Accountability and Nursing Practice

Professional Issues M a r y J. R ock R o b e r ta H o e b e k e

In fo rm ed Consent: W hose D u ty to Inform ?

A lmost all nurses are engaged in elements of informed consent with their patients at some point in their careers. From a legal perspective, however, they may be unaware of w hat is involved in obtaining truly informed consent. Nurses are n o t con­ sistent in their roles in obtaining consent. They assume differing am ounts of responsibility in obtaining consent from their patients, thus exposing themselves to liabili­ ty claims and placing their nursing licenses at risk (Guido, 2010). The history of consent, different types of consent, the duties of the physician and the nurse with regard to informed consent, and ways in which nurses can decrease the risk of liability related to their role in obtaining informed consent will be discussed.

History of Informed Consent An essential and fundamental patient right is the right

to consent to medical treatment. The ethical principle of autonom y protects this fundamental right. This principle provides the foundation for the belief that patients are given the authority to evaluate medical treatm ent choic­ es. Based on the patient's beliefs and values, treatment alternatives can be rejected or embraced (Fry, Veatch, & Taylor, 2011).

Historically, the right to consent was protected through common law decisions. These early court deci­ sions gave some guidance to health care providers about how to comply with the requirements of consent. A sig­ nificant comm on law case that established the right of consent and self-determination was the landmark case Schloendorff v. Society o f New York Hospitals (1914). Justice Cardoza, a highly respected and well-known judge who presided in this case, often is quoted:

Every hum an being of adult years and sound m ind has a right to determine what will 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. This is true, except in cases of emergency where the patient is unconscious, and where it is necessary to operate before consent can be obtained, (p. 93)

The court in Natanson v. Kline (1960) further defined the concept of self-determination as included in Anglo- American law. Each patient is considered to be the master of his or her own body. A patient of sound m ind may pro-

Mary J. Rock, JD, MSN, RN, is Assistant Clinical Professor of Nursing, University of Southern Indiana, Evansville, IN.

Roberta Hoebeke, PhD, FNP-BC, is Professor of Nursing, University of Southern Indiana, Evansville, IN.

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hibit medical treatm ent expressly even if it is lifesaving. Even if the physician believes the medical treatm ent is desirable or lifesaving, American law does not permit him or her to substitute personal judgment for that of the patient.

This comm on law right of consent later was extended and expanded by requiring health care providers to fulfill their duty by providing clear, necessary information vital to the understanding of the procedure to their patients before obtaining consent. A seminal informed consent case, Salgo v. Leland Stanford Jr. University Board o f Trustees (1957), held that a physician had a duty to relate "any facts necessary to form the basis of an intelligent consent by the patient to proposed treatment" (p. 181).

During World War II, the issue of consent was brought to the public's attention during the Nuremberg war crimes trials. The experiments and torture performed by Nazi physicians led to development of the Nuremberg Code, which absolutely required patient consent prior to medical research (National Com m ission for the Protection of Hum an Subjects of Biomedical and Behavioral Research, 1979; Nuremberg Military Tribunals, 1949). Since then, the requirement of consent prior to research has been extended to clinical procedures.

More recently, m any states have enacted patient bill of rights statutes. These laws prohibit treating a patient without first providing necessary information to obtain informed consent. They also are based on common law principles and the premise that patients have the right to make decisions about their own medical care and treat­ m ent (Backlund v. University o f Washington, 1999).

The American Nurses Association (ANA, 2010) em pha­ sized the importance of the com m itm ent to patient self- determination.

