Experimentación con seres humanos : Modernizing Human Subjects Research Protections: Legally Authorized Representati
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Modernizing Human Subjects Research Protections: Legally Authorized
Representatives and Consent Capacity
Written by Karen Meagher on October 9, 2015
This is the last installment in a series of blog posts about recent proposed changes to the Common Rule, and how they relate to the work of the Bioethics Commission. The Common Rule currently requires permission from a legally authorized representative (LAR) to enroll participants who lack consent capacity in research. LARs consider and evaluate the merits of research participation on behalf of others—often loved ones—who lack consent capacity.
In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2) the Bioethics Commission noted that the Common Rule does not specify who can serve as an LAR, what kinds of decisions an LAR can make, and what processes and procedures are required to establish an LAR. Rather, it indicates that these decisions be made according to “applicable law,” including state law. However, while some states have laws that outline LARs for clinical care, few states have laws that specifically address LARs for research, leaving researchers and IRBs with uncertainty. In Gray Matters, Vol. 2, the Bioethics Commission recommended that “federal regulatory bodies should establish clear requirements to identify who can serve as legally authorized representatives for individuals with impaired consent capacity to support their responsible inclusion in research.”
- See more at: http://blog.bioethics.gov/2015/10/09/modernizing-human-subjects-research-protections-legally-authorized-representatives-and-consent-capacity/?utm_source=Presidential+Commission+for+the+Study+of+Bioethical+Issues+List&utm_campaign=921ebb9782-RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_336f8c07f0-921ebb9782-78447261#sthash.nXZSRiJn.dpuf
Modernizing Human Subjects Research Protections: Legally Authorized
Representatives and Consent Capacity
Written by Karen Meagher on October 9, 2015
This is the last installment in a series of blog posts about recent proposed changes to the Common Rule, and how they relate to the work of the Bioethics Commission. The Common Rule currently requires permission from a legally authorized representative (LAR) to enroll participants who lack consent capacity in research. LARs consider and evaluate the merits of research participation on behalf of others—often loved ones—who lack consent capacity.
In Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2) the Bioethics Commission noted that the Common Rule does not specify who can serve as an LAR, what kinds of decisions an LAR can make, and what processes and procedures are required to establish an LAR. Rather, it indicates that these decisions be made according to “applicable law,” including state law. However, while some states have laws that outline LARs for clinical care, few states have laws that specifically address LARs for research, leaving researchers and IRBs with uncertainty. In Gray Matters, Vol. 2, the Bioethics Commission recommended that “federal regulatory bodies should establish clear requirements to identify who can serve as legally authorized representatives for individuals with impaired consent capacity to support their responsible inclusion in research.”
- See more at: http://blog.bioethics.gov/2015/10/09/modernizing-human-subjects-research-protections-legally-authorized-representatives-and-consent-capacity/?utm_source=Presidential+Commission+for+the+Study+of+Bioethical+Issues+List&utm_campaign=921ebb9782-RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_336f8c07f0-921ebb9782-78447261#sthash.nXZSRiJn.dpuf
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