Informed consent for research participation in frail older persons

Abstract

Informed consent has been the most scrutinized and controversial aspect of clinical research ethics. Institutional review boards (IRBs), government regulatory agencies, and the threat of litigation have all contributed to increasingly detailed consent documents that hope to ensure that subjects are not misled or coerced. Unfortunately, the growing regulatory burden on researchers has not succeeded in protecting subjects, but has rather made the consent process less effective and has discouraged research on vulnerable populations. As a matter of fact, investigators and ethicists continue to identify failures of the consenting process, particularly concerning participation in research of older individuals. The challenges involved in ensuring appropriate consent from the elderly include physical frailty, reduced autonomy and privacy, and impaired decision-making capacity due to dementia, delirium, or other neuropsychiatric illnesses. Ageism among investigators also contributes to failure of informed consent. The evaluation and continuing re-evaluation of an individual's decision-making capacity is critical but difficult. In the most extreme cases, the older adult's ability to participate in the consent process is clearly impaired. However, in many instances, the decision-making capacity is only partially impaired but declines during the course of a research project. Implementing methods of effective communication may enable many frail elderly individuals to make informed decisions. Special challenges are posed by research on end-of-life care, which typically involves frail, older subjects who are uniquely vulnerable, and research is conducted in institutional settings where subtle violations of autonomy are routine. Clearly, the frail elderly represent a vulnerable population that deserves special attention when developing and evaluating an informed consent process. Two important ethical conflicts should be kept in mind. First, although vulnerable older patients must be protected, protection should not prevent research on this important population. Similarly, because informed consent documents are often written to prevent legal jeopardy, these technical documents, expressed in language sometimes difficult to understand, can prevent comprehension of basic issues, defeating the ethical purpose of human protection.

Mixed Methods Research in the Development and Evaluation of Complex Interventions in Palliative and End-of-Life Care: Report on the MORECare Consensus Exercise

“…12 There can also be an inability to provide informed consent. 12,14-17 Gatekeeping can occur when well-intentioned clinicians 12,14,17,[18][19][20] or family members 15 seek to protect patients from research participation at the end of life, despite research suggesting that some even very ill patients [21][22] and bereaved relatives 23 find it helpful and would like the opportunity to participate. This gatekeeping can impact on the efficiency of research, as well as its validity and reliability due to potentially biased samples.…”

Ethical issues in consenting older adults: academic researchers and community perspectives

“…This was in agreement with results from this study that emphasized the influence of age‐related health changes on the process of informed consent in older adults. Matching target population capabilities in light of participants' abilities and age‐related physical frailty is a very important consideration when obtaining informed consents from older adults . Moore et al advocated that information should be disclosed at the appropriate level of the target population in relation to education, maturation, language, age and cognitive ability.…”

“…For example, evidence‐based health services provided to older adults should be based on research conducted specifically on older adult populations. However, elderly based research is still inadequate and less illustrative compared to research involving younger populations . One of the important factors leading to underrepresentation of older adults in clinical, social and behavioural research is the difficulty associated with obtaining informed consents from older adult individuals .…”

Do People Comprehend Legal Language in Wills?

“…But with the exception of informed consent documents (e.g. Barron, Duffey, Byrd, Campbell & Ferrucci, 2004) and advance directives (e.g. Jacobson et al, 1994), we know little about older adults' abilities to understand and apply legal text, and nothing about how they understand the lexicon and concepts conveyed by last wills and testaments.…”