Respect for hum an dignity requires the recognition of specific patient rights, particularly, the right of self- determination. Self-determination, also known as autonomy, is the philosophical basis for informed consent in health care. Patients have the moral and legal right to determine what will be done with their own person; to be given accurate, complete, and understandable information in a m anner that facili­ tates an informed judgment; to be assisted with weighing the benefits, burdens, and available options in their treatment, including the choice of no treat­ ment; to accept, refuse, or terminate treatm ent with­ out deceit, undue influence, duress, coercion, or penalty; and to be given necessary support through­ out the decision-making and treatm ent process. Such support would include the opportunity to make deci­ sions with family and significant others and the pro­ vision of advice and support from knowledgeable

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P r o fe s s io n a l Issues

nurses and other health professionals. Patients should be involved in planning their own health care to the extent they are able and choose to participate, (p. 148)

In fact, nurses are obligated to understand their patients' legal and moral rights to self-determination. In the role of advocates, nurses are positioned uniquely to assess the patient's understanding of the information pre­ sented by physicians regarding procedures and the impli­ cations of decisions.

Types o f C o n sen t Consent generally is expressed or implied. Express con­

sent can be an oral declaration of consent or it can be pro­ vided by printed words in a written consent form (usual­ ly called informed consent). General consent forms are signed upon admission to a health care facility. Implied consent can be provided by patient conduct rather than verbally or in writing. W hen a nurse asks a patient to extend an arm for blood pressure measurement, the nurse infers the patient has given consent. Implied consent fre­ quently is given for routine care and minor procedures. In addition, implied consent is inferred in emergency situa­ tions. If a patient is not able to communicate consent prior to an emergency treatm ent and the delay will result in loss of life or threatened well-being, the health care provider may proceed with care (Guido, 2010).

In health care, informed consent usually is provided by the patient in a formal, written consent form. Informed consent is a person's agreement to allow some­ thing to happen, such as surgery or other invasive proce­ dure, based on a full disclosure of risks, benefits, alterna­ tives, and consequences of refusal. Unless a patient knows the risks and dangers of a medical procedure before con­ sent, the decision to have the procedure performed does not represent truly informed consent and is ineffectual (State v. Presidential Women's Center, 2006).

Courts have supported the physician's duty to disclose based on the fiduciary quality of the physician-patient relationship. A fiduciary relationship is a unique relation­ ship in which the law imposes specific liabilities and duties. A fiduciary duty includes a duty to act for some­ one else's benefit, while subordinating personal interests to the interests of the other person. It is the highest stan­ dard of duty implied by law (Garner, 2009). In the case of health care relationships, the patient is untrained in med­ ical science and consequently depends completely on the education, training, skill, and experience of the physician to provide information the patient can use to make an informed decision (Johnson v. Sears, Roebuck & Co., 1992). Patients trust in their physicians' knowledge, skill, and clinical experience when making choices about treatment options.

If proper informed consent is not obtained, the patient may recover damages in an action against the physician under different theories of recovery. The performance of surgery or treatm ent by a physician without first obtain­ ing informed consent may constitute the intentional tort of assault and battery. This claim is completely separate

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from a claim based on the skill and care employed during the surgery or medical treatm ent (Blanchard v. Kellum, 1998). Likewise, battery may be established if a physician obtains consent to perform one type of treatm ent and then performs a substantially different treatment (Cline v. Lund, 1973).

Another theory of recovery for lack of proper consent is negligent failure to disclose. The doctrine of informed consent focuses on the reasonableness of the physician's disclosures to the patient (Johnson by Adler v. Kokemoor, 1996). It is based on the information communicated by the physician to the patient before the surgery or treat­ ment. A final theory for recovery used in some jurisdic­ tions to recover for inadequate consent would be a claim for professional m isconduct or malpractice (Hill v. Women's Medical Center o f Nebraska, 1998).

D u ty o f Physician The physician has an ethical duty to ensure the patient

is involved in decisions about his or her health care. The physician who gives the treatm ent or performs surgery has the duty to inform the patient about the procedure and obtain the consent (Bryant v. HCA Health Services o f Tenn., 2000). The process of securing informed consent involves patient education by the physician. The physi­ cian explains the procedure, possible risks, and alterna­ tive therapies in words the patient can understand. The physician then should evaluate the patient's understand­ ing, if the patient accepts the risk of the treatment, and if the patient has given consent to proceed with the proce­ dure or treatm ent with full knowledge. The patient then is required to sign the consent form. A physician may appoint another member of the health care team to obtain the patient's signature on the consent form with the reassurance the physician has explained the proce­ dure fully. A physician may be liable for lack of informed consent if he or she abandons the patient by improperly delegating to others the professional task and responsibil­ ity of securing informed consent ( Veith v. O'Brien, 2007).

Generally, the doctrine of informed consent requires the physician to explain the nature and probable conse­ quences of a recommended surgery, the material risks associated with the surgery, and the alternatives to the rec­ ommended procedure. Common law and statutes require slightly different disclosures depending upon the law in each state. For instance, the state of Indiana requires infor­ mation regarding informed consent to include the follow­ ing (Indiana Code 34-18-12-3; Lasley v. Moss, 2007): 1. The general nature of the patient's condition. 2. The proposed treatment, procedure, examination, or

test. 3. The expected outcome of the treatment, procedure,

examination, or test. 4. The material risks of the treatment, procedure, exam­

ination, or test. 5. The reasonable alternatives to the treatment, proce­

dure, examination, or test. In some jurisdictions, a physician's duty to disclose

information for consent is measured from the patient's

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Informed Consent: Whose Duty to Inform?

point of view; in other jurisdictions, the duty is measured from the physician's point of view. Still other jurisdictions require both the physician's and the patient's perspective. If the patient's viewpoint is used to determine what infor­ m ation should be disclosed prior to informed consent, the standard is based on the data or information required by a reasonable patient to make an intelligent decision con­ cerning performance of a particular procedure (Brown v. Dibbell, 1999). As measured by the physician standard, the duty to disclose information before informed consent is obtained reflects a professional medical standard. Courts would identify what a reasonable, pm dent physician would disclose under the same or similar circumstances, or what the customary disclosure practices of physicians are in a similar community (Weber v. McCoy, 1997).

D u ty o f Nurse Although a physician may appoint a nurse to obtain

the patient's signature on the consent form, he or she may not delegate the professional task of educating the patient about the risks and benefits of the proposed sur­ gery, available alternatives to surgery, and the expected outcome. A physician or other independent practitioner performing the surgery alone has the legal duty to obtain informed consent (Davis v. Hoffman, 1997). After review­ ing court cases across the United States, the Supreme Court of Nebraska concluded a hospital and nursing staff do not have the legal responsibility to inform the patient about the risks of surgery. Liability for not getting appro­ priate informed consent lies with the physician (Giese v. Stice, 1997).

Accurately informing the patient about the particulars of a surgery or procedure is clearly in the realm of the physician's education and expertise. Even though sea­ soned perioperative nurses may know the requisite risks and benefits of a particular surgery, relaying the details of surgery could result in conflicting information and, at the very least, interfere with the physician-patient relation­ ship (Giese v. Stice, 1997). Nurses can create accountabili­ ty for informed consent through their actions (Guido, 2010; Rogers v. T.f. Samson Community Hospital, 2002). A nurse who decides to explain the minutiae of a particular surgery, complications, and available alternatives to the surgery, exposes himself or herself and the hospital to potential liability. A nurse can be held liable for profes­ sional negligence if a patient is harmed because a nurse's explanation to a patient falls short of properly informing the patient of the risks and benefits of the contemplated procedure or the nurse's conduct invades the physician- patient relationship (Davis v. Hoffman, 1997).

Although a physician may try to delegate informed consent to a nurse, he or she does so at the risk of liabili­ ty. The nurse needs to understand his or her role in obtaining informed consent is limited to the patient advocate role and a witness to the patient's signature. After the details of the surgery are explained adequately to the patient and the patient signs the informed consent form, the nurse simply witnesses that (a) the patient is giving consent voluntarily, (b) the patients appear lucid

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and competent to give consent, and (c) the patient's sig­ nature is authentic (Guido, 2010).

If the nurse has reason to believe the patient either is not lucid or is not informed appropriately about the pro­ cedure, the nurse should never proceed with witnessing the patient's signature. The patient's concerns should be documented in the medical record, and the physician (and perhaps the immediate supervisor) notified that informed consent may be deficient. The nurse has a legal duty to investigate the situation and notify the primary provider of concerns about informed consent prior to sur­ gery (Guido, 2010).

Conclusion In the past, the process of obtaining informed consent

was a somewhat automatic, habitual procedure. The physician handed the nurse the form and told the nurse to get it signed prior to the procedure. Patients sponta­ neously signed forms, all too often without asking vital questions. Fortunately, this procedure has changed. Patients often ask critical questions about proposed treat­ m ent or procedure options. Furthermore, nurses must be knowledgeable about the legal and moral rights of their patients to self-determination. Nurses are patient advo­ cates who should protect and preserve their patient's interests by assessing the patient's understanding of pre­ sented information and the implications of treatment decisions (ANA, 2010). ESEH

REFERENCES American Nurses Association (ANA). (2010). Guide to the code of

ethics for nurses. Silver Spring, MD: Author. Backlund v. University of Washington, 975 P.2d 950 (Wash. 1999). Blanchard v. Kellum, 975 S.W.2d 522 (Tenn. 1998). Brown v. Dibbell, 595 N.W.2d 358 (Wis. 1999). Bryant v. HCA Health Services of Tenn., 15 S.W.3d 804 (Tenn. 2000). Cline v. Lund, 31 Cal.App.3d 755, 107 Cal.Rptr. 629 (1st Dist. 1973). Davis v. Hoffman, 972 F.Supp. 308 (E.D. Pa. 1997). Fry, S., Veatch, R., & Taylor, C. (2011). Case studies in nursing ethics

(4th ed.). Sudbury, MA: Jones & Bartlett Learning. Garner, B.A. (Ed.). (2009). Black's law dictionary (9th ed.). St. Paul,

MN: West. Giese v. Stice, 567 N.W.2d 156 (Neb. 1997). Guido, G. (2010). Legal & ethical issues in nursing (5th ed.). Upper

Saddle River, NJ: Pearson. Hill v. Women’s Medical Center of Nebraska, 580 N.W.2d 102

(Neb.1998). Indiana Code § 34-18-12-3 (West). Johnson v. Sears, Roebuck & Co., 832 P.2d 797 (N.M. App. 1992). Johnson by Adler v. Kokemoor, 545 N.W.2d 495 (Wis. 1996). Lasley v. Moss, 500 F.3d. 586 (7th Cir. 2007). Natanson v. Kline, 350 P.2d 1093 (Kan. 1960). National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research. (1979). Belmont report: Ethical principles and guidelines for the protection o f human subjects o f research. Retrieved from http://www.fda.gov/ ohrm s/dockets/ac/05/briefing/20054178b_09_02_Belm ont% 20Report.pdf

Nuremberg Military Tribunals. (1949). The Nuremberg code. In Trials of war criminals before the Nuremberg military tribunals under control council law no. 10 (vol. 2, pp. 181-182). Washington, DC: U.S. Government Printing Office. Retrieved from http://www. hhs.gov/ohrp/archive/nurember.html

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Professional Issues continued from page 191

Rogers v. T.J. Samson Community Hospital, 276 F.3d 228 (6th Cir. 2002).

Salgo v. Leland Stanford Jr. University Board of Trustees, 317 R2d 170 (Calif. Ct. App. 1957).

Schloendorff v. Society of New York Hospitals, 211 N.Y. 125, 105 N.E. 92 (1914).

State v. Presidential Women’s Center, 937 So.2d 114 (Fla. 2006). Veith v. O’Brien, 739 N.W.2d 15 (S.D. 2007). Weber v. McCoy, 950 P.2d 548 (Wyo. 1997).

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