Notice Number: NOT-HD-15-034

Key Dates
Release Date: November 10, 2015
Response Date: December 21, 2015

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is soliciting comments and suggestions from the public on ways to enhance the timely sharing of high quality data generated by NICHD funded clinical studies. Responses to this Request for Information (RFI) will be used to inform NICHD policy development.

Background

Data sharing has been a longstanding expectation of the research that the National Institutes of Health (NIH) funds and supports (e.g., see the Final NIH Statement on Sharing Research Data published in the NIH Guide in 2003 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html)). Data sharing can achieve many important goals for the scientific community, including but not limited to:

• promoting new research, testing of new or alternative hypotheses and methods of analysis
• facilitating education of new researchers
• enabling the exploration of topics not envisioned by the initial investigators
• supporting re-analysis and reproducibility of findings

In NIH's view, all data should be considered for data sharing, consistent with applicable NIH policies, laws, and regulations. Data should be made as widely and freely available as possible while appropriately safeguarding the privacy of participants, and protecting confidential and proprietary data.

The 2003 NIH data sharing policy discussed making data available for sharing no later than the acceptance for publication of the main findings from the
final data set. More recently, the Food and Drug Administration Amendments Act of 2008 Section 801 established a legal requirement that clinical trials that are designated as applicable clinical trials must have data submitted to clinicaltrials.gov. The primary outcome results must be submitted 12 months following completion of the last study designated assessment or the sponsor may be subject to penalties. In addition, medical journal editors noted publicly that submission and posting of clinical trial results in compliance with the legal requirements of clinicaltrials.gov would not compromise the ability to publish the research.

Information Requested

This RFI invites the scientific community, health professionals, and the general public to provide comments and suggestions on potential policies regarding timely data sharing from NICHD funded studies. For this purpose, the data available for sharing refers to line level or patient level de-identified data suitable for construction of analytic datasets and not summary or aggregate data such as used to prepare tables for publications.

Your comments can include but are not limited to the following areas:

• Using the milestone of 12 months following the last study designated assessment as the general expectation for making primary outcome data available for sharing for all NICHD clinical studies. Clinical studies are defined here as all phases of clinical trials, observational studies of clinical or high-risk populations, and epidemiological studies
• Potential operational and scientific barriers and potential solutions to data sharing when using the milestone of 12 months following the last study designated assessment
• Any other aspect of the timing of data sharing that may be relevant. (Some topics related to data sharing such as privacy, security, and participant permission and consent are considered outside the scope of this RFI).

How to Submit a Response

Responses will be accepted until December 21, 2015. All responses must be submitted via this URL: https://grants.nih.gov/grants/rfi/rfi.cfm?ID=51.

The submitted information will be reviewed by the NICHD and used at its discretion. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information provided and will not provide feedback to respondents. This RFI is for planning purposes only and should not be construed as a solicitation for applications or proposals, or as an obligation in any way on the part of the United States Federal government. The Federal government will not pay for the preparation of any information submitted for the government’s use. Additionally, the government cannot guarantee the confidentiality of the information provided.

Inquiries

Please direct all inquiries to:

Steven Hirschfeld, MD PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-0044
Email: hirschfs@mail.nih.gov