TY - JOUR
T1 - Sharing clinical research data in the United States under the health insurance portability and accountability act and the privacy rule
AU - Miller, James D.
PY - 2010/11/19
Y1 - 2010/11/19
N2 - Sharing of final research data from clinical research is an essential part of the scientific method. The U.S. National Institutes of Health require some grant applications to include plans for sharing final research data, which it defines as the factual materials necessary to document, support, and validate research findings. In the U.S., however, the Privacy Rule adopted under the Health Insurance Portability and Accountability Act impedes the sharing of final research data. In most situations, final research data may be shared only where all information that could possibly be used to identify the subject has been deleted, or where the subject has given authorization for specific research, or an Institutional Review Board has granted a waiver.
AB - Sharing of final research data from clinical research is an essential part of the scientific method. The U.S. National Institutes of Health require some grant applications to include plans for sharing final research data, which it defines as the factual materials necessary to document, support, and validate research findings. In the U.S., however, the Privacy Rule adopted under the Health Insurance Portability and Accountability Act impedes the sharing of final research data. In most situations, final research data may be shared only where all information that could possibly be used to identify the subject has been deleted, or where the subject has given authorization for specific research, or an Institutional Review Board has granted a waiver.
UR - http://www.scopus.com/inward/record.url?scp=78349232065&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=78349232065&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-11-112
DO - 10.1186/1745-6215-11-112
M3 - Article
C2 - 21092099
AN - SCOPUS:78349232065
SN - 1745-6215
VL - 11
JO - Trials
JF - Trials
M1 - 112
ER -