The U.S. Department of Health and Human Services (HHS) has just taken a giant step forward in enabling the public to obtain results of government-funded research, by releasing a comprehensive set of plans outlining how its agencies will expand access to the results of scientific research for the public. These plans were developed in response to a White House Office of Science and Technology (OSTP) memorandum that directed federal research agencies to increase access to peer-reviewed scientific publications and digital data developed by researchers.
Within HHS, five of the largest research funding agencies developed plans in accordance with HHS’s common approach to Public Access: National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Agency for Healthcare Research and Quality (AHRQ), and the Assistant Secretary for Preparedness and Response (ASPR). These plans build on our existing Open Government goals of increasing transparency, collaboration and participation, and lowering barriers to accessing health information. The plans expand upon an NIH requirement that investigators make any peer-reviewed publications resulting from their NIH-funded research available to the public within 12 months of publication. The centerpiece of the effort is PubMed Central (PMC), a free full-text archive of the biomedical and life sciences journal literature, supported by the National Library of Medicine.
HHS’ Public Access Plan Details
HHS’s public access plans are expanding access to research results in two key domains: peer-reviewed publications and digital data.
- Peer-reviewed Publications – HHS is expanding the types of peer-reviewed articles that will be required to be deposited into PMC. Researchers funded by NIH, CDC, FDA, AHRQ and ASPR will be required to submit their publications into PMC within 12 months of their publication. The addition of these agencies will increase the body of available research to include new topics such as: comparative effectiveness, emergency preparedness, public health, environmental health, and toxicological research.
- Digital Data - HHS is also requiring that the data produced by researchers be made publically accessible in a digital format. At a minimum, the data underlying publications will need to be available at the time of publication. As part of this effort, agencies will require that investigators submit data management plans outlining how their data will be managed and shared as part of their initial research proposals.
Impact of Greater Access to Health Information
Given that health information is one of the most highly sought after types of information on the web, the impact of successful implementation of these public access plans is likely to be significant. The efforts will augment the over 3 million papers that are currently available to the public through PMC. The requirements will add to this repository an estimated 110,000 peer-reviewed scholarly articles authored by HHS-funded researchers each year. As a result of the partnerships HHS has established with many of the leading scientific publishers, additional journal articles are being voluntarily added to PMC. As the contents of PMC grow and diversify, more opportunities will be created for new connections to be made among disparate fields of scientific inquiry, and new types of knowledge and insights that can benefit health and healthcare.
The new requirements for data sharing will be highly impactful, not only in terms of follow-on research that can be enabled, but also for ensuring the integrity of the scientific enterprise through allowing others to confirm the reproducibility of any published experiment. By ensuring that all publicly released research data is provided in open, machine-readable formats that can easily be accessed for computational analysis and machine-learning, the hope is to assist the realization of the promise of “big data” in medicine and healthcare.
A major focus over the coming year will be the policy development processes necessary to turn these plans into practice. Several agencies, such as FDA, AHRQ and ASPR, will be developing public access policies for the first time. Other agencies, such as NIH and CDC, will be updating existing policies. In parallel with the policy development efforts, HHS will be working to integrate new partners into PMC, which will include new segments of the publishing and research communities. These efforts will increase the usability of health research funded by HHS, and create an information ecosystem that will catalyze improvements in health and healthcare for all Americans.