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:5/2/2016)... WACO, Texas (PRWEB) , ... May 02, 2016 , ... ... Corporation will offer an incentive to people who share their fitness journey on ... footwear and premium first aid products, will award a $100 product voucher each week ...
(Date:5/2/2016)... New York, NY (PRWEB) , ... May 02, 2016 , ... ... Highlighting the year’s best in pet gear and toys, leading product review site ... TTPM Pets Paw of Excellence Awards at their Spring Showcase at the Metropolitan ...
(Date:5/2/2016)... Netherlands (PRWEB) , ... May 02, 2016 , ... Further ... honored to announce that the new WHIMZEES Variety Value Boxes were selected from over ... New Product Showcase Award. , WHIMZEES natural dental chews for dogs are a ...
(Date:5/2/2016)... Rafael, CA (PRWEB) , ... May 02, 2016 , ... The 2016 World Ultimate & ... Nike Ultimate Camp at Manhattan College, made the cut. The WUGC is being held in ... National Teams won the gold in the men’s division, another gold in the women’s masters ...
(Date:5/2/2016)... , ... May 02, 2016 , ... ... (AAC) event, will be held at the Bellagio Hotel in Las Vegas, NV ... Social Work (NASW) will be co-hosting the event. , This year’s conference will ...
Breaking Medicine News(10 mins):
(Date:5/2/2016)... 2016  Celsion Corporation (NASDAQ: CLSN ), ... from the first cohort of patients in its ... Study) combining GEN-1, the Company,s DNA-based immunotherapy, with ... newly-diagnosed patients with advanced ovarian cancer who will ... In the first three patients dosed, GEN-1 plus ...
(Date:4/29/2016)... , April 29, 2016 /PRNewswire/ ... Contamine, Directeur Financier Sanofi, ... santé, publie ses résultats pour le ... du Groupe, Jérôme Contamine, commente les ... et les perspectives pour le reste ...
(Date:4/28/2016)... -- Research and Markets has announced the ... 2016-2020" report to their offering.      ... global plastic surgery products market is expected to grow ... , ,The growing adoption of laser in aesthetics is ... market. Lasers are used to treat a broad range ...
Breaking Medicine Technology: