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Chaplin, F. Stuart . 1947 Experimental Designs in Sociological Research, Rev. Ed. New York: Harper. Fisher, RA 1951 The Design of Experiments. Edinburgh: Oliver and Boyd. Hamblin, R. 1974 Social attitudes: Magnitude Measurement and Theory In Measurement in the Social Sciences H.M. Blalock, Jr., ed. Chicago: Aldine Publishing Co. Hamblin, R.L., D. Buckholdt, D. Ferritor, M. KozloH, and L. Blackwell 1971 The Humanization Processes. New York: Wiley. Hinshaw, Ada Sue 1978 Role Attitudes: A Measurement Problem, In Role Theory. Perspectives for Health Professionals. M. Hardy and M. Conway, eds. New York: Appleton-Century-Crofts. Peregrin, J., A Longman, A Hinshaw, P. King, and E. DeWalt In press EHects of Teaching Nonprofessional Care Givers Standardized Assessment and Interventions on Health Outcomes of Nursing Home Clients: A Pilot Study. In Clinical Nursing Research: Its Strategies and Findings. Vol. II. E. Bauwens, ed. New York: Sigma Theta Tau. Wooldridge P., R. Leonard, and J. Skipper 1978 Methods of Clinical Experimentation To Improve Patient Care. St. Louis: C.V. Mosby Co.
Ethical Issues In Nursing Research Anne J. Davis
INFORMED CONSENT Informed consent lies at the heart of most ethical issues in research involving human subjects. Five fundamental principles generally have been identified to cover the elements of this concept: (1) the person who participates in the study must have volunteered on the basis of having all the necessary information in order to make an informed decision, (2) the subject may withdraw from the study at any time, (3) all unnecessary risks should have been eliminated through previous animal research and in the study design itself to the greatest extent possible, (4) the benefits either to society or to the individual subject or to both should outweigh the possible risks Downloaded from wjn.sagepub.com at GEORGE MASON UNIV on June 4, 2016
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to the individual subject, and (5) research involving human subjects should be conducted by those qualified to undertake such work (Gray 1975:7). Informed consent is a complex process, and in reality the subject may never fully know all aspects of the study. This does not lessen the duty of the researcher to try to explain all pertinent information in simple language which can be understood by the potential subject. Along with a discussion of alternatives and the risk-benefit ratio, the researcher needs also to mention the uncertainties. Most people understand that we live in a world of many uncertainties, but not always do they transfer this knowledge to cover experiences in health care and research. Unmet or unrealistic expectations, compounded by lack of adequate information, can lead to events which surprise a person; at the extreme, this surprise can lead to a malpractice case. Such a situation often involves reparative justice which focuses on the fault of one party for an injury to another, and the party causing injury is blameworthy and held liable for it. One of the difficulties with the informed consent format developed by the federal government has been noted by several social scientists. The guidelines assume a typical biomedical study with specific predetermined boundaries and hypotheses, whereas much of social science research evolves the questions and hypotheses from the data as they are being collected. Recently, at the American Association for the Advancement of Science meeting in Washington, D.C., several papers addressed this issue. This lack of fit between guidelines and social science research will be discussed more fully in a later column. In California, Assembly Bill 1752, Human Subjects Research, became law on January 1, 1979. The bill provides that any person who is being asked to participate in, or is being asked to consent on behalf of another person to participate in, a medical experiment, must be provided with an "experimental subject's bill of rights" which lists the rights written in a language in which the subject is fluent. The Research Subject's Bill of Rights includes, but is not limited to, the five elements of informed consent mentioned earlier. Additionally, it says that the subject must be informed of the avenues of medical treatment, if any, available after the experiment if complications should arise. For several years questions have been raised as to what would happen jf a research subject were injured in the course of the study. Questions include: Who would pay the costs and for how long? How would the costs be managed? Which costs would be covered? Would compensation include only money or only treatment or both? Would third parties be compensated? Beginning January 2, 1979, the Department of Health, Education and Welfare policy states that where research presents risk of physical harm, subjects should be Downloaded from wjn.sagepub.com at GEORGE MASON UNIV on June 4, 2016
