Drawing on ethical principles and general ethical rules governing discrete aspects of human research, this article identifies and analyzes the following ethical problems distinctive to biomedical and behavioral research with aged subjects: (1) anti-aging research; (2) health problems in the aged that make them vulnerable to excessive selection for research; (3) conditions of the elderly that create problems of competence and free consent to research; (4) surrogate consent and the problem of guardianship; and (5) special problems in competence and free consent for the institutionalized elderly. Policy recommendations governing research in the aged are offered as well as an agenda for an extensive research project in this area.

Ethical Issues Related to Research Involving Elderly Subjects1

In recent years, significant studies (Capron, 1978; Freund, 1970; Fried, 1974; Walters, 1977) have appeared dealing with general ethical issues in medical experimentation. Very little, however, has been published on ethical aspects of biomedical and behavioral research involving elderly subjects (Axelsen & Wiggins, 1977; Bernstein & Nelson, 1975; Katz et al., 1972; Young, 1978), leaving many questions still to be explored in depth. Public policy governing human experimentation is based on the Nuremberg Code (19461949, 1970), the 1964 Declaration of Helsinki together with its 1975 Tokyo Revision (World Medical Association, 1964; 1976), the .U.S. Federal regulations (U. S., DHEW, 1977), and the standards being developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (referred to hereafter as "The National Commission") (U. S., National Commission, 1975; 1976; 1977a, b, c). The National Commission has investigated special categories of research subjects for purposes of determining need for special protection — fetuses, children, prisoners, and the institutionalized mentally infirm. Noteworthy for its absence from the National Commission's inquiry is an examination of ethical and policy dimensions of research in the aged.

There are several reasons why it is difficult to identify the extent of the need for specific protection of the aged in research settings. First, there are problems in defining the category known as the aged, though this probably presents no more difficulty than the definition of other categories of research subjects such as children and prisoners. Second, there is not sufficient data on research in the aged, as will be noted in more detail below. Third and most fundamentally, it may seem that there is no special need to regard the aged as a distinct class in terms of the requirements for research guidelines: some of the aged are competent, others are not; some are institutionalized, others are not; some are sick, others are not. They appear simply to be people for whom general regulations should suffice— namely, the regulations which already exist for federally sponsored research, together with new regulations that are being developed for special categories of research subjects, such as the institutionalized mentally ill, which includes many aged persons. Yet it is not essential that the elderly be a distinct class in general legal or social terms: we need only know whether there are some ethical aspects of research involving the aged which, taken singly or cumulatively, warrant special protection.

Ethical Principles and Issues 'This paper was prepared for the Protection of Elderly Subjects Conference, NIA, NIH, 18-19 July, 1977, and was revised after the conference. The author is grateful to the conferees, to his colleagues at the Kennedy Inst. of Georgetown Univ., and to John Robertson for their helpful suggestions. 'Warren T. Reich, STD, Dept. of Community & Family Medicine, and the Kennedy Inst. of Ethics, Georgetown Univ., Washington 20057.

Three ethical principles are commonly appl ied nowadays to the moral dilemmas in human research. The principle of beneficence is the principle that we ought to produce good and

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Warren T. Reich, STD2

(2) Risk-benefit analysis. — A research project should not be conducted unless the anticipated probable benefits to individuals, groups,, and/or society proportionately justify the risks or harms (physical, psychological, or social) to the subject, other individuals, or society. Furthermore, the anticipated benefits must not be obtainable through other, less risky, means. In the application of this rule, it is helpful to distinguish between research that is regarded as medically beneficial to the subject of the research action, and other research that is called medically nonbeneficial to the subject. (The terms "therapeutic" and "nontherapeutic" research, which are commonly used, are inadequate inasmuch as they do not seem to include research on diagnostic and preventive techniques. Hence the choice of the term, "medical.") While any research might be beneficial to someone, the point of the distinction is that some research (the first kind) is "research on practices which have the intent and reasonable probability of improving the health or wellbeing of the subject" (U. S. National Commission, 1977), while other research (the second kind) pertains to practices that do not have that intent and probability: it is done principally for the benefit of others (Capron, 1978). To the extent that research subjects do not stand to benefit by an action that places them-at risk, it is more difficult to justify the action, particularly in the case of an incompetent person; and special rules regarding minimization of risk and avoidance of harms and offenses become necessary.

(3) Selection of subjects. — This issue deals with the question of whether any category of (1) Goals and purposes of the research: its research subjects is being used disproportionmoral justification. —This ethical issue includes ately. There should be equity in the selection questions of the usefulness, necessity, and of subjects of research, involving all elements overall priority of the research in comparison of society; discrimination against the sick, with other research that might be undertaken, against captive populations (e.g., the instituas well as the element of motivation on the part tionalized), or against any who are not able to of investigator or sponsor (e.g., improved health, exercise fully their power of choice must be financial profit, etc.). There is wide agreement avoided. Relevant factors for judging whether that research efforts should have the goal and any group is being used disproportionately reasonable probability of yielding results that would be judged differently depending, for are beneficial, within limits set by the right of example, on whether the dominant criterion self-determination. The moral justification of were an equitable distribution of burdens, the research is not complete without a con- avoidance of dangers of exploitation, proviceptual determination of whether every benefit sion of maximum benefits to that category of persons, etc. is to be regarded as imperative.

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prevent harm. Many claim that this principle is closely identified with the entire research effort, for research is undertaken to identify which therapeutic practices cause harm, which cause good, etc. The principle of just distribution requires that, in the comparative treatment of individuals, there be a fair and equitable distribution of benefits and burdens in society. Distribution of the burdens and benefits of research among persons and groups can vary, but only if there is a relevant dissimilarity among these subjects or their circumstances. The principle of respect for persons requires that the dignity and autonomy of persons be protected and promoted. For example, failure to obtain informed consent is regarded as a violation of this principle. These and other ethical principles are used to resolve moral dilemmas as they are identified in human research. The basic conflict of values in human research arises from the fact that, on the one hand, the research action, which is designed to develop general izable new knowledge, is expected to contribute to medical science in a way that will be beneficial to the health of people; while on the other hand, a person is being used to produce the benefits that may not be benefits to him, he may be placed at risk, and is in danger of being manipulated for research purposes (Jonas, 1970). This fundamental conflict is perceived in the form of several more specific ethical issues. In human research generally, there are four ethical issues that have special relevance for research with the aged; and there is considerable debate regarding which ethical principle or which combination of principles should be applied in resolving them.

Ethical Problems in Research with Elderly Subjects

Five distinct areas of research in the elderly raise ethical problems that may call for special provisions or regulations: (1) anti-aging research; (2) health problems in the aged that make them vulnerable to selection for research; (3) conditions of the elderly that create problems of competence and free consent to research; (4) surrogate consent and the problem

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of guardianship; and (5) special problems in competence and free consent for the institutionalized elderly. (1) Anti-aging research. — There is increasing interest in research into the causes of biological aging that are not disease-associated and that determine the maximum life span — research aiming not merely to expand the life expectation of individuals but to develop antiaging techniques that might have the effect of extending the human life span itself. This research may not appear to have immediate implications for "research involving the elderly," inasmuch as most of the research currently done in this area does not involve the elderly as subjects, and the beneficiaries of such research might be any segment of the population, not just the elderly of the future. Yet this kind of research raises an important ethical issue: since a major emphasis is now being placed on research on aging as part of our biomedical effort to benefit the aged (U. S., DHEW, PHS, NIH, National Institute on Aging, 1977), the dominant ethical issue is allocation of resources for research on aging as compared to other benefits that might be made available for the aged. This general ethical issue in anti-aging research becomes an issue specific to research in the aged as anti-aging studies in elderly human subjects increase — a development that is becoming more likely at the present time (National Research Council, 1975; U. S., DHEW, PHS, NIH, National Institute on Aging, 1977b). This type of research in the elderly raises the following interrelated ethical issues: the equitable selection of elderly subjects who are already in demand for other research purposes, the justification of the research in light of its proposed goals and purposes, and the risk-benefit issue. The latter two are the most troublesome ethical problems in anti-aging research, as the following discussion indicates. The goals of anti-aging research include such intended benefits as reduction of vulnerability to disease and to physiological decrements. But it is not at all clear how desirable it is to gain knowledge of the basic biological processes of aging and to manipulate aging, for it is not certain, first of all, whether these capabilities will indeed benefit the individual or society (Hayflick, 1978). The results of the research might be the el imi nation of al I age-related physiological decrements, with the effect that humans could live vigorous, youthful lives until they die, without any natural slowing-down

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(4) Informed consent. — Consent — a voluntary act whereby an individual agrees to participate in the research action or project — is an essential requirement for human research. A reason commonly given for this requirement is that consent is a necessary means of protecting personal integrity and autonomy. Its prerequisites include: (1) the capacity or competence to give consent; (2) sufficient knowledge on which to decide; (3) sufficient comprehension of the information so as to be able to make an enlightened decision; and (4) freedom, both internal and external, as regards the choice to be made. In addition to the four basic ethical issues discussed above, there are five other ethical issues in research which are less directly related to the ethical problems of research in the aged. First, the research design itself raises ethical questions concerning the adequacy of the methods and procedures to be employed and the qualifications of all those involved in conducting the research. Virtually ignored in the literature is a second requirement of research, which calls for just remuneration (or compensation) for participation: a fair distribution of favors as inducements to participate, restrained appeals to altruism to encourage volunteerism, etc. A third issue addressed only recently is indemnification (or compensation) for injury, whereby the sponsor of research is obliged to redress physical, psychological, or social injury suffered by persons in connection with biomedical or behavioral research (U. S., DHEW, Office of the Secretary, 1977a, b, c). Additional ethical demands in the investigatorsubject relationship, such as privacy and confidentiality, constitute a fourth issue. Fifth, the entire area of social and professional control of research on the part of research institutions and sponsors (state and federal government, private industry) involves the ethical issues of responsibility and accountability.

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can be resolved, particularly by application of the three principles of beneficence, justice, and respect for persons, but only if the above mentioned factors are examined and monitored in terms of both ethics and technology assessment. (A national plan for research on aging has recently been developed [U. S., DHEW, PHS, NIH, National Institute on Aging, 1977a]). This assessment should take the following considerations and criteria into account (Christiansen, 1978; National Research Council, 1975): (1) identification and clarification of the objectives in anti-aging research, determination of its priority, and choice of investigations to serve desired objectives; (2) analysis of the anticipated benefit of the proposed technique (to the individual, to groups, and to society) as compared with potential physical and psychological harms or inconveniences; (3) the degree of availability of the anticipated technique; (4) the impact of anti-aging research on the just allocation of resources for biomedical research and health care generally; and (5) a just distribution of resources that may benefit the elderly: biological research in aging, health care services, and other needs such as housing, income, independence, and social role.

(2) Vulnerability to selection. — Much has been said about the vulnerability of the aged. For purposes of ethics, a distinction should be made between the health conditions of the elderly that make them a desirable pool of subjects for research and hence vulnerable to excessive use in research (i.e., the ethical issue of selection of subjects), and those health conditions and environmental circumstances of the elderly that reduce their competence and freedom and hence make them vulnerable to exploitation (i.e., the issue of informed consent). The problem of vulnerability to excessive selection affects the elderly, first, because physiological and psychological conditions unique to them are desirable objects of research. In addition to research into the normative biological, behavioral, and social aspects of aging in the aged, increasing research is being undertaken among populations of the elderly who are psychiatrically impaired because the prevalence of psychiatric impairment increases substantially with age. As it has been pointed out (Whanger & Busse, 1975), "As there is so little known about many of the psychiatric and social disorders of the elderly, and how they may best

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process. Or the results might enable an alteration of our "biological clocks" so that we might have, say, a 10-year extension of life, but only in the infirm years of old age. Or perhaps the biological clock could be stalled at any chronological age — say, 20— necessitating a choice that would be particularly difficult inasmuch as life-satisfaction and productivity can occur at any age (Hayflick, 1978). Furthermore, satisfaction may not be achieved because of the psychological impact and social tensions caused by the life extension. How desirable are these goals, particularly when compared with other competing research goals, such as arthritis research, which could notably improve the condition of the aged, or when compared with health care advances where benefits to the poor may be seriously restricted by the development of sophisticated technologies? Ironically, more desirable than the first goal, and also more attainable, may be a less successful version of the same — the reduction, not elimination, of physiological vulnerabilities associated with biological aging. Besides the question of personal benefit, the ethical issues in anti-aging research involve social, economic, and demographic elements. If a successful anti-aging technology is introduced (National Research Council, 1975), "its most likely effect will be to increase further both the number and proportion of people who live to be 'old' (i.e., chronologically old)," and who may or may not experience pronounced improvement in health and vigor. Changes in the productivity, earning power, and consumption of the elderly could cause far-reaching economic and political changes (National Research Councils 975). On the other hand, judging from the experience of the elderly in today's society, extending the life span could greatly aggravate and complicate the problems of poverty among the elderly, their health problems (especially chronic ailments), and problems of isolation. These problems would require extensive social and economic adjustment, not only for coping with the increased needs of the elderly, but — due to the interdependency between the older population and those in the labor force — with the increased social and economic problems of the young and middle-aged (National Research Council, 1975). In the development of research policy regarding the aged, the issues of moral justification of anti-aging research and its risk-benefit analysis

Ethical questions related to selection policies cannot be settled until more data on research

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with aged populations are available. A recent survey of institutional review boards (Survey Research Center, 1977) at 61 institutions indicates that, during a one-year period, approximately 10% of the more than 2,000 projects on which data were reported included as research subjects more than 25% in the 65-andolder category. Projects involving substantial proportions of older people were more likely to be expected to benefit the research subjects than those drawing more heavily on 19 to 40 year 6lds and to be less likely than the latter group to have risk that outweighs benefit to subjects, as evaluated by the research investigators. While surveys of this kind are beginning to provide some helpful data, additional studies are needed on the incidence and kinds of research in the aged, comparisons with the use and circumstances of other categories of subjects, and evaluations of research in the aged against the criteria for research such as standards for consent, selectivity, and risk.

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be dealt with, there is ample opportunity for basic and clinical research on psychogeriatric services." Second, the elderly are highly vulnerable to selection because they manifest a higher incidence of almost all noncontagious diseases than other age groups. Bernstein and Nelson conclude that "exploitation of this group in medical research may exceed that of children or the mentally handicapped": hence they believe geriatric subjects require special protections (Bernstein & Nelson, 1975). Clearly, the elderly are more vulnerable when one considers their greater likelihood of reduced competence and freedom, and particularly when they are institutionalized — factors that will be discussed below. But even prior to those considerations there exists an ethical question of the possibility of excessive selection of elderly subjects for research. The dilemma is a sharp one: on the one hand, the principle of respect for persons would incline toward a restricted use of the elderly because of their various vulnerabilities; on the other hand, the princi pie of beneficence incl ines toward an expanded use of elderly subjects, due to the likelihood that some research (e.g., that dealing with psychiatric impairments in aging), may be beneficial to the elderly. The principle of just distribution, though normally regarded as the dominant one in the allocation of research burdens and benefits, certainly cannot be regarded as the sole criterion. A proportionate or disproportionate use of the elderly in research is not simply calculated arithmetically (e.g., in proportion to the percentage of the aged in the population at large), but rather by an assessment of relevant factors. Among these factors are: whether the elderly have the same basic obligation as others to promote health through involvement in research; whether the elderly subjects are vulnerable to exploitation; whether they are bearing other social burdens; whether other less coerced or less vulnerable categories of potential research subjects are available; the urgency of the need to gain knowledge from the research; whether the potential subjects might benefit from personal involvement in the research activity itself (e.g., a feeling of satisfaction, free medical treatment); whether they are expected to benefit medically from the anticipated knowledge to be gained from research, etc.

(3) Vulnerability due to reduced competence and freedom. — The principle of respect for persons requires one to determine whether, as stated in the Nuremberg Code, the subject is "so situated as to be able to exercise free power of choice" in consenting to participate in research. The high incidence of physical and mental impairment in the aged, together with other negative factors, in the experience of being elderly, can greatly hinder competence and freedom, even for the noninstitutionalized. This situation is the basis for concern about the voluntariness and freedom of the aged subject's informed consent (Bernstein & Nelson, 1975). Among the elderly there is a high incidence of anemia and a variety of physical impairments and chronic illnesses. Psychiatric impairments increase with age, whether caused by degenerative diseases, "senility," or psychological stress (Libow & Zicklin, 1973; U. S., White House Conference, 1971). "Of the estimated 20,000,000 persons in the United States who are 65 years of age or older, approximately 4,000,000 have suffered moderate to severe psychiatric impairment secondary to eithe; cerebral arteriosclerosis, senile dementia, functional psychoses, alcoholism, or various other medical conditions." The loss of physical and mental powers is frequently accompanied by a loss of social and economic resources at a time when special adjustments are necessary because of internal and external changes. These

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the study and who is committed to assisting the elderly subject assert his or her own best interest, may assist in providing the necessary assurance of competence and freedom (Axelsen & Wiggins, 1977). (4) Surrogate consent: the problem of guardianship. — There is an important ethical question which requires legal as well as nonlegal policy clarification: What distinctive requirements should exist as regards participation of an incompetent or questionably competent elderly person in research? More specifically, can surrogate or proxy consent to human research involving the aged who are morally incompetent be justified, and if so, under what conditions and with what restrictions? When the elderly are no longer morally competent to manage their personal or business affairs, it is possible, in many states, to appoint either a guardian of property or a guardian of person to make significant, legally binding decisions on behalf of the elderly person. A guardian of property (or estate) can be appointed when someone has been declared legally incompetent to manage his own affairs; a guardian of person is appointed to be responsible for the care of the person. Generally, when a guardian has been appointed for the estate, the individual continues to be competent for matters governing his person. Thus, as to informed consent for research, the individual would be regarded as legally competent to give or withhold it. In jurisdictions where guardians are appointed for the person and such a guardian is actually appointed, or where there is no distinction between guardian for the person and the estate, in such circumstances the individual is regarded as not capable of providing informed consent to personal involvement in research. Although the vast majority of mentally impaired elderly individuals has not been declared legally incompetent, reflection on the role of a guardian functioning for an elderly person raises two important questions that deserve careful study: (1) What procedural protections should be offered for the incompetent elderly in reference to their involvement in human research? and (2) What substantive rules should govern the consent requirement in reference to the incompetent elderly? Regarding the first question, it is important to note that whereas a child is generally presumed in the law to be legally incompetent and the parent to be its guardian for all matters, an

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experiences of increasing powerlessness are often accompanied by feelings of helplessness, the fear of dependency due to chronic disability, and the anticipation of feelings of humiliation (Christiansen, 1978). Other factors further aggravate this ethical problem. First, the sick present a special problem, inasmuch as they may be quite suggestible and may fear the loss of attentive medical care (American Heart Association, 1974). This would be particularly true of the sick elderly. This consideration has led Jonas to argue that the sick should be involved in research only as a last resort and then only if the experiment is directly related to their own disease (Jonas, 1970; Walters, 1977). Second, when a physician uses his or her own elderly patients as subjects, there is considerable likelihood that the dependency relationship between patient and care-giver will cause the subject to trust blindly, without judging whether the action is suitably beneficial or nonharmful: thus the freedom and voluntariness of the action may be seriously impaired (Axelsen & Wiggins, 1977). Third, if, in addition, the project offers medication or other care which otherwise is not available to the subjects or which they cannot afford, the freedom and voluntariness of the subjects' choice may be rendered suspect (Axelsen & Wiggins, 1977; Freund, 1970). Fourth (Butler, 1975), "many older people want the opportunity to contribute to others through participation in research studies; but they should . . . not be misled or abused" (i.e., the elderly should not be made victims of their own altruism or of their need to be needed). In summary, the physical, mental, social, economic, and psychological conditions of the elderly, together with special circumstances in their therapeutic setting, make them particularly vulnerable to exploitation due to reduced competence and freedom. If these factors are assessed, whether singly or cumulatively, in light of the principle of respect for persons, special protections may be needed for the elderly. The following are some possible protections: (1) The review process should include the perspective of elderly persons who are not institutionally committed to the research. (2) Some special assessment of the competence of the elderly may be required, if this can be done without undue offense against the principle of respect for persons. (3) The additional judgment of a third party such as a relative or a patient advocate, who has no vested interest in

One might assume that the application of this rule to experimentation with the legally and morally incompetent elderly would mean that consent could be given only for the protec-

tion of the interests or welfare of the individual subject (Annas et al., 1977). However, in some legal cases dealing with medical decisions, the courts have interpreted "the interests or welfare of the individual subject" somewhat broadly, as in a case in which a guardian was appointed — in this case, a parent — who consented to a kidney donation from an incompetent adult to his sibling on grounds of the benefit to the donor (Strunk vs. Strunk, 1969). Whether this is the direction that should be taken in human experimentation is far from settled. It should be noted that the National Commission has proposed regulations that would permit surrogate consent to nonbeneficial research on children and the insitutionalized mentally infirm by employing principles other than those designed to protect the interests of the individual subject. Yet partly because of the legal ambiguity existing in regard to the protection of the incompetent elderly, one must reexamine the moral arguments offered concerning proxy consent — arguments that may be applicable to the situation of the elderly. The literature on proxy consent to research in children can provide some principles. For example, there is Ramsey's view that the use of nonconsenting children is wrong, whatever the risk, simply because it involves an "unconsented touching," except perhaps when the intervention is medically therapeutic to the subject (Ramsey, 1970). Or one might take McCormick's position that the nonconsenting child may be used as a subject of research not medically beneficial to the subject, provided there is no discernible risk, since all are obliged to contribute to the general welfare in a good as basic as developing means for preserving life, especially when this contribution requires little or no sacrifice (McCormick, 1974). However, there is a crucial distinction to be drawn between incompetent children and persons who are incompetent only at an advanced age: the former have never had a set of personal values while the latter have. Furthermore, there is a problem of a more general sort. Benefits may flow to the surrogate for giving the consent while all the potential burdens will be carried by the subject. The benefits that might have accrued to the elderly subject are those that may no longer be benefits (e.g., the altruism that he felt at a time when he could express it but which at this point he does not feel at all). The moral hazards of permitting surrogate decision-makers to give proxy consent for re-

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adult is presumed to be of sound mind. Should an adult become incompetent in fact, a guardian of his person would be appointed only if someone initiates judicial proceedings to have him declared incompetent and to have a guardian appointed. Consequently, as regards the nonadjudicated, incompetent elderly who are potential research subjects, particularly those who are not institutionalized, there is absent a presumption of protection that is present in the case of children. On the other hand, one should not assume that guardianship ought to be the standard means of protecting the elderly. Guardianship is, by and large, an extraordinarily intrusive legal device. It strips the individual of his legal capacity to vote, to determine place of residence, and to make free and independent choiceson a variety of things; petitions for guardianship over the allegedly incompetent elderly are rarely challenged; and one cannot assume that guardianships are always placed upon the elderly in their interests. A first step toward resolving the procedural dilemma would be the recommendation (Libow & Zicklin, 1973) that the incompetent, prior to their mental decline, be permitted by law to designate the person they want to be their guardian, for medical and other personal decisions. Whether consent to research with the incompetent elderly should be restricted to such guardians or, in their absence, to near relatives is a question deserving the most careful attention. The second question, regarding substantive rules for surrogate consent, can also take the conditions for legal guardianship as a starting point. A guardian is appointed for one who (Annas et al., 1977) "does not have the intelligence and capability to comprehend fully the nature and purpose of a procedure or to engage in the weighing of risks and benefits which is involved in the decision-making process." The purpose for the legal appointment of a guardian for an incompetent elderly person is "the protection of the incompetent individual Trom harm that might result from either his own lack of knowledge or from coercive methods used to obtain his consent... Under the common law, guardian consent on behalf of an incompetent may only be granted or withheld on the sole basis of the incompetent's welfare."

(5) Vulnerability of the institutionalized elderly. — It has been claimed (Butler, 1975) that research involving the aged "has concentrated primarily on studies of the 5% of elderly who are in institutions." Whatever may be the extent of research in the institutionalized elderly, it is clear that nursing homes are the setting for both biomedical (Axelsen & Wiggins, 1977) and behavioral research (Citrin & Dixon, 1977). Furthermore, according to sociological studies by Barber and Gray (Walters, 1977), clinic or ward patients "seem to be involved to a disproportionate extent as the subjects of biomedical research." A significant ethical issue arises in the context of research among elderly persons in nursing homes, homes for the aged, geriatric wards, and institutions for the mentally infirm, insofar as they are captive populations subject to exploitation in general and a diminution of freedom and voluntariness in particular. That the institutionalized elderly, especially the sick or weak elderly, are a captive population open to explicit abuses in research is

