Tag: Collaboration

OSP Takes on Technology Transfer

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The Office of Science Policy (OSP) has added technology transfer and innovation policy to its scope of advice and support to the NIH Director on issues affecting the biomedical research community, the NIH, and the public.  As described previously, OSP participates in the development of new policies and programs in a variety of arenas that span the research continuum from basic laboratory science, through translational and clinical research, and from domestic to global public health.   With the addition of tech transfer policy to our portfolio, OSP staff now collect data and assess activities involving the commercialization of technologies based on NIH funded research.  Ongoing research programs invariably require the application of policies related to technology transfer. In addition, the advent of new technologies and collaboration paradigms raises questions and may merit application of new policies.

For example, in receiving a material from a third party, what level of restrictions, if any, is NIH willing to accept on its use, the publication of research results, and ownership of newly developed materials?  If a new inventive technology arises, will it be patented, what institution(s) owns the patent, and who has rights to use it for research or commercial use?  These are typically fact-specific questions made by NIH Institutes and Centers (ICs) and grantees.   However, policy guidance shapes where the lines are drawn and when.  Access to new technologies and creative collaborative arrangements may require creative applications of existing policies or the development of new ones.

While taking on a leading role within the Office of the Director, OSP works closely with the Office of Intramural Research (OIR), the Office of Extramural Research (OER), and ICs on policy issues within their respective domains.  In the past, technology transfer policy issues have included arrangements for the receipt and distribution of approved stem cell lines, patenting of genomic technologies, and the restrictions under which samples of pandemic flu strains would be distributed internationally to researchers and organization preparing vaccine seed strains.  The reorganization of technology transfer at NIH and the introduction of staff focused on technology transfer in OSP have led to the newly created Technology Transfer and Innovation Policy Division.   Among our areas of current interest: the evolving nature of complex prognostic tests requiring greater clinical development prior to commercialization and an analysis of drugs and biologics approved for precision medicine applications.

This staffing of expertise within OSP will benefit the OD and the NIH community in strengthening the management and oversight of policy functions and the programs that provide vital support to the NIH community on matters involving technology transfer and innovation policy.

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Clarifying NIH’s Priorities in Health Economics

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Today, NIH is releasing a Guide Notice on Clarifying NIH’s Priorities in Health Economics, demonstrating the importance NIH places on supporting research that examines “how scarce resources are allocated among alternative uses for the care of sickness and the promotion, maintenance, and improvement of health, including the study of how health care and health-related services, their costs and benefits, and health itself are distributed among individuals and groups in society.”  In other words, how economic models and methods can be used to support NIH’s mission to use fundamental knowledge to enhance health, lengthen life, and reduce illness and disability.

Health economics can provide rigorous tools for answering important questions about how new medical innovations are adopted and deployed; about how patients and doctors can make the best informed choices for treatment and prevention; and about how different ways of delivering health care can affect the health of individuals and populations.   Answering these sorts of questions is vital to our work here at NIH, and as of 2015, NIH funding has supported the work of five Nobel Laureates in Economic Sciences who made great advancements in our understanding of health and society.  In fact, health economics is only one example of the type of behavioral and social science research funded by NIH that is absolutely central to our ability to prevent and treat disability and disease.

Today’s Guide Notice clearly demonstrates the importance that NIH places on supporting health economics research in which health outcomes and health-related behaviors are the primary focus, and the connection between the subject(s) of the study and improved understanding of health are clear and explicit.  Health economics research that makes a strong, explicit tie to health and health-related outcomes is central to the NIH mission, and NIH believes that such studies are a worthy investment of taxpayer funds.  It is also true that an economic analysis is often included as one piece of a larger study and that such analysis is often part of understanding the real-world consequences of health interventions. Studies where the primary focus of the research is not health economics, but include such analyses as a secondary aim, continue to be a valued part of the NIH portfolio.

Some topics and approaches which are not necessarily NIH-wide priorities may still be priorities for the missions of individual Institutes and Centers. Principal Investigators (PIs) and potential PIs for NIH research grants should consult with NIH program officers in Institutes and Centers appropriate to their proposed topic if they have questions about whether their work will fit program priorities.

The Notice also identifies study topics outside the NIH mission, which will not be funded by the agency. These topics, although potentially valuable areas of research, do not connect clearly to NIH’s mission or priorities related to the understanding of health, and therefore may be a better fit at other organizations and agencies. This underscores NIH’s strong commitment to responsible stewardship of the taxpayer dollars and to transparency in setting priorities for the agency.

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Biosafety at NIH and Beyond….A Shared Responsibility

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Co-Authored by Carrie Wolinetz and Deborah Wilson

Following this week’s release of the Office of Science and Technology Policy’s joint memo on biosafety and biosecurity, coming at the tail end of National Biosafety Stewardship Month, it seems like an excellent time to discuss how NIH helps ensure the research we conduct at our own facilities as well as the research we fund across the globe is done safely.

