NEWS

NIH Seeks Comment on Proposed Data Sharing Policy

Sanyin Siang

The National Institutes of Health recently released a draft policy on sharing data procured from NIH-funded studies. The statement is the latest in a series of requirements for material and resource sharing that have been developed in the past few years.

In 1999, NIH published its guidelines for sharing biomedical research resources. Those guidelines advised researchers to provide access to a broad range of research tools such as cell lines, reagents, drugs and drug targets, laboratory equipment and machines, databases, and computer software. NIH has also required data sharing in several areas such as DNA sequences, mapping information, and crystallographic coordinates since 1996. The proposed policy would be applied across all disciplines and funding types (grants, contracts, and cooperative agreements).

More Effective Process

NIH cites a more effective and efficient scientific process as a benefit of the new proposed guidelines. Furthermore, according to NIH, by avoiding "duplication of expensive data collection activities," the practice will preserve funds for use by a greater number of investigators.

Although sharing information through publication in science is common, the emergence of new relationships between industry and science has made the process of data sharing much less systematic.

Under the policy, investigators applying for NIH grants will need to include a plan for data sharing. According to the statement, data may be disseminated through various forums including publication in journals, posting on Web sites with built-in privacy protections, and placement in public archives or restricted access data centers for highly sensitive data.

The policy applies to data generated with support from NIH, including basic research, clinical studies, surveys, and other types of research. NIH noted that it is particularly important to share unique data sets that cannot be replicated and data sets that are large and expensive. Examples include studies of unique populations, studies conducted at unique times, and studies of rare phenomena, such as rare metabolic diseases.

Other Examples

Examples of previous successes include the Framingham Heart Study for shared epidemiologic data, the Safety and Efficacy Trial of Zidovudine for Asymptomatic HIV Infected Individuals for clinical trials data, and GenBank for data sets. Since data sharing can entail other expenses beyond data collection, the budget section of the application can include requests for related costs.

In certain cases where data cannot be shared, investigators need to explain why compliance with the policy is not possible. There may be cases in which proprietary data and agreements with third parties impose restrictions on data sharing.

Another example where data sharing may not be feasible is in some cases of clinical trials. The data used in human subjects research may contain potentially identifiable information, so ensuring the anonymity of research participants in phase I and II clinical studies may be difficult since these types tend to have relatively small number of subjects. In such cases, data may only be shared if "stringent safeguards exist to ensure confidentiality and protect the identity of the subjects." For the larger phase III trials, the data should be stripped of all identifiers and anonymized.

Time Limit

While the data should be shared in a timely manner, the proposed policy does not impose a time constraint on its dissemination because of the nature of the different types of studies. For example, analyzing data from small studies may take relatively little time while those collected from larger studies "can undergo primary and secondary analyses for extended periods of time."

There are also concerns arising from proprietary interests and incentives for commercial development. Researchers filing patent applications from the data may need to delay data sharing. NIH also awards Small Business Innovation Research (SBIR) grants to small businesses for research and development. Under the Small Business Act, SBIR grantees may hold their data for as long as 4 years after the award period ends.

Institutions and individuals are invited to comment on the draft policy (http://grants.nih.gov/grants/policy/data_sharing/index.htm). The comment period ends on June 1, 2002. NIH expects to finalize a new policy by Aug. 1 with a proposed effective date of Jan. 1, 2003.



             
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