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Presented here are the U.S. Department of Health and Human Services’ (HHS) guiding principles and approach taken by our Operating Divisions (OPDIVs) for increasing public access to the results of federally funded research. HHS is providing a common framework for OPDIVs to work synergistically in implementing their public access plans while recognizing their unique missions and stakeholder needs. There are two distinct components to our public access policy. The first relates to making the publications resulting from our funded research freely available to the public.
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The second relates to making the scientific data publicly available in digital formats. With respect to the publication component, HHS has an existing public access infrastructure in place upon which we will build. For the data component, the infrastructure is still emerging. In developing our approach, we have sought to consider the interests and needs of our various stakeholders, including federally funded researchers, universities, libraries, publishers, data users, and civil society groups, among others. Background The digitization of scientific publications and the generation of increasing volumes of digital scientific data have occurred alongside a growing expectation of openness in government and publicly-funded research within the scientific community and the public.
Pursuant to Section 103 of the America COMPETES Reauthorization Act of 2010 (Pub L. 111-358), the Executive Office of the President, Office of Science and Technology Policy issued a memorandum (“the OSTP memo”) on February 22, 2013 to the heads of federal agencies directing them to develop plans to enhance access to results of federally funded scientific research. The memo calls upon federal agencies to make the results of research that are published in peer-reviewed publications directly arising from federal funding to be stored for long-term preservation and to be made publicly accessible to search, retrieve, and analyze in ways that maximize impact and accountability of the federal research investment. Agencies are further asked to maximize access to digitally-formatted scientific data resulting from research supported wholly or in part by federal funding and to develop a strategy for improving the public’s ability to locate and access this data. There are several related executive directives and policy memoranda from the Office of Management and Budget (OMB) that impact the ways in which HHS is approaching its response to the OSTP memo. The May 9, 2013 Executive Order on Making Open and Machine Readable the New Default for Government Information, and the accompanying implementation memo pertaining to “Open Data Policy – Managing Information as an Asset” (M-13-13) provides an overarching framework for government agencies to institutionalize the principles of effective information management and to promote interoperability and openness. These efforts build upon President Obama’s 2009 Open Government Directive, which calls upon the agencies to take action to become more transparent, participatory and collaborative.
Division H, Section 527 of the 2014 HHS Appropriations Act, calls upon agencies funded under the Appropriations Act to develop policies for making their peer-reviewed publications publicly accessible. The development of a common approach to our public access policy supports two goals of the HHS Strategic Plan FY 2014-2018. These include: Strategic Goal 2 which relates to advancing scientific knowledge and innovation and Strategic Goal 4, Objective B which relates to enhancing access to and use of data to improve HHS programs and support improvements in the health and well-being of the American people. Guidance from OMB for development of the Open Government Plan for 2014-2016 requires federal agencies to address their open data planning efforts and strategies over the next two years. Data and information services are among the most critical assets for the HHS enterprise. HHS is composed of eleven OPDIVs including eight that are in the U.S. Public Health Service and three human service OPDIVs.
Collectively, HHS is responsible for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS works closely with state and local governments and many HHS funded services are provided at the local level by state or county agencies, or through private sector grantees. HHS administers more grant dollars than all other federal agencies combined, and through many programs, enables equitable treatment of beneficiaries nationwide, as well as the collection of national health and other data. HHS is committed to ensuring that, to the fullest extent possible, the results of its funded scientific research are made available to and are useful for the public, industry, and the scientific community. Development of HHS Plans and Guiding Principles The OSTP memo directs federal agencies with greater than $100 million in annual research and development expenditures to prepare plans to ensure that peer-reviewed publications and digital scientific data are accessible to the public, industry, and the scientific community.
OSTP has determined that this threshold be applied on an OPDIV by OPDIV basis, and not to all of HHS. Four HHS OPDIVs meet the Research and Development (R&D) threshold, accounting for 99 percent of our R&D expenditures. These include: the National Institutes of Health (NIH); the Centers for Disease Control and Prevention (CDC); the Agency for Healthcare Research and Quality (AHRQ), and the Food and Drug Administration (FDA). Given that these OPDIVs have unique missions, oversee vastly different types of research portfolios, operate under separate legal authorities, and typically receive independent funding streams for their infrastructure, it was practical for each of these four agencies to draft their own implementation plans. Recognizing that many other HHS OPDIVs with smaller research portfolios conduct important research, all HHS agencies were invited to participate in the response.
The Office of the Assistant Secretary for Preparedness and Response (ASPR) is also developing a public access plan for their portfolio of funded projects. In an effort to ensure continuity across the federal agencies, our OPDIVs participated in the interagency meetings sponsored by OSTP as well as an internal working group coordinated by the HHS Office of the Deputy Secretary. The internal working group convened key parts of HHS with public access interests. Taking into account the entire life cycle of a research project, the workgroup included participation from components, such as the Office of Grants and Acquisition Policy and Accountability, Office of General Counsel, Assistant Secretary for Planning and Evaluation and Office of the Chief Information Officer, and Office of the Chief Technology Officer. In addition, we engaged planning communities across HHS to ensure close alignment of our public access plans with ongoing strategic planning and budgetary efforts.
Each of the OPDIVs was asked to include budgetary considerations for operationalizing their public access plans as part of OPDIV budget requests for FY 2016. The workgroup set forth guiding principles around which the OPDIVs could develop plans for implementing a common approach to our public access policy.
Our goal is to provide continuity where feasible, keeping in mind the particular needs of OPDIV research communities and data users. Public access will help to further HHS’s strategic goals for health care, scientific knowledge and innovation by promoting a science information infrastructure that:. Encourages broad use and application of HHS supported research results across all areas of the economy, and in so doing improves the health and well-being of all Americans;. Accelerates the pace at which scientific communities are able to translate basic research into understanding, and hasten the delivery of treatments from bench to bedside;. Supports innovative breakthroughs that can drive the U.S. Economy, fuel exploration into new areas of science, and create new products, services, and analytic tools that can enhance health and contribute to advances in related fields;. Encourages private investment and new markets in value-added, innovative analysis, use and application of the knowledge found in HHS funded publications and digital data; and.
Increases transparency and accountability of our science agencies. HHS recognizes that delicate balances exist in the research information ecosystem.
We must work closely with external partners to ensure that policies are revised or developed in an environment of trust and respect. Interests in promoting openness must be carefully balanced with recognition of proprietary interests, business confidential information, and intellectual property in determining the types of research information to make publicly available. In creating policies, consideration must be given to preserving the balance between the relative value of long-term preservation and access and the associated cost and administrative burden. Many health researchers are funded by multiple federal agencies; thus, harmonization of policies and uses of common infrastructure for managing the resources is highly desired among the OPDIVs.
HHS Advances in Promoting Public Access to Research Results Our common approach to public access has two broad components: Access to publications arising from federally funded research, and access to scientific data in digital formats. HHS has been a leader in these two domains, both in terms of infrastructure and underlying policies. Provided here are several examples of how HHS has demonstrated leadership in each of these areas.
In 2000, the NIH launched PubMed Central (PMC), a free full-text archive of biomedical and life science journal literature. This was followed by the issuance of NIH’s first public access policy in 2005. The NIH goal was to improve access to cutting-edge biomedical research and to provide a long-term, stable repository of the scientific literature that researchers could continue to draw on in their work, recognizing the cumulative nature of science. The NIH’s experiences with PMC have illustrated the benefits that a centralized repository of the biomedical literature could have, not only for scientists, but also for healthcare practitioners, companies involved in the development of medical products and services, and the public. Based on NIH’s experience, we have gained an understanding of the systems and processes that must be established to advance public access.
In the early days, voluntary deposition of articles yielded a relatively small number of submissions. However, since passage of the Consolidated Appropriations Act of 2008, which made NIH’s public access policy mandatory, compliance with the public access policy has grown dramatically. Based on NIH’s experiences, we have learned that it is not enough to develop a repository. It is critical to have authorities and policies to require the deposit of articles, and a strong set of accompanying compliance measures. Partnerships with publishers and professional organizations that sponsor journals and information sources are also critical. CDC’s experience with public access has demonstrated the value of making public health information as widely available as possible.
In 2012, the CDC launched Stacks, a free, digital repository of scientific research and literature produced or funded by CDC. The Stacks repository demonstrates the important role that electronic access can play in increasing availability of public health and scientific information to the public. Articles stored and shared through CDC Stacks are increasing collaborations among research scientists, helping CDC to further its mission to save lives and protect the health of U.S. Citizens and international populations. Five years ago, HHS launched healthdata.gov.
Today, that catalog serves as the primary public-facing listing of HHS’s information resources. HHS’s healthdata.gov catalog has been recognized by the Administration as a model for how the federal government can make agency data publicly available. This catalog, which provides links to nearly 1,800 datasets, affords members of the public with access and the ability to discover HHS datasets. This resource serves as a common place of discovery for those in need of data resources related to a broad array of HHS programs. In addition to the provision of data, healthdata.gov provides a wealth of information that can help the public interpret and maximize use of our data.
The healthdata.gov platform can serve as a hub for connecting HHS datasets through technologies, such as application program interfaces (API), to other data resources. Common Approach to Public Access to Scientific Publications The first component of our common public access policy approach relates to making peer-reviewed publications resulting from OPDIV funded research freely available to the public. For this aspect of our public access policy, the OPDIVs will utilize existing infrastructure developed by the National Library of Medicine (NLM). Key elements of the NLM infrastructure include: 1) PubMed Central, a web-based repository of biomedical journal literature providing free, unrestricted access to full-text articles; 2) PubMed, a publicly available database of journal citations; and 3) the NIH Manuscript Submission System (NIHMS) for the deposit of final peer-reviewed manuscripts or published articles. Each OPDIV is developing its own agreement with NLM for use of these systems, as detailed in their plans. The common approach will be to utilize NIHMS for the deposit of final peer-reviewed manuscripts or published articles emanating from OPDIV funded research. PubMed Central will serve as the common repository for OPDIV funded publications, and full-text articles will be available through this repository.
PubMed will serve as the primary mechanism through which metadata about these articles, including supplemental information, will be made freely available to the public. These platforms have been in use for over a decade, have demonstrated their value as a public-private partnership, and meet all the requirements of the OSTP memo. A full description of the features and interactions between PMC, PubMed and NIHMS are more fully described in the NIH plan. Use of a common infrastructure for ingesting and displaying publications and metadata is advantageous because it:. Enables our agencies to leverage an existing archive that is successfully accessed by millions of users each day. Permits members of the public to access an expanded corpus of HHS funded research, including new areas such as public health, comparative effectiveness and emergency preparedness research. Members of the public that wish to read, download, or analyze in digital form the full-text articles emanating from HHS funded research will be able to conveniently do so through a single location.
Fosters private-public partnerships with the scientific journals through expanding the breadth of journals with established relationships to PMC, and increase the range of articles deposited by publishers to PMC. Reduces discrepancies in how grantees must submit research articles and in so doing enhance compliance. Creates an economy of scale in the administration and use of the platform, benefitting the OPDIVs and the publishing communities. Maximizes the impact of the Federal research investment by allowing us to avoid unnecessary duplication of effort. The OPDIVs will utilize a common embargo period of not more than 12 months, in accordance with the timeframes set forth in the OSTP memo, 2014 HHS Appropriations Act, and the 2008 Consolidated Appropriations Act. The OSTP memo requires agency implementation plans to address the means by which the public can petition for changing the embargo period for a specific field.
In its feedback on the draft plans, OSTP specified that HHS should develop a common mechanism to be utilized across its OPDIVs. Our common approach to providing a mechanism for petitions to the embargo period is described in Appendix A. Over the past decade, the NIH in partnership with NLM has developed a robust compliance infrastructure to support its public access policy.
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The systems that have been developed for research reporting, monitoring and tracking are interoperable and extensible. To the extent feasible, our OPDIVs will explore use of these systems as they develop their compliance infrastructure to support public access.
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For our approaches to be effective, outreach and training related to public access for publications will be essential. As our OPDIVs adopt the NLM’s systems, we will seek to leverage training materials or related communications that can assist our research community and program officers in understanding how to utilize PMC, PubMed and NIHMS. Common Approach for Public Access to Scientific Data in Digital Formats The second component of our common public access policy approach relates to improving the public’s ability to locate and access digital data resulting from our funded scientific research. While we have made great advances in providing public access to health information through healthdata.gov and in data sharing for genetics and genomics data, many opportunities remain for data sharing across our OPDIVs. Unlike our approach for public access to publications, our Department does not have a common repository for research data holdings, nor common standards for data management and archiving, nor common requirements or enforcement practices for the sharing of data. Given the emerging challenges of managing a rapidly expanding and increasingly complex set of data resources, our strategies for enhancing access to OPDIV funded data and optimizing search, archival, and dissemination capabilities will evolve over time.
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See HHS Strategic Plan and Secretary’s Strategic Initiatives at PMC will serve as the central gateway for all the OPDIV funded research. In addition, CDC will use its Stacks Repository (as a mirror registry to PMC) for the storage and retrieval of peer-reviewed manuscripts funded by CDC, as well as the other public health resources that CDC maintains. See It is understood in the context of this policy that ‘field’ refers to a domain of research and publications such as biomedical research, public health or engineering.