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Ethical dilemmas in perioperative research
AORN JOURNAL
FEBRUARY 1990, VOL 51, NO 2
Ethics Ethical dilemmas in perioperative research
T
he American Nurses’ Association Code for Nurses with Interpretive Statements clearly supports the current impetus toward nursing research. Principle 7 of the code refers to continued development of the knowledge base, and principle 8 refers to continued improvement in the standard of patient care. (See “Code for Nurses.”) Both principles impose an obligation on nurses to take an active part in research that leads to better therapeutic outcomes for patients. Consistent with the patient-centered philosophy of the nursing profession is the ethical mandate to become involved in research. Several moral dilemmas arise from the mandate to become actively involved in research. One particular dilemma centers on the issues of informed consent, patient autonomy, and potential therapeutic benefit. A person faces a dilemma when he or she must choose between at least two alternative actions, and choosing any one will result in unintended negative consequences. For example, suppose that a particular research project, the results of which might benefit the patient, was unlikely to be completed if the patient’s informed consent was sought. The researcher could choose to follow the ethical mandate for increasing knowledge, which will benefit the patient and violate the principle of informed consent, or attempt to obtain the patient’s informed consent and risk the patient’s refusal to participate. The latter choice prevents the nurse from acquiring new knowledge which would, in turn, benefit the patient. Because the researcher cannot do both, he or she experiences a dilemma. The particular course of action the 612
researcher takes will depend on the priority he or she gives the competing principles.
Patients’ Rights
P
rinciple 1 of the code of ethics for nurses begins with the admonition to treat the patient “with respect for human dignity and the uniqueness of the client.” Human dignity and uniqueness of the client are other ways of referring to the Kantian dictum to treat individuals as ends in themselves and not solely as means to another end. Being
Willard P. Green, PhD, is a professor and chairman of the department of humanities and social sciences, Hahnemann Universiv, Philadelphia He earned his bachelor of arts degree in philosophy from Haverford (Pa) College: his master’s degree in divinity from Yale University Divinity School, New Haven, Conn; and his doctorate of philosophy from Temple Universiv, Philadelphia.
treated as an end is being recognized as a person who sets goals and has the ability to order the environment in such a way to achieve those goals. Fundamental to the ability to reach established goals is possessing knowledge about oneself and the surrounding environment. When research involves people as necessary components for the study, principle 1 becomes fundamental.The individual has the right to decide whether he or she wants to participate in the proposed study, and this decision will reflect his or her value system. Therefore, informed consent is essential.The patient needs to know the potential benefits, risks, and inconveniences to assimilate the appropriate information into his or her value system to decide if the recommended course of action fits his or her goals. Neglecting to obtain informed consent would be treating the patient as a means to the researcher’s goal, which may not be congruent with the patient’s goals. The person would become a mere object for manipulation like any other object in the environment to be controlled. Regardless of how benign the outcome, one person has made a decision for another. A particular difficulty arises for nurses who carry out research projects in an operating room environment. Fundamental to most research protocols is the possibility for the subject to withdraw from the protocol at any time. Such a stipulation preserves the participant’s autonomy throughout the duration of the research. Clearly, this is not possible for an unconscious patient undergoing a surgical procedure. Suppose a study is being carried out to determine the effect on the patient of having music in the operating room. The patient cannot decide to withdraw from the research project during the middle of the operation. Therefore, the patient needs to know precisely what the researcher’s expectations are so that he or she can give or withhold consent at the outset, recognizing that once a decision is made and the operation is begun there is no longer the possibility to withdraw consent. Some researchers might believe that it is not necessary to obtain a patient’s informed consent for a study that does not involve invasive
Codefor Nurses
5 6
9 10 l1
The nurse provides services with respect for human dignity and the uniqueness of the client, unrestricted by considerationsof social or economic status, personal attributes, or the nature of health problems. The nurse safeguards the client’s right to privacy by judiciously protecting information of a confidential nature. The nurse acts to safeguard the client and the public when health care and safety are affected by the incompetent, unethical, or illegal practice of any person. The nurse assumes responsibility and accountability for individual nursing judgments and actions. The nurse maintains competence in nursing. The nurse exercises informed judgment and uses individual competence and qualifications as criteria in seeking consultation, accepting responsibilities, and delegating nursing activities to others. The nurse participates in activities that contribute to the ongoing development of the profession’s body of knowledge. The nurse participates in the profession’s efforts to implement and improve standards of nursing. The nurse participates in the profession’s efforts to establish and maintain conditions of employment conducive to high quality nursing care. The nurse participates in the profession’s effort to protect the public from misinformation and misrepresentation and to maintain the integrity of nursing. The nurse collaborates with members of the health professions and other citizens in promoting community and national efforts to meet the health needs of the public.
