Download document: Plan to Increase Access To Results of CPSC-Funded Scientific Research
I. Background and Purpose
On August 25, 2022, the White House Office of Science and Technology Policy (OSTP) issued a memorandum entitled “Ensuring Free, Immediate, and Equitable Access to Federally Funded Research” (the “2022 Memorandum”).1 The 2022 Memorandum recommends that Federal agencies with annual research and development (R&D) expenditures, which includes the U.S. Consumer Product Safety Commission (CPSC), develop and submit to OSTP a plan to increase public access to the agencies’ peer-reviewed, scientific research publications and research data (herein after referred to as a “public access plan”). The 2022 Memorandum references another memorandum issued by OSTP on February 22, 2013 (the “2013 Memorandum”) – which directed agencies with $100 million or more in annual R&D to develop a public access plan. In addition to reaching more agencies, the 2022 Memorandum adds additional criteria for transparency and accessibility for publications and data to the original public access plan elements in the 2013 Memorandum.
This memorandum describes CPSC’s Public Access Plan that will further increase access to results of CPSC-funded scientific research, as defined in 16 C.F.R. §1028.102(l), consistent with the objectives of the 2022 and 2013 Memoranda. The 2022 Memorandum recommends that agencies with $100 million or less in annual R&D, such as CPSC, present a public access plan to OSTP and the Office of Management and Budget (OMB) by December 31, 2024, with an effective date one year after publication. On December 3, 2024, consistent with the 2022 Memorandum, CPSC submitted and received approval of this Public Access Plan from the Subcommittee on Open Science.2
CPSC’s mission is to protect the public against unreasonable risks of injuries and deaths associated with consumer products. To achieve this mission, CPSC generates and assesses information derived from engineering sciences, laboratory testing, health sciences, epidemiology, economic analysis, and other life and social science research.
CPSC already makes publicly available, as appropriate, a large amount of scientific and technical work, including information that supports regulatory decisions. For example, CPSC routinely makes publicly available staff briefing packages containing materials and scientific information supporting proposed Commission actions, including regulations. Additionally, Saferproducts.gov, the Commission’s consumer product safety information database,3 the National Electronic Injury Surveillance System (NEISS), and Clearinghouse injury and incident data4 are all publicly available online. These databases help to inform the scientists, technical subject matter experts, and decision makers at CPSC on current hazards and risks to the public.
This public access plan, in contrast, specifically covers peer-reviewed scientific research publications in scholarly journals and digital research data that result from CPSC-funded research.
While CPSC strives to increase access to its research and technical work, it recognizes, consistent with the OSTP memoranda, generally applicable federal law, and CPSC’s agency-specific statutes, that the Commission has a responsibility to protect confidentiality, personal privacy, proprietary interests, and intellectual property rights. It is important to recognize that some research data cannot be made fully available to the public consistent with national security, business confidentiality, or privacy safeguards, but instead may need to be made available in more limited ways such as establishing data use agreements with researchers that respect necessary protections.
II. Overview of CPSC's Public Access Plan
This plan describes how CPSC intends to increase access to peer-reviewed scholarly publications and their underlying data resulting from CPSC-funded research, along with other data from CPSC-funded research, consistent with applicable law and CPSC policy. The policies and approaches outlined in this plan are consistent with the OSTP memoranda and with the OMB Open Data Policy (M-13-13) issued May 9, 2013.5
The goals of this public access plan are to:
- Support and expand upon CPSC’s long-standing commitment to transparency and public access;
- Support appropriate and effective access to, and reliable preservation of, CPSC-funded scientific research;
- Promote innovation and support opportunities for collaborative, cross-disciplinary scientific research; and
- Increase public access to research data while protecting legitimate confidentiality interests including proprietary interests, intellectual property, and personal privacy.
III. Authorities, Scope, and Applicability
This public access plan is subject to law, CPSC’s mission, resource constraints, and the objectives detailed in the OMB Open Data Policy (M-13-13) to the extent that research data are collected, stored, or managed by CPSC. This public access plan aims to increase access to CPSC-funded research results while protecting confidentiality and personal privacy, recognizing proprietary and intellectual property rights, and promoting long-term data preservation with consideration for its associated costs and administrative burdens, consistent with the OSTP Memoranda and 2 C.F.R. § 200.315.
This public access plan, and any newly established requirements based upon it, applies to CPSC-generated and CPSC-sponsored scientific research data collected after implementation of the public access plan (on December 31, 2025), and not to scientific research data collected before then. Scientific research data are the digital recorded factual material commonly accepted in the scientific community as necessary to validate research findings (OSTP Memoranda, 2 C.F.R 200.315).
Classified information, confidential business information, or otherwise protected CPSC-funded scientific research data will not be made publicly available. This public access plan does not apply to scientific research not funded by CPSC that may be cited by CPSC.
This public access plan is subject to and does not limit or impair other CPSC policies, procedures, guidance, or authorities. The validity of scientific conclusions drawn from research publications or their associated research data, and CPSC’s ability to consider those conclusions and data in its actions, do not depend on compliance with this public access plan.
