TY - JOUR
T1 - Food and Drug Administration Public Hearing on the Conduct of Emergency Clinical Research
T2 - Testimony of Dr. Schmidt
AU - Schmidt, Terri A.
PY - 2007/4
Y1 - 2007/4
N2 - The rules surrounding exception from informed consent in emergency research need to strike a balance between protecting human subjects and allowing important research to move forward. The rules have been in place since 1996, and there is now a body of experience with using the rules but limited empirical research on attitudes and experience with the rules. This experience shows that community consultation may be a valuable method of protecting subjects, but its implementation has been difficult. IRBs continue to have questions about interpreting the rules, the public has not shown an interest in attending public meetings, and researchers express frustration about how to conduct the process in a timely and cost-effective manner while protecting subjects.
AB - The rules surrounding exception from informed consent in emergency research need to strike a balance between protecting human subjects and allowing important research to move forward. The rules have been in place since 1996, and there is now a body of experience with using the rules but limited empirical research on attitudes and experience with the rules. This experience shows that community consultation may be a valuable method of protecting subjects, but its implementation has been difficult. IRBs continue to have questions about interpreting the rules, the public has not shown an interest in attending public meetings, and researchers express frustration about how to conduct the process in a timely and cost-effective manner while protecting subjects.
UR - http://www.scopus.com/inward/record.url?scp=33947354498&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33947354498&partnerID=8YFLogxK
U2 - 10.1197/j.aem.2006.11.028
DO - 10.1197/j.aem.2006.11.028
M3 - Comment/debate
C2 - 17331913
AN - SCOPUS:33947354498
SN - 1069-6563
VL - 14
SP - e59-e62
JO - Academic Emergency Medicine
JF - Academic Emergency Medicine
IS - 4
ER -