6

Research in Biomedical Ethics

Individual older persons and the aging American society as a whole face dilemmas regarding life-sustaining treatment, distribution of limited health care resources, and participation in clinical research by vulnerable elderly persons. Research can help clarify the underlying ethical issues, analyze the arguments for and against various stances, and forge a social consensus to guide clinical care and overall health care policy. Furthermore, empirical studies in biomedical ethics can help identify in current practice any variance from recommended guidelines, and develop guidelines and evaluate interventions to improve clinical practice.

Although the topics and research recommendations developed in this chapter focus on the problems of older persons, many of these issues (e.g., decreased mental competence, need for advance directives, disabled patients without families or friends) concern younger disabled persons as well.

RESEARCH PRIORITIES

Sufficient funds should be made available to conduct research on the ethical dilemmas involved in the provision of life-sustaining treatment, the allocation of health care resources, and the participation in clinical research by frail and elderly persons. Using the broad areas of investigation listed here, one can formulate specific research questions to include both empirical and analytical studies.



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Extending Life, Enhancing Life: A National Research Agenda on Aging 6 Research in Biomedical Ethics Individual older persons and the aging American society as a whole face dilemmas regarding life-sustaining treatment, distribution of limited health care resources, and participation in clinical research by vulnerable elderly persons. Research can help clarify the underlying ethical issues, analyze the arguments for and against various stances, and forge a social consensus to guide clinical care and overall health care policy. Furthermore, empirical studies in biomedical ethics can help identify in current practice any variance from recommended guidelines, and develop guidelines and evaluate interventions to improve clinical practice. Although the topics and research recommendations developed in this chapter focus on the problems of older persons, many of these issues (e.g., decreased mental competence, need for advance directives, disabled patients without families or friends) concern younger disabled persons as well. RESEARCH PRIORITIES Sufficient funds should be made available to conduct research on the ethical dilemmas involved in the provision of life-sustaining treatment, the allocation of health care resources, and the participation in clinical research by frail and elderly persons. Using the broad areas of investigation listed here, one can formulate specific research questions to include both empirical and analytical studies.

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Extending Life, Enhancing Life: A National Research Agenda on Aging Life-Sustaining Treatment in Older Persons The committee recommends research on decisions regarding life-sustaining treatment in older persons. The medical technology that allows physicians to prolong life in patients with serious illnesses may not always be appropriate. According to ethical, medical, and legal guidelines, competent informed patients may refuse life-sustaining treatments. For patients who lack the capacity to give informed consent or refusal, such as elderly patients with severe dementia, decisions concerning medical care should respect wishes previously expressed by the patient (President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982, 1983; Annas and Glantz, 1986a; American College of Physicians, 1989a,b). Such declarations by competent patients of what care they would or would not want if they became incompetent are called “advance directives.” However, these guidelines may be problematic for elderly persons. Although most elderly persons welcome the opportunity to discuss their preferences for (or against) life-sustaining treatment, they infrequently develop or invoke specific advance directives (Lo et al., 1986). Further knowledge is needed about ethical questions concerning both those isolated elderly patients who are institutionalized and those older persons who are not institutionalized, but who do not have relatives or close friends to act as surrogates. (It is important to note that the number of isolated older people most likely will continue to grow in the coming decades.) Improving Discussions About Life-Sustaining Treatment Research is required to lay the foundation for increased understanding of what requires improvement in decisions about life-sustaining treatment among physicians, families, and institutions. Educational interventions that encourage health care providers and patients to discuss life-sustaining treatments need to be developed. In the absence of explicit discussions, physicians and family members cannot predict a patient's preferences for (or against) treatment (Bedell and Delbanco, 1984; Uhlmann et al., 1988). Such discussions might be more effective if more were known about how physicians currently engage in them. More needs to be known about how well elderly patients understand the issues at stake, how their understanding might be improved, how their preferences might change over time, and how they can be given specific directives about life-sustaining treatments.

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Extending Life, Enhancing Life: A National Research Agenda on Aging The focus of research on older patients' acceptance or rejection of life-sustaining treatment may vary, depending on whether the decision involves patients and their families or is limited to isolated institutionalized and noninstitutionalized older persons. Several problems with advance directives must be resolved. The durable power of attorney for health care is the most effective type of advance directive because it allows competent patients both to designate surrogates and to specify the types of treatments they do and do not want (President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1983; Buchanan and Brock, 1986; Force, 1988). However, such advance directives cannot be used by patients with no relatives or friends to be designated as surrogate decision makers. Living wills are ineffective for such patients because they apply only in cases of terminal illness and are inapplicable to such situations as severe dementia (President 's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1983; Buchanan and Brock, 1986; Force, 1988). Thus, to ensure that patients' preferences are respected if they become incompetent, new procedures need to be devised for patients with no one to serve as a surrogate. Because legal problems often arise in this context, as well as in other areas reviewed in this chapter, these problems present an opportunity for collaborative research between medical and legal scholars. Improving Decision Making for Incompetent Patients Who Have Not Given Clear Advance Directives Such situations are common and perplexing. Consensus has not been reached regarding either the level of specificity required by an advance directive or the discretion afforded family members in interpreting such directives (Veatch, 1984; Rhoden, 1988). Further, when the incompetent patient's preferences are unclear or unknown, no specific guidelines delineate how the patient's best interests should be determined, what role quality of life considerations should play, and what safeguards are desirable for particularly vulnerable nursing home residents (Buchanan and Brock, 1986; Lo and Dornbrand, 1986; Lo, 1988). In addition, research is indicated on how advance directives play out —behaviorally and legally—to inform revision in ethical standards and law. Further analysis of these issues is needed; discrepancies among clinical practice, ethical guidelines, and case law must be studied.

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Extending Life, Enhancing Life: A National Research Agenda on Aging Defining the Role of Institutional Ethics Committees, Particularly Within Nursing Homes Such committees have been proposed to improve decision making about life-sustaining treatments and to serve as an alternative to time-consuming and cumbersome legal proceedings (Cranford and Doudera, 1984). However, more must be learned about the benefits and drawbacks of such committees, their optimal structure and procedures, and their impact on clinical decisions (Lo, 1987). Establishing Medical Futility Physicians and other providers sometimes decide to withhold treatment because it is considered medically futile. Better data are needed on prognosis and outcome in seriously ill elderly patients. Although some good data are available about cardiopulmonary resuscitation (Bedell and Delbanco, 1984), many other life-sustaining treatments should be studied, particularly those affecting the critically ill and patients of very advanced age (over age 85) (Force, 1988). In addition, the concept of futility itself should be analyzed. The term can be used in many ways, some of which do not constitute acceptable justification for physicians to withhold treatment (Youngner, 1988). Resolving Disagreements Between Health Care Professionals and Patients (or Patients' Families) Caregivers may insist on giving a treatment—particularly artificial feedings—despite the refusal of the patient or family (Steinbrook and Lo, 1988; Miles et al., 1989). Court rulings on cases involving such disagreements are often misunderstood by physicians, such as interpreting the Supreme Court's ruling on nasogastric feedings in the Cruzan case to mean that nasogastric feedings can never be discontinued in incompetent patients (Kapp and Lo, 1986; Annas, 1990; Lo et al., 1990). Formal study should be undertaken to learn more about how physician perception of legal requirements and liability affects decision making, and further legal and ethical analyses are needed to begin to develop a consensus on how best to resolve these dilemmas. An area of research involving disagreements between caregivers and patients that deserves further attention, although it relates more to patient comfort and contentment than to life-and-death issues, involves study of day-to-day ethical problems, such as conflicts between autonomy and paternalism in long-term care (Kane and Caplan, 1989). Specific examples include nursing home patients

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Extending Life, Enhancing Life: A National Research Agenda on Aging who do not wish to have their hours of rising and retiring, along with other activities, set by caregivers, or who want to be able to refuse therapy, even when it is indicated. Issues of Equity and Access The committee recommends research on issues of equity and access. The projected increase in the number of elderly Americans, the rising costs of Medicare, competing social needs, and continuing federal budget deficits have imposed artificial pressures on caregivers to limit health care spending in general and to limit care to the elderly in particular (as seen, for example, in the early discharge and decreased rehabilitative care given to patients operated on for hip fracture). Although difficult decisions regarding allocation of scarce resources are inevitable, no agreement now exists on how such rationing may be accomplished in an equitable manner that does not compromise access to basic health care resources (Daniels, 1986; Engelhardt and Rie, 1986; Miller and Miller, 1986). Identification of Criteria for Appropriate Practice Standards Standards must be developed for such health care services as cataract surgery, hip replacement, and cancer screening and treatment for the elderly. Given the wide regional variation in the use of such treatments, it is important to develop criteria that establish when these treatments become appropriate. Health services research on functional outcomes can elucidate the effectiveness of various therapies and identify those groups of patients for whom certain therapies are less effective. In addition, public forums and consensus conferences that focus on resource allocation can seek to forge public and professional agreement on the priorities to be set among various therapies to be made available to different patient populations. Age as a Criterion for Allocating Health Care Resources Chronological age per se has been proposed as the basis upon which health care expenditures should be limited (Brook, 1989). However, critics point out that the elderly are heterogeneous in both function and prognosis and that justice requires that costly therapies used in other age groups also should be scrutinized (Avorn, 1984; Callahan, 1987; Schneider, 1989). More data, debate, and analysis are needed to determine if or when health care resources should be

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Extending Life, Enhancing Life: A National Research Agenda on Aging allocated on the basis of age and to define those basic health care resources to which all elderly persons should have access. No data concerning how the American public regards rationed care based on age have been amassed. It is important to identify misunderstandings of fact regarding rationing (e.g., that inordinate sums are spent on the intensive care of dying older patients) that might hinder policy decisions; educational programs must be devised to correct such misconceptions. Furthermore, the views of the public will be crucial in shaping a social consensus on these complicated and potentially divisive issues. In addition to helping us determine how health care resources should be allocated, research can help us understand the current system of allocating health care services to the elderly (Avorn, 1984; Scitovsky and Capron, 1986; Anderson et al., 1989). For example, present incentives for early patient discharge, for outpatient in lieu of inpatient care, and for technological services rather than preventive and case management care may have particularly deleterious effects on the elderly (Grumet, 1989; Leaf, 1989). The distribution of benefits and burdens of the current allocation system should be examined, discussed, and debated more explicitly to facilitate more realistic decision making. Allocation of Resources for Patient Care and for Research Resources available to devote to biomedical research, health services research, and patient care research are not unlimited. As suggested throughout this report, priorities need to be set to allocate these limited resources in a rational manner. Until recently, little research was dedicated to the most prevalent and disabling diseases of old age—the degenerative neurological diseases and the musculoskeletal diseases. Wide-ranging discussion, both with members of the public at large (especially the elderly) and with scientists, could help clarify the value choices that must be made to set future research priorities and could help establish procedures and criteria for allocating resources to the research endeavor. Other research issues concerning allocation of resources include decisions about distribution of funds to support preventive care versus high-technology care in older persons, the allocation of funds to support health education compared with direct health care, the competition among different age cohorts for expensive treatment programs (e.g., bone marrow and organ transplant, hemodialysis, coronary artery bypass surgery), and the assignment of research

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Extending Life, Enhancing Life: A National Research Agenda on Aging support to study the role of poverty in health among elderly persons as compared to younger subjects. Ethical Issues in Aging Research The committee recommends research on biomedical ethical issues involving participation in clinical research by frail elderly persons. This report documents the need for significant increases in research on diseases and disorders afflicting the elderly. Disorders such as dementia, incontinence, and falls impair functioning and may lead to either home-based or institutional long-term care. Paradoxically, frail elderly persons with such disorders—ideal research subjects —may be among those least likely or physically able to participate as subjects of research (Brieger, 1978; Annas and Glantz, 1986b; Dubler, 1987; Kane and Manoukian, 1989). However, intensive research is needed to elucidate the etiology of these conditions and to find effective treatments. Patients with severe dementia lack the capacity to give informed consent to participate in research. Institutionalization, regardless of cognitive function, impairs the autonomy of residents, making it difficult for them to decline to participate in research (Cassel, 1985, 1987, 1988). These problems were amply documented by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974 and led to appropriate restraint in the use of nursing home patients as research subjects (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978a, b). For this vitally needed research, the population of incapacitated and institutionalized people able to serve as research subjects, including those not of geriatric age, must be expanded. How best to accomplish this goal is, itself, an important research question. Innovative Approaches to Informed Consent Researchers should develop and evaluate the use of simplified or alternative ways to inform patients about research projects (Levine, 1986). For example, videotapes might enable persons with mild to moderate dementia to understand enough about a research project to give informed consent (Cassel, 1987). Similarly, linguistic analysis of impaired language processing might help physicians communicate better with research-eligible patients suffering from mild dementia.

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Extending Life, Enhancing Life: A National Research Agenda on Aging Proxy Consent for Incompetent Patients Consent by a family member or a close friend may not meet the standard of substituted judgment, which states that the proxy has given consent or refusal as desired by the incapacitated subject (Tymchuck et al., 1988). Studies have shown that proxies often give consent based on their own value system, not that of the patient. Thus, the practice of obtaining consent from relatives of incapacitated patients needs to be reevaluated. Several methods to improve such substituted judgment should be considered, such as education of the public and, in particular, of relatives of patients eligible for research studies in the concept of proxy consent to research participation. Furthermore, educational interventions aimed at the elderly could encourage them to give advance directives for participating in research, just as they are encouraged to do for medical care decisions. Institutional ethics committees might evaluate the appropriateness of a proxy's consent. In some situations, the appropriate standard for participation of incompetent patients in research might be that of the patient's best interests (Warren et al., 1986). Research and further discussion should disclose the specific situations in which the best-interest standard is most appropriate. Attitudes Toward Participation in Research Philosophers have posited that research should be a partnership between investigator and subject in which both parties understand the potential benefits to the patient and to the larger society (Fletcher et al., 1985; Veatch, 1987). However, some older people fear being research subjects (Faden and Beauchamp, 1986). Institutional safeguards are enacted based on the assumption that exploitation is possible, or even probable, without such protection. Thus, it becomes important to examine public attitudes about research. What responsibility does an ill person have to participate in research designed to understand and ameliorate conditions afflicting himself and others of a similar age? What discourages an elderly person from participating in research, and how might those barriers be overcome? Understanding how elderly people answer these questions would further our nation's sense of mission regarding research on aging. Research Review in Long-Term Care Although an increasing amount of research is being conducted in nursing homes, the process of review through institutional review

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Extending Life, Enhancing Life: A National Research Agenda on Aging boards (IRBs) remains sporadic and irregular (Ratzen, 1980). Nursing home and home care research affiliated with an academic center is generally reviewed by the center's IRB. However, such IRBs may not be knowledgeable about long-term care and may react in either an overprotective or an underprotective manner. Moreover, research lacking academic affiliation is being conducted increasingly in nursing homes and home care programs. In such cases, review of research may be ad hoc or totally lacking. In order to promote the quality of research, to educate investigators about the ethical dilemmas they face, and to protect research subjects, scientists should explore the establishment of community-based IRBs or other alternatives for review of methods used in research projects. ADDITIONAL RESEARCH OPPORTUNITIES The following topics provide additional research opportunities: treatment of older persons with experimental therapies that may involve increased risk to them, such as genetic engineering or organ transplants, which may raise ethical issues that require systematic study through research; and the trade-off between quality of care and quality of life for older patients. CONCLUSIONS AND RESOURCE RECOMMENDATIONS Ethical issues are an inevitable aspect of medical care and health care policy affecting the elderly. Furthermore, difficult ethical issues arise in the conduct of research on elderly subjects. However, to date, no federal resources have been allocated to conduct research on ethical issues concerning older persons. In order to carry out this important work, the federal government should apportion additional funds for research in biomedical ethics. An important step in this direction recently was taken by the National Institutes of Health 's National Center for Human Genome Research, which earmarked 3 percent of its grant funds for study of ethical and social issues. Support for research on biomedical ethics in the treatment and study of older persons may help our society better understand and resolve these difficult dilemmas.

