Guidance from the Office of Acquisition Management and Policy (OAMP) was provided by Diane Frasier on April 9, 2003 as background for the May 23, 2003 NIH Data Sharing Policy Training.

While the basic policy is the same for both grants and contracts, there are some differences.

It is NIH policy that data sharing plans be requested of offerors responding to a request for proposal at any dollar level. In solicitations where contract award is expected on or after October 1, 2003 and it is expected that the contract will generate research data, the following language will be incorporated:

“Sharing Research Data

The NIH endorses the sharing of final research data to expedite the translation of research results into knowledge, products and procedures to improve human health. This contract is expected to generate research data. Therefore, the offeror must submit a plan for data sharing or state why data sharing is not possible. If data sharing is limited, the offeror should explain such limitations in the data sharing plan. NIH's data sharing policy may be found at the following Web site:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html ”

In addition, the contracting community has taken the stance that guidance must be given for multicenter clinical trials or epidemiological studies and has provided the language below that will be inserted into applicable solicitations:

“If the resultant contract is part of a collaborative program involving multiple sites, the data sharing will be governed by a dissemination plan to be developed jointly following award. Offerors must include in their proposals a statement of willingness to work collaboratively after award with the other funded sites to prepare a joint dissemination plan. Coordinating Center proposals should describe methods to coordinate the dissemination planning and implementation. The Coordinating Center must include a budget and justification for any additional costs of this collaborative effort.”

Insofar as evaluation of the data sharing plan presented by the offerors in response to a solicitation, OAMP envisions two scenarios: (1) the NIH determines that the contract will generate research data that must be shared, and (2) the NIH determines that the contract will generate research data, and the sharing of that data must be addressed. OAMP has therefore provided language that may be used depending on which of these circumstances apply. In both cases, the prescription states that the plan or documentation as to why a plan is not possible must be evaluated by program staff and shall not be scored. However, weaknesses in a plan or in the rationale for not permitting the sharing of research data may become a part of discussions with offerors in the competitive range. This language is provided below:

Scenario 1:

“The offerors plan for the sharing of final research data shall be assessed for appropriateness and adequacy.

If your proposal does not include a plan or if the plan in your proposal is considered “unacceptable,” and the Government includes your proposal in the competitive range, (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to further discuss, clarify or modify your data sharing plan during discussions and in your Final Proposal Revision (FPR). If your data sharing plan is still considered “unacceptable” by the Government after discussions, your proposal may not be considered further for award.”

Scenario 2:

“The offeror's plan for the sharing of final research data, or, if data sharing is not possible, the offeror's documentation of its inability to share research data, shall be assessed for appropriateness and adequacy.”

NIH contract documents will contain a clause when the offeror receiving an award has submitted an acceptable data sharing plan:

“The data sharing plan submitted by the contractor is acceptable OR

The contractor's data sharing plan, dated _______ is hereby incorporated by reference. ( Note – Contracting Officer to pick one of these two sentences, at his/her discretion ). The contractor agrees to adhere to its plan and shall request prior approval of the Contracting Officer for any changes in the plan.

The NIH endorses the sharing of final research data to expedite the translation of research results into knowledge, products and procedures to improve human health. This contract is expected to generate research data that must be shared with the public and other researchers. NIH's data sharing policy may be found at the following Web site:
http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html

NIH recognizes that data sharing may be complicated or limited, in some cases, by institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule (see HHS-published documentation on the Privacy Rule at http://www.hhs.gov/ocr/). The rights and privacy of people who participate in NIH-funded research must be protected at all times; thus, data intended for broader use should be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.”

Additional questions can be directed to Ms. Barbara Levy, 6-6014 or via email.

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