(Reprinted with permissionfrom Code for Nurses with Interpretive Statements, 0198.5, American Nurses’ Association, Kansas City,Mo,p l ) 613
FEBRUARY 1990, VOL. 51, NO 2
procedures. Changes in an operating room or other environment in which preoperative and/or postoperative interactions with patients take place do not invade a patient’s body and appear not to have a direct consequence for the patient’s health. Therefore, according to some researchers, obtaining informed consent is not morally mandated. Furthermore, because medications may inhibit the patient’s ability to give informed consent, it usually is not possible to obtain informed consent when the patient is in the operating room. Thus, the principle investigator needs additional time to seek the patient’s informed consent before the patient is premedicated. Others believe there is no substantive difference between research that requires the invasion of a patient’s body and that which affects a patient as a result of changes in the environment. In either situation, the research has an anticipated outcome for the patient. Presumably, the environmental change is expected to have a positive effect on the patient, otherwise there would be no justification for the research. Given that in either case the patient is affected by the research, respect for human dignity and the uniqueness of the patient carries with it the moral requirement to obtain the patient’s informed consent. A dilemma may result from this interpretation. The researcher can set aside the necessary time to supply the patient with all relevant information so that his or her decision can be informed. This supports the patient’s autonomy but takes time away from some other important function. The researcher also could concentrate his or her energy on other necessary duties, diminishing the importance of the patient’s selfdetermination. The action the researcher takes depends on the weight he or she places on the various relationships from which competing obligations arise. Resolving a dilemma requires moral reasoning. The person facing the dilemma needs to be aware of the nature of the competing claims. The nursing code of ethics appears to place the patient at the center of the various obligations imposed on the nurse. Unless there is some other overriding moral value, obtaining the patient’s informed consent is necessary.
AORN JOURNAL
Researchers’ Rights
A
nother potential dilemma facing the nurse researcher stems from the dual role as patient advocate and researcher. In addition to the potential benefit to the patient from the results of a given research protocol, there are potential benefits to the researcher. He or she may work in a research-oriented institution where research is taken into consideration for promotions and/ or salary increases. Suppose it is not possible to obtain a patient’s informed consent because the patient is incapacitated due to organic brain syndrome. Suppose further that the results of the research will either benefit the patient or have no particular effect on the patient. The nurse researcher can respect the principle of informed consent and not use patients who are unable to give informed consent. This would reduce the number of subjects and diminish the research sample. On the other hand, the researcher could continue the research and discount the principle of patient autonomy. Again, the action the nurse researcher takes depends on the priority he or she places on various values. At the least, principles 7 and 8 are in potential conflict with principle 1. The nurse will need to rank the importance of each of those principles when making the choice between respecting patient self-determination and the need for increased knowledge and potentially beneficial therapies. Numerous additional dilemmas confront the perioperative nurse, not only in the area of experimentation, but across the spectrum of his or her professional expertise. As a result, the question of a nurse’s competence includes not only “professional” knowledge, but also the ability to solve problems when moral dilemmas arise. WILLARD P. GREEN
615
FEBRUARY 1990, VOL 51, NO 2
Ethics Ethical dilemmas in perioperative research
T
he American Nurses’ Association Code for Nurses with Interpretive Statements clearly supports the current impetus toward nursing research. Principle 7 of the code refers to continued development of the knowledge base, and principle 8 refers to continued improvement in the standard of patient care. (See “Code for Nurses.”) Both principles impose an obligation on nurses to take an active part in research that leads to better therapeutic outcomes for patients. Consistent with the patient-centered philosophy of the nursing profession is the ethical mandate to become involved in research. Several moral dilemmas arise from the mandate to become actively involved in research. One particular dilemma centers on the issues of informed consent, patient autonomy, and potential therapeutic benefit. A person faces a dilemma when he or she must choose between at least two alternative actions, and choosing any one will result in unintended negative consequences. For example, suppose that a particular research project, the results of which might benefit the patient, was unlikely to be completed if the patient’s informed consent was sought. The researcher could choose to follow the ethical mandate for increasing knowledge, which will benefit the patient and violate the principle of informed consent, or attempt to obtain the patient’s informed consent and risk the patient’s refusal to participate. The latter choice prevents the nurse from acquiring new knowledge which would, in turn, benefit the patient. Because the researcher cannot do both, he or she experiences a dilemma. The particular course of action the 612
