“Sign Here”: Nursing Value and the Process of Informed Consent
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Risk Management Department “Sign Here”: Nursing Value and the Process of Informed Consent Wesley E. Cook , BSN, RN, CPSN law, ethics, and process of informed consent as well as a Protecting patient autonomy is a key nursing role. The basic literature review and discussion of nursing’s value Code of Ethics (American Nurses Association, 2010), within the process. (Legal Disclaimer: This information contextualizes the nurse’s call to advocacy within the is provided for educational purposes only and does not doctrine of informed consent. This article offers a primer constitute legal advice. A licensed attorney should be con- on the legal, ethical, and practical aspects of procedural sulted for any specifi c questions concerning the law and informed consent and examines the value of nursing’s its interpretation.) role within the process. The theory of nursing’s value is sound, but the literature lacks data. Higher levels of evidence are necessary to make sound decisions about UNDERSTANDING INFORMED CONSENT best practice for the process of informed consent. As such, this article concludes that adding nursing research to the Legal and Ethical Underpinnings current discourse should prove most valuable to patients, The legal doctrine of informed consent is rooted in tort providers, and the nursing profession as a whole. law. Failure to obtain informed consent before proceed- ing with a procedure that requires an invasive technique is a breach of the provider’s duty to the patient. As such nformed consent is an integral component of the surgi- breach “may amount to a tort–to a common law battery” cal care continuum. “Sign here!” is a pervasive request (Canterbury v. Spence, 1972). Physically, the provider Iin pre-procedural areas. In the harried pace of these touched the patient without permission. environments, it can be tempting to mistake effi ciency for The ethical imperative toward informed consent effectiveness (Plawecki & Plawecki, 2009). While obtain- is formed out of the principle of autonomy, or self- ing informed consent through an adequate dialogue is the determination. If the patient were unaware of potential duty of the provider, nurses have an ethical obligation to risks or harm, s/he could not properly use his or her act as advocates of the patient’s autonomy within the pro- own criteria to determine whether to proceed. Hence, the cess (American Nurses Association [ANA], 2001). The eth- doctrine has evolved past being rooted within the law of ics that undergird the nurses’s role as advocate are sound, battery so that a “majority of courts have adopted a self- backed by well-established philosophy. But are these eth- determination rationale” ( Buppert, 2012 , p. 278). ics supported by data that show how well nurses improve While criminal law categorizes “offences against the outcomes and mitigate risk within the process of informed community at large,” tort law covers civil offences in consent? In a climate that promotes evidence-based care which a legally defi ned duty from one person to another as the gold standard, it is critical that the role of advocacy has been breached (Black’s Law Dictionary, 4th pocket is supported by data as well as contextualized by theory. ed., 2010, pp. 189, 763). Tort law defi nes battery as This article provides a primer for procedural nurses of the “[a]n intentional and offensive touching of another without lawful justifi cation” (Black’s LawDictionary, 4th pocket ed., 2010, p. 69). It defi nes the doctrine of Wesley E. Cook, BSN, RN, CPSN, is a board certifi ed plastic surgical informed consent as: nurse and master of science in nursing (FNP, 2015) candidate at Drexel University, having earned his BSN (2008) at the Johns Hopkins Univer- sity. He is an active member of the American Society of Plastic Surgical a patient’s knowing choice [emphasis added] about a Nurses and Chair of the Risk Department for Plastic Surgical Nursing . medical treatment or procedure, made after a physi- Mr. Cook specializes in clinical aesthetics nursing and legal nurse consult- ing, practicing in the greater Washington, DC. area. cian or other healthcare provider discloses what ever The author reports no confl icts of interest. information a reasonably prudent provider in the medi- Address correspondence to Wesley E. Cook, BSN, RN, CPSN, 215 C. cal community would give to a patient regarding the St SE, Washington, DC 20003 (e-mail: [email protected] ). risks involved in the proposed treatment or procedure. DOI: 10.1097/PSN.0000000000000030 (Black’s Law Dictionary, 4th pocket ed., 2010, p. 149) Plastic Surgical Nursing www.psnjournalonline.com 29 Copyright © 2014 American Society of Plastic Surgical Nurses. Unauthorized reproduction of this article is prohibited. PPSN-D-14-00003.inddSN-D-14-00003.indd 2929 22/25/14/25/14 77:53:53 PMPM Risk Management Department Thus, the doctrine of informed consent legally recognizes Elements of Process that healthcare providers have a duty to protect patients In practice, signifi cant amount of focus is placed on by carrying out invasive or high-risk treatments only after whether the consent form is signed. This is understand- authorization. able. It is tangible, effi cient, and readily accessible to the The decision of Schloendorff v. Society of New York multiple clinicians and administrators vested in patient Hospital (1914) contains especially plain language about safety. Yet, informed consent is more than just a the a patient’s right to informed consent: medical record: as previously defi ned, it is a dynamic exchange between the provider and the patient that “Every human being of adult years and sound mind has allows the patient to make knowledgeable decisions the right to determine what shall be done with his own about their care. body; and a surgeon who performs an operation with- While jurisdiction-specifi c regulations apply, the core out his patient’s consent commits an assault, for which elements of informed consent are stable, rooted in au- he is liable in damages, except in cases of emergency tonomy, and handed down through case law: where the patient is unconscious, and where it is neces- sary to operate before consent can be obtained.” • an evaluation of patient capacity and a continual assessment of comprehension, It affi rms informed consent as an explicit right, assigns • a description of the procedure, through the pro- duty to the provider, establishes the need for capacity, cess, risks and benefi ts, as well as its supplemental and offers a provision for treating an emergent case. The requirements (i.e., anesthesia, secondary specialty opinion given in this landmark case made way for more assistance), specifi c language from Canterbury v. Spence (1972): • a discussion of procedural alternatives, including no procedure , as well as the availability, risks and “It is well established that the physician must seek and benefi ts of each, secure his patient’s consent before commencing an opera- • the patient’s express and autonomous consent to tion or other course of treatment. It is also clear that the proceed made with no obstruction to informed consent, to be effi cacious, must be free from imposition refusal (Buppert, 2012; Lachman, 2009; Quallich, upon the patient. It is the settled rule that therapy not 2004 ). authorized by the patient may amount to a tort–-a com- mon law battery–-by the physician. And it is evident that These stable elements provide the framework for con- it is normally impossible to obtain a consent worthy of the tent customized to the patient’s specifi c clinical picture, name unless the physician fi rst elucidates the options and intellectual capacity, and cultural acceptance of who the perils for the patient’s edifi cation. Thus the physician is involved in the decision-making process (Lachman, has long borne a duty, on pain of liability for unauthorized 2009 ). treatment, to make adequate disclosure to the patient.” Institutions generally utilize a form for the documenta- tion of informed consent: only after the actual exchange This decision explicitly recognizes the patient’s vulner- in which consent is granted does the patient verify his or ability vis-a-vis their lack of health science knowledge, her consent with a signature on the institution’s form. In the provider’s obligation and capacity to make a full dis- addition, it is the patient’s prerogative to change his or closure of the risks and benefi ts, and the necessity for the her mind even after the form has been signed. Thus, the process to be devoid of coercion. It called attention to patient’s signature is a symbol of the consent given, not the right of the patient to grant informed refusal as well the consent itself ( Brooke, 2011 ). as consent: in order for the patient to grant truly informed When a form is used, the patient’s signature is authen- consent, the patient must feel free to decline services ticated by a witness’ signature. Witnesses who sign the based on the risks, benefi ts, and alternatives presented. form attest only to the patient as signatory and are not Generally speaking, regulations and legal require- legally culpable for disclosure breaches or patient com- ments vary from state to state. Most differ in 1) documen- prehension issues. The witness is simply verifying that tation requirements, 2) who may perform consent, and 3) the patient, him/herself , signed the form ( Sharpe, 1999 ). the treatments that require informed consent. The general consensus is to obtain informed consent if the treatment REVIEW OF THE LITERATURE is invasive and of substantial risk for harm, regardless of how rare the incidence of harm may be. Those who obtain consent or design pre-procedural policy should Methodology refer to their local health code to ensure that all require- A search of the peer-reviewed literature published in ments are met ( Buppert, 2012 ).