May 20, 2022

Volume XII, Number 140

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OSTP Releases Highly Anticipated Guidance on National Security Strategy for Federally Funded Research

On January 4, 2022, the White House Office of Science and Technology Policy (OSTP) issued the long-anticipated guidance for federal agencies to implement National Security Presidential Memorandum (NSPM)-33. Encouraging an approach that balances research security with continued scientific innovation, the guidance stresses consistency in requirements, transparency regarding those requirements, and collective responsibility among researchers, awardee institutions, and funding agencies in meeting those requirements.

NSPM-33, published during the final week of the Trump administration, outlined steps the United States can take to protect intellectual capital, discourage research misappropriation, and ensure responsible management of taxpayer dollars while maintaining an open environment to foster research discoveries, collaborations, and innovation. The Biden administration endorsed the memorandum, and in August, OSTP announced that it was in the process of creating guidance for federal agencies to implement NSPM-33 “effectively, rigorously, and uniformly … in a way that protects the nation’s interests in both security and openness.” In recent years, federal agencies have devoted significant time and effort to combat the threat of undue foreign influence on federally funded research and the potential theft of U.S. intellectual property. Many agencies, such as the National Institutes of Health, have recently updated their disclosure requirements in response to such concerns. The Department of Justice has also prosecuted researchers and institutions for allegedly failing to comply with these requirements and concealing their affiliations with foreign entities.

OSTP recognizes that compliance with NSPM-33 and relevant laws and regulations must be as easy and uncomplicated as possible for the research community and expects that standardized disclosure requirements across agencies will reduce uncertainty and establish clear, persistent guidelines for researchers to follow.

The guidance document includes (i) general guidance that agencies should apply across their implementation efforts, and (ii) more detailed guidance in five key areas addressed in NSPM-33:

  1. Disclosure Requirements and Standardization

  2. Digital Persistent Identifiers (DPIs)

  3. Consequences for Violation of Disclosure Requirements

  4. Information Sharing

  5. Research Security Programs

Of note, the guidance sets out that federal agencies are required to implement NSPM-33 in a nondiscriminatory manner that does not stigmatize or treat unfairly members of the research community, including members of ethnic or racial minority groups. In addition, the guidance sets out that federal agencies should:

  • coordinate, through the National Science and Technology Council (NSTC), to ensure that implementation of NSPM-33 is uniform across agencies, to the greatest extent practicable and variations of disclosure requirements should be limited to cases (i) where required by law, (ii) where more stringent protections are necessary for protection of research that is classified, export-controlled, or otherwise legally protected, or (iii) for other compelling reasons consistent with individual agency authorities and as coordinated through the NSTC;

  • avoid taking any major NSPM-33 implementation actions, unless coordinated through the NSTC;

  • engage with the research community throughout the implementation process (including testing, piloting, and soliciting feedback), and consider stakeholder and community input and concerns;

  • avoid any retroactive application of new policies or procedures that would unnecessarily harm researchers currently supported by federal funding;

  • allow submission of required disclosure information via a DPI service, but also may retain the option for a grant or cooperative agreement application to be processed without it; and

  • encourage individuals to come forward and correct past omissions by ensuring that mechanisms for correcting disclosures exist, are communicated clearly, specify timeframes, and are simple and straightforward.

The guidance also (i) includes a table detailing the types of activities to be disclosed by “Tier I individuals” (i.e., principal investigators and other senior/key personnel, program officers, or intramural researchers); (ii) provides recommendations for agencies to determine appropriate consequences for violations of such disclosure requirements (including circumstances for potential imposition of consequences on research organizations); and (iii) explains how certain research organizations (i.e., those that receive federal support in excess of $50 million per year) will be expected to satisfy NSPM-33’s research security program requirements, and the agencies’ role in developing such programs.

With respect to how the government will use the disclosed information in making decisions about research funding and support, OSTP will address this question and others in the future.

Next Steps: Model Award Proposal Disclosure Forms to Be Developed Within 120 Days

As a next step, OSTP has directed federal research agencies to work together within the next 120 days to develop model award proposal disclosure forms and instructions that can be used (and adapted where required) by any federal research funding agency. The goal of these standardized forms is to increase clarity and reduce administrative burden on the research community by creating consistency in the form and content of required disclosures across all federal funding agencies. These models can also provide clarity to developers building electronic CVs and other tools to help streamline the processes for disclosure. Next steps also include efforts by the NSTC’s Subcommittee on Research Security to develop common standards for the research security program requirements for use by federal agencies, as well as a standard and centralized research security program certification process for use by research organizations.

What Stakeholders Should Do Now

Although OSTP’s guidance document is primarily intended to aid federal research agencies in harmonizing their processes, the research community should be equally engaged in understanding and complying with the implications of this guidance. As the agencies work on developing the model award proposal disclosure forms, research institutions should:

  • take stock of their current conflict of interest and conflict of commitment policies, as well as internal procedures to collect information from researchers related to conflicts in research (including, as it relates to other support, foreign relationships and activities);

  • evaluate existing communication pathways between institutional grants and contracts departments and other institutional conflicts disclosure processes;

  • prepare for the incorporation of the new funding award forms and associated training for the researcher community per OSTP’s guidance; and

  • use this time to improve communication with the researcher community and reiterate the informational and educational resources available to them related to the issues of financial disclosures and how to avoid undue foreign influence.

©2022 Epstein Becker & Green, P.C. All rights reserved.National Law Review, Volume XII, Number 7
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About this Author

Kate Gallin Heffernan Healthcare Lawyer Epstein Becker Green
Member of the Firm

When academic medical centers, hospitals, universities, research institutes, start-up biotechnology companies, and other research stakeholders need advice on a comprehensive range of issues affecting biomedical research, they turn to Kate Gallin Heffernan. Kate counsels clients on issues related to:

  • Human subjects protection

  • Research noncompliance and misconduct proceedings

  • Research affiliations and contracting

  • Investigator and institutional conflicts of interest

  • Repositories for data, genomic, and...

617-737-3539
Marylana Saadeh Helou Healthcare Attorney Epstein Becker Green Boston
Associate

Marylana Saadeh Helou is an Associate in the Health Care and Life Sciences practice, in the Boston office of Epstein Becker Green. She focuses her practice on advising academic medical centers, hospitals, universities, pharmaceutical and medical device companies, and other health care and research organizations on issues related to human subjects research and data privacy.

Ms. Helou’s experience includes:

  • Assisting clients in navigating requirements under the Common Rule, HIPAA, and other...

617-737-8738
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