researcher takes will depend on the priority he or she gives the competing principles.
Patients’ Rights
P
rinciple 1 of the code of ethics for nurses begins with the admonition to treat the patient “with respect for human dignity and the uniqueness of the client.” Human dignity and uniqueness of the client are other ways of referring to the Kantian dictum to treat individuals as ends in themselves and not solely as means to another end. Being
Willard P. Green, PhD, is a professor and chairman of the department of humanities and social sciences, Hahnemann Universiv, Philadelphia He earned his bachelor of arts degree in philosophy from Haverford (Pa) College: his master’s degree in divinity from Yale University Divinity School, New Haven, Conn; and his doctorate of philosophy from Temple Universiv, Philadelphia.
treated as an end is being recognized as a person who sets goals and has the ability to order the environment in such a way to achieve those goals. Fundamental to the ability to reach established goals is possessing knowledge about oneself and the surrounding environment. When research involves people as necessary components for the study, principle 1 becomes fundamental.The individual has the right to decide whether he or she wants to participate in the proposed study, and this decision will reflect his or her value system. Therefore, informed consent is essential.The patient needs to know the potential benefits, risks, and inconveniences to assimilate the appropriate information into his or her value system to decide if the recommended course of action fits his or her goals. Neglecting to obtain informed consent would be treating the patient as a means to the researcher’s goal, which may not be congruent with the patient’s goals. The person would become a mere object for manipulation like any other object in the environment to be controlled. Regardless of how benign the outcome, one person has made a decision for another. A particular difficulty arises for nurses who carry out research projects in an operating room environment. Fundamental to most research protocols is the possibility for the subject to withdraw from the protocol at any time. Such a stipulation preserves the participant’s autonomy throughout the duration of the research. Clearly, this is not possible for an unconscious patient undergoing a surgical procedure. Suppose a study is being carried out to determine the effect on the patient of having music in the operating room. The patient cannot decide to withdraw from the research project during the middle of the operation. Therefore, the patient needs to know precisely what the researcher’s expectations are so that he or she can give or withhold consent at the outset, recognizing that once a decision is made and the operation is begun there is no longer the possibility to withdraw consent. Some researchers might believe that it is not necessary to obtain a patient’s informed consent for a study that does not involve invasive
Codefor Nurses
5 6
9 10 l1
The nurse provides services with respect for human dignity and the uniqueness of the client, unrestricted by considerationsof social or economic status, personal attributes, or the nature of health problems. The nurse safeguards the client’s right to privacy by judiciously protecting information of a confidential nature. The nurse acts to safeguard the client and the public when health care and safety are affected by the incompetent, unethical, or illegal practice of any person. The nurse assumes responsibility and accountability for individual nursing judgments and actions. The nurse maintains competence in nursing. The nurse exercises informed judgment and uses individual competence and qualifications as criteria in seeking consultation, accepting responsibilities, and delegating nursing activities to others. The nurse participates in activities that contribute to the ongoing development of the profession’s body of knowledge. The nurse participates in the profession’s efforts to implement and improve standards of nursing. The nurse participates in the profession’s efforts to establish and maintain conditions of employment conducive to high quality nursing care. The nurse participates in the profession’s effort to protect the public from misinformation and misrepresentation and to maintain the integrity of nursing. The nurse collaborates with members of the health professions and other citizens in promoting community and national efforts to meet the health needs of the public.
