Practices for protecting human research subjects with Alzheimer's disease and other conditions that make them incapable of giving informed consent are widely variable and in need of more concrete ethical and legal guidance, according to a study in IRB: Ethics & Human Research.
The findings are significant for several reasons. First of all, the authors write, many countries have made research on dementia a national health priority and launched clinical trials that involve people who are, or are likely to become, cognitively impaired. These trials increasingly involve invasive interventions which may pose more than minimal risk. And yet throughout the world, regulations and guidelines provide little direction to ethics review committees about how best to protect these people – and about who can make decisions on their behalf.
The new study, part of a larger Canadian research program called Substitute Consent for Research in Elderly Subjects (SCORES), involved telephone interviews with 46 research ethics board chairs in Canada, assessing their attitudes toward enrolling in clinical trials older adults without decision-making capacity and asking what safeguards they would require. Twenty respondents said they had reviewed research protocols involving such persons during the past year and all allowed them to participate in research under certain conditions, such as minimal risks or consent from a substitute decision-maker.
More than half of the ethics board chairs said that they required additional protections for this population, such as assessing decisional capacity. "Yet the fact that some REBs [research ethics boards] did not require these additional safeguards is cause for concern," wrote the researchers. Four allowed older adults without decision-making capacity to participate in minimal risk studies that could benefit them personally, even when there was no one legally authorized to provide substitute consent. The authors raised concerns about this practice, though they acknowledged that the legal requirement regarding substitute consent for research is unclear in the provinces where those REBs are located.
Given the variability in research protections for older adults with cognitive impairment, the researchers "recommend that policy-makers and stakeholders consider developing appropriate protective measures for this population."
The lead author is Gina Bravo, professor in the Department of Community Health Sciences, at the University of Sherbrook, and Research Centre on Aging, University Institute of Geriatrics of Sherbrooke in Quebec. Coauthors are from University Institute of Geriatrics of Sherbrooke, Dalhousie Law School in Halifax, and University of Toronto.
Michael Turton | EurekAlert!
New study from the University of Halle: How climate change alters plant growth
12.01.2018 | Martin-Luther-Universität Halle-Wittenberg
Disarray in the brain
18.12.2017 | Universität zu Lübeck
On the way to an intelligent laboratory, physicists from Innsbruck and Vienna present an artificial agent that autonomously designs quantum experiments. In initial experiments, the system has independently (re)discovered experimental techniques that are nowadays standard in modern quantum optical laboratories. This shows how machines could play a more creative role in research in the future.
We carry smartphones in our pockets, the streets are dotted with semi-autonomous cars, but in the research laboratory experiments are still being designed by...
What enables electrons to be transferred swiftly, for example during photosynthesis? An interdisciplinary team of researchers has worked out the details of how...
For the first time, scientists have precisely measured the effective electrical charge of a single molecule in solution. This fundamental insight of an SNSF Professor could also pave the way for future medical diagnostics.
Electrical charge is one of the key properties that allows molecules to interact. Life itself depends on this phenomenon: many biological processes involve...
At the JEC World Composite Show in Paris in March 2018, the Fraunhofer Institute for Laser Technology ILT will be focusing on the latest trends and innovations in laser machining of composites. Among other things, researchers at the booth shared with the Aachen Center for Integrative Lightweight Production (AZL) will demonstrate how lasers can be used for joining, structuring, cutting and drilling composite materials.
No other industry has attracted as much public attention to composite materials as the automotive industry, which along with the aerospace industry is a driver...
Scientists at Tokyo Institute of Technology (Tokyo Tech) and Tohoku University have developed high-quality GFO epitaxial films and systematically investigated their ferroelectric and ferromagnetic properties. They also demonstrated the room-temperature magnetocapacitance effects of these GFO thin films.
Multiferroic materials show magnetically driven ferroelectricity. They are attracting increasing attention because of their fascinating properties such as...
08.01.2018 | Event News
11.12.2017 | Event News
08.12.2017 | Event News
19.01.2018 | Materials Sciences
19.01.2018 | Health and Medicine
19.01.2018 | Physics and Astronomy