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clear from the classic case of The Jewish Chronic Disease Hospital, in which three physicians, with approval from the hospital's director of medicine, injected "live cancer cells" subcutaneously into 22 chronically ill and debilitated patients. The test was unrelated to the patients' normal therapeutic program, their consent was not obtained, and many of them were incapable of giving consent (Katz et al., 1972). In addition to the possible problem of explicit abuses of consent requirements; among the institutionalized elderly, more subtle yet equally crucial problems of consent can arise among these populations. Whether or not the residents of these institutions are intellectually competent, the demeaning treatment, the dependence created by institutionalization, and the powerful inducements to conform to institutional expectations create inherent coercions, constraints, and obstacles to both competent and free (voluntary) consent in a significant number of these institutions (American Public Health Association, 1973; Mason, 1974). Many institutions for the aged are characterized by dehumanizing conditions. For example, while some U. S. nursing homes are excellent institutions, a large number are characterized by neglect, leading to sickness and death; inadequate feeding; poor sanitation and hygiene; reprisals against those who complain; poor surveillance of medication; stealing and manipulation of inmates' money; profiteering; denial of free public access — and most of the elderly residents have little or no choice of living elsewhere (Butler, 1975; U. S. Congress, 1976). One may also point (Butler, 1975) to similar conditions in other institutions, such as mental hospitals, where many people are housed who really should not have to be there. Many nursing homes, geriatric wards, and mental hospitals have the characteristics of total institutions: simply by their institutional structures and expectations, they determine the behavior of their residents (Goffman, 1961). According to one description (Citrin & Dixon, 1977), a radical alteration in life-style following institutional ization, joined with increasing demands by the institution's staff and decreasing physical functioning frequently brings about socially withdrawn, confused, or disoriented behavior among the elderly. Thus (Butler, 1975), substantial numbers of patients in mental hospitals develop a chronic state of psychological dependence and deterioration. Infantilization

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search in the elderly deserve the most careful scrutiny. My own view is that the principle of respect for persons, as applied to this kind of situation, obliges us to respect the autonomy of the individual and not to act in a way that violates or may violate the personal values of the subject, whether those values are presently being expressed or were previously expressed. In an area like human research, where justification relies on such individual attitudes and values like altruism and acceptance of risk, it seems that the principle of respect for persons requires a policy that an incompetent elderly subject, who previously had a personal set of values, may not be approved for participation in a nonbeneficial research project by a surrogate decision-maker ("proxy consent") unless the surrogate is familiar with, and presumably acting on, the significant attitudes and values of the potential subject. Furthermore, the principle, "Do no harm," would seem to require that the research not entail any but minimal risk of harm, unless expressly stated otherwise by the incompetent person while he was still competent. The other canons of research should be appl ied (e.g., that no less risk-filled research action can achieve the same worthwhile purposes, that there is a compelling reason why the competent cannot be used as subjects, etc.).

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the benefit of taking part in a research project to bring diversity and purpose into their lives, this beneficent motive cannot be expected to correct whatever constraining conditions may already exist in the institution. Precautions may also be necessary because of considerations of justice. If the institutionalized aged are used in research (U. S., National Commission, 1976) "because of their captive status and administrative availability" without due regard for the need to distribute these burdens among noncaptive populations, this would be a violation of the equitable distribution required by justice. Furthermore, when institutions seriously and systematically neglect their responsibility to provide humane care of the aged, making the elderly excessively vulnerable to risks and exploitation, that would seem to raise a prima facie suspicion about the ethical propriety of research — particularly research that is medically nonbeneficial to the subjects — involving that population in that same environment of care, namely in those nursing homes, mental hospitals, etc., where those abuses occur. These institutional factors may warrant some of the following policy protections, in addition to those recommended above in response to problems of reduced competence and freedom: (1) When there are risks of physical or psychological harm, the burden of proof must fall on potential investigators to show that the reasons for using institutionalized elderly are compelling. Noninstitutionalized volunteers from the community should be preferred. (2) Minimal requirements for free consent on the part of the institutionalized elderly should probably include (a) adequate living and health conditions, verified by an accreditation system; (b) provisions for effective redress of grievances; and (c) a system of public access to, and scrutiny of, the institutions. Exception to requirement (a), dictated by a principle of beneficence, might include studies of mental hospitals, nursing homes, etc., as institutional structures (provided these studies "present minimal or t no risk and no more than mere inconvenience to the subjects"), as well as research on practices which are intended as, and are likely to be, medically beneficial to the elderly subject-resident (U. S., National. Commission, 1976).