(Reprinted with permissionfrom Code for Nurses with Interpretive Statements, 0198.5, American Nurses’ Association, Kansas City,Mo,p l ) 613
FEBRUARY 1990, VOL. 51, NO 2
procedures. Changes in an operating room or other environment in which preoperative and/or postoperative interactions with patients take place do not invade a patient’s body and appear not to have a direct consequence for the patient’s health. Therefore, according to some researchers, obtaining informed consent is not morally mandated. Furthermore, because medications may inhibit the patient’s ability to give informed consent, it usually is not possible to obtain informed consent when the patient is in the operating room. Thus, the principle investigator needs additional time to seek the patient’s informed consent before the patient is premedicated. Others believe there is no substantive difference between research that requires the invasion of a patient’s body and that which affects a patient as a result of changes in the environment. In either situation, the research has an anticipated outcome for the patient. Presumably, the environmental change is expected to have a positive effect on the patient, otherwise there would be no justification for the research. Given that in either case the patient is affected by the research, respect for human dignity and the uniqueness of the patient carries with it the moral requirement to obtain the patient’s informed consent. A dilemma may result from this interpretation. The researcher can set aside the necessary time to supply the patient with all relevant information so that his or her decision can be informed. This supports the patient’s autonomy but takes time away from some other important function. The researcher also could concentrate his or her energy on other necessary duties, diminishing the importance of the patient’s selfdetermination. The action the researcher takes depends on the weight he or she places on the various relationships from which competing obligations arise. Resolving a dilemma requires moral reasoning. The person facing the dilemma needs to be aware of the nature of the competing claims. The nursing code of ethics appears to place the patient at the center of the various obligations imposed on the nurse. Unless there is some other overriding moral value, obtaining the patient’s informed consent is necessary.
AORN JOURNAL
Researchers’ Rights
A
nother potential dilemma facing the nurse researcher stems from the dual role as patient advocate and researcher. In addition to the potential benefit to the patient from the results of a given research protocol, there are potential benefits to the researcher. He or she may work in a research-oriented institution where research is taken into consideration for promotions and/ or salary increases. Suppose it is not possible to obtain a patient’s informed consent because the patient is incapacitated due to organic brain syndrome. Suppose further that the results of the research will either benefit the patient or have no particular effect on the patient. The nurse researcher can respect the principle of informed consent and not use patients who are unable to give informed consent. This would reduce the number of subjects and diminish the research sample. On the other hand, the researcher could continue the research and discount the principle of patient autonomy. Again, the action the nurse researcher takes depends on the priority he or she places on various values. At the least, principles 7 and 8 are in potential conflict with principle 1. The nurse will need to rank the importance of each of those principles when making the choice between respecting patient self-determination and the need for increased knowledge and potentially beneficial therapies. Numerous additional dilemmas confront the perioperative nurse, not only in the area of experimentation, but across the spectrum of his or her professional expertise. As a result, the question of a nurse’s competence includes not only “professional” knowledge, but also the ability to solve problems when moral dilemmas arise. WILLARD P. GREEN
615