Procedures for Obtaining Datasets

Investigators wishing to request limited access data sets 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 limited access 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. 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.