Document Detail

Is Informed Consent Broken?
MedLine Citation:
PMID:  21817873     Owner:  NLM     Status:  Publisher    
For as long as the federal regulations governing human subjects research have existed, the practice of informed consent has been attacked as culturally biased, legalistic, ritualistic and unevenly enforced. Its focus on meeting the regulatory requirements is seen as undermining a truly ethical process that produces informed and voluntary participation in medical research. Recent changes in the clinical translational research enterprise, with large scale genomic and other data sharing made possible by advanced bioinformatic technologies, may further challenge this goal. Study participants are asked to consent to future studies with unspecified aims, broad data sharing policies and ongoing uncertainties regarding confidentiality protections and the potential benefit of incidental genomic research findings. Because more research is conducted under these new conditions, the very nature of the researcher-subject relationship is shifting and will require new governance mechanisms to promote the original goals of informed consent.
Gail E Henderson
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-8-3
Journal Detail:
Title:  The American journal of the medical sciences     Volume:  -     ISSN:  1538-2990     ISO Abbreviation:  -     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-8-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370506     Medline TA:  Am J Med Sci     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
From the Department of Social Medicine, UNC School of Medicine and Clinical Research Ethics Core, NC TraCS, and the Center for Genomics and Society, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina.
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