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and loss of self-image are frequently the result of institutionalization and interaction with the institution's staff. In addition the residents are inclined to want to please staff or physicians upon whom their well-being depends; they are frequently economically captive; and are highly vulnerable to manipulation by the granting or withholding of institutional privileges. They are subject, furthermore, to all the vulnerabilities of selection and reduced competence and freedom that are characteristic of the noninstitutionalized elderly mentioned earlier. Indeed it has been estimated (Butler, 1977) that senile dementia is "probably the reason at least 50% of the patients enter American nursing homes." The institutional conditions of many of the aged may, then, present coercions, constraints, and obstacles to competent and free consent. Although these institutions are diversified and their residents are to some extent heterogeneous, serious doubts arise as to whether sufficient and minimal protection is being offered to their residents with regard'to biomedical and behavioral research. This observation can be supported by the way in which some basic principles have been applied to an analogous situation in prisons. The National Commission, in its Report, Research Involving Prisoners, concluded that the conditions of social and economic deprivation in which prisoners live compromise their freedom, even if individually they affirm that they participate freely in research. The Commission stated (U. S., National Commission, 1976): "When persons seem regularly to engage in activities which, were they stronger or in better circumstances, they would avoid, respect dictates that they be protected against those forces that appear to compel their choices." Because the principle of respect for persons "consists of protection from exploitation," the Commission concluded (U. S., National Commission, 1976) there is need for "certain safeguards intended to reduce the elements of constraint under which prisoners give consent," and it further suggested "that certain kinds of research would not be permitted where such safeguards cannot be assured." A preliminary view of conditions in many institutions for the aged leads one to suspect that a similar conclusion may be warranted for the protection of the elderly. And while one might employ a principle of beneficence to argue that the institutionalized elderly should be provided

(3) The review process must include (American Public Health Association, 1973) "a monitoring of ongoing research for altered research plans, or other changed circumstances, in addition to the review of research protocols."

Conclusion

There are five areas in which significant ethical issues are raised by research with the aged. Whether taken singly or especially when regarded cumulatively, these ethical problems seem to require some special protections, in the form of federal regulations or guidelines, institutional regulations, and/or professional standards and codes. Certainly some well designed, interdisciplinary studies, focusing on the ethical issues, are essential. This article is intended as a partial agenda for a sustained investigation in this area. The investigation should make inquiry into: (1) the definition of the aged for purposes of clarifying the situation with respect to research involving them; (2) the nature and extent of biomedical and behavioral research involving the aged together with criteria used for their selection; (3) the current state of knowledge on physiological and psychological conditions in the aged that may make them vulnerable in the various ways suggested in this article; (4) the conditions under which research in the aged is conducted, especially in institutions — homes for the aged, nursing homes, geriatric wards, and mental hospitals — including a profile of the relevant institutional factors especially those posing a risk for impairing freedom; (5) the question of consent and how it is obtained, as well as the differences of consent obtained with or without the assistance of advocates; (6) the goals, purposes, and priorities of research involving the aged, the risks and benefits commonly expected, and the principles for assessing them; and (7) the possible grounds for promoting research in conformity with present and developing regulations, or for regulating such research according to reasonable, ethical standards.

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Noting a general neglect of studies on ethical aspects of biomedical and behavioral research involving elderly subjects, this article first explains three ethical principles that are particularly applicable to human research — the principles of beneficence, Just distribution, and respect for persons — and the four ethical issues in human research that have a special bearing on research in the aged: (1) the goals and purposes of research: its moral justification; (2) risk-benefit analysis; (3) selection of subjects; and (4) informed consent. Second, within a methodological framework characterized by these principles and issues, together with associated ethical rules, the article identifies five aspects of research in the elderly that raise distinctive ethical problems: (1) anti-aging research; (2) health problems in the aged that make them vulnerable to excessive selection for reseach; (3) conditions of the elderly that create problems of competence and free consent to research; (4) surrogate consent and the problem of guardianship; and (5) special problems in competence and free consent for the institutional izecJ elderly. Scientific studies and sources from various disciplines are cited to clarify the problems, to arrive at ethical conclusions, and to make tentative proposals concerning policies needed for the protection of elderly research subjects. The policy proposals include recommendations regarding clarification of the objectives and priorities of research such as anti-aging studies; a just distribution of research burdens and benefits among the aged according to stated factors; inclusion in the review process of the perspective of elderly persons not committed to the research; assessment of the competence of the elderly in some circumstances; use of a patient advocate to assist in assessing competence and freedom of potential elderly subjects; facilitation of legal designation of personal guardian by the subject prior to mental decline and incompetence; restriction on use of institutionalized elderly subjects; and accreditation of institutions for the elderly where research would be conducted. Third, the article proposes an agenda for a sustained interdisciplinary study of the ethical and policy dimensions of research with aged subjects. References American Heart Assoc, Committee on Ethics. Ethical im-

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(4) Institutional review committees should include (American Public Health Association, 1973) "representatives of the proposed subject population and noninstitutionally affiliated professionals selected by the subjects and other appropriate citizens from the community at large."

Summary

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1975,23, 327-329. &Row, New York, 1975. Butler, R. N. Statement of Robert N. Butler, MD, Director, National Inst. on Aging. Medicine and aging: An assessment of opportunities and neglect: Hearing before the Special Committee on Aging, United States Senate. 94th

Cong., 2d sess., New York, 13 Oct., 1976. USGPO, Washington, 1977. Capron, A. M. Human experimentation: Basic issues. In W. T. Reich (Ed.), Encyclopedia of bioethics. Free Press, New York (in press). Christiansen, D. Aging and the aged: Ethical implications in aging. In W. T. Reich (Ed.), Encyclopedia of bioethics. Free Press, New York (in press). Citrin, R. S., & Dixon, D. D. Reality orientation: A milieu therapy used in an institution for the aged. Cerontologist, 1977, 17, 39-43. Freund, P. A.v(Ed.) Experimentation with human subjects.

