Greater Patient Access to Fed-Funded Scientific Research? Coming in 2015

Rare disease patients, advocacy organizations, and researchers will soon have greater access to results from federally-funded scientific research.

In 2013, the Office of Science and Technology Policy (OSTP) within the Executive Office of the President directed all federal research agencies receiving more than $100 million in federal funding to develop plans to expand public access to the publicly-funded research. This week, the Department of Health and Human Services (HHS) released the plans for improving public access for its four operating divisions that fall under OSTP’s directive: the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Agency for Healthcare Quality and Research (AHQR).

The agencies’ plans focus on two components: access to publications in scientific journals and access to data sets developed as part of research projects. NIH developed a policy on access to publications in 2008, requiring all researchers to submit any publications to PubMed Central, a database of publications maintained by the NIH’s National Library of Medicine. The NIH policy also requires that access to the full text of the publication must be made available to the public within 12 months of the date of publication. The FDA, CDC, and AHQR will now also require publications presenting funded research to be submitted to PubMed Central. The CDC will also provide access to publications through its CDC Stacks system.

Policies on improving access to data sets are in the early stages of implementation. The NIH and CDC are working to make digital data findable and easily searchable. The FDA expects researchers to deposit data in relevant, existing open data repositories, such as GenBank. AHRQ is planning to develop and maintain a data repository.

Open access to publications and data benefits scientific innovation. But it also provides a great benefit to patients, allowing them ready access to current research. This gives patients an additional way to learn about the effectiveness of current treatments and efforts being tested in clinical trials. Access can also facilitate collaborations among patients and researchers, allowing patients another way to find researchers and companies working on their disease and possibly even to connect with other patients. These plans are another step to strengthen the ability of patients to take active roles in managing their disease.

The detailed plans are available at https://www.hhs.gov/open/public-access/index.html. The repository of publications at PubMed can be accessed at https://www.ncbi.nlm.nih.gov/pubmed. CDC Stacks can be accessed at https://stacks.cdc.gov/.

TIMELINES