“Sign Here”: Nursing Value and the Process of Informed Consent

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)

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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 necessary 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 common 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). the United States was conducted using CINAHL. Date

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parameters were not defi ned in the original or refi ned search) and 2) search methodology (i.e., possibly lim- returns to evaluate any thought evolution of the nurse’s ited keyword selection). However, CINAHL is a compre- role in informed consent. When the Boolean search hensive database of nursing literature. It is likely to be phrase “informed consent NOT research,” fi ltered for selected by a working nurse in need of quick information the keyword “consent,” was applied to full-text fi les, amidst the controlled chaos of a procedural area. Also 704 results were returned. These 704 results were fur- the keyword search is researcher defi ned and easy to use ther fi ltered for the keyword “nursing role,” 36 results for those with even rudimentary knowledge of database remained. Of the remaining, one was excluded because inquiries. Hence the results yielded may point to limita- it did not relate to procedural consent, two were elimi- tions in current practice of keyword selection: there may nated because they are reprints of Quallich (2004) , and be research, articles that may pertain to the nurse’s role thirteen were unable to be reviewed because their full- in informed consent but are not tagged with keywords text record were absent from the electronic database. that would make it readily accessible for the research consumer. Findings The remaining 23 articles shared many common themes. THE VALUE OF NURSES TO THE PROCESS These include: (1) a clear defi nition of informed consent, OF INFORMED CONSENT (2) the responsibility of the treatment provider to obtain consent, (3) varied regulations according to jurisdiction and the importance of referring to the local statutes for An Evolution of Thought specifi cs, (4) the importance of well-developed institu- While the legal requirement might compel a nurse to tional policies that include a clear delineation of role adopt a minimal role in the process, the nurse’s drive to- responsibilities and expectations of those involved in the ward excellence in care and commitment to ethical prac- process, and (5) the witness’ signature is a legal attesta- tice demands more. In 2001, the Code of Ethics for Nurses tion that the patient him/herself is the signatory. (ANA, 2010, herein “Code ”) received a substantial facelift Certain individual themes, however, stood out. Both from its 1985 release, including expanded interpretive Peterson (2010) and Sweeny (1991) point out that con- statements of the ethical imperatives by which nurses are veying a form to a patient is not tantamount to obtain- called to practice. Of immediate concern is the explicit ing consent once the dialogue between provider and pa- language concerning the nurse’s role in protecting and tient is complete. Garvis (2005) , Plawecki and Plawecki championing self-determination in the informed consent (2009) , Quallich (2004) , and Sweeny (1991) all highlight process. the need for nurses to evaluate capacity and advocate that In 2001, the Code stressed that nurses must assess the incapacitated patients have surrogate decision makers. A quality and adequacy of the process as well as patient total of 16 articles highlight the idea that nurses’ special- capacity and comprehension: “The nurse preserves, pro- ity training in assessment and interdisciplinary commu- tects, and supports [patient autonomy] by assessing the nication gives them added value as active participants in patient’s comprehension of both the information present- the process of informed consent. (Brooke, 2004, 2007, ed and the implications of decisions” (Section 1.4, para- 2011; Cain, 1998; Dunn, 1999; Garvis, 2005; Lea, Spahis, graph 2). It explicitly states nurses are ethically bound to & Williams, 2002; Olsen-Chavarriaga, 2000; Petersen, ensure patients have access to thorough and understand- 2010; Plawecki & Plawecki, 2009; Quallich, 2004; Sulli- able information, an environment free of power struc- van, 1998; Sweeney, 1991; Switzer, 1995; Urbanski, 1997; tures that would inhibit an autonomous decision, and the White, 2000 ). While the aforementioned articles attribute resources necessary to remedy any identifi ed knowledge this value to the nurse’s ethical obligation, White (2000) defi cits (ANA, 2001, Section 1.4, paragraph 1). and Quallich (2004) plainly tie the nurse’s participation in In 1989, Yorker’s language choice refl ects an earlier, informed consent to the Code of Ethics for Nurses (ANA, implied understanding, noting: “the nurse should [em- 2010 herein “Code”). phasis added] question whether conditions for informed None of the reviewed articles were research articles. consent has been actually met” ( p. 132). White (2000) Because these articles largely fi t into the category of later shifts the narrative in accordance with the expanded expert opinion, the highest level of evidence available language that would be released in 2001: “A crucial [em- was Level V (John Hopkins Nursing Evidence-Based phasis added] aspect of the nurse’s role as patient advo- Practice Model, 2007). cate is the obligation to ensure that medical interventions don’t proceed unless the patient fully comprehends the Limitations details” (p. 83). This new narrative is clear: verifying con- The author admits limitations to the asserted data gap sent is as much of a compulsory process for nurses as in two ways: 1) database selection (i.e., single database obtaining it is for providers.

