Research Issues-Module 8

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.


  1. 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.

  2. 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.