THE NURSE AS INVESTIGATOR AND MEMBER OF THE RESEARCH TEAM

Rosemary Ellis, R.N., Ph.D.

Case Western Reserve University Cleveland, Ohio

Nurses are involved increasingly in human research in two major roles. The first, in terms of the number of nurses so engaged, and probably in historical time, is that of practitioner giving care to patients who are subjects in a research study or to those who are undergoing experimental procedures or therapies. The second is that of investigator, directing studies of subjects who are patients as well as studies of nonpatients.

In both practitioner and investigator roles, the nurse functions as a nurse and because she is a nurse. From this, some special contributions and some special problems derive. They derive because of the historical and functional relationships between medicine and nursing; they derive from the nurse’s know- ledge of hospital life and of patients; and they also derive from the fact that until recently, nurses have had little experience in the investigator role, and have not focused sufficiently upon their participation in human research in their activities as practitioners of nursing. There is not an extensive history of research ethics for nursing to draw upon, and little nursing literature on research ethics.’ This is not to say that there is not experience in nursing to draw upon.

One of the special circumstances that occurs for the nurse is that she may become a participant in human research without consciously choosing to do so. Two-thirds of all employed registered nurses work in hospitals and related institutiom2 As a practitioner, it is not uncommon for a nurse caring for patients in almost any large hospital today to be involved in research to the extent that she carries responsibility for the nursing care of patients who are receiving experimental therapies. Her care must include at least observations and judgments of patients, and often may involve actual administration of therapies such as investigational drugs, which are part of medical investigations. These functions are an expected part of her job responsibilities, and her consent to be involved in research is not sought.

This characteristic circumstance of the nurse, in regard to studies of patients, generates the need to attend to her rights, responsibilities, and ethics as they affect her practice. Her concerns for patients and her typical activities with patients will be continued whether investigation is carried out or not. Any professional nurse’s action must be predicated upon sufficient information about the therapy the patient is receiving or has received, about what effects are anticipated, or what untoward effects could occur, to enable the nurse to meet her responsibilities for patient welfare. The nurse’s primary commitment is to the patients’ care and safety. To meet this commitment, the nurse accepting responsibility for the nursing care of a patient must know what is happening to that patient. This is particularily true when therapies or practices deviate from the known or the generally accepted. The code for nurses states that the nurse participates in research or experimental activity only when the project has appropriate sanction of a review committee or other appropriate authority within the institutional setting. It also stipulates that the nurse needs sufficient

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knowledge of a research design to be able to participate in an informed and effective way.

A typical research involvement of the nurse as practitioner is in the care of a patient receiving an investigational drug. The responsibility for obtaining patient consent for the use of the drug and for the supervision of the use of the drug under such circumstances rests with a physician authorized to engage in such investigation. If the nurse is to administer the drug, she too must be informed about drug dosage, actions, uses, side effects, and symptoms of toxicity, in order to meet adequately her own ethical and legal responsibilities. A nurse should refuse to administer investigational drugs if she has a lack of adequate informa- tion or if there is inadequate medical supervision and responsibility.

The use and administration of investigational drugs is one of the areas for which authoritative statements from professional bodies may serve to clarify medical-nursing interfaces and serve to assure both patient and practitioner of appropriate safeguards. Such statements are joint statements of official organizations of registered nurses such as the State Nurses’ Association, and other professional bodies such as medical or hospital associations, to cover questions raised by nurses regarding their professional responsiblities or obligations that are not answered in existing statutes such as nursing or medical- practice acts.* Such joint statements establish principles and procedures to guide the nurse practitioner and the agency that employs her in some of the areas where medical practice or research involves the nurse in investigational pro- cedures or where nurses are being asked to perform therapeutic measures that are new to nursing practice.

The nurse practitioner is engaged in research where patients are subjects in other less obvious or less defined ways. Although medical research literature rarely even alludes to the influence of the nurse as a possible factor in patient response, it was the advent of modern nursing, as a consequence of Miss Florence Nightingale’s work, that initiated significant change in hospitals that permitted advances in medical practice and cure. Hospitals were also signifi- cantly changed with the widespread introduction of the registered nurse for bedside care in the early 19303, with resulting increased potential for clinical research and advancement of care.