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Value within Patient Interactions CONCLUSION While providing a witness signature may remain a legal attestation of the patient as signatory, it is perhaps Articles are readily available that speak to the nurse’s the most suitable time to verify consent with the patient. theoretical value within the process of informed consent. The occasion provides an inlayed reminder, a hard stop, The ethical underpinnings provided by the Code of when preparing a patient for the procedure. Addition- Ethics for Nurses (ANA, 2001) carry with them compelling ally, nurses who have an ongoing relationship with their implications: when nurses participate as advocates, the patients—like those who work in offi ce-based plastic system gains an added level of risk mitigation, patients surgical settings—are well suited to serve as both witness have strong advocates, and quality care-systems are ad- and verifi er because of the level of assessment they bring vanced. However, the articles retrieved lack data to sup- to the process. port this postulate. When patients admit confusion or an aspect of the “Sign here” remains ubiquitous in procedural en- treatment plan changes, nurses are not responsible for dis- vironments, and the pace of care is not slowing. It is seminating the information needed to proceed. Instead, more important than ever that nurses vigilantly devel- the nurse adds value to the process by assuming the re- op evidence-based systems that promote quality care. sponsibility of liaising the patient with the provider, who Considering the wide scope of informed consent, both clarifi es the poorly understood material. If capacity is com- quantitative and qualitative study opportunities abound. promised or incapacity is not recognized, the nurse also And this research will be necessary to develop evidence- adds value to the process by advocating for the presence based models of procedural care and to demonstrate of a surrogate decision maker (Brooke, 2001; Plawecki how nurses best support patient outcomes and mitigate & Plawecki, 2009). While the provider may perceive ad- risk within them. vocacy efforts as impediments to the work of treatment, In the age of evidence-based practice and the current nurses who stand fi rm in their ethical obligations are in- Nurses Code of Ethics (2001), the wider value nurses valuable extensions of the quality improvement and risk can add to the process of informed consent is that of management teams. higher levels of evidence within the professional discourse. Opportunities for quantitative and qualitative Value within the Healthcare System studies alike are available in the light of the information When nurses actively participate in the informed con- presented here. Nurses’ patients and their profession sent process, they provide systemic value as well. When alike deserve compelling data on the value of nurses empowered thusly by their institution, they help mitigate in assessing competency for consent, verifying consent risk by identifying process errors, ineffective communi- is informed, and liaising patient and provider when cation patterns, and coercive power structures. Based necessary. By applying an evidence-based approach to on their experiences, nurses can provide valuable input the nurse’s role in informed consent, nurses can better about the institutional sensitivity toward patient capacity, improve outcomes and mitigate risk as they hear and identifying patterns in which this vital component may be say, “Sign here.” overlooked. These may be apparent in specialities that involve strong emotions like trauma or oncology and spe- cialties that have higher concentrations of patients with REFERENCES Body Dysmorphic Disorder (BDD) like aesthetic plastic American Nurses Association . (1985, 2001). Code of ethics for nurses surgery or cosmetic dermatology. Both heightened emo- with interpretive statements . Retrieved from http://www.nursing world.org/codeofethics tions and BDD have the power to cloud judgement and Brooke , P. S. (2004 ). Legal questions. Informed consent: Signed compromise capacity (Sturmey & Hersen, 2012). under duress? Nursing , 34 (6 ), 24 . Additionally, nurses guard against systemic paternal- Brooke , P. S. ( 2007). Legal questions. Informed consent: The yes ism and coercion by ensuring that the patient does not that wasn’t. Nursing , 37 (1 ), 12 . Brooke , P. S. (2011 ). Legal questions. Informed consent: Take time feel intimidated by the surrounding environment, pres- to ask . Nursing , 41 ( 8 ), 12 . doi:10.1097/01.NURSE.0000399586 sured by time constraints, or silenced by underlying .58357.a9 social mores. As the nurse evolves from novice to expert, Buppert , C. (2012 ). Nurse practitioner’s business practice and legal it becomes easier to see the larger context within which guide . 4th ed. Sudbury, MA: Jones & Bartlett Learning. Cain , N. J. ( 1998 ). Getting consent… “getting the go ahead: Helping each exchange is situated. With time and experience, the patients understand informed consent” (June 1997). AWHONN nurse learns to recognize early warning signs that the Lifelines , 2 (1 ), 11 . process is failing. Acting early to remedy the situation Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972 ) could save signifi cant time and energy, and economy Dunn , D. ( 1999). Exploring the gray areas of informed consent. Nursing , 29 (7 ), 41 – 45 . of both is critical for peak effectiveness and quality care Garvis , M. S. ( 2005 ). Advice of counsel. Getting informed consent delivery. when competence is at issue. RN , 68 ( 8), 68 .