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advised at the outset whether there will be any financial protection for them in the event that they are injured. To this end, such a statement should be part of the initial written informed consent form. The scope and limitations of a social obligation to compensate injured research subjects, although a complex issue, does have moral grounding. Compensatory justice is giving an individual his/her due by taking account of a previous state of affairs and attempting to restore a "fallen" person or group to it. Such restoration can rarely be literal; it often requires monetary substitutes. The person who incurs a research-related injury cannot be thought of as simply another individual who has needs. On the contrary, that person has taken certain risks for society's benefit through advancing health science knowledge. In this context, where there is no evidence of negligence, recovery is premised on the assumption that the injured party was exposed to risks in the public interest (Columbia Law Review 1970:974). Compensatory justice is a concrete application of the principle of fairness in the imposition of risks for the benefits of society (Childress 1976:22). In the past, some have argued that consent constitutes a waiver of claims for compensation. But the fact remains that researchers cannot foresee all possible injuries which might result; therefore, the subject cannot be held to consent to unforeseen and unanticipated risks. Unavoidable injuries seem outside the risks which the subject voluntarily assumes in the original consent. Special cases include (1) the consideration of compensation with such subjects as healthy volunteers who usually will not directly benefit from the experiment and (2) the situation where the individual is involved with experimental or innovative therapy where, as both a patient and a research subject, he/she may benefit from being in both of these roles. To date, the notion of positional risk for research subjects and the ethical principle of compensatory justice have led to a policy in which "injury" is narrowly construed, but which does acknowledge society's obligation to compensate all those who suffer injury as a result of participating in research. The ethical principles involved in this issue will continue to be applied in evolving policy in this matter.
REFERENCES Childress, James 1976 Compensating Injured Research Subjects. The Hastings Center Report. December. Columbia Law Review 1970 Medical Experiment Insurance. May. Gray, Bradford 1975 Human Subjects in Medical Experimentation. New York: John Wiley and from Sons. Downloaded wjn.sagepub.com at GEORGE MASON UNIV on June 4, 2016
145
Chaplin, F. Stuart . 1947 Experimental Designs in Sociological Research, Rev. Ed. New York: Harper. Fisher, RA 1951 The Design of Experiments. Edinburgh: Oliver and Boyd. Hamblin, R. 1974 Social attitudes: Magnitude Measurement and Theory In Measurement in the Social Sciences H.M. Blalock, Jr., ed. Chicago: Aldine Publishing Co. Hamblin, R.L., D. Buckholdt, D. Ferritor, M. KozloH, and L. Blackwell 1971 The Humanization Processes. New York: Wiley. Hinshaw, Ada Sue 1978 Role Attitudes: A Measurement Problem, In Role Theory. Perspectives for Health Professionals. M. Hardy and M. Conway, eds. New York: Appleton-Century-Crofts. Peregrin, J., A Longman, A Hinshaw, P. King, and E. DeWalt In press EHects of Teaching Nonprofessional Care Givers Standardized Assessment and Interventions on Health Outcomes of Nursing Home Clients: A Pilot Study. In Clinical Nursing Research: Its Strategies and Findings. Vol. II. E. Bauwens, ed. New York: Sigma Theta Tau. Wooldridge P., R. Leonard, and J. Skipper 1978 Methods of Clinical Experimentation To Improve Patient Care. St. Louis: C.V. Mosby Co.