Here at NIH, the NIH Division of Occupational Health and Safety (DOHS) is responsible for overseeing the day-to-day operations of a large and diverse biosafety program. A committed team of biosafety professionals helps ensure that the vital research being carried out by NIH is being done safely. To manage the unique challenges associated with the NIH intramural program, DOHS must be flexible in order to adapt to the changing research landscape.  Recently, DOHS has instituted changes to NIH policies for working with and storing potentially hazardous biological agents including human, plant, and/or animal infectious agents, poisons and toxins. These are significant changes to the way NIH has been doing business for almost four decades. Although NIH registers, reviews, and approves all active work with human pathogens and research involving non-exempt recombinant nucleic acids, it became clear we also needed to re-evaluate and optimize the methods used for keeping track of all biological agents that might have been stored in laboratories or repositories. In addition to support received from senior NIH management, a plan for interactions and information sharing was developed.  A continuous, open dialogue with NIH’s safety committees, such as the institutional biosafety committee (IBC), was also essential to invoking changes to long-standing programs and processes.

In support of the biosafety programs of the institutions that NIH funds, the NIH Office of Science Policy (OSP) conducts an extensive program of outreach and education on topics related to biosafety.  One of the signature programs in OSP is our extramural site visit program for grantee institutions.   The aim of these educational visits is to enable NIH to have a face to face dialog with institutions and to assist IBCs with their programs of biosafety oversight.  The visit includes a review of the policies and procedures that the institution is implementing to ensure the safe conduct of recombinant or synthetic nucleic acid research.  To date, OSP has visited over 110 institutions, and a write up of the program received the 2015 Richard C. Knudsen Memorial Publication Award from the American Biological Safety Association.

OSP has also used the information we have gathered from our site visits to develop a body of information on best practices, in particular the IBC Self-Assessment tool which institutions can use to evaluate their own IBC program.  We encourage all institutions to use the self-assessment tool, which addresses all of the major requirements of the NIH Guidelines.

These are just of few examples NIH is doing to ensure essential biomedical research is conducted safely.  Biosafety is a shared responsibility for all those involved in the research enterprise.  The close and collaborative relationship between the DOHS and OSP help ensure that NIH is at the top of the class with respect to biosafety oversight.  To learn more about NIH’s intramural biosafety program, please visit http://www.ors.od.nih.gov/sr/dohs/Pages/default.aspx.  More information on how NIH engages our extramural grantee institutions with respect to biosafety can be found at: /office-biotechnology-activities

RADM Deborah Wilson, Dr.P.H., is the Director of the Division of Occupational Health and Safety at NIH

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Talkin’ About an Evolution (of research oversight, that is!)

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To many scientists, the name Asilomar is synonymous with an historic event in the regulation of biotechnology. In 1975, experts from around the globe convened at the Asilomar conference center in California to discuss the promise and potential perils of an exciting and emerging technique, recombinant DNA technology.  The discussion laid the foundation for the  NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) The NIH Guidelines, aimed at ensuring the safe conduct of this burgeoning area of research, also gave rise to the   Recombinant DNA Advisory Committee (known simply as “the RAC”), an expert group comprising scientists, ethicists, public health experts, biosafety officials, and more, charged with providing advice to the NIH on matters related to recombinant DNA technology. In the late 1980s, the RAC took on a new role: advising NIH on the promising but very new area of human gene transfer research.

Forty years after Asilomar, recombinant DNA technology is ubiquitous in both basic and clinical research settings. As scientific understanding of recombinant DNA technology has evolved, so have the requirements that govern its use.  With this in mind, NIH has been examining the current oversight system for human gene transfer experiments and whether the review processes can be streamlined. To help craft a policy that maximizes scientific advances while ensuring public safety and trust, NIH asked the Institute of Medicine (IOM) to assess the role of the RAC in the oversight of human gene transfer research.  The IOM noted in its report that the RAC has served a valuable role, but concluded that the current level of oversight over each individual human gene transfer protocol is no longer justifiable.  The NIH agreed with this assessment and began developing a proposal for revising the process.

I am delighted to announce that today the proposal to simplify the human gene transfer protocol review process has been published in the Federal Register for public comment.  In short, NIH is proposing that protocols should only be reviewed by the RAC if an institutional oversight body (such as an Institutional Review Board or an Institutional Biosafety Committee) requests review because the proposed research is sufficiently novel.

This change is in keeping with current practice, as these committees have played a large role in overseeing this research for decades and have the expertise needed to ensure research is conducted in accordance with the highest scientific, safety, and ethical standards.

I encourage research stakeholders to provide feedback on the proposal during the 45 day comment period. Once NIH has considered all input, a final notice outlining the changes will be posted. Until then, the current requirements are still applicable.  This represents an important science policy principle: As science evolves, so must the policies that govern it.

I look forward to hearing your comments.

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