The views of Alzheimer disease patients and their study partners on proxy consent for clinical trial enrollment

Department of Medicine, Alzheimer's Disease Center, Leonard Davis Institute for Health Economics, University of Pennsylvania, School of Medicine, Philadelphia, PA 19104, USA.
American Journal of Geriatric Psychiatry (Impact Factor: 3.52). 04/2008; 16(3):240-7. DOI: 10.1097/JGP.0b013e318162992d
Source: PubMed

ABSTRACT To examine the views of Alzheimer disease (AD) patients and their study partners on the ethics of proxy consent for clinical research.
Cross-sectional interview.
At the 13 study sites of a randomized and placebo controlled study of simvastatin for the treatment of AD.
Patients with mild-to-moderate AD and their study partners enrolled in an Alzheimer's Disease Cooperative Study trial of simvastatin.
Interviews to assess how participants made the decision to enroll in a randomized controlled trial and their attitudes on proxy consent.
Study partners of patients judged not capable of providing informed consent reported the same degree of patient involvement in the decision to enroll as the study partners of patients capable of providing informed consent. Most study partners and patients supported proxy consent for this clinical trial and nearly all patients chose their study partner as their proxy. Study partners generally made research enrollment decisions based on what they thought would maximize the patient's well-being as opposed to a substituted judgment.
Patients and their study partners who were enrolled in a clinical trial supported proxy consent both for themselves and as a matter of policy. Our findings suggest that policies that require substituted judgments may not accord with the views of the people currently participating in AD clinical trials.

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background Persons with Alzheimer's disease (AD) sometimes express themselves through behaviours that are difficult to manage for themselves and their caregivers, and to minimise these symptoms alternative methods are recommended. For some time now, animals have been introduced in different ways into the environment of persons with dementia. Animal-Assisted Therapy (AAT) includes prescribed therapy dogs visiting the person with dementia for a specific purpose.AimThis study aims to illuminate the meaning of the lived experience of encounters with a therapy dog for persons with Alzheimer's disease.Method Video recorded sessions were conducted for each visit of the dog and its handler to a person with AD (10 times/person). The observations have a life-world approach and were transcribed and analysed using a phenomenological hermeneutical approach.ResultsThe result shows a main theme ‘Being aware of one's past and present existence’, meaning to connect with one's senses and memories and to reflect upon these with the dog. The time spent with the dog shows the person recounting memories and feelings, and enables an opportunity to reach the person on a cognitive level.Conclusions The present study may contribute to health care research and provide knowledge about the use of trained therapy dogs in the care of older persons with AD in a way that might increase quality of life and well-being in persons with dementia.Implications for practiceThe study might be useful for caregivers and dog handlers in the care of older persons with dementia.
    International Journal of Older People Nursing 05/2014; DOI:10.1111/opn.12053
  • [Show abstract] [Hide abstract]
    ABSTRACT: The ethical problem of the need to conduct research on the very conditions that impair the ability to consent to such research is widely acknowledged. People with cognitive impairment and mental illness have an equitable right to research being conducted in areas relevant to their treatment and care, and should be given an equitable opportunity to participate in such research, even if they lack capacity. They also have a right to adequate safeguards to protect their interests and respect their wishes in regards to research participation. Provisions for involvement in research of those who are unable to give consent have only developed over the last 50 years. Over this period we have witnessed a proliferation of policies, regulations and laws that govern research involving subjects unable to give consent. There has been a parallel increase in our understanding of the concepts of consent and capacity, specifically as it relates to the research context, with development of standards for research consent and instruments to guide capacity evaluation. We review the evolution of research governance and the underlying ethical principles that underpin such regulations, approaches to capacity evaluation and the use of proxies and advance research directives to facilitate research participation in adults who lack capacity.
    Asia-Pacific Psychiatry 12/2012; 4(4). DOI:10.1111/j.1758-5872.2012.00210.x · 0.42 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: ABSTRACT Background: In Canada and elsewhere, research policies require researchers to secure consent from a legally authorized representative (LAR) for prospective participants unable to consent. Few jurisdictions, however, offer a clear legislative basis for LAR identification. We investigated Canadian researchers' practices regarding the involvement of decisionally incapacitated participants and tested whether reported practices were associated with (1) researchers' understanding of the law on third-party authorization of research and (2) their comfort with allowing a family member to consent on behalf of an incapacitated relative. Methods: We surveyed researchers in aging from four Canadian provinces about their practices with prospective participants deemed incapable of consent, their understanding of relevant law, and comfort with family consent for research purposes. Understanding and comfort were measured with research vignettes that briefly described hypothetical studies in which an adult who lacks the capacity to consent was invited to participate. Results: Many respondents reported soliciting consent from a family member (45.7% for low-risk studies and 10.7% for serious risks studies), even in jurisdictions where such authority is uncertain at law. Researchers' tendency to solicit family consent was associated with their comfort in doing so, but not with their understanding of the law on substitute consent for research. Conclusions: Findings underscore the need to clarify who may authorize an incapacitated adult's participation in research. Meanwhile, people should inform their relatives of their desire to participate or not in research in the event of incapacity, given researchers' tendency to turn to family for consent, even where not supported by law.
    International Psychogeriatrics 08/2013; 25(11):1-10. DOI:10.1017/S1041610213001336 · 1.89 Impact Factor