters are as follows:
Competence - Most state laws are based on the premise that a mentally competent individual is able to concur to a particular intervention proposal after receiving full disclosure and understanding the ramifications of their choices, and with the understanding that the full responsibility of the outcome of their actions/choices lies with them.5,7 Age of consent varies from state to state, therefore, it is imperative for the healthcare practitioner to be familiar with applicable guidelines and laws in their jurisdiction especially with regards to the exact nature of proposed medical intervention or procedure. 5An adult patient is deemed incompetent or incapable of making rational decision when, for one reasons or the other, he is unable to provide an effective or valid informed consent. If the individual is a minor, the parent, guardian, or legal representative/surrogate decision maker would be required to provide the consent. If the individual is incapacitated, unconscious or displays psychotic manifestations consistently or sporadically, or an intellectually challenged adult, then the next of kin (decision maker) would provide the informed consent.5,6
Information - Health care providers' codes of ethics recognize the ethical duty of practitioners to provide the patients with adequate disclosure of information that would facilitate the process of informed consent, based on the ethical principle of autonomy.4 For instance, the American Medical Association guidelines for physicians stated that in order for a patient to provide informed consent, the individual must be accorded the opportunity to make an educated decision is also applicable.8 Likewise, according to the American Physical therapy Association in the Guide to Professional Conduct provided some (ethical) guidance for physical therapist (PT) with regards to the duty of informed consent.9 The PT is advised to respect the patient's right to make decisions, relay the results of evaluation and assessment to the patient using sound professional discretion when relating information about associated risks of a proposed intervention(s) or tests and measures.9 However, there are two generally applicable standards to the health care providers when determining the extent of full disclosure. 4-6 There is the medical standard which is based on consensus expert or professional opinions as it obtains in that particular jurisdiction or locale. The other is the reasonable person standard, which is based on the consideration of what is applicable to an average person in a similar circumstance or comparable situation. Thus, a full disclosure of proposed treatment or intervention must include:4-6,8-9
- Objective presentation of associated benefits and risks (adverse reactions, side effects, impact on life/lifestyle);
- Estimated financial cost (anticipated third party payers coverage and out of pocket expenses);
- Duration of treatment and expected outcome (prognosis);
- Alternative treatments, available options, along with the likely impact of those options;
- Suggestions on non-intervention and the possible impact on the overall quality of life.
Voluntariness - practitioners must respect patients as autonomous beings who must be allowed to willingly, based on individual preferences, provide or withhold their consent to evaluation, examination, and treatment without undue constraint, coercion, intimidation, manipulation or intimidation.3-6 This means patients must be allowed to deliberately make their own choices and be active participants in the healthcare planning. Their voices must be heard with regards to their hopes, goals, fears, and doubts.6
The process must allow them to recognize that the full responsibility of their actions in relation to their well-being rest with them. Although, in some circumstances, an educated patient who is familiar with the ramifications of their choices may intentionally relinquish their right to be informed and authorize their physician (or health care provider) the authority to make all the decisions for them. In this instance, the physician is said to be under no obligation of the duty to inform.7,8
Justifications for Legal Exceptions
At stated above, informed consent is a process deeply rooted in medical ethics on the basis that every individual has a right to decide what is done to them.6 Based on the idea that to act with beneficence and respect for autonomy, there are certain circumstances under which the practitioner may bypass the informed consent in order to provide evaluation or intervention. 4-7 These include:
Emergency situation - this apply when the patient is unconscious or incapable of consenting, and the risk of decline or imminent harm occurring due to delay or inaction outweigh the potential side effects of the intervention. Even in this situation, significant effort must be made to contact the next of kin to secure consent before proceeding with the intervention. If on the other hand, the emergency presents a significant public health risk,4,6 the informed consent process may be initiated but not completed by the time the intervention is delivered.
Therapeutic privilege - this applies when the full disclosure may cause the patient severe distress and impair their ability to make rational intelligent decision, or even pose substantial risk of physical and psychological harm to the overall health and well being of the patient. The practitioner in this situation may withhold such information until such a time an informed consent can be obtained with the aid of a surrogate.4 This privilege also allows the physician to override patient autonomy rights for paternalistic reasons - for their own good.4,5,7
Common Knowledge - the duty to inform does not apply when the matters involved are beyond the scope of the practice of the professional. In addition, the provider is not obligated if the patient demonstrate significant awareness (actual knowledge) of the risk involved and the provider is able to obtain a waiver from the patient to this regard. 5,7
The failure to properly obtain and document informed consent by a healthcare practitioner constitutes professional negligence under the umbrella of health care malpractice. Thus, any physical contact with the patient that is occurring without the expressed consent of the individual which may be tantamount to battery (physical assault).8 When the physical contact is deemed as harmful, it is prosecuted under the criminal system as intentional battery.7,8 Although, unlike other medical malpractice cases such as wrongful death or practitioner's error in judgment, informed consent malpractice is rarely successful. One cannot discount the psychological impact involved in defending such claims. Informed consent malpractices cases can however be are proven only when there is significant injury because of the intervention to which the patient may claim they were not privy to the full ramifications of their choice. This was highlighted in a 2008 case, whereby the plaintiff claimed the surgical debridement performed by the physician on her husband contributed to his death. The courts awarded a multimillion-dollar judgment against the surgeon based on battery for performing procedure "without informed consent" rather than "without consent." 11
The failure to obtain informed consent may be deemed as proximate cause of injury to the patient which may be processed as a medical malpractice issue on the basis of preponderance of the evidence.4,9 This means that the assumption made would be that a rational person in a comparable situation to the patient would not have concurred to such intervention or procedure if he had received full disclosure regarding the intervention, as was highlighted in the case of a Connecticut physician sued for negligence - medical malpractice and assault and battery.
