Modifications to NHLBI Policy for Distribution of Data from Clinical Trials and Epidemiology Studies

Notice Number: NOT-HL-05-115

Key Dates
Release Date: April 14, 2005
Response Due Date: May 11, 2005

Issued by
National Heart, Lung, and Blood Institute (NHLBI), (


The National Heart, Lung, and Blood Institute (NHLBI) has supported data collection from participants in numerous clinical trials and epidemiologic studies. These data from well-characterized population samples constitute an important scientific resource. It is the view of the NHLBI that their full value can only be realized if they are made available, under appropriate terms and conditions consistent with the informed consent provided by individual participants, in a timely manner to the largest possible number of qualified investigators.

NHLBI has for many years distributed “Limited Access Data Sets” (LADS) in accordance with the NHLBI Policy for Distribution of Data as described at ( These policies were established in the mid-1990s, when computing and information processing were more time-consuming and cumbersome than they are today. In addition, the pace of scientific discovery has increased, and more rapid and extensive release of data from other types of research studies has become the norm. The recent doubling of the NIH budget has also increased the scrutiny and accountability of NIH in ensuring that the maximum value of the public investment in research is realized. For these reasons, NHLBI is considering updating its data distribution policies for clinical trials and epidemiology studies and is soliciting input from the scientific community on these policy modifications.


This request for information seeks comments on proposed modifications to NHLBI policies for distribution of data through its “Limited Access Data Sets” procedures. These modifications are shown in a “marked-up” version of the existing policy and are available at: Respondents are asked to comment on the modifications using the link to the online form at the end of this document if possible.

Information Requested

1) Please provide any information considered important and relevant to the modification and implementation of policies for distribution of limited access data from clinical trials and epidemiology studies.

This request for information is for planning purposes only and shall not be construed as a solicitation for applications or as an obligation on the part of the Government. The Government will not pay for the preparation of any information submitted or the Government's use of that information.

Responses will be compiled and shared internally and with our advisory committees as appropriate. Should the responses be shared with other individuals, the names of the respondents will be withheld.

We look forward to your input and hope you will share this document with your colleagues. Thank you very much for your help.

To respond, please link to the online form at:, or send a letter, fax or email to the following address:

Mr. Kevin Purkiser
6701 Rockledge Drive
Room 8155, MSC 7934
Bethesda, Maryland 20892
Phone: (301) 435-0711
FAX: (301) 480-1667

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H H S Department of Health
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  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892