Position Statement

Informed Consent

The intent of this position statement is to recognize the evolving process of informed consent and the complexity of the legal and moral issues surrounding the role of the professional nurse in the process of healthcare decision making. The position also seeks to clarify the nurse’s role in protecting the legal and moral rights of patients.

Position

It is the position of the New York State Nurses Association that:

  1. Informed consent seeks to establish the rights of the individual through self-determination. Inherent in the employee status of the professional nurse are multiple instances of role conflict that arise through the occasionally conflicting responsibilities to the patient, the family, the agency, care-providing colleagues, society, and to the advancement of knowledge. In instances of role conflict, the patient’s human rights, including the right to autonomous decision making, should assume primacy.
  2. Patients must be as fully involved in planning, implementing and evaluating their personal health care as they are able. If the patient is declared incapacitated, or unable to make decisions about their health care, a designated health care proxy agent should assume the patient’s role in planning, implementing and evaluating care. Refer to the attached Ethical Decision Making Pathway (attached).
  3. Patients (or their designated healthcare proxy agent(s)) have the right to determine what will be done with their person. Each patient or health care proxy agent must be permitted to accept, refuse or terminate treatment without duress.
  4. Each patient or designated health care proxy agent must be given the information necessary for making informed judgments. This information should include, but is not limited to: risks, benefits and alternatives to any proposed test or treatments.
  5. Each patient has a right to freedom from the imposition of another’s beliefs or judgmental attitudes.
  6. The nurse is not responsible for providing the information necessary for informed consent to the patient or health care proxy agent. The nurse’s role is both as a witness and as a patient advocate. First, the nurse as witness acknowledges that the patient has been given the information and is the witness to the patient’s signature on the consent form. Second, as patient advocate, the nurse asks questions of the patient to determine whether the patient has received sufficient information to make an informed decision.
  7. The nurse should keep information received from patients regarding their treatment confidential and should disclose this information only to those directly involved with the patient’s care (ANA, 2001 and Dickey, 2003-2004).

Background

Health care continues to increase in complexity. Each advance in technology and treatment, while bringing with it the promise of greater efficacy in curing, has the potential for more iatrogenic complications and negative outcomes. The ability to understand and make informed decisions regarding health care can become arduous. The Cruzon case that was argued before the Supreme Court raised concerns about who can make healthcare decisions for the incapacitated patient. The Federal Patient Self-Determination Act of 1991 and the New York State Health Care Proxy Act of 1990 were enacted to provide patients with the opportunity to designate an agent to act as their health care proxy in the event that they were no longer capable of making decisions in their own behalf. Patients (or their agents) must often make difficult choices that have significant consequences for their health status.

Informed consent is grounded in both the ethical and legal foundations of nursing practice; the American Nurses Association’s Code for Nurses with Interpretive Statements provides the ethical framework for decision making in nursing (2001). The Code’s guidelines for practice reflect inherent professional nursing beliefs about the nature of individuals, nursing health and society. Although the Code does not specifically address the issue of informed consent, the statements within the Code reinforce a set of values. Recipients and providers of nursing services are viewed as individuals and groups who possess basic rights and responsibilities, and whose values and circumstances command respect and human dignity at all times. Nurses are obligated to know and follow laws, both New York State and federal privacy and confidentiality laws, including the Health Insurance Portability and Accountability Act (HIPAA) (Dickey, 2003-2004).

The need to obtain a patient’s consent before rendering diagnostic testing or treatment has long been recognized by the law. Lack of proper consent except in cases of emergency could lead to charges of battery, even in cases when the care rendered meets standards of practice. There has been universal agreement by the courts that the basis for the requirements of the patient’s consent is the right of the individual to the inviolability of person. Consent may be either verbal or written. NYSNA’s position on informed consent also complies with the Nurse Practice Act, as contained in Article 139 of Title VIII of the Education Law of New York State; and the Rules of the New York State Board of Regents relating to definitions of Unprofessional Conduct (Section 29.1, Regents Rules on Unprofessional Conduct, (b)(1)).

Healthcare ethics, and more specifically nursing ethics, rely on five basic moral principles that have been derived from ethical theories:

The principle of autonomy, which has the most relevance to the issue of informed consent, supports the position that rational individuals should be permitted to be self-determining. Self-determination requires freedom from duress in making choices, the availability of options from which to choose, and the possession of information necessary to make a reasoned decision. Because of the often complex and technical nature involved in making healthcare decisions, concern over providing the patient or health care proxy agent with knowledge adequate to making informed choices becomes critical in maintaining the patient’s autonomy.