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Lachman , V. ( 2009). Ethical challenges in health care: Developing Sharpe , C. C. ( 1999). Nursing malpractice: Liability and risk man- your moral compass . New York : Springer . agement . Westport, CT: Auburn House . Lea , D. H. , Spahis , J. , & Williams , J. K. (2002 ). Informed consent: Sturmey, P. & Hersen, M. (2012). Handbook of Evidence-Based making sure patients are fully informed is a crucial part of the Practice in Clinical Psychology, VOl. 2. Hoboken, NJ: Wiley. nurse’s role. American Journal of Nursing , 102 (7 ), 41 . Sullivan , G. H. (1998 ). Legally speaking. Getting informed consent . Olsen-Chavarriaga , D. (2000 ). Informed consent: do you know your RN , 61 (4 ), 59 . role? Nursing , 30 (5 ), 60 – 61 . Sweeney , M. L. (1991 ). Your role in informed consent . RN , 54 (8 ), Petersen , C. ( 2010). Clinical issues. Responsibility for obtaining 55 –60 . the surgical informed consent . AORN Journal , 92 (5 ), 585– 586 . Switzer , K. H. ( 1995). The legal side. Informed consent for inserting doi:10.1016/j.aorn.2010.08.011 a CVC… central venous catheters. American Journal of Nurs- Plawecki , L. H. , & Plawecki , H. M. ( 2009 ). Simply stated: Obtain- ing , 95 ( 6), 66 . ing informed consent can be a very complex task. Journal of Urbanski , P. K. ( 1997). Getting the “go ahead”: Helping patients Gerontological Nursing , 35 (2 ), 3 –4 . understand informed consent. AWHONN Lifelines , 1 ( 3), 45 –48 . Quallich , S. A. (2004 ). Issues in urologic nursing practice. The prac- White , G. (2000 ). Workplace rights. Informed consent. American tice of informed consent. Urologic Nursing , 24 (6 ), 513 – 515. Journal of Nursing , 100 (9 ), 83 . Schloendorff v. Society of New York Hospital, 211 N.Y. 125; 105 Yorker , B. C. (1989 ). Informed consent . Journal of Neuroscience N.E. 92 (NY Ct. App. 1914 ) Nursing , 21 (2 ), 130 – 132 .

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