Informed consent is an integral component of the surgical care continuum. "Sign here!" is a pervasive request in pre-procedural areas. In the harried pace of these environments, it can be tempting to mistake efficiency for effectiveness (Plawecki & Plawecki, 2009). While obtaining informed consent through an adequate dialogue is the duty of the provider, nurses have an ethical obligation to act as advocates of the patient's autonomy within the process (American Nurses Association [ANA], 2001). The ethics that undergird the nurses's role as advocate are sound, backed by well-established philosophy. But are these ethics supported by data that show how well nurses improve outcomes and mitigate risk within the process of informed consent? In a climate that promotes evidence-based care as the gold standard, it is critical that the role of advocacy is supported by data as well as contextualized by theory. This article provides a primer for procedural nurses of the law, ethics, and process of informed consent as well as a basic literature review and discussion of nursing's value within the process. (Legal Disclaimer: This information is provided for educational purposes only and does not constitute legal advice. A licensed attorney should be consulted for any specific questions concerning the law and its interpretation.)

UNDERSTANDING INFORMED CONSENT

Legal and Ethical Underpinnings

The legal doctrine of informed consent is rooted in tort law. Failure to obtain informed consent before proceeding with a procedure that requires an invasive technique is a breach of the provider's duty to the patient. As such breach "may amount to a tort-to a common law battery" (Canterbury v. Spence, 1972). Physically, the provider touched the patient without permission.

The ethical imperative toward informed consent is formed out of the principle of autonomy, or self-determination. If the patient were unaware of potential risks or harm, s/he could not properly use his or her own criteria to determine whether to proceed. Hence, the doctrine has evolved past being rooted within the law of battery so that a "majority of courts have adopted a self-determination rationale" (Buppert, 2012, p. 278).

While criminal law categorizes "offences against the community at large," tort law covers civil offences in which a legally defined duty from one person to another has been breached (Black's Law Dictionary, 4th pocket ed., 2010, pp. 189, 763). Tort law defines battery as "[a]n intentional and offensive touching of another without lawful justification" (Black's LawDictionary, 4th pocket ed., 2010, p. 69). It defines the doctrine of informed consent as:

a patient's knowing choice [emphasis added] about a medical treatment or procedure, made after a physician or other healthcare provider discloses what ever information a reasonably prudent provider in the medical community would give to a patient regarding the risks involved in the proposed treatment or procedure. (Black's Law Dictionary, 4th pocket ed., 2010, p. 149)

Thus, the doctrine of informed consent legally recognizes that healthcare providers have a duty to protect patients by carrying out invasive or high-risk treatments only after authorization.

The decision of Schloendorff v. Society of New York Hospital (1914) contains especially plain language about a patient's right to informed consent:

"Every human being of adult years and sound mind has the right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damages, except in cases of emergency where the patient is unconscious, and where it is necessary to operate before consent can be obtained."

It affirms informed consent as an explicit right, assigns duty to the provider, establishes the need for capacity, and offers a provision for treating an emergent case. The opinion given in this landmark case made way for more specific language from Canterbury v. Spence (1972):

"It is well established that the physician must seek and secure his patient's consent before commencing an operation or other course of treatment. It is also clear that the consent, to be efficacious, must be free from imposition upon the patient. It is the settled rule that therapy not authorized by the patient may amount to a tort-a common law battery-by the physician. And it is evident that it is normally impossible to obtain a consent worthy of the name unless the physician first elucidates the options and the perils for the patient's edification. Thus the physician has long borne a duty, on pain of liability for unauthorized treatment, to make adequate disclosure to the patient."

This decision explicitly recognizes the patient's vulnerability vis-a-vis their lack of health science knowledge, the provider's obligation and capacity to make a full disclosure of the risks and benefits, and the necessity for the process to be devoid of coercion. It called attention to the right of the patient to grant informed refusal as well as consent: in order for the patient to grant truly informed consent, the patient must feel free to decline services based on the risks, benefits, and alternatives presented.

Generally speaking, regulations and legal requirements vary from state to state. Most differ in 1) documentation requirements, 2) who may perform consent, and 3) the treatments that require informed consent. The general consensus is to obtain informed consent if the treatment 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 refer to their local health code to ensure that all requirements are met (Buppert, 2012).

Elements of Process

In practice, significant amount of focus is placed on whether the consent form is signed. This is understandable. It is tangible, efficient, and readily accessible to the multiple clinicians and administrators vested in patient safety. Yet, informed consent is more than just a the medical record: as previously defined, it is a dynamic exchange between the provider and the patient that allows the patient to make knowledgeable decisions about their care.

