INFORMED CONSENT: BEYOND LEGALITIES

Authors

  • Mary-Scovill Elder C.N.M., M.S. Associate Editor


Informed consent is and has been an implicit and explicit part of nurse-midwifery practice. Providing clients with information about all areas of the reproductive continuum so they can make responsible choices is part of the traditions of midwifery. However, a recent New York State law,1 proposed amendment to the law,2 and court decision cogently demonstrate the urgency for the American College of Nurse-Midwives (ACNM) and its individual members to give intense thought to the multifaceted issues of informed consent. Although mechanisms to deal with the issues already exist through ACNM's diverse committees and divisions, plans of action must be developed to deal with the educational, clinical practice, legislative, publication, research, interorganizational, publicity, public relations, and economic aspects of the issues. This editorial will focus on some general ideas, centrally and peripherally related to informed consent, which are crucial for nurse-midwives (CNMs) to consider.

According to Department of Health, Education, and Welfare (DHEW) guidelines informed consent is defined as:

… the knowing consent of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.3

Is informed consent a misnomer? Many ethicists, nurses and physicians think so. Benjamin Freedman states that “… ‘fully informed consent’ is a goal which we can never achieve, but toward which we must strive.”4 Emphasis is placed on the ritual of giving enough information to supposedly avoid the basis for a malpractice suit. Concerns with how much the consumer understands, needs or wants to know are often relegated to second place. What the health provider wants to tell, what she/he thinks the consumer needs and wants to know takes precedence.

Practitioners must distinguish between consent, informed consent, and its documentation. Consent is ineffective as a legal defense unless the client fully understands what she/he is consenting to. It is commonly and erroneously assumed that a client's signature on a consent form satisfies the legal requirements for full disclosure.

Ironically, fewer neglience suits are instigated and settled solely on the lack of informed consent than on other types of claims. However, this fact will change in view of a recent precedent setting cause of action decision rendered by the New York State Court of Appeals. The Court ruled by majority opinion that an obstetrician who fails to offer a pregnant woman genetic counseling “… can be held financially liable for the lifelong care of a child born with an inherited disorder that could have been predicted.”5 The Court did not recognize recovery for parental “mental anguish” or the “wrongful causation of life” on the child's behalf as causes of action. The Court's decision has ominous yet exciting implications for nurse-midwifery practice in terms of responsibilities and opportunities.

As litigations based on insufficient disclosure increase so will defensive clinical practices and discussions. If one were to ask clinicians and consumers to ennumerate the positives and negatives of informed consent, the answers most likely would reveal a tremendous disparity in opinion. Clinicians probably would preface their answers with a statement that although they agree in principle with informed consent, the awesome realities of implementation present enormous difficulties. Consumers would probably stress the positives and either deemphasize or not be aware of any disadvantages to themselves or the nurse-midwife and physician. This conceptual imbalance will only intensify the clinician's defensiveness and the consumer's dissatisfaction. Can a balance be achieved?

Perhaps a starter would be to examine how we think about informed consent. Is it enough to just meet the legal requirements? Do we think in systems terms? By using a systems approach one is concerned with how the issues and ramifications of informed consent are interconnected not only with the immediate setting but also with other parts of, e.g., the client's life, family, formal/informal social networks and structures, and the institutions of the culture such as educational, economic, and political systems.

Does informed consent generate additional responsibilities to the client, family, and society? How far beyond the legal requirements to inform are CNMs responsible to their clients and others? For example, is it sufficient to advise pregnant women of the potentially deleterious effects of alcohol consumption on the fetus? Or does the CNM have extended responsibilities to collaborate with consumers to organize and participate in lobbying groups to pressure the Bureau of Alcohol, Tobacco, and Firearms (BATF) to implement required labeling on alcoholic beverages and leaflets warning women of the hazards of the substance on the fetus and urging pregnant women not to drink; to serve as witnesses on BATF public hearing panels; to participate in BATF public education campaigns?

Will an expanded consideration of and involvement in the extensions of informed consent intensify or diminish defensive thinking? Is expanded involvement economically feasible for the CNM? As new information accumulates about topics discussed before and after the consent form was signed, what are the CNM's responsibilities to update clients, especially as new information may alter earlier decisions? How can CNMs keep abreast of new developments to satisfy legal, ethical, and extended professional responsibilities of informing?

Irrespective of one's opinions about the issues raised thus far, there are pragmatic aspects of informed consent which nurse-midwives who are involved in clinical practice and research activities can not afford to ignore. The most essential item to consider is: What information should be given to the client?

The DHEW guidelines, previously referred to, are comparatively well-developed and detail the minimum basic elements of information necessary to informed consent:

… (1) A fair explanation of the procedures to be followed, and their purposes, including identification of any procedures which are experimental;

(2) A description of any attendant discomforts and risks reasonably to be expected;

(3) A description of any benefits reasonably to be expected;

(4) A disclosure of any appropriate alternative procedures that might be advantageous for the subject;

(5) An offer to answer any inquiries concerning the procedures;

(6) An instruction that the person is free to withdraw his consent and to discontinue participation in the project or activity at any time without prejudice to the subject; and

(7) With respect to biomedical or behavioral research which may result in physical injury, an explanation as to whether compensation and medical treatment is available if physical injury occurs and, if so, what it consists of or where further information may be obtained….6

Although the guidelines apply primarily to subjects in biomedical or behavioral research and are procedurally oriented, CNMs can easily incorporate the components into their clinical discussions.

Referring to items 1, 3, and 4 above: What is a “fair” explanation? How are intangible “benefits” determined and evaluated? What are “appropriate” alternatives? Should a statement requiring assessment of the client's understanding of the information be added? How does the communication process, including factors such as, e.g., the state of relatedness between the CNM and client, the client's physical and mental condition, the environment, influence the content of the discussions and the client's comprehension of material?

How is informed consent obtained? Is documentation of informed consent necessary? If so, what procedures are used to document? With the legal mandates for information disclosure, should consent forms include the specific content discussed? Are there exceptions to full disclosure? Are there instances when consent is implied? Does informed consent impose constraints on clinical practice and research? Should guidelines be developed which encompass the rights of the researcher and clinician? What are the implications of requiring that informed consent be obtained from parents or guardians of adolescents who want abortion or contraceptive services? What should CNMs do if they think colleagues have not adequately informed clients? What are the responsibilities of the clients before, during, and after the informing process? Just as the International Childbirth Education Association has developed statements7 on the rights and responsibilities of the pregnant woman, should a similar document be developed for the expectant and new father?

An especially perplexing problem is how and when to obtain consent from the father of a fetus/infant in instances where the mother is the focus of the research and the fetus may incidentally be involved or when the in/ex utero, viable/nonviable fetus is the focus.

DHEW guidelines state that pregnant women can be involved in research only if:

… (1) The purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or (2) the risk to the fetus is minimal.8

An activity may be conducted only if:

… the mother and father are legally competent and have given their informed consent after having been fully informed regarding possible impact on the fetus, except that the father's informed consent need not be secured if: (1) The purpose of the activity is to meet the health needs of the mother; (2) his identity or whereabouts cannot reasonably be ascertained; (3) he is not reasonably available; or (4) the pregnancy resulted from rape.9

Similar parental consent directives apply to the fetus as central research subject. Granted there are significant loopholes disallowing the necessity of obtaining informed consent from the father. However, these guidelines are one of the few that mandate the inclusion of the father in some capacity.

For a variety of reasons, nurse-midwives have been somewhat remiss in documenting the components of the informing process, including clients' understanding of and reaction to information. Why document this inherent part of nurse-midwifery practice? What are the consequences of not documenting? Could the costs of increased documentation outweigh its benefits to the CNM and client?

Few nurse-midwives will disagree that detailed documentation is necessary, but many will argue that if documentation is to be meaningful it will add more time to client management, thereby decreasing the number of clients cared for per hour. This could be a problem in settings where quantity of client contacts are a measure of CNMs' economic feasibility. Perhaps concurrently audiotaping and later dictating notes on the discussion are partial answers. But the time to transcribe, confidentiality, storage of, and access to the tapes generate new problems.

How relevant is written documentation for nurse-midwifery practice? The question deserves elaboration. Meaningful documentation not only is a potential legal safeguard but also can be used for a variety of other purposes: (1) to indicate that clients have been given information to enable them “… to make appropriate decisions and to assume appropriate responsibility for their own health”10 —a core competency in nurse-midwifery education; (2) to illustrate the CNM's expertise and broad range of functions and responsibilities—one way of demonstrating her economic feasibility to society, national health insurance proponents, and third party reimbursers; (3) to provide a data base for historical and research purposes; (4) to develop a master teaching—learning plan with the client as an active participant; (5) to provide data for auditing and peer review activities; (6) as part of the problem-oriented health record for nurse-midwifery management; and (7) as a more complete record for consumers who want to see their chart to correct or add information.

There are additional questions that the American College of Nurse-Midwives must consider in relation to informed consent: Should the ACNM develop a code of nurse-midwifery ethics and ethical guidelines for the conduct of research and clinical practice? Does the ACNM need a committee on Scientific and Professional Ethics? How do various professional, governmental and international codes of ethics and guidelines, e.g., The Nuremburg Code, the World Medical Association's Declaration of Helsinki and International Code of Medical Ethics, influence nurse-midwives' thinking, opinions, discussions and actions, especially regarding clients' rights? Are the ACNM's grievance procedures adequate to handle infractions of ethical codes? Should ethical concepts and issues be incorporated into the nurse-midwifery curriculum? What are the implications of informed consent for nurse-midwifery education? Should the Journal of Nurse-Midwifery develop editorial policies for use when the ethics of research are called into question, e.g., uninformed consent? As consumers demand more information about alternatives to the illness-oriented approach to pregnancy and birth, how can they secure this information? How can consumers find out about CNMs and nurse-midwifery services? Should the ACNM develop a policy statement on the advertising of CNMs' qualifications, functions, fees, and affliations and nurse-midwifery services? How can consumers most effectively and efficiently let CNMs know what they want and need to be informed about? Do adequate communicational and participatory channels exist for consumers in the ACNM? Should there be consumer representation on the ACNM Board of Directors and committees? Should consumers and CNMs be represented on the ethical review boards and human subject protection committees of professional associations, institutions, and local, state, and federal governments? The complexities and extensions of the issues and questions generated by informed consent are unlimited.

The issues and ramifications of informed consent pervade the lay and scientific literature and influence the medical litigation pursuits of lawyers, the demands of consumers, the deliberations on ethics of institutional research review boards and the legal liability concerns of medical and nurse-midwifery practitioners. It is a truism that informed consent exists more for the protection of the clinician than the benefit of the consumer. Is it not time for nurse-midwives to develop a broader and more balanced perspective of informed consent?

Footnotes

  • 1

    Section 2503 of New York State Public Health Law, Chapter 484C, Effective September 1, 1978:Drug information to be furnished expectant mothers. The physician or nurse-midwife to be in attendance at the birth of a child shall inform the expectant mother, in advance of the birth, of the drugs that such physician or nurse-midwife expects to employ during pregnancy and of the obstetrical and other drugs that such physician or nurse-midwife expects to employ at birth and of the possible effects of such drugs on the child and mother.Editor's note: The law was instigated by consumers and in an initial version did not mention the nurse-midwife only the physician. Through organized efforts by New York State nurse-midwives, CNMs were included in the final version.

  • 2

    New York State Senate Bill 3045, Section 2503-a. Proposed amendment to Section 2503 of New York State Public Health Law:Information to be furnished to an expectant mother. A physician attending a pregnant woman during the puerperium or a physician to be in attendance at the birth of a child shall discuss with the expectant mother the methods or procedures they expect to use, during such attendance, including but not limited to, the methods of preparation, position of mother during labor and birth, induction or augmentation of labor, surgical methods of delivery, crowning or episiotomy techniques, techniques for initiating normal breathing, cord clamping protocol, delivery of the placenta, bonding experience, weighing and measuring protocol, separation of mother and infant, rooming-in options and feeding methods and schedules, and the possible effects, if any, on the child and mother. The required transmittal of the above information to the expectant mother shall have no application to or be construed to affect or prevent the furnishing of medical assistance in an emergency. Nothing in this section or in section twenty-five hundred three of this article shall be construed to create a cause of action for lack of informed consent in any instance in which such cause of action would be limited by section twenty-eight hundred five-d of this chapter.Editors note: The bill was introduced into the New York State Senate on February 28, 1979 and referred to the Senate's Committee on Health. As of April 1979, the bill remained in Committee.

  • 3

    Department of Health, Education, and Welfare. Code of Federal Regulations 45 CFR 46-Protection of Human Subjects, Subpart A, Section 46.103(c), November 16, 1978, p. 4

  • 4

    Freedman, B A Moral theory of informed consent. Hastings Center Report, 5(August, 1975):33

  • 5

    Physicians sued for failing to give genetic counseling. Science, 203(January 19, 1979): 251

  • 6

    Department of Health, Education, and Welfare. Code of Federal Regulations 45 CFR 46-Protection of Human Subjects, Subpart A, Section 46.103(c), November 16, 1978, p.4

  • 7

    “The Pregnant Patient's Bill of Rights,” Prepared by Doris Haire, Chairperson, ICEA Committee on Health Law and Regulation, “The Pregnant Patient's Responsibilities,” Prepared by ICEA Members. Rochester, New York: International Childbirth Education Association, Inc.

  • 8

    Department of Health, Education, and Welfare. Code of Federal Regulations 45 CFR 46-Protection of Human Subjects, Subpart B, Section 46.207(a), November 16, 1978, p. 13

  • 9

    Department of Health, Education, and Welfare. Code of Federal Regulations 45 CFR 46-Protection of Human Subjects, Subpart B, Section 46.207(b), November 16, 1978, p. 13

  • 10

    Core Competencies in Nurse-Midwifery: Expected Outcomes of Nurse-Midwifery Education, American College of Nurse-Midwives, 1978, p.2

ICEA Conferences

“Freedom of Choice Through Knowledge of Alternatives” is the motto of the International Childbirth Education Association. Five conferences were scheduled for 1979; these sought to incorporate the needs, ideas, and interests of its members in the areas of childbirth and nurturing. The following conferences have yet to take place.

Tomorrow's Child—Today's Concern (August 16–18, Dearborn, Michigan).

For information write: Dawn Carver-Saverino, 15318 Mack Avenue, Grosse Point, MI 48224.

The Developing Decade—A Legacy to Our Children (August 27–31, Colorado Springs, Colorado).

For information write: Cheryl Massaro or Carol Sutherland, P.O. Box 7996, Colorado Springs, CO 80933.

For additional information about the International Childbirth Association, write: ICEA, P.O. Box 20852, Milwaukee, WI 53220.

Ancillary