The clinical nurse's role in informed consent

The Clinical Nurse's Role in Informed Consent ANNE

J. DAVIS, RN,

PHD,

Semistructured interviews were obtained with 27 master's-prepared nurses to investigate the nurse's role in informed consent. Four treatment vignettes and four research vignettes were used to clarify elements of informed consent that respondents thought were necessary for consent to be informed and the roles that nurses assumed in obtaining consent from patients. Respondents viewed that informed consent was a process that occurs over time and that the consent was more informed when patients had prior preparation. Five roles were identified in which nurses have a s s u m e d active i n v o l v e m e n t : 1) watchdog to monitor informed consent situations, 2) advocate to mediate on behalf of patients, 3) resource person to provide information on alternatives, 4) coordinator to preserve an open, friendly atmosphere for discussion, and 5) facilitator to clarify differences between involved parties. (Index words: Informed consent; Ethical issues, in informed consent; Patient autonomy; Doctor-patient relationship; Nurse-patient relationship.) J Prof Nurs 4:88-91, 1988. © 1988 by W.B. Saunders Company. DESCRIPTIVESTUDY, based on semistructured interviews with 27 master's-prepared nurses, investigated the nurse's role in informed consent. Little is known about this role because the bioethics literature focuses on the physician-researcher and patient-human subject interaction and ethical obligation and rights. The President's Commission on the Protection of H u m a n Subjects in Biomedical and Social Science Research, with a group of nurse consultants, raised questions regarding whether nurses were in any way involved in informed consent, and if so, how. These questions and the inadequate answers available at that time led to this study. Two positions about the function and justification of informed consent have been present in the legal and ethics literature. One position is that informed THIS

* Professor, Department of Mental Health, Community, and Administrative Nursing, University of California-San Francisco School of Nursing, San Francisco, California. Barbara Cobb, DNS student, and Irma Zuckerman, PhD student, were supported on this study by funds from the Academic Senate Research Committee. Address correspondence and reprint requests to Dr. Davis:" University of California-San Francisco, School of Nursing, San Francisco, CA 94143-0608. © 1988 by W.B. Saunders Company. 8755-7223/88 $0.00 + .25 88

DSc

(HON),

FAAN*

consent serves to protect persons from various risks of harm. T h e other position uses respect for the autonomy of patients by recognizing their rights to know and choose. In this research, the second posit i o n - i n f o r m e d consent protects and promotes individual a u t o n o m y - - w a s taken as the primary function. These findings point to the need for more systematic data on the role that nurses play in this most central m e c h a n i s m developed to protect patients when they are asked to consent to treatment and research. This research limits its focus to the clinical nurse's rote in those instances where o t h e r s , s u c h as physicians and researchers, o b t a i n e d informed consent. It does not deal with the issue of obtaining consent for nursing procedures and care, which also needs examination. This article does two things. It outlines the elem e n t s o f informed consent that the respondents thought were necessary for consent to be informed and the roles that they have assumed in obtaining inf o r m e d c o n s e n t f r o m patients. T h i s c o n v e n i e n t sample of nurses worked in two settings: A large medical center and a city hospital, both of which serve as a clinical, teaching, and research facility. Seventeen of the 27 had worked as nurses in these settings for five or more years. Staff nurses constituted approximately one half of those interviewed, and the others were head nurses and clinical specialists. Methods Vignettes have been used by social scientists and nurse researchers to measure broad concepts, such as attitudes, beliefs, values, and perceptions, l Although the vignettes used here are hypothetical, they are composites of actual cases and have been evaluated for validity. SpecA4ically for this study, four treatment vignettes and four research vignettes were used. For each treatm e n t vignette, it was assumed that the treatment would have potential benefit to the patient. The research vignettes were similar to the treatment ones in the ethical issues raised, with the addition that the procedure was not necessarily beneficial to the patient.

