Notice Number: NOT-HL-06-116

Key Dates
Release Date: January 31, 2006
Response Due Date: March 8, 2006

Issued by
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)

Purpose

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" (new portion is in green) version of the existing policy and are available at: http://www.nhlbi.nih.gov/funding/inits/ladspolicy.htm.

Respondents are asked to comment on the modifications using the link to the online form at the end of this document if possible.

Background

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.

The NHLBI has for many years distributed data from selected population-based studies in accordance with the NHLBI Policy for Distribution of Data as described at (http://www.nhlbi.nih.gov/resources/deca/policy_new.htm).

The policy has heretofore been primarily concerned with providing access to phenotypic data. However, now that available technologies make large-scale genotyping both feasible and affordable, the NHLBI believes that the policy should be modified to require more rapid release of data from genome-wide association studies. The NHLBI is soliciting input from the scientific community on its proposed modifications to the policy.

Proposed modification:

For selected NHLBI-initiated clinical trials and epidemiology studies for which the NHLBI obtains high-density, genome-wide genotyping, curated (i.e., de-identified, documented, cross-referenced, standardized, and linked) phenotypic, genotypic, and pedigree (if appropriate) data are to be delivered to the NHLBI after quality control protocols are completed. Completion of quality control protocols is not to exceed 6 months following completion of the raw genotyping or receipt by the trial or study of raw genotyping data. Immediately after receipt by the NHLBI or its designee of the curated data set, the NHLBI will make the data available to qualified scientific investigators with IRB approval who sign a data distribution agreement AND agree in writing not to submit a manuscript using the data for one year following the data release date.

For all other NHLBI-supported clinical trials and epidemiology studies for which high-density, genome-wide genotyping is obtained with NHLBI support, curated phenotypic, genotypic and pedigree (if appropriate) data are to be delivered to the NHLBI after quality control protocols are completed. Completion of quality control protocols is not to exceed 6 months following completion of the raw genotyping or receipt by the trial or study of raw genotyping data. One year after receipt by the NHLBI or its designee of the curated data set, the NHLBI will make the data available to qualified scientific investigators with IRB approval who sign a data distribution agreement.

Information Requested

Please provide any information considered important and relevant to the proposed modifications to the NHLBI Policy for Distribution of Data.

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: http://www.nhlbi.nih.gov/funding/inits/ladsform.htm, or send a letter, fax or email to:

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

Weekly TOC for this Announcement
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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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