TY - JOUR
T1 - Interpretation of the subjects' condition requirement
T2 - A legal perspective
AU - Shah, Seema
AU - Wendler, David
PY - 2010/6
Y1 - 2010/6
N2 - The U.S. Federal regulations allow institutional review boards (IRBs) to approve non-beneficial pediatric research when the risks are a minor increase over minimal, provided that the research is likely to develop generalizable knowledge about the subjects' disorder or condition. This " subjects' condition" requirement is quite controversial; commentators have argued for a variety of interpretations. Despite this considerable disagreement in the literature, there have not been any attempts to apply principles of legal interpretation to determine how the subjects' condition requirement should be understood.
AB - The U.S. Federal regulations allow institutional review boards (IRBs) to approve non-beneficial pediatric research when the risks are a minor increase over minimal, provided that the research is likely to develop generalizable knowledge about the subjects' disorder or condition. This " subjects' condition" requirement is quite controversial; commentators have argued for a variety of interpretations. Despite this considerable disagreement in the literature, there have not been any attempts to apply principles of legal interpretation to determine how the subjects' condition requirement should be understood.
UR - http://www.scopus.com/inward/record.url?scp=77954899905&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77954899905&partnerID=8YFLogxK
U2 - 10.1111/j.1748-720X.2010.00495.x
DO - 10.1111/j.1748-720X.2010.00495.x
M3 - Article
C2 - 20579233
AN - SCOPUS:77954899905
VL - 38
SP - 365
EP - 373
JO - Law, medicine & health care : a publication of the American Society of Law & Medicine
JF - Law, medicine & health care : a publication of the American Society of Law & Medicine
SN - 1073-1105
IS - 2
ER -