Ethical Issues In Nursing Research Anne J. Davis
INFORMED CONSENT Informed consent lies at the heart of most ethical issues in research involving human subjects. Five fundamental principles generally have been identified to cover the elements of this concept: (1) the person who participates in the study must have volunteered on the basis of having all the necessary information in order to make an informed decision, (2) the subject may withdraw from the study at any time, (3) all unnecessary risks should have been eliminated through previous animal research and in the study design itself to the greatest extent possible, (4) the benefits either to society or to the individual subject or to both should outweigh the possible risks Downloaded from wjn.sagepub.com at GEORGE MASON UNIV on June 4, 2016
146
Western Journal of Nursing Research
to the individual subject, and (5) research involving human subjects should be conducted by those qualified to undertake such work (Gray 1975:7). Informed consent is a complex process, and in reality the subject may never fully know all aspects of the study. This does not lessen the duty of the researcher to try to explain all pertinent information in simple language which can be understood by the potential subject. Along with a discussion of alternatives and the risk-benefit ratio, the researcher needs also to mention the uncertainties. Most people understand that we live in a world of many uncertainties, but not always do they transfer this knowledge to cover experiences in health care and research. Unmet or unrealistic expectations, compounded by lack of adequate information, can lead to events which surprise a person; at the extreme, this surprise can lead to a malpractice case. Such a situation often involves reparative justice which focuses on the fault of one party for an injury to another, and the party causing injury is blameworthy and held liable for it. One of the difficulties with the informed consent format developed by the federal government has been noted by several social scientists. The guidelines assume a typical biomedical study with specific predetermined boundaries and hypotheses, whereas much of social science research evolves the questions and hypotheses from the data as they are being collected. Recently, at the American Association for the Advancement of Science meeting in Washington, D.C., several papers addressed this issue. This lack of fit between guidelines and social science research will be discussed more fully in a later column. In California, Assembly Bill 1752, Human Subjects Research, became law on January 1, 1979. The bill provides that any person who is being asked to participate in, or is being asked to consent on behalf of another person to participate in, a medical experiment, must be provided with an "experimental subject's bill of rights" which lists the rights written in a language in which the subject is fluent. The Research Subject's Bill of Rights includes, but is not limited to, the five elements of informed consent mentioned earlier. Additionally, it says that the subject must be informed of the avenues of medical treatment, if any, available after the experiment if complications should arise. For several years questions have been raised as to what would happen jf a research subject were injured in the course of the study. Questions include: Who would pay the costs and for how long? How would the costs be managed? Which costs would be covered? Would compensation include only money or only treatment or both? Would third parties be compensated? Beginning January 2, 1979, the Department of Health, Education and Welfare policy states that where research presents risk of physical harm, subjects should be Downloaded from wjn.sagepub.com at GEORGE MASON UNIV on June 4, 2016
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advised at the outset whether there will be any financial protection for them in the event that they are injured. To this end, such a statement should be part of the initial written informed consent form. The scope and limitations of a social obligation to compensate injured research subjects, although a complex issue, does have moral grounding. Compensatory justice is giving an individual his/her due by taking account of a previous state of affairs and attempting to restore a "fallen" person or group to it. Such restoration can rarely be literal; it often requires monetary substitutes. The person who incurs a research-related injury cannot be thought of as simply another individual who has needs. On the contrary, that person has taken certain risks for society's benefit through advancing health science knowledge. In this context, where there is no evidence of negligence, recovery is premised on the assumption that the injured party was exposed to risks in the public interest (Columbia Law Review 1970:974). Compensatory justice is a concrete application of the principle of fairness in the imposition of risks for the benefits of society (Childress 1976:22). In the past, some have argued that consent constitutes a waiver of claims for compensation. But the fact remains that researchers cannot foresee all possible injuries which might result; therefore, the subject cannot be held to consent to unforeseen and unanticipated risks. Unavoidable injuries seem outside the risks which the subject voluntarily assumes in the original consent. Special cases include (1) the consideration of compensation with such subjects as healthy volunteers who usually will not directly benefit from the experiment and (2) the situation where the individual is involved with experimental or innovative therapy where, as both a patient and a research subject, he/she may benefit from being in both of these roles. To date, the notion of positional risk for research subjects and the ethical principle of compensatory justice have led to a policy in which "injury" is narrowly construed, but which does acknowledge society's obligation to compensate all those who suffer injury as a result of participating in research. The ethical principles involved in this issue will continue to be applied in evolving policy in this matter.
REFERENCES Childress, James 1976 Compensating Injured Research Subjects. The Hastings Center Report. December. Columbia Law Review 1970 Medical Experiment Insurance. May. Gray, Bradford 1975 Human Subjects in Medical Experimentation. New York: John Wiley and from Sons. Downloaded wjn.sagepub.com at GEORGE MASON UNIV on June 4, 2016