Medical researchers have often relied upon nurses to interpret to patient- subjects aspects of investigational regimens such as special diets, fluid intake, or other matters that may be factors in some regime. They have relied upon nurses to make and record observations and measurements essential in some research; they often rely upon nurses for the collection of a variety of specimens. Practically, the integrity of the regimens established for some investigations of patient-subjects may be highly dependent upon the nurse practitioner. The wise investigator would supply the nurse practitioner with sufficient information so that she can facilitate the achievement of regimens where these are desired, or of observations and measurements, or where she can alert the investigator to problems or inadvertent deviations. As a professional engaged daily and continuously in the care of patient-subjects in the hospital, the nurse practitioner should be considered a factor in most hospital based research on patient-subjects. Her participation or contribution may be an uncontrolled factor affecting the conduct of research or the patients’ attitude toward it. Her participation should be a planned factor, both for the nurse’s sake and for that of the investigation.

The nurse can be a resource for information about the hospital life of patients, the perceptions of patients, and various protocols and procedures. All

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of these could serve to minimize the impact of research on patients or to facilitate the integration of research into the normal life of a hospital division. If the nurse is not informed or is not consulted, her patterns and her concerns can work against those of an investigator.

The nurse’s attitude toward investigative procedures as a factor in patient attitude or response has not been systematically explored, but there is the impression that the patient’s receptiveness, acceptance of, or possibly response to investigative procedures may be influenced by the nurse. It is not uncommon for the patient to ask a nurse’s opinion about a drug, a procedure, an operation, or a physician. He may ask about the nurse’s experience with patients like himself. Even if the nurse avoids giving an opinion, which she rarely really can avoid, she conveys something to the patient that he may use in arriving at his decisions or conclusions. This is particularly likely if the drug, procedure, or operation is new or thought to be risky. An informed nurse may be the physician investigator’s best ally. An uninformed nurse unintentionally, but subtly, may contribute to a negative patient reaction or attitude. The nurse may also influence an attitude of a patient’s family toward research.

Wherever she cares for and interacts with patients who are research subjects, the nurse practitioner should be given information about investigative procedures affecting the patient for whom she cares adequate for her to meet her own professional responsibilities. Participation in research activities under a physi- cian’s direction does not relieve the professional nurse of responsibility for her own acts and judgments. She also should be adequately informed about research or experimental procedures affecting her patients so that her intentional or unintentional actions, conveyance of information, or attitude to the patient is not detrimental to research or to a physician investigator’s plan for therapy.

The second major role in which nurses may be concerned with human research is that of investigator. This is a relatively new role for the nurse, and one in which proportionately few nurses are engaged or are likely to be engaged. Nevertheless, research by nurses adequately educated and trained for research is now seen as an essential means for developing the knowledge required to improve nursing practice.

The ethical code that guides the professional nurse was adopted by the American Nurses’ Association in 1950 and was revised in 1960 and again in 1968.3 The principles enunciated in this code were extended to provide nurses with definitive statements on the ethical premises applying to research activities. These statements were prepared by the Committee on Research and Studies of the American Nurses’ Association, and were published in July 1968.5 These guidelines delineate the rights and responsibilities of the nurse investigator. They also serve other investigators and the public as premises upon which to base their expectations of the nurse investigator. These guidelines, however, do not answer all specific questions for each investigator; they are as full of interpretive issues as are all such codes or declarations. Some of the specific dilemmas that have arisen in investigations illustrate the influence of tradition, situation, or context on the design or conduct of human research by a nurse investigator. They may serve to highlight some ethical questions.

One example of the influence of the traditional perspective of the nurse as a factor in research design can be given in the consideration of a study of a patient’s adherence or nonadherence to therapeutic regimens. One theoretical orientation to adherence-nonadherence might be that of risk-taking. The patient’s characteristic behavior toward risk-taking might be a factor in his decision

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to disregard professional advice as to a therapeutic regimen. Risk-taking has been a behavior studied by psychologists, and typically has been measured by involving subjects in experiments resembling gambling games. While this may be completely appropriate in the psychologists’ laboratory, it is not likely to be as readily seen by the patient, other nurses, or the patient’s physician as appropriate for the nurse investigator in the hospital setting. This is apt to hold even if the nurse is trained as a psychologist. The traditionally oriented view of the nurse and her interests in patients does not usually encompass interest in gambling. In any event, sufficient explanation to relate a nurse’s interest in gambling behavior to patient welfare, in order to ensure the patient’s informed consent and to give him knowledge of anticipated benefits from a study, could influence the variable under study. It is also not improbable that the traditional view of the nurse would affect the acceptance of the investigation by the physician or by other nurses caring for the patient subject. What may be completely appropriate for the psychologist investigator in his setting relevant to subject information and experimental procedures may not be deemed appro- priate for the nurse investigator in her setting. Perhaps the self-consciousness of the nurse investigator is a reflection of the recency of this role, but tradition and contexts are factors to be considered in judging ethical behavior and in patient and colleague perception of what is appropriate.