While jurisdiction-specific regulations apply, the core elements of informed consent are stable, rooted in autonomy, and handed down through case law:

* an evaluation of patient capacity and a continual assessment of comprehension,

* a description of the procedure, through the process, risks and benefits, as well as its supplemental requirements (i.e., anesthesia, secondary specialty assistance),

* a discussion of procedural alternatives, including no procedure, as well as the availability, risks and benefits of each,

* the patient's express and autonomous consent to proceed made with no obstruction to informed refusal (Buppert, 2012; Lachman, 2009; Quallich, 2004).

These stable elements provide the framework for content customized to the patient's specific clinical picture, intellectual capacity, and cultural acceptance of who is involved in the decision-making process (Lachman, 2009).

Institutions generally utilize a form for the documentation of informed consent: only after the actual exchange in which consent is granted does the patient verify his or her consent with a signature on the institution's form. In addition, it is the patient's prerogative to change his or her mind even after the form has been signed. Thus, the patient's signature is a symbol of the consent given, not the consent itself (Brooke, 2011).

When a form is used, the patient's signature is authenticated by a witness' signature. Witnesses who sign the form attest only to the patient as signatory and are not legally culpable for disclosure breaches or patient comprehension issues. The witness is simply verifying that the patient, him/herself, signed the form (Sharpe, 1999).

REVIEW OF THE LITERATURE

Methodology

A search of the peer-reviewed literature published in the United States was conducted using CINAHL. Date parameters were not defined in the original or refined returns to evaluate any thought evolution of the nurse's role in informed consent. When the Boolean search phrase "informed consent NOT research," filtered for the keyword "consent," was applied to full-text files, 704 results were returned. These 704 results were further filtered for the keyword "nursing role," 36 results remained. Of the remaining, one was excluded because it did not relate to procedural consent, two were eliminated because they are reprints of Quallich (2004), and thirteen were unable to be reviewed because their full-text record were absent from the electronic database.

Findings

The remaining 23 articles shared many common themes. These include: (1) a clear definition 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 specifics, (4) the importance of well-developed institutional policies that include a clear delineation of role responsibilities and expectations of those involved in the process, and (5) the witness' signature is a legal attestation that the patient him/herself is the signatory.

Certain individual themes, however, stood out. Both Peterson (2010) and Sweeny (1991) point out that conveying a form to a patient is not tantamount to obtaining consent once the dialogue between provider and patient is complete. Garvis (2005), Plawecki and Plawecki (2009), Quallich (2004), and Sweeny (1991) all highlight the need for nurses to evaluate capacity and advocate that incapacitated patients have surrogate decision makers. A total of 16 articles highlight the idea that nurses' speciality training in assessment and interdisciplinary communication gives them added value as active participants in the process of informed consent. (Brooke, 2004, 2007, 2011; Cain, 1998; Dunn, 1999; Garvis, 2005; Lea, Spahis, & Williams, 2002; Olsen-Chavarriaga, 2000; Petersen, 2010; Plawecki & Plawecki, 2009; Quallich, 2004; Sullivan, 1998; Sweeney, 1991; Switzer, 1995; Urbanski, 1997; White, 2000). While the aforementioned articles attribute this value to the nurse's ethical obligation, White (2000) and Quallich (2004) plainly tie the nurse's participation in informed consent to the Code of Ethics for Nurses (ANA, 2010 herein "Code").

None of the reviewed articles were research articles. Because these articles largely fit into the category of expert opinion, the highest level of evidence available was Level V (John Hopkins Nursing Evidence-Based Practice Model, 2007).

Limitations

The author admits limitations to the asserted data gap in two ways: 1) database selection (i.e., single database search) and 2) search methodology (i.e., possibly limited keyword selection). However, CINAHL is a comprehensive database of nursing literature. It is likely to be selected by a working nurse in need of quick information amidst the controlled chaos of a procedural area. Also the keyword search is researcher defined and easy to use for those with even rudimentary knowledge of database inquiries. Hence the results yielded may point to limitations in current practice of keyword selection: there may be research, articles that may pertain to the nurse's role in informed consent but are not tagged with keywords that would make it readily accessible for the research consumer.

THE VALUE OF NURSES TO THE PROCESS OF INFORMED CONSENT

An Evolution of Thought

While the legal requirement might compel a nurse to adopt a minimal role in the process, the nurse's drive toward excellence in care and commitment to ethical practice demands more. In 2001, the Code of Ethics for Nurses (ANA, 2010, herein "Code") received a substantial facelift from its 1985 release, including expanded interpretive statements of the ethical imperatives by which nurses are called to practice. Of immediate concern is the explicit language concerning the nurse's role in protecting and championing self-determination in the informed consent process.