This public access plan specifically covers peer-reviewed scientific research publications in scholarly journals and its related data. This public access plan uses the definition of research stated by the Commission in 16 C.F.R. §1028.102(l). Under that definition, research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. This definition does not include public health surveillance activities that include collection of injury and incident data and testing information. Such surveillance activities are limited to those necessary to allow CPSC to identify, monitor, assess, or investigate potential public health signals, consumer product hazards, or conditions of public health importance (including trends, signals, risk factors, or increases in injuries from using consumer products), including those associated with providing timely situational awareness and priority setting during an event or crisis that threatens public health.
Some CPSC data that are not subject to the public access recommendations of the 2022 Memorandum are nevertheless available to the public online. These include data from the National Electronic Injury Surveillance System and Consumer Product Safety Risk Management System.
IV. Plan for Public Access of CPSC Peer-Reviewed Publications and Scientific Data
The 2022 Memorandum states that “all peer-reviewed scholarly publications authored or co-authored by individuals or institutions resulting from federally funded research [will be] made freely available and publicly accessible by default in agency-designated repositories without any embargo or delay after publication.”6
Along with the publication of peer-reviewed articles, CPSC will make publicly available appropriate metadata7 associated with scholarly publications and data resulting from CPSC’s federally funded research to the extent possible at the time of deposit in a public access repository. Such metadata should include at minimum:
- All author and co-author names, affiliations, and sources of funding referencing digital persistent identifiers, as appropriate;
- The date of publication; and
- A unique digital persistent identifier for the research output.
The 2022 Memorandum also states that “Scientific data underlying peer-reviewed scholarly publications … should be made freely available and publicly accessible by default at the time of publication.”8 CPSC will use the National Institutes of Health’s (NIH) PubMed Central to meet the public access requirements in the 2022 Memorandum. PubMed Central is a free, full-text archive of biomedical and life sciences journal literature at NIH's National Library of Medicine. PubMed Central has existing agreements with several publishers and journals to make their manuscripts available for public access. PubMed Central can also store both metadata and scientific data associated with the published article. NIH personnel have streamlined access to PubMed Central for small agencies for the purpose of meeting the public access requirements of the 2022 Memorandum.
The remainder of this Public Access Plan delineates actions for the CPSC as an agency, for CPSC’s designated Public Access person-of-contact (POC), and for the author of a peer-reviewed article subject to CPSC’s Public Access Plan.
Agency’s Actions
- The agency will designate a Public Access POC.
- The agency will establish an annual milestone starting in FY2026 to report the number of peer-reviewed articles that fall under the 2022 Memorandum and CPSC’s Public Access Plan which were published.
- The agency will establish an agency directive and standard operating procedure (SOP) for reporting that follows the actions in CPSC’s Public Access Plan.
Public Access POC Actions
- The Public Access POC will be responsible for overseeing the actions and processes needed to ensure all peer-reviewed articles that fall under the 2022 Memorandum and CPSC’s Public Access Plan are made publicly available.
- The Public Access POC will be responsible for guiding authors of peer-reviewed articles in following the protocol of publishing articles in compliance with CPSC’s Public Access Plan.
- The Public Access POC will be familiar with the process of submitting a manuscript in the NIH Manuscript Submission System (NIHMS) for PubMed Central, including the associated metadata and scientific data.
- The Public Access POC will coordinate with authors to ensure that the authors’ manuscripts are in the correct journal format that is acceptable to PubMed Central. The Public Access POC will also ensure that the correct accompanying metadata and scientific data are collected from the author.
- The Public Access POC will be responsible for submitting the manuscript and accompanying metadata and scientific data in NIHMS for each peer-reviewed publication that falls under the CPSC Public Access Plan, from a CPSC author.
- If the metadata and scientific data exceed the size limit for NIHMS, the Public Access POC will work with the author to make the data public through an alternate platform, such as the CPSC website.
Author’s Actions
- The author will preferably publish in an open access journal or in a journal that allows for authors to retain any rights in the manuscript necessary to deposit their final accepted manuscripts into CPSC’s designated repository, PubMed Central. Manuscripts prepared by CPSC employees in the course of their official duties are not protected by copyright in the United States and are in the public domain.
- If journal is not open access, the author will notify the journal that this submission falls under CPSC’s Public Access Policy and that the author is required to retain any rights necessary to their final accepted manuscript for public access. If this is not acceptable to the journal, the author will work with their agency supervisor or Public Access POC to determine whether to proceed.
- Once the article is accepted for publication, the author will notify the Public Access Plan POC about the public access policy of the journal.
- The author will coordinate with the Public Access POC to submit a manuscript in journal format, along with accompanying metadata and scientific data, to NIHMS for PubMed Central.
- If the metadata and scientific data exceed the size limit for NIHMS, the author will work with the Public Access POC to make the data public through an alternate platform, such as the CPSC website.
- The author will coordinate with the Public Access POC to answer any questions PubMed Central may have about the peer-reviewed article or journal.
- If PubMed Central is unable to make the manuscript public (which is expected to be very rare), the author will be responsible for getting approval of CPSC funds to make their article public before it is submitted for publication.
References
1 https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf
2 This subcommittee is within the Committee on Science within the National Science and Technology Council. This subcommittee led the approval process and included members from both OSTP and OMB.
3 https://www.saferproducts.gov/
5 https://obamawhitehouse.archives.gov/sites/default/files/omb/memoranda/2013/m-13-13.pdf
6 Page 3. https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf
7 Information conveyed with the publications and data upon deposit in a public access repository to ensure proper attribution and versioning.
8 Page 4. Ibid.