Checklist for addressing the unique aspects and potential ethical challenges of conducting research involving elderly persons
1. Adhere to responsibilities listed in Table 7.3
2. Employ beneficent research design and methods
• Scientifically valid
• Protocol clearly describes ethical considerations (e.g., IRB processes, informed consent, assessment of decisional capacity, etc.)
• Requires the involvement of elders
• Minimizes harms and maximizes benefits to elders
• Protects vulnerable elderly subjects (e.g., due to impaired decision-making capacity)
3. Address barriers to enrollment of elders (e.g., sensory impairments, mobility issues, etc.)
4. Ensure elements of informed consent are realized
• Adequate amount of information about the study is conveyed to and understood by subject
• Subject voluntariness (i.e., free of coercion)
• Subject decision-making capacity
5. Assess decision-making capacity
• Ability to evidence a choice
• Ability to understand the nature of the research study and other information relevant to participants disclosed by the investigator
• Ability to understand and appreciate the risks and consequences of participating and the procedures to follow if adverse events occur or if withdrawal from participation is desired
• Ability to manipulate information rationally
6. Adhere to requirements for enrolling subjects with impaired decision-making capacity
• Consent articulated in an advance directive for research
• Consent by a legally authorized proxy
• Subject assent regardless of level of decision-making capacity
7. Adhere to acceptable standards of risk when conducting research involving subjects with impaired decision-making capacity
• Study has direct therapeutic benefit to the subject
• If no direct benefit to the subject, no more than a minimal increment greater than minimal risk and has the prospect of yielding generalizable new knowledge about the subject's illness or condition
• For studies of greater than a minor increment above minimal risk, enrollment should be offered only to potential subjects who have an advance directive for research that allows enrollment in such a study
8. Ensure that research involving elders is just
• Study does not unfairly include or exclude elders
• Study includes sufficient numbers of elders to facilitate understanding of the physiologic processes, diseases and other factors that pertain to elders research studies using the specimens. Investigators who use and maintain identified or identifiable specimens must scrupulously maintain subject confidentiality. Information derived from these specimens must not be divulged to anyone (e.g., family members, insurance companies, etc.) without the explicit written permission of the subject. Subjects should be given the opportunity to decide whether or not to receive the information discovered by the investigation (i.e., some subjects may not want to know the results of testing if nothing can be done constructively with the information).
Beyond the ASHG statement, investigators should consider additional ethical aspects of genetic research. First, because genetic research usually involves blood, buccal, and/or stool specimens, investigators may regard these studies as minimal risk. However, risk must be understood as something larger than the discomforts associated with collecting specimens. Indeed, the ASHG statement recognizes that the risks of genetic research include psychosocial risks such as disrupted family dynamics caused by the discovery of genetic information (e.g., carrier status) and employment and insurance discrimination (American Society of Human Genetics, 1996). Hence, these studies should be regarded as greater than minimal risk. Second, information derived from genetic research that is disclosed to the subject or the proxy decision-maker should be recorded in the subject's medical record, since such information may influence clinical practice. Care, however, must be taken to avoid inappropriate disclosure of this information. Third, investigators should inform subjects of situations in which disclosure of information to subjects may be ethically obligatory (e.g., information that, if not known and addressed by the subject, poses high risk of harm) and how such disclosure will be done. Fourth, genetic research may have implications for blood relatives of subjects. Investigators, for various reasons, may desire to contact relatives. Investigators should obtain consent from subjects to contact relatives where appropriate. Relatives should be contacted in a nonthreatening way (e.g., certified letter) that explains (a) how their name was obtained; (b) the nature of the research involving the subject (without divulging the research results pertaining to the subject); (c) the possible implications of the research for the relatives; and (d) how to contact the investigator for more information (e.g., counseling regarding the study).
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