In 2001, the Code stressed that nurses must assess the quality and adequacy of the process as well as patient capacity and comprehension: "The nurse preserves, protects, and supports [patient autonomy] by assessing the patient's comprehension of both the information presented and the implications of decisions" (Section 1.4, paragraph 2). It explicitly states nurses are ethically bound to ensure patients have access to thorough and understandable information, an environment free of power structures that would inhibit an autonomous decision, and the resources necessary to remedy any identified knowledge deficits (ANA, 2001, Section 1.4, paragraph 1).

In 1989, Yorker's language choice reflects an earlier, implied understanding, noting: "the nurse should [emphasis added] question whether conditions for informed consent has been actually met" (p. 132). White (2000) later shifts the narrative in accordance with the expanded language that would be released in 2001: "A crucial [emphasis added] aspect of the nurse's role as patient advocate is the obligation to ensure that medical interventions don't proceed unless the patient fully comprehends the details" (p. 83). This new narrative is clear: verifying consent is as much of a compulsory process for nurses as obtaining it is for providers.

Value within Patient Interactions

While providing a witness signature may remain a legal attestation of the patient as signatory, it is perhaps the most suitable time to verify consent with the patient. The occasion provides an inlayed reminder, a hard stop, when preparing a patient for the procedure. Additionally, nurses who have an ongoing relationship with their patients-like those who work in office-based plastic surgical settings-are well suited to serve as both witness and verifier because of the level of assessment they bring to the process.

When patients admit confusion or an aspect of the treatment plan changes, nurses are not responsible for disseminating the information needed to proceed. Instead, the nurse adds value to the process by assuming the responsibility of liaising the patient with the provider, who clarifies the poorly understood material. If capacity is compromised or incapacity is not recognized, the nurse also adds value to the process by advocating for the presence of a surrogate decision maker (Brooke, 2001; Plawecki & Plawecki, 2009). While the provider may perceive advocacy efforts as impediments to the work of treatment, nurses who stand firm in their ethical obligations are invaluable extensions of the quality improvement and risk management teams.

Value within the Healthcare System

When nurses actively participate in the informed consent process, they provide systemic value as well. When empowered thusly by their institution, they help mitigate risk by identifying process errors, ineffective communication patterns, and coercive power structures. Based on their experiences, nurses can provide valuable input about the institutional sensitivity toward patient capacity, identifying patterns in which this vital component may be overlooked. These may be apparent in specialities that involve strong emotions like trauma or oncology and specialties that have higher concentrations of patients with Body Dysmorphic Disorder (BDD) like aesthetic plastic surgery or cosmetic dermatology. Both heightened emotions and BDD have the power to cloud judgement and compromise capacity (Sturmey & Hersen, 2012).

Additionally, nurses guard against systemic paternalism and coercion by ensuring that the patient does not feel intimidated by the surrounding environment, pressured by time constraints, or silenced by underlying social mores. As the nurse evolves from novice to expert, it becomes easier to see the larger context within which each exchange is situated. With time and experience, the nurse learns to recognize early warning signs that the process is failing. Acting early to remedy the situation could save significant time and energy, and economy of both is critical for peak effectiveness and quality care delivery.

CONCLUSION

Articles are readily available that speak to the nurse's theoretical value within the process of informed consent. The ethical underpinnings provided by the Code of Ethics for Nurses (ANA, 2001) carry with them compelling implications: when nurses participate as advocates, the system gains an added level of risk mitigation, patients have strong advocates, and quality care-systems are advanced. However, the articles retrieved lack data to support this postulate.

"Sign here" remains ubiquitous in procedural environments, and the pace of care is not slowing. It is more important than ever that nurses vigilantly develop evidence-based systems that promote quality care. Considering the wide scope of informed consent, both quantitative and qualitative study opportunities abound. And this research will be necessary to develop evidence-based models of procedural care and to demonstrate how nurses best support patient outcomes and mitigate risk within them.

In the age of evidence-based practice and the current Nurses Code of Ethics (2001), the wider value nurses can add to the process of informed consent is that of higher levels of evidence within the professional discourse. Opportunities for quantitative and qualitative studies alike are available in the light of the information presented here. Nurses' patients and their profession alike deserve compelling data on the value of nurses in assessing competency for consent, verifying consent is informed, and liaising patient and provider when necessary. By applying an evidence-based approach to the nurse's role in informed consent, nurses can better improve outcomes and mitigate risk as they hear and say, "Sign here."

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