Linked Life Data

9408725

Source:http://linkedlifedata.com/resource/pubmed/id/9408725

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
1998-1-27
pubmed:abstractText
There is widespread consensus on the need for informed consent procedures in medical research. Nevertheless, aspects of the informed consent process remain controversial, and innovative approaches to research may raise new issues and concerns. The randomized consent design for clinical trials, proposed by Zelen (N Engl J Med 1979; 300:1242-1245), permitted physicians to randomize patients without consent, then obtain informed consent from only those patients randomized to the experimental (as opposed to the standard treatment) arm. More recently, the proposal has been made to allow waiver of informed consent for study of patients in emergency circumstances who may be temporarily incapable of providing such consent, and for whom no family member is immediately available to give a "proxy" consent (Biros M.H. et al. JAMA 1995; 273:1283-1287). The medical community and federal regulatory policy have responded differently to these proposals.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
0197-2456
pubmed:author
pubmed:issnType
Print
pubmed:volume
18
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
628-36; discussion 661-6
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
1997
pubmed:articleTitle
Informed consent: protection or obstacle? Some emerging issues.
pubmed:affiliation
Division of Biostatistics and Epidemiology, Food and Drug Administration, Rockville, Maryland, USA.
pubmed:publicationType
Journal Article, Review