Journal of ProfessionalNursing, Vol 4, No 2 (March-April), 1988: pp 88-91

THE NURSE'S ROLE IN INFORMED CONSENT

Among the treatment vignettes, Vignette I concerns a nurse who, while talking with a patient, realizes that the patient does not understand the treatment procedure about to be undertaken and the possible risk, although this patient has signed the form. Vignette 2 concerns a patient with a poor prognosis who is refusing treatment. The physician asks the nurse to use her well-established relationship with the patient.to get the patient to change her mind and consent. A five-year-old girl with osteosarcoma is the patient in Vignette 3. The physician has told her parents 1) that her leg should be amputated, followed by chemotherapy and radiation, and 2) that there wiIl be side effects and about a 15 per cent chance of survival. The child does not want anything else done. The parents ask the nurse caring for the child if she thinks they should consent to the treatment. Vignette 4 describes an 18-year-old woman with brain cancer who refuses all treatment. Her parents want her to receive all possible treatment. The physician is torn between the pattent and the parents because he thinks he can prolong the patient's life for about one year but is unsure as t o h e r mental status. The parents turn to the nurse caring for their daughter and ask for help in obtaining consent from their daughter. The four research vignettes are similar to the treatment vignettes, except the treatment is experimental and therefore there may be more clinical uncertainty and less or no benefit to the patient. Each respondent selected an alternative action ranging from 1) do nothing to 2) actively participate. The latter category was subdivided into options appropriate to the vignette, and each option meant more direct involvement. Once a choice was made, comments about the ethical dilemmas and possible ethical behavior were obtained through a semistructured interview.

Elements of Informed Consent All of the nurses interviewed viewed informed consent as a process that occurs over some period of time." Ideally, this process has logical stages that can be identified and evaluated. Although this ideal situation is not necessarily the norm, from their experiences with informed consent for treatment and research purposes, the nurses said that the ethical elements of it were best upheld under the conditions of informed consent as a process. Essentially, the respondents viewed the responsibility of the physiciah and/or researcher to provide technical information, tile range of options available

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and possible, and the requisite time for reflection. The nurse often became involved almost immediately after the first interaction focused on obtaining informed consent. If the physician had given the patient the needed information prior to hospital admission, the nurse still became involved fairly early and usually did so when the intern or medical student did an intake interview to gather clinical data. Such an interview between patient and medical staff often led to the patient and nurse discussing what treatment the patient would receive. So, in both instances of giving technical information prior to and during hospitalization, nurses became involved in the informed consent process early in treatment decisions. When the nurse became involved in consent for research was less predictable because such involvement depended on the timing of the patient's participation in research and this varied greatly. Nevertheless, although this latter involvement was less patterned, these nurses said that they had been as involved and as often involved in research consent as in treatment consent. Importantly, the respondents said that, on the basis of their experience, consent was more informed when the patient had received prior preparation for consent. This prior preparation needed to include clear c o m m u n i c a t i o n in understandable language about the procedures that the patients would undergo and an open discussion about the degree of control the patients could exercise and the choices that they could make. These nurses indicated that most acutely ill patients did not have much idea of their rights, whereas patients who had a chronic illness and had been previously hospitalized were more likely to have developed some understanding in this regard. Occasionally, patients conveyed that they received double messages; that is, they were overtly told that they had options and the right to choose, but they received the covert message that the physician preferred one of these options and the patient should select that option. For example, one patient told the nurse that the p~ysician had outlined her options for breast cancer treatment and told her she had a choice to make and at the same time had indicated which option she should select. The patient said she seemed to have a choice as'~ong as it was the one the physician would choose. Nussbaum's dissertation 2 addresses the ethical problems of the double message received by patients in drug trials. If patients did, i n fact, have rights in their role ,as patients, understood this, and perceived the d o c t o r - p a t i e n t reIationship as coIIaborative, then this double message could be discussed

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and worked through. These respondents understood that rights such as consent are greatly hindered or supported by the social context in which they occur. The consent form itself presented problems that often led to the patient's discussing the situation with the nurse. In these situations, the patient initiated the discussion, focused on the meaning of the words, and wanted a more detailed description of the procedures" being proposed. A concern voiced by most patients was whether they would feel pain, and if so, how much and for how long. If the pain were more likely to be prolonged, they wanted some assurance that this would be managed medically. The major problems that these nurses experienced with the consent forms themselves were 1) words used were too complex although not necessarily technical, and 2) not enough description was given, especially of painful procedures. Another problem, and one that compounded the just-noted problem, was the timing. In their own active involvement in informed consent, these respondents took into account the stress level of the patient, the urgency of treatment, and the sequence of concurrent events. At times, they had encouraged those seeking consent to do likewise and had suggested that seeking consent be postponed based on their assessment of the patient. One way they dealt with these problems was to include the patient's significant others in the informed consent process. The others may be a family member(s), friend(s), or a hospital staff person provided that a relationship defined by the patient as meaningful to him or her existed. Another activity, and one which goes a long way in dealing with the spirit of informed consent as a process grounded in the ethical principle of autonomy, was to have several discussions with the patient and, if possible, the significant other(s). These on-going discussions were not always possible because of the urgency and timing of the treatment; however, even in those instances when such discussions could occur, they rarely did because clinicians and researchers defined informed consen't as a one-time encounter. W i t h this as the norm, opportunities to give the information in different terms and styles of presentation were lost. Nurses acted to reinforce, repeat, and deal with patients' questions that arose as they entered different stages of involvement in treatment*or research protocols. These functions the respondents viewed as central to the informed consent process. In some research situations, the nurses' lack of information regarding the protocol hampered them in carrying out these functions.

ANNE J. DAVIS

Another major problem in consent was lack of assessment regarding the patient's comprehension of the information given. Many people obtaining consent evidence little knowledge of communication as a process and the importance of establishing and maintaining feedback channels. Therefore, from their observations, these nurses said that assessment of patient comprehension was usually superficial and perfunctory. Therefore, they believed that a witness needed to be present to ascertain what actually went on in the consent interaction. Indeed, most of these nurses preferred to act as a witness because it made their later involvement in making consent informed easier. There was seldom an opportunity specifically provided for the patient to re-evaluate the decision that had been made earlier. Practical considerations were a realistic factor here, but also the idea that consent, once given, does not need to be further discussed came into play as well. On-going discussions, assessment of comprehension, and re-evaluation of the initial agreement take time and some interpersonal skill. Time was, or was viewed as being, in short supply by those seeking consent, and the extent to which the interpersonal skills were lacking made informed consent as a process more difficult and less likely to be successful (that is, to achieve its intended goal). Even for those health professionals who understood the ethical and legal underpinning of informed consent, such an achievement was difficult and, at times, impossible. But, in the final analysis, these respondents said that their observations of informed consent situations indicated that most of those obtaining consent did not view it as a process but as a single encounter. This, more than all of the other factors, they believed, created the need for their active involvement in making consent informed.

Forms of Active Involvement These nurses perceived themselves as having a more complex, less biased view of the informed consent situation than many physicians and researchers. This perception led them to identify five roles they assumfa:t as forms of active involvement. 1. Watchdog. This role functioned to monitor informed consent situations. Nurses often accompanied the patient to witness the consent. They also conferred about and reported what they saw as violations of the consent process. In this role, they attempted to establish and maintain clear limits regarding their ethical obligations to patients, physicians, and the

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THE NURSE'S ROLE IN INFORMED CONSENT

institution. Their major concern about this role was their lack of information, especially regarding research protocols. 2. Advocate. Nurses enacted this role in order to mediate on behalf of patients. As a part of this role, the nurse thought it was important to bring crucial new or additional information to the physician or researcher from the patient or family. For example, the patient's rationale for certain choices and decisions often functioned to recast the meaning of events and expose the underlying values at play. As advocates, the nurses also supported the decision-making process per se and the decision made by the patients with few exceptions. 3. Resource Person. As resource persons, the nurses collected, dispensed, and reported information about all alternatives available, guided patients regarding their informational needs, and clarified as to their importance the features of consent that the patients misunderstood or overlooked. 4. Coordinator. "I~his role functioned to preserve an open, friendly atmosphere rather than having the situation become one of dissension. In this role, nurses explored impli'cations for and observed direct and indirect effects on the patient and family. Additionally, they integrated treatment and care with the workings of the system in a way so as to try to ensure necessary time for working through any issues that might arise, such as informed consent. 5. Facilitator. In this role, the nurses cIarified and validated differences in perspective between parties

involved in informed consent. They discussed with patients and families sucll topics as long- and shortterm consequences of choice, suffering, and pain, as well as psychological and physical benefits. As a facilitator they tried to build in opportunities for re-evaluation at a later stage. And finally, they assumed the responsibility of getting the team together to discuss aspects of specific situations, including those of informed consent, that raised issues to be discussed.

Conclusions This study, based on interviews with 27 nurses in two clinical settings, points to the need for more systematic data on what actually happens in situations of informed consent and the nurse's role in obtaining it. Futher exploration is needed of such questions as Do nurses tend to view informed consent as a process? What roles do they play in obtaining consent? What values and ethical principles are evident in their involvement or noninvolvement in the informed consent process?

References 1. Flaskerud JH: Use of vignettes to elicit responses toward broad concepts. Nurs Res 28:4, 1979 2. Nussbaum J: Informed consent in the recruiting of subjects into pharamacologic research [dissertation]. Washington, DC, The Catholic University of America, 1986