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:6/25/2016)... , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on ... Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ability ... fumigation is not a common occurrence, but a necessary one in the event that lice ...
(Date:6/25/2016)... City, Oklahoma (PRWEB) , ... June 25, 2016 ... ... helping both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic ... the Oklahoma City area —Johnson is one of the first doctors to perform ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic ... many turn to unhealthy avenues, such as drug or alcohol abuse, as a coping ... released tools for healthy coping following a traumatic event. , Trauma sufferers tend to ...
(Date:6/24/2016)... ... 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida ... their peers for this recognition are considered among the top 2 percent of lawyers ... as members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are ... Code Talker Award, an essay contest in which patients and their families pay tribute ... presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Va. , June 24, 2016 The ... set of recommendations that would allow biopharmaceutical ... (HCEI) with entities that make formulary and coverage decisions, ... the "value" of new medicines. The recommendations ... does not appear on the drug label, a prohibition ...
(Date:6/24/2016)... June 24, 2016 According to ... Type (Standard Pen Needles, Safety Pen Needles), Needle Length ... Growth Hormone), Mode of Purchase (Retail, Non-Retail) - Trends ... report studies the market for the forecast period of ... USD 2.81 Billion by 2021 from USD 1.65 Billion ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
Breaking Medicine Technology: