Today, the U.S. Department of Health and Human Services (HHS) took a giant step forward in enabling the public to obtain results of government-funded research. HHS released 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 Policy (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. Our 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 – We are 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 corpus of available research to include new topics such as: comparative effectiveness, emergency preparedness, public health, environmental health, and toxicological research.
- Digital Data – We are 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, our 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.
View HHS’s public access plans.
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 our public access plans is likely to be significant. We anticipate our public access efforts will augment the over 3 million papers that are currently available to the public through PMC. Our requirements will add to this repository an estimated 110,000 peer-reviewed scholarly articles authored by HHS-funded researchers each year. This is just the tip of the iceberg. As a result of the partnerships we have 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, we anticipate that it will create yet more opportunities 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. We expect it will allow for faster dissemination of research results into products, services and clinical practices that can improve healthcare. We expect 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, it is our hope that we can help realize the promise of ‘big data’ in medicine and healthcare.
Next Steps for Public Access
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, we will be working to integrate new partners into PMC, which will include new segments of the publishing and research communities. Over the next year, we will continue our efforts to explore how we can develop the infrastructure necessary to support data linkages across HHS, and facilitate the public’s ability to locate and access data published by our funded researchers. Outreach and communications to our partners, both internal and external, will be critical to the success of our public access efforts. We look forward to working together with all of the stakeholders to increase the usability of health research funded by HHS, and to creating an information ecosystem that will catalyze improvements in health and healthcare for all Americans.
 Per the OSTP memorandum, digital data is defined as the digital recorded factual material commonly accepted in the scientific community as necessary to validate research findings including data sets used to support scholarly publications, but does not include laboratory notebooks, preliminary analyses, drafts of scientific papers, plans for future research, peer review reports, communications with colleagues, or physical objects, such as laboratory specimens.