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Determining Data Sharing Policies for NIH Grant Recipients

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The NIH has policies on sharing of research data that apply to recipients of funding through their grant programs. Their definition of research data is: "recorded factual material as is typically understood by the scientific community to be necessary to validate reported research findings". This excludes drafts of papers, plans for future research, peer reviews and communications with colleagues, and items that are legally protected through IP laws, such as trade secrets and proprietary information. The privacy of those who participate in clinical trials is also protected. Some of the various guidance documents are:

1. OMB Circular A-110

A guide to the administrative requirements (i.e. record keeping, reporting) that apply uniformly to institutions of higher education, hospitals and non-profit organizations. These requirements do not apply to private companies or government agencies. The document was revised in November 1993 and again in September 1999.

2. NIH Data Sharing Policy

A "Final NIH statement" on sharing research data dated February 26, 2003.

3. NIH Grants Policy Statement

A policy statement regarding open access to research data obtained using NIH money. This also now applies to research funding obtained from the government for stem cell research as a result of the stem cell controversy and new policies set forth by President Obama.

4. The Shelby Ammendment

Dated March 16, 2000, this ammendment applies to organizations covered by the OMB Circular.

5. US Department of Health and Human Services

The US Department of Health and Human Services has published "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice", December 23, 1999, available in PDF.

6. Molecular Libraries Screening Centers Network

Additional guidelines for sharing data, specific to use of the Molecular Libraries Screening facilities, are found in: "Guidance for Sharing of Data and Resources Generated by the Molecular Libraries Screening Centers Network (MLSCN)", April 21, 2004. These guidelines pertain to users of the pilot program to provide a national resource for high throughput molecular screening (HTS), to identify small organic molecules (compounds) of biological relevance, such as siRNA.
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