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Original. Doubleday, Garden City, New York, 1961. Hayflick, H. Aging and the aged: Theories of aging and antiaging techniques. In W. T. Reich (Ed.), Encyclopedia of bioethics. Free Press, New York (in press). Jonas, H. Philosophical reflections on experimenting with human subjects. In P. A. Freund (Ed.), Experimentation with human subjects. The Daedalus Library. George Braziller, New York, 1970. Katz, J., Capron, A. M., & Glass, E. S. Experimentation with human beings: The authority of the investigator, subject, professions, and state in the human experimentation

process. Russell Sage Foundation, New York, 1972. Libow, L. S., & Zicklin, R. The penultimate will: Its potential as an instrument to protect the mentally deteriorated elderly. Gerontologist, 1973, 13, 440-442. McCormick, R. A. Proxy consent in the experimentation situation.

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havioral Research. 1 Nov., 1977. (Available from The National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161, order no. PB273360/AS). U. S. Congress, House Select Committee on Aging, Subcommittee on Health and Long-term Care. Nursing home auditing and standards: Preliminary findings. New perspectives in health care for older Americans, recommendations and policy directions: Report, together with additional and supplemental views. 94th

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no. 05-77-003. NIH, Bethesda, MD. USGPO, Washington, 1977. (a) U. S. Dept. of Health, Education, & Welfare, Office of the Secretary. HEW Secretary's Task Force on the Compensation of Injured Research Subjects. Appendix A: Materials cited in the principal report. HEW Publ. no.

OS-77-004. NIH, Bethesda, MD. USGPO, Washington, 1977. (b) U. S. Dept. of Health, Education, & Welfare, Office of the Secretary. HEW Secretary's Task Force on the Compensation of Injured Research Subjects. Appendix B: Materials and correspondence not cited in the principal report, but relevant to the works of the Task Force.

HEW Publ. no. OS-77-005. NIH, Bethesda, MD. usgpo, Washington, 1977. (c) U. S. Dept. of Health, Education, & Welfare, Public Health Service, N I H , NIA. Our future selves: A research plan toward understanding aging. DHEW Publ. no.

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U. S. White House Conference on Aging, 1971, Technical Committee on Physical and Mental Health, E. J. Lorenze, chairman. Physical and mental health: Background, issues. USGPO, Washington, 1.971. Walters, L. Some ethical issues in research involving human subjects. Perspectives in Biology and Medicine, 1977, 20, 193-211. Whanger, A. D., & Busse, E. W. Care in hospital. In J. G. Howells (Ed.), Modern perspectives in the psychiatry of old age. Modern perspectives in psychiatry, J. G. Howells (Ed.), no. 6. Brunner/Mazel, New York, 1975. World Medical Assoc. Declaration of Helsinki. New England Journal of Medicine, 1964,27/, 473-474. World Medical Assoc. The Declaration of Helsinki: Recommendations guiding doctors in biomedical research involving human subjects, adopted by the 18th World Medical Assy., Helsinki, Finland, 1964, and as revised by the 29th World Medical Assy., Tokyo, Japan, 1975. World Medical Journal, 1976, 23, 76-77, App. B. Young, E. W. D. Aging and the aged: Health care and experimentation in the aged. In W. T. Reich (Ed.), Encyclopedia of bioethics. Free Press, New York, (in press)

Fact Book on Aging A Profile of America's Older Population Published by the National Council on the Aging. 270 pp., 8V2 x 11, paperback. $8.50, NCOA Members; $10, Non-Members. Invaluable reference tool. First complete sourcebook of information on U.S. older population. Consolidates extensive current data. Categorizes and summarizes present knowledge in eight areas of aging: demography, income, employment, physical and mental health, housing, transportation and criminal victimization. Tables, charts and bibliography accompany the narrative of each chapter. Provides total profile, filling out easily accessible facts with data not readily available. Sources include computer tapes, national social science studies, books arid articles by leading gerontologists, federal government publications and the landmark NCOA/Louis Harris & Associates survey, The Myth and Reality of Aging in A merica. Order from: Publications Dept. G, The National Council on the Aging, Inc. 1828 L St., NW, Washington, D.C. 20036

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chosurgery: Report and recommendations. DHEW Publ. no. (OS) 77-0001. USGPO, Washington, 1977. (a) S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Disclosure of research information under the Freedom of Information Act. DHEW Publ. no. (OS) 77-0003. UGSPO, Washington, 1977. (b) S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Research involving children: Report and recommendations. DHEW Publ. no. (OS) 77-0004. USGPO, Washington, 1977. (c) (Reports are forthcoming on research involving the institutionalized mentally infirm, advances in biomedical and behavioral research, basic ethical principles that should underlie the conduct of research on human subjects, the performance of institutional review boards, and application of research guidelines to the delivery of health service. Each report, except Disclosure of Research Information, includes an extensive appendix published separately. All these, and various unpublished materials, may be obtained by writing the National Commission, Public Information Officer, Westwood Bldg., Room 125, 5333 Westbard Ave., Bethesda, MD 20016.)