The plaintiff, the administrator of the estate of the diseased patient (diagnosed with schizophrenia and sleep apnea), maintained that the decedent had failed to give informed consent for the uvulopalatopharyngoplasty procedure which contributed to his demise.12 The initial jury verdict resulted in substantial monetary award against the physician; although, the verdict was later overturned by the appeals court. Nevertheless, the inescapable moral of the case points to the need to properly obtain and document informed consent evidence. Such documentation that would show that the patient participated in care planning based on the history, signs and symptoms, diagnosis, impressions from tests and measures, and was given the opportunity to exercise their right to decline or accept prescribed or proposed method of intervention prior to its administration.
The advent of direct access to a PT services signals the placement and acceptance of more responsibilities on PTs, more importantly the higher risk of liability that places a heavier ethical and legal burden on the autonomous practitioner to ensure they exercise diligence in educating their patient, and keeping them updated about their conditions. This is especially important because PTs, regardless of the practice setting, utilize "touch" as an important consummate part of (manual) therapy approach to delivery of care, more than any other health care practitioner does. Therefore, PTs should make significant efforts to ensure clarity of intentions and explanation of all associated risks prior to delivery of care. PTs must view informed consent as a risk management issue and a quality assurance issue; the better informed a patient is, the more likely they are going to comply with the treatment program and the lower the probability of issues such as negligent practice arising.7
Such incidence was highlighted in a 2005 case in the state of Vermont whereby a patient sued his dentist for lack of informed consent and battery, because the treatment he received was not the one he had expected. The patient claimed that the dentist changed the course of treatment without his knowledge after he had obtained his consent.13 Although, the lack of informed consent claim was withdrawn; the plaintiff still claimed battery in the lawsuit. The final judgment was found in his favor because the court noted that he was not guilty of battery charge, even though the court acknowledged that the dentist did fail to meet his due-care duty to disclose pertinent information; a situation under which he would have been liable for negligence.
One may argue that our techniques are not as invasive in most practice situations as may be obtainable in medical or dental practice, as such confers on us certain degree of protection from the potential malpractice or medical battery claims. However, this protection is only lessened to the extent of the severity of damage or injury as compared to surgeons. PTs should be cognizant of the fact that even if the malpractice claim is unsuccessful, the amount of emotional, psychological and financial resources involved to defend such claims can be significant.
A more difficult scenario may be obtainable with a claim of medical battery, which can be brought based on the patient simply claiming his or her right to be touched or not to be touched was violated. 10 No longer can we be protected under the umbrella of the "just following physician's orders."9 We must strive to obtain and document the nature of communication employed as evidence of agreement to our services. Especially, when one considers the fact that such malpractice claims can be easily reduced by communication to the patient in simple detailed "jargon free" language and meticulous documentation of the signed consent form as an evidence of informed consent, and ensure that the patient is continuously updated as deemed necessary by the physical therapist.
PTs must recognize that informed consent is a process not a single document or a form,8,9 it is part of a health care quality control program instituted to ensure best practice scenario for the benefit of the patient and enhance the peace of mind of the practicing professional.
Olaide Sangoseni, PT, DPT, MSc , is a patient advocate and a private practice PT with AOS Integrated Clinical Consultants in Saint Louis, Missouri.
- U.S. Supreme Court ROE v. WADE, 410 U.S. 113 (1973) at Find Law for Legal Professionals. Available at http://caselaw.lp.findlaw.com/
- Resources for Attorneys. Roe v. Wade, 410 U.S. 113 (1973). Available at http://www.resourcesforattorneys.com/
- Bryce EM. Just Social Policy on Life Issues: Ethical Considerations. Rev Policy Res. 2005;13(1-2): 187 - 194
- Scott R. Promoting Legal and Ethical Awareness: A primer for health professionals.2009. St. Louis, MO: Mosby Elsevier
- Liang BA, Moore R. Informed consent: know rules and exceptions, when they apply. ED Legal Letter. 2003; 8 Available at www.accessmylibrary.com/
- Raab EL. Parameters of informed consent. Trans Am Ophthalmol Soc 2004;102:225-232
- Kiss CG, Richeter-Mueksch S, Stifter E. et al. Informed consent and decision making by cataract patients. Arch Opthamol. 2004;122:94-98
- American Medical Association. Informed Consent. Available at http://www.ama-assn.org/ama/pub/category/4608.html
- American Physical Therapy Association Guide for Professional Conduct Available at http://www.apta.org/
- Lawyer Central - Gross Negligence and Lack of Informed Consent. Available at http://injury.lawyercentral.com/Lack-of-Informed-Consent-
- Saxena v. Goffney (January 24, 2008) 07 C.D.O.S. 1180 Available at http://www.hassard.com/recent_decisions/SaxenaGoffney
- Poremba v. Yale-New Haven Hospital Available at http://www.jud.state.ct.us/external/supapp/Cases/
- Sfikas PM. Informed consent: How performing a less invasive procedure led to claim of battery. J Am Dent Assoc 2006; 137:101-103. Available at http://jada.ada.org/cgi/content/full/137/1/101