The situation or context of the hospitalized patient also poses ethical prob- lems for the nurse investigator in terms of the possible impact of her research on the patient. While it is usually desirable that the roles of investigator and practitioner be considered mutually exclusive in order that neither the quality of research nor the quality of patient care suffer, this is not always feasible practically.

In the course of research interviews about unusual sensory experiences of patients undergoing reduced sensory input, by reason of eye-patching and restriction of movement in conjunction with surgery for cataract, it became apparent that some patients were concealing such experiences from their physician and from the nurses caring for themes The relating of the experiences to the nurse investigator and the information from the investigator that other patients had had such experiences often gave considerable relief to the patient. Some patients had concealed the experiences because they feared they would be considered “crazy” or might be transferred to a psychiatric unit. A research interview coincidentally provided some relief or reassurance for the patient. In a few rare instances, the nurse investigator felt that the patient’s concern or agitation about his experiences warranted further follow-up and attention, not for research purposes, but in the interests of the patient’s welfare. The dilemma for the investigator was whether to continue to see the patient for the purpose of providing the patient with opportunity to talk about the experiences and to give further reassurance or whether to violate the promise of confidentiality and to report the patient’s experiences and his reaction to them to the patient’s physician, if the patient himself could not be helped to report them to his physician. The patient’s welfare was, of course, the primary ethic. But how the patient’s welfare was to be best served was a matter of judgment. In some instances the nurse investigator continued to visit the patient in the role of nurse, not investigator. In one instance the research interview elicited patient remarks clearly indicating that a patient with detached retina was contemplating suicide. Had this occurred with a psychiatric patient within the context of a psychiatric hospital, where there are safeguards to reduce the chance of suicide

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and where staff is apt to be alert to potential suicide, the problem might have seemed less acute. It arose in the context of a general hospital division, where safeguards and expectations are somewhat different. In this instance, it was essential to violate the promise of confidentiality and to communicate clinical information elicited in the course of a research interview to a professional directly responsible for the patient’s clinical care. It may be advisable for the nurse investigator, in discussing confidentiality with a patient in relation to some research, to indicate to a patient subject that should the nurse investigator feel her observations or information might need to be communicated to the patient’s physician or nurse for the patient’s welfare, the investigator would inform the patient and discuss this with the patient before acting. With all due regard to confidentiality and the hazards for patient and investigation if this is violated, patient welfare and safety must take precedence for the nurse.

Such situations may rarely be encountered, but they do arise. The nurse investigator cannot relinquish professional responsibility for a patient, although her relationship with a patient may arise solely from a research process. A physician investigator often simultaneously carries the responsibility for prescrip- tion of therapy and for safeguards for a patient together with the responsibility for an investigation. The nurse investigator does not have sole authority for a hospitalized patient and must consider research design, procedure, and possible effects with reference to a subject who is admitted by a physician’s order and who is the responsibility of a physician as well as the responsibility of other nurses. This may compel special considerations not required of the physician investigator or the laboratory scientist.

The areas of interest to nurses may also compel some special considerations. Patient behavior generally, or patient behavior in response to nursing actions, is of considerable interest to nurses. Insight as to factors affecting patient behavior would be useful in maximizing the patient’s use of the special facilities and resources of a hospital or health agency and in suggesting possibilities for moderating unsuccessful patient behavior or behavior detrimental to health goals. But the study of a behavior such as decision-making may present some problems with implications for ethics. To return to the example of a possible study of patient adherence or nonadherence, consider the possible effect of interviewing a patient about his decisions. There is the matter of timing. From an investigational point of view, it could be considered advantageous to study the patient during his process of decision-making. The best insights might be gained if an investigator could follow the patient’s considerations or attitudes as he learns of a proposed regimen, or is given information about his disease condition, or is deciding whether or not to submit to some procedure or plan for care. It is likely, however, that questions necessary to elicit a patient’s thoughts, attitudes, or rationales could become factors in the decision itself. The questions an investigator asks may crystallize a tentative decision or may raise to attention or consciousness elements the patient has not deliberated upon, or the patient may erroneously infer information or values from the study questions or activities. These possibilities are disadvantages from an investigative point of view, because the investigation itself alters the phenome- non under study. More importantly, the investigation may affect a significant personal decision of a patient or may adversely alter his understanding of information or options offered to him by those responsible for his care. Where study of patient behavior such as decision-making could affect or alter that behavior, the nurse investigator must consider the ethics involved. This is of

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particular importance when the role of investigator and that of practitioner are not carried as dual roles.

The nurse’s interest in patients’ families and their attitudes or behavior as a factor in patient response may raise the need to clarify ethics of consent. Consider a study of family members’ perceptions of changes in the family, or in what the family had always done, which they attribute to, or associate with, a patient’s severe disability and long-term hospitalization for rehabilitation. For such a study, the subjects are relatives of patients. They are to be asked about their own perceptions. No information about the patient is to be asked of the relative, though potential subjects are identified by their relationship to a patient. The question could be raised as to whether there is a need to obtain a patient’s consent to approach his relative to request the relative to participate in a study. This is perceived as an ethical, not a legal, issue, around the matter of a patient’s right to privacy and the complex triadic relationship of professional to patient to patient’s family, within the context of hospitalization. This example highlights an area not directly addressed in codes or ethical guidelines: that of the need to consider the potential effect upon a patient of the use of his relatives as research subjects where interest in the relative derives from a family member’s status as patient. Study of families with reference to illness, study of family impact on patient rehabilitation or the like, are areas for research by nurse investigators to improve preventive and rehabilitative care. Such studies require that the investigator give due concern to the effect of the investigation on the perceptions and feelings of patients who may not be themselves the subjects of investigation but who cannot help being associated with an investigation, and possibly affected by it, if their families are the sources for subjects.

The above examples illustrate some types of ethical issues that have arisen to date that may not be unique to nursing but that have been raised by nurse investigators or nursing research review committees. The ethical guidelines developed by the professional organization for nursing, the American Nurses’ Association,3* parallel those of other professional codes in statement of the protection of human rights of privacy; self-determination; conservation of personal resources as time and energy expenditure; freedom from constraint; freedom from arbitrary hurt; freedom from intrinsic risk of injury; and the rights of minors and incompetent persons. Yet, as with other professions, much depends upon the moral integrity and training of the individual investigator. The profession of nursing endorses research review committees of peers, estab- lishment of institution or agency policy and structure to safeguard patients and practitioners, and the development of joint statements of nursing, medical, or hospital organizations to guide practitioners in the gray areas between medi- cine and nursing and to clarify responsibilities.

With all of this, however, the nurse investigator will face dilemmas because the profession has not had long or extensive involvement in research, and has not, until recently, had many practitioners adequately educated and trained for research. Nursing suffers from a paucity of measurable criteria against which to evaluate the effectiveness of alternatives or modifications of existing nursing practices or procedures.‘ Though some research using animals is carried out by nurse investigators, the bulk of questions raised by nurses do not lend themselves to preliminary study and trials with animals prior to the study of human beings.

The questions to be answered are complex. The measurement of benefit is difficult. Yet if the patient is to be served, there is need for systematic investiga-

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tions by nurses toward analysis and improvement of practice, or of the science or theories upon which nursing practice is based.

From the nurses’ view, research objectivity does not require that the subject become, or be treated, as an object. Nursing personifies humanitarianism, and human research that involves the nurse must be based on this ethic.

REFERENCES

1. DOWNS, F. S. 1967. Ethical inquiry in nursing research. Nurs. Forum 6 12-20. 2. AMERICAN NURSES’ ASSOCIATION. 1968. Facts About Nursing. New York, N.Y. 3. AMER. J. NURS. 1968. Code for nurses. 68: 2581-2585. 4. NURSING PRACTICE DEPARTMENT, AMERICAN NURSES’ ASSOCIATION. 1968.

The Fundamentals of Joint Statements on Nursing Practice. (Mimeograph.) American Nurses’ Association. New York, N.Y.

5 . AMER. J. NURS. 1968. The nurse in research: A.N.A. guidelines on ethical values. 68: 1504-1507.

6. ELLIS, R., C. JACKSON, JR.. R. RICH, G. A. HUGHEY & R. M. SCHLOTFELDT. 1968. Suggestions for the care of eye surgery patients who experience reduced sensory input. In American Nurses’ Association Regional Clinical Conferences 1967: 131-137. Appleton-Century Crofts, Inc. New York, N.Y.

7. AYDELOTTE, M. K. 1962. The use of patient welfare as a criterion measure. Nurs. Res. 11: 10-14.