Navigation Links
Cognitively-impaired human research subjects need better protection
Date:12/7/2010

(Garrison, NY) 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."


'/>"/>

Contact: Michael Turton
turtonm@thehastingscenter.org
845-424-4040 x242
The Hastings Center
Source:Eurekalert

Related medicine news :

1. Species Extinctions May Spell Trouble for Human Health
2. Experts urge US to create emergency cholera vaccine stockpile for humanitarian use
3. Female fish -- and humans? -- lose interest when their male loses a slugfest
4. To be or not to be? Public event examines question of human identity and consciousness
5. PARP inhibitor, MK-4827, shows anti-tumor activity in first trial in humans
6. HFES announces Release of Reviews of Human Factors and Ergonomics, Volume 6
7. Rogue gene hijacks stem cells to jumpstart human cancer
8. Scientists Use Tarantulas to Explore Human Fear
9. Dangerous chemicals in food wrappers likely migrating to humans: U of T study
10. Early Humans More Advanced Than Thought
11. Wildlife health reporting tools may help prevent human illness
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... ... PurhealthRX , a leading Health and Nutrition Company, is announcing the ... spectrum CBD oil will revolutionize the rapidly growing CBD market by reducing the amount ... into liquid products, while reducing costs to end users. , The team of researchers ...
(Date:10/13/2017)... SAN LUIS OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... with Alzheimer’s or dementia. However, many long-term care insurance companies have a waiver for ... mean is the 90-day elimination period, when the family pays for care, is often ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... most popular and least understood books in the Holy Scriptures, Revelation. The Book of ... baffled scholars for centuries. Many have tossed it off as mere rubbish, but Yisrayl ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history ... The Brink” is the creation of published author, William Nowers. Captain Nowers and ... WWII veteran, he spent thirty years in the Navy. Following his career as ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company ... of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every ... meet the highest standard. , These products are also: Gluten Free, Non-GMO, ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)...  Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today provided ... Piedras, Puerto Rico , where the ... Following a comprehensive onsite ... structural damage, temporary loss of power and minimal water ... manufacturing operations have resumed, and the company expects to ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... -- AllianceRx Walgreens Prime, the combined central specialty pharmacy and ... manager Prime Therapeutics LLC (Prime), today officially began the ... of new signage at its headquarters in ... few other company-owned facilities across the country. This also ... whom will begin to see the AllianceRx Walgreens Prime ...
Breaking Medicine Technology: