Geriatrics: Research Issues

Elderly Subjects in Research

The objective of this module is to provide information and generate discussion about ethical issues associated with using elderly individuals as research subjects.

The need for regulations governing the use of human subjects in research was largely recognized after the Second World War.In response to the atrocities that occurred, the Nuremberg Code was instituted, providing standards to protect human participants in research. Approximately thirty years later, the Belmont Report explicitly articulated notions such as autonomy, beneficence, and valid (informed) consent, which are crucial to performing ethically sound research.The Common Rule established additional guidelines to protect human subjects participating in federally funded medical research. According to the Common Rule, the scientific and ethical merits of research protocols must be assessed by Institutional Review Boards (IRB's).The mandate of IRB's is to assess research protocols before subjects are enrolled and to ensure that ongoing research is conducted in an ethical manner.

When conducting any type of research involving human subjects, obtaining proper consent from participants is crucially important.The consent process must be carefully and thoroughly undertaken before a subject, elderly or otherwise, is enrolled in a research protocol. There have been documented cases where proper consent was not obtained and research subjects were mistreated.For example, in 1966, Dr. Henry Beecher pointed out ethics violations in a number of research protocols, including one study where dementia patients were being injected with cancer cells without their consent.In principle, obtaining consent should prevent that kind of abuse from occurring in the future.

Researchers must make sure that potential subjects are competent to make the decision to participate and that the decision is made voluntarily. Researchers need to inform every subject of the potential benefits and risks associated with the research. Subjects might hastily assume that since they are being asked to enroll in research, that they will receive some type of therapeutic benefit.Yet there are protocols where subjects will receive little or no benefit, and this information must be properly disclosed.For instance, a protocol that investigates the different stages of Alzheimer’s disease might enable researchers to develop better therapies to treat the illness, but the subjects themselves might not experience any direct benefit from participation.

Physical and mental impairments associated with aging can make it difficult for elderly individuals to understand the nature and purpose of a research protocol. A significant problem associated with researching illnesses like Alzheimer’s disease is that potential subjects are frequently unable to provide consent to enroll in the protocol because of the nature of the disease.The memory loss typically associated with Alzheimer’s disease can invalidate the consent process. Further, enrolled subjects might lose decision-making capacity during the course of a study. Advance directives, although not commonly used, may be able to help resolve some of the uncertainty by specifying the conditions under which an individual would want to be a research subject.

Additional barriers to participation include that elderly subjects might be vulnerable to coercion because of the pressure placed on them by researchers, friends, and family. Researchers should be aware that merely because an elderly individual agrees to participate in research, that this does not necessarily guarantee that the decision was truly voluntary. A debilitating illness associated with aging can make a potential subject susceptible to being manipulated. Further, a potential subject might enroll in a protocol out of desperation because he or she may believe that no other treatment option is available. Researchers must be cautious not to take advantage of this desperation in order to promote their own agenda, and they must inform potential participants regarding existing treatment options for their condition.

On the other hand, concerns of “ageism” arise if elderly populations are categorically excluded from a research protocol without justifiable scientific or moral reasons for doing so. Researchers cannot automatically assume that merely because a potential subject is elderly, that he/she is not competent to be involved in research. Although an elderly individual might initially appear to be reluctant to enroll research, this might be due to a failure on the part of researchers to properly and fully explain the protocol to the potential subject.

Questions To Consider:

Why should researchers be concerned about the decision of a surrogate to enroll an incompetent elderly subject in a research protocol?Unfortunately, decisions regarding research participation are rarely discussed.Thus, the wishes of an incompetent person are probably not fully known by the surrogate, and the surrogate may make a decision that does not match what the person actually would want.The surrogate should aim to make decisions that are consistent with the incompetent person’s values and past choices. Further, researchers should be aware of the surrogate’s motives and how familiar the surrogate is with the incompetent individual and his/her conception of his/her best interests.

When can a surrogate decision-maker remove an incompetent elderly subject from a research protocol?In principle, a surrogate should be able to remove a research subject from the protocol at any time. However, there may be special circumstances where research subjects are asked to remain in the protocol for a predetermined amount of time before they are permitted to leave.If this type of arrangement is necessary, then the details of the arrangement must be clearly delineated within the consent form for the research prior to enrollment in the study.

Relevant Links And Resources

Abernethy DR. Pharmacokinetic investigations in elderly patients: Clinical and ethical considerations. Clin Pharmacokinet 1990;19(2):89-93.

Agency for Healthcare Research and Quality: Elderly Healthcare

Appelbaum P. Psychiatric research and the incompetent subject. Psychiatric Services 1997;48(7):873-874.

Baskin SA et al. Barriers to obtaining consent in dementia research: Implications for surrogate decision-making. Journal of the American Geriatric Society 1998;46(3):287-290.

Bayer A, Tadd W. Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval: Descriptive study. BMJ 2000;321:992-993.

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Bioethics Resources on the Web: Human Subjects Research and IRBs (provided by the NIH)

Bugeja G, Kumar A, Banerjee AK. Exclusion of elderly people from clinical research: A descriptive study of published reports. BMJ 1997;315:1059.

Cahill M. Research involving persons with cognitive impairments: results of a survey of Alzheimer disease research centers in the United States. Alzheimer Dis Assoc Disord 2000;14(1):20-27.

Centers for Disease Control and Prevention: Guidelines for Defining Public Health Research and Public Health Non-Research

Centerwatch: Clinical Trials Listing Service (provided by the National Institutes of Health)

The Common Rule: Protection of Human Subjects

Department of Education: Protection of Human Subjects in Research

Vanderpool HY, Ed. The Ethics of Research Involving Human Subjects: Facing the 21st Century. Maryland: University Publishing Group, 1996.

Fitten LJ. The ethics of conducting research with older psychiatric patients. Int J Geriatr Psychiatry 1993;8(1):33-39.

High DM. Guidelines for addressing ethical and legal issues in Alzheimer disease research: A position paper. National Institute on Aging. Alzheimer Dis Assoc Disord 1994;8(Suppl 4):66-74.

High DM. Research with Alzheimer's disease subjects: Informed consent and proxy decision making. J Am Geriatr Soc 1992;40(9):950-957.

Hope T. Aging, research and families. J Med Ethics 1997;23(5):267-268.

Kim SY et al. Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. American Journal of Psychiatry 2001;158(5):712-717.

National Institutes of Health (NIH): Research Involving Individuals with Questionable Capacity to Consent

The Nuremberg Code: Directives for Human Experimentation

Office of Human Subjects Research (OHSR): Regulations and Ethical Guidelines

Rikkert MGMO et al. Experienced consent in geriatrics research: A new method to optimize the capacity to consent in frail elderly subjects. Journal of Medical Ethics 1997;23(5):271-76.

Sachs GA et al. Ethical aspects of dementia research: Informed consent and proxy consent. Clinical Research 1994;42(3):403-412.

Sugarman J et al. How proxies make decisions about research for patients with Alzheimer's disease. Journal of the American Geriatrics Society 2001;49(8):1110-1119.

University of Miami-HIPAA/Privacy Education: Research