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Extending Life, Enhancing Life: A National Research Agenda on Aging REFERENCES American College of Physicians. 1989a. American College of Physicians ethics manual. Part 1: History; the patients; other physicians. Annals of Internal Medicine 111: 245-252. American College of Physicians. 1989b. American College of Physicians ethics manual, Part 2: Research, life-sustaining treatment; other issues. Annals of Internal Medicine 111: 327-335. Anderson, G. M., J. P. Newhouse, and L. L. Roos. 1989. Hospital care for elderly patients with diseases of the circulatory system: A comparison of hospital use in the United States and Canada New England Journal of Medicine 321: 1443-1448. Annas, G. J. 1990. Nancy Cruzan and the right to die (Sounding Board). New England Journal of Medicine 323: 670-672. Annas, G. J., and L. H. Glantz. 1986a. The right of elderly patients to refuse life-sustaining treatment Milbank Memorial Fund Quarterly; Health and Society 64(Supp. 2): 95-162. Annas, G. J., and L. H. Glantz. 1986b. Rules for research in nursing homes. New England Journal of Medicine 315: 1157-1158. Avorn, J. 1984. Benefit and cost analysis in geriatric care: Turning age discrimination into health policy. New England Journal of Medicine 310: 955-959. Bedell, S. E., and T. L. Delbanco. 1984. Choices about cardiopulmonary resuscitation in the hospital: When do physicians talk with patients? New England Journal of Medicine 310: 1089-1093. Brieger, G. 1978. Human experimentation history. Pp. 684-692 in The Encyclopedia of Bioethics, W. T. Reich, ed. New York: Free Press. Brook, R. H. 1989. Practice guidelines and practicing medicine: Are they compatible? Journal of the American Medical Association 225: 1159-1164. Buchanan, A., and D. W. Brock. 1986. Deciding for others. Milbank Memorial Fund Quarterly; Health and Society 64(Supp. 2): 17-94. Callahan, D. 1987. Setting Limits: Medical Goals in an Aging Society. New York: Simon and Schuster. Cassel, C. K. 1985. Research in nursing homes: Ethical issues. Journal of the American Geriatrics Society 33: 795-799. Cassel, C. K. 1987. Informed consent for research in geriatrics: History and concepts Journal of the American Geriatrics Society 35: 542-544. Cassel, C. K. 1988. Ethical issues in the conduct of research in long-term care. Gerontologist 28(Supp.): 90-96. Cranford, R. E., and A. E. Doudera, eds. 1984. Institutional Ethics Committees and Health Care Decision Making. Ann Arbor, Mich.: Health Administration Press. Daniels, N. 1986. Why saying no to patients in the United States is so hard. New England Journal of Medicine 314: 1383-1386. Dubler, N. 1987. Legal judgments and informed consent in geriatric research. Journal of the American Geriatrics Society 35: 545-549. Engelhardt, H. T., Jr., and M. A. Rie. 1986. Intensive care units, scarce resources, and conflicting principles of justice. Journal of the American Medical Association 225: 1159-1164. Faden, R. R., and T. L. Beauchamp. 1986. A History and Theory of Informed Consent. New York: Oxford University Press. Fletcher, J. C., F. W. Dommel, and D. D. Cowell. 1985. Consent to research with impaired human subjects. Institutional Review Board 7: 1-6.

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Extending Life, Enhancing Life: A National Research Agenda on Aging Grumet, G. W. 1989. Health care rationing through inconvenience: The third party's secret weapon. New England Journal of Medicine 321: 607-611. Kane, N. M., and P. D. Manoukian. 1989. The effect of the Medicare prospective payment system on the adoption of new technology: The case of cochlear implants. New England Journal of Medicine 321: 1378-1383. Kane, R. A., and A. L. Caplan. 1989. Everyday Ethics: Resolving Dilemmas in Nursing Homes. New York: Springer Publishing. Kapp, M., and B. Lo. 1986. Legal perceptions and their influence on medical decision making. Milbank Memorial Fund Quarterly; Health and Society 64(Supp.): 163-202. Leaf, A. 1989. Cost effectiveness as a criterion for Medicare coverage. New England Journal of Medicine 321: 898-900. Levine, R. J. 1986. Ethics and Regulation of Clinical Research. Baltimore, Md.: Urban and Schwarzenberg. Lo, B. 1987. Behind closed doors: Promises and pitfalls of ethics committees. New England Journal of Medicine 317: 46-49. Lo, B. 1988. Quality of life judgments in the care of the elderly. Pp. 140-147 in Medical Ethics: A Guide for Health Care Professionals, D. C. Thomas and J. Monagle, eds. Rockville, Md.: Aspen Press. Lo, B., and L. Dornbrand. 1986. The case of Claire Conroy: Will administrative review safeguard incompetent patients. Annals of Internal Medicine 104: 869-873. Lo, B., G. A. MacLeod, and G. Saika. 1986. Patient attitudes towards discussing life-sustaining treatment. Archives of Internal Medicine 146: 1613-1615. Lo, B., S. Rous, and L. Dornbrand. 1990. Family decision making on trial. Who decides for the patient? New England Journal of Medicine 322: 1228-1232. Miles, S. F., P. A. Singer, and M. Siegler. 1989. Conflicts between patients' wishes to forego treatment and the policies of health care facilities New England Journal of Medicine 318: 48-50. Miller, F. H., and G. A. H. Miller. 1986. The painful prescription: A procrustean perspective? New England Journal of Medicine 314: 1383-1386. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1978a. Report and Recommendations on Research Involving Those Institutionalized as Mentally Infirm. Washington, D.C.: U.S. Government Printing Office. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1978b. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Bethesda, Md: U.S. Government Printing Office. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 1982. Making Health Care Decisions. Washington, D.C.: U.S. Government Printing Office. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 1983. Deciding to Forgo Life-Sustaining Treatment. Washington, D.C.: U.S. Government Printing Office. Ratzen, R. M. 1980. Being old makes you different: The ethics of research with elderly patients. Hastings Center Report 10: 32-42. Rhoden, N. K. 1988. Litigating life and death. Harvard Law Review 102: 375-446. Schneider, E. L. 1989. Options to control the rising health care costs of older Americans Journal of the American Medical Association 261: 907-908. Scitovsky, A. A., and A. M. Capron. 1986. Medical care at the end of life: The

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Extending Life, Enhancing Life: A National Research Agenda on Aging interaction of economics and ethics. Annual Review of Public Health 7: 59-75. Steinbrook, R., and B. Lo. 1988. Artificial feedings: Solid ground, not slippery slope. New England Journal of Medicine 318: 286-290. Tymchuck, A. J., J. G. Gouslander, B. Rahbar, and J. Fitten. 1988. Medical decision making among elderly people in long-term care. Gerontologist 28(Supp.): 59-63. Uhlmann, R. F., R. A. Pearlman, and K. C. Cain. 1988. Physicians' and spouses' predictions of elderly patients' resuscitation preferences. Journal of Gerontology 43: M115-M121. Veatch, R. M. 1984. An ethical framework for terminal care decisions. Journal of the American Geriatrics Society 32: 665-669. Veatch, R. M. 1987. The Patient as Partner: A Theory of Human-Experimentation Ethics. Bloomington, Ind.: Indiana University Press. Warren, J. W., J. Sobal, J. H. Tenney, J. M. Hoopes, D. Damron, S. Levenson, B. R. Deforge, and H. L. Muncie, Jr. 1986. Informed consent by proxy: An issue in research with elderly patients New England Journal of Medicine 315: 1125-1128. Youngner, S. H. 1988. Who defines futility? Journal of the American Medical Association 260: 2094-2095.