The National Institutes of Health (NIH) has developed a Web site to inform scientists about a new regulation that requires researchers who have federal funding to share their data.
The regulation, known as the Office of Management and Budget Circular A-110, requires scientists to release their data to the public through the Freedom of Information Act (FOIA) if those data are published and cited by a federal agency in support of a regulation. Data first produced under awards and grants made before Nov. 8, 1999, are not affected by the regulation.
Since there is no way for researchers to know in advance whether or not their data might be used this way, NIH is advising federally funded scientists to become familiar with the regulation, says Christine Bachrach, PhD, chief of the demographic and behavioral sciences branch at the National Institute of Child Health and Human Development. "We're encouraging scientists to think about data archiving as they plan their studies and to consider the implications of sharing data for informed consent and protecting the confidentiality of their data," she says. "It's important that investigators begin to plan now for the possibility that their data could be accessible under these new regulations."
To help scientists prepare for data sharing and head off problems with the regulation, NIH developed a guidance site.
The NIH Web site is divided into four sections:
Applicability. Clarifies the types of data and grants to which the regulation applies. For example, it applies to data collected by institutions of higher education or nonprofit organizations, but it does not apply to data collected by commercial organizations.
Definitions. Includes how the regulation defines "research data" and "published." The section also offers a list of research materials that are not governed by the regulation, including peer reviews, physical objects, intellectual property and information that could be used to identify a research participant.
Overview of the process. Includes a list of information required for the submission of FOIA requests for federally funded research data, and outlines how NIH responds to FOIA requests.
Frequently asked questions. Answers questions such as "What happens if a FOIA request is made for data that are available to the public in an archive?" and "What happens if the principal investigator of a study has moved?"
In addition, the Web site links to the full text of the regulation, http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi ?dbname=1999_register&docid=99-26264-filed.
NIH will update their implementation guidance on the Web site as they gain more experience with the process.
Scientists seeking further guidance on the regulation can also contact the FOIA coordinator for the NIH institute or center funding their grant. A list of all FOIA coordinators is provided on the NIH FOIA web site: http://www.nih.gov/od/foia/index/htm.
In addition, APA's Public Policy Office provides background information on the changes in the federal rules for data sharing on their Web site at APA Public Interest.