Purpose

Introduction

The purpose of this Notice is to solicit public input on proposed key provisions that could serve as a foundation for a future NIH policy for data management and sharing.

Background

NIH has a longstanding commitment to making the results and accomplishments of the research that it funds and conducts available to the public. In NIH's view, data should be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Increasing access to scientific data resulting from NIH funding or support offers many benefits and reflects NIH’s responsibility to maintain stewardship over taxpayer funds. Specifically, sharing of scientific data and results enables researchers to more vigorously test the validity of research findings, strengthen analyses by combining data sets, access hard-to-generate data, and explore new frontiers. Data sharing also informs future research pathways, increases the return on investment of scientific research funding, and accelerates the translation of research results into knowledge, products, and procedures to improve health and prevent disease. Effective data sharing practices rely upon appropriate identification, adoption, and crediting of good data management and sharing practices, thus, NIH encourages data sharing consistent with the FAIR (Findable, Accessible, Interoperable, and Re-usable) data principles.¹

In 2015, NIH released its Plan for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research (NIH Plan). ²To help NIH establish priorities for data management and sharing, NIH in 2016 released a Request for Information on Strategies for NIH Data Management, Sharing, and Citation³ and, in 2017 co-hosted with the National Science Foundation a joint workshop, focused on the value of data sharing.⁴ Public input from these events has helped to inform NIH’s thinking about key provisions for a future NIH policy for the management and sharing of data, which would replace the 2003 NIH Data Sharing Policy.⁵

Stakeholder feedback is essential to inform the development of a new NIH policy on the management and sharing of scientific data. This Notice aims to solicit public comment on proposed key policy provisions. Feedback obtained through this Notice and other outreach efforts will help to inform the development of a draft NIH policy for data management and sharing, which is expected to be released for an additional public comment period upon its development.

60-day Comment Period

Comments on this Notice must be received no later than December 10, 2018.

Information Requested

NIH is specifically requesting public comment on the proposed policy provisions and proposed required elements for data management and sharing plans, linked here: https://osp.od.nih.gov/provisions-data-managment-sharing/ . Response to this Notice is voluntary. Respondents are free to address any or all of the topics listed below, or any other relevant topic for NIH to consider. Respondents should not feel compelled to address all items. Instructions on how to respond to this Notice are provided below under the section entitled Submitting a Response"

I. The definition of Scientific Data,

II. The requirements for Data Management and Sharing Plans, and

III. The optimal timing, including possible phased adoption, for NIH to consider in implementing various parts of a new data management and sharing policy and how possible phasing could relate to needed improvements in data infrastructure, resources, and standards.

Submitting a Response

Comments should be submitted electronically to the following webpage: https://osp.od.nih.gov/provisions-data-managment-sharing/ or mailed to: Office of Science Policy (OSP), National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, or by fax to: 301-496-9839by December 10, 2018.

This Notice is for planning purposes only and should not be construed as a policy, solicitation for applications, or as an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for its use of that information.

Responses will be compiled and shared publicly in an unedited version after the close of the comment period. Please do not include any proprietary, classified, confidential, or sensitive information in your response. The Government reserves the right to use any non-proprietary technical information in summaries of the state of the science, and any resultant solicitation(s). The NIH may use information gathered by this Notice to inform development of future funding opportunity announcements and policy development.

We look forward to your input and hope that you will share this Notice with your colleagues.

1. Wilkinson, M., Dumontier, M. et al, The FAIR Guiding Principles for scientific data management and stewardship (2016), available at https://www.nature.com/articles/sdata201618.

2. https://grants.nih.gov/grants/NIH-Public-Access-Plan.pdf

3. NIH Request for Information (RFI): Strategies for NIH Data Management, Sharing, and Citation (November 14, 2016): https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-015.html

4.NIH Office of Science Policy Blog, Data with Destiny: A Debrief of an NIH-NSF Workshop, (December 18, 2017) https://osp.od.nih.gov/2017/12/18/data-destiny-debrief-nih-nsf-workshop/

5. Final NIH Statement on Sharing Research Data (February 26, 2003): https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy
NIH Office of the Director
Telephone: 301-496-9838
Email: [email protected]