Procedures for Obtaining Datasets
Investigators wishing to request data from the NHLBI data
repository must complete and sign the Distribution Agreement including: 1) the name
of the requester ("recipient"); 2) the data set requested; and 3) a brief
description of the research project for which the data are to be used.
Requesters must also include a copy of the Institutional
Review Board (IRB) approval for their study. Please note that due to the
wealth of individual level data available on study participants, the possibility of
of direct identification of a study subject cannot be eliminated. Therefore, only IRB reviews
from an expedited or full review can be accepted. IRB letters of exemption are not sufficient.
The Distribution Agreement describes the following
restrictions placed upon the requester as a condition of receiving the NHLBI data set: 1) use of the data for the sole purpose of the described
research project; 2) non-transferability of the Distribution Agreement; 3)
agreement not to attempt to identify or contact study subjects; 4) compliance
with subjects' informed consent; 5) compliance with relevant IRB requirements,
including a non-exempted review of the proposed study; and 6) prior
notification of NHLBI of upcoming publications, as well as acknowledgment in
publications of contributions of Study Investigators and support of NHLBI for
data collection.
A separate Distribution Agreement should be completed
for each data set requested. A signed paper copy should be mailed to:
Mr. Sean
Coady, Epidemiology Branch, Division of Prevention and Population Sciences, National Heart, Lung, and Blood Institute, 6701
Rockledge Drive MSC 7936 Suite 10018, Bethesda, MD 20892. On receipt and approval of the
signed Distribution Agreement and IRB approval, a CD-ROM with the data set will
be mailed to the requester, typically within two weeks. Inquiries and comments
may be E-mailed to Mr. Kevin Purkiser (PurkiseK@nhlbi.nih.gov) , or phone
301-435-0711.
Researchers are invited to contact investigators in
ongoing studies to determine whether their proposed research overlaps with that
being conducted within the study as well as to explore possibilities for
collaboration with study investigators. In addition, requesters wishing to
analyze variables not included in the distributed data set due to their
sensitivity or greater potential for identifying individual subjects should
contact one of the study Principal Investigators or the Project Officer to
obtain approval. The preferred approach would be to establish a collaboration
with the original study investigators and have the analysis performed within
the study itself and within the approval of the original investigator's IRB. If
this is not possible, the study leadership (Principal Investigators and Project
Officer) will need to determine whether providing the information would
endanger subject privacy. If approved for release by the NHLBI Project Office,
the requester must supply a signed Distribution Agreement and approval from his
or her IRB of the project.
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