Recommendations

The New York State Nurses Association recommends that:

  1. The professional nurse’s role in the process of informed consent includes that of patient advocate: providing health teaching, health counseling and support for the patient in seeking clarification of any information that is not clear.
  2. The professional nurse respects the patient’s decision whether or not the nurse is in agreement with that decision. A nurse may choose not to participate in cases in which the patient’s decision could harm others, would require the nurse to participate in giving care that is inconsistent with the standards of nursing practice or violates the nurse’s conscience. If this occurs, the nurse must then delegate nursing responsibilities to insure continuity of patient care.
  3. The professional nurse should not participate in any test or treatment in which informed consent of the patient or the patient’s health care proxy agent has not been properly obtained as per agency policy.
  4. The professional nurse should initiate appropriate action if the established tenets of informed consent are not duly processed and implemented. This action includes, but is not limited to:
    • consulting with the responsible healthcare practitioner to seek resolution;
    • utilizing an agency’s policies, procedures and channels to assure protection of the patient; and,
    • reporting unresolved informed consent issues to the appropriate professional and/or regulatory bodies.

Approved by the Board of Directors on 6/22/79, 1/20/93. Reviewed/revised by the Councils on Ethical Practice and Human Rights on 8/27/04. Approved by the Board of Directors on 9/15/04.

Note: The use of the term “patient” anywhere in this document is intended to be generic and refers to the recipient of nursing care.

References

American Nurses Association. (2001). Code for nurses with interpretive statements. Washington, DC: Author.

Arnold, R. M., Beauchamp, T. L., Brennan, T. A., Brown, A. P., Faden, R. R., & Katz, J. (1995). Informed consent. In W. T. Reich (Ed.), Encyclopedia of bioethics: Revised edition (Vol. 3, pp. 1232-1270). New York, NY: Simon & Schuster Macmillan.

Byrne, J. A. (1997). Informed Consent. New York, NY: McGraw-Hill.

Cisar, N. S., & Bell, S. K. (1995). Informed consent: An ethical dilemma. Nursing Forum, 30(3), 20-28.

Cushing, M. (1991). Demystifying informed consent. American Journal of Nursing, 91(11), 17-19.

Dickey, S. B. (2003-2004). Nurses should be concerned about the ethical implications of HIPAA regulations (pp. 1-5). Washington, DC: American Nurses Association.

Dunn, D. (1999). Exploring the gray areas of informed consent: Learn why the process calls for more than just dotting "i's" and crossing "t's". Nursing, 29(7), 41-45.

Gould's Consolidated Laws of New York: (2004), Chapter 6 - Civil Rights Law, Article 7 - Miscellaneous rights, Section 79-I - Discrimination against person who refuses to perform certain acts prohibited.

Informed consent. (1994). In T. D. Aiken & J. T. Catalano (Eds.), Legal, ethical and political issues in nursing (pp. 96-117). Philadelphia, PA: F.A. Davis Company.

Lea, D. H., Spahis, J., & Williams, J. K. (2002). Informed Consent: Making sure patients are fully informed is a crucial part of the nurse's role. American Journal of Nursing, 102(7), 41.

National Health Lawyers Association. (1991). The patient self-determination directory and resource guide for those who want to know about autonomous health care decision making. Washington, DC: Author.

New Technology presents new ethical dilemmas. (1995). Advanced Technology in Surgical Care, 13(9), 112-114.

Official Compilation Codes, Rules and Regulations of the State of New York. Title 8 (Vol. A) Education, Part 29 Unprofessional Conduct, Section 29.1 General Provisions.

Official Compilation Codes, Rules and Regulations of the State of New York. Title 10 (Vol. C), Health, Section 405.25 Request for a consent to an anatomical gift.

Official Compilation Codes, Rules and Regulations of the State of New York. Title 10 (Vol. C), Health, Section 405.7, Patients Rights.

Official Compilation Codes, Rules and Regulations of the State of New York. Title 10 (Vol. C) Health, Section 415.3 Residents' rights.

Olsen-Chavarriaga, D. (2000). Obtaining informed consent means more that witnessing a signature. Read this to make sure you're meeting all of your nursing responsibilities. Nursing, 30(5), 60-61.

Smith, G. K. (1990). Legal review: Informed consent - a shift from paternalism to self-determination. Topics in Health Records Management, 11(1), 71-75.

Urbanski, P. K. (1997). Getting the "go ahead". Association of Women's Health, Obstetric and Neonatal Nurses, 1(3), 45-48.

PLEASE NOTE: For copies of the Ethical Decision Making Pathway graphic, contact NYSNA's Education, Practice and Research (EPR) Program.

For more information on nursing practice, contact NYSNA's Education, Practice and Research Program at 518.782.9400, ext. 282 or by e-mail.