National Institutes of Health Office of Science Policy

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NIH Office of Science Policy is the primary advisor to the Director of the NIH on matters of biomedical research policy issues that are of significance to the agency, the research community, and the public. The office also works with stakeholders within and outside of NIH to develop policies that promote progress in the life sciences. The current Acting NIH Associate Director for Science Policy and Acting Director of the NIH Office of Science Policy is Lyric Jorgenson, Ph.D. [1]

Contents

Function and structure

The NIH Office of Science Policy works on a wide range of issues including biosafety, [2] biosecurity, [3] genetic testing, genomic data sharing, [4] human subjects protections, [5] the organization and management of the NIH, and the outputs and value of NIH-funded research. This is accomplished through a wide range of analyses and reports, commentary on emerging policy proposals, and the development of policy proposals for consideration by NIH, the Federal government, and the public.

Structurally, the Office is composed of five Divisions:

Biosecurity, Biosafety, and Emerging Biotechnology Policy

Life sciences research is essential to protecting global health security by helping us to understand the fundamental nature of human-pathogen interactions and informing public health and preparedness efforts, such as the development of vaccines and medical countermeasures. OSP develops policies to promote the safe and secure conduct and oversight of life sciences research, preserving the benefits of this research while minimizing its potential misuse.

Clinical and Healthcare Research Policy

NIH invests more than $17 billion in clinical research each year. OSP works with clinical researchers, patients, research participants, healthcare providers, ethicists, government agencies, and other stakeholders to ensure NIH policies prioritize research participant trust, privacy, autonomy, and safety and enhance the clinical trial enterprise to catalyze new scientific breakthroughs to improve health.

Scientific Data Sharing Policy

Sharing scientific data accelerates biomedical research discovery, enhances research rigor and reproducibility, provides accessibility to high-value datasets, and promotes data reuse for future research studies. As a steward of the nation’s investment in biomedical research, OSP develops policies that make research available to the public to achieve these goals.

Science Policy Coordination, Collaboration, and Reporting

The SPCCR Division has responsibilities in three program areas:

Coordination, Collaboration, and Scientific Reporting.

By monitoring the research and science policy landscape and through consultation, coordination, synthesis, and analysis, as well as collaboration with all Institutes, Centers and Offices of NIH, SPCCR coordinates NIH policy activities and reporting including:

  1. Coordinating NIH participation in Federal scientific councils and interactions with non-governmental agencies;
  2. Reporting on NIH accomplishments and initiatives;
  3. Evaluating the economic impact of NIH’s contributions.

Specific areas of emphasis within SPCCR include the coordination of NIH’s interactions with the National Academy of Sciences, the generation of the yearly Congressional Justification, and the coordination of the NIH Scientific Management Review Board.

Technology Transfer and Innovation Policy

Investment in NIH spurs economic growth, both by supporting research jobs and by generating biomedical innovations commercialized by the private sector into new products. OSP supports partnerships between government agencies and industry to accelerate progress toward common goals and leverage taxpayers’ investments in research.

Staff

The NIH Office of Science Policy staff consists of approximately 50 people. The senior leadership of the Office consists of: [6]

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<span class="mw-page-title-main">Biosafety</span> Prevention of large-scale loss of biological integrity

Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include the conduction of regular reviews of biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety is used to protect from harmful incidents. Many laboratories handling biohazards employ an ongoing risk management assessment and enforcement process for biosafety. Failures to follow such protocols can lead to increased risk of exposure to biohazards or pathogens. Human error and poor technique contribute to unnecessary exposure and compromise the best safeguards set into place for protection.

<span class="mw-page-title-main">National Institutes of Health</span> US government medical research agency

The National Institutes of Health, commonly referred to as NIH, is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late 1880s and is now part of the United States Department of Health and Human Services. Many NIH facilities are located in Bethesda, Maryland, and other nearby suburbs of the Washington metropolitan area, with other primary facilities in the Research Triangle Park in North Carolina and smaller satellite facilities located around the United States. The NIH conducts its own scientific research through the NIH Intramural Research Program (IRP) and provides major biomedical research funding to non-NIH research facilities through its Extramural Research Program.

<span class="mw-page-title-main">Biosafety level</span> Set of biocontainment precautions

A biosafety level (BSL), or pathogen/protection level, is a set of biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels in a publication referred to as BMBL. In the European Union, the same biosafety levels are defined in a directive. In Canada the four levels are known as Containment Levels. Facilities with these designations are also sometimes given as P1 through P4, as in the term P3 laboratory.

The National Institute of Mental Health (NIMH) is one of 27 institutes and centers that make up the National Institutes of Health (NIH). The NIH, in turn, is an agency of the United States Department of Health and Human Services and is the primary agency of the United States government responsible for biomedical and health-related research.

<span class="mw-page-title-main">National Institute of Nursing Research</span>

The National Institute of Nursing Research (NINR), as part of the U.S. National Institutes of Health, supports clinical and basic research to establish a scientific basis for the nursing care of individuals across the life span—from management of patients during illness and recovery, to the reduction of risks for disease and disability, and the promotion of healthy lifestyles.

<span class="mw-page-title-main">Medical research</span> Wide array of research

Medical research, also known as health research, refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.

<span class="mw-page-title-main">Biocontainment</span> Physical containment of pathogenic organisms or agents in microbiology laboratories

One use of the concept of biocontainment is related to laboratory biosafety and pertains to microbiology laboratories in which the physical containment of pathogenic organisms or agents is required, usually by isolation in environmentally and biologically secure cabinets or rooms, to prevent accidental infection of workers or release into the surrounding community during scientific research.

<span class="mw-page-title-main">National Institute of Biomedical Imaging and Bioengineering</span> Component of the U.S. National Institutes of Health

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), founded at the National Institutes of Health (NIH) in 2000, is located in Bethesda, Maryland. It is one of 27 institutes and centers that are part of NIH, an agency of the U.S. Department of Health and Human Services (HHS).

The National Science Advisory Board for Biosecurity (NSABB) is a panel of experts that reports to the Secretary of the United States Department of Health and Human Services. It is tasked with recommending policies on such questions as how to prevent published research in biotechnology from aiding terrorism, without slowing scientific progress.

Lana Skirboll is the former director of the National Institutes of Health Office of Science Policy.

Biosecurity in the United States is governed by the Bureau of Western Hemisphere Affairs, which is part of the US Department of State. It obtains guidance and advice on specific matters relating to biosecurity from various other government agencies.

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The Office of Portfolio Analysis was established in the Division of Program Coordination, Planning, and Strategic Initiatives in 2011 to assist NIH Institutes and Centers with scientific portfolio analysis. Per the Federal Register, the Office of Portfolio Analysis serves the following goals:

  1. Prepare and analyze data on NIH sponsored biomedical research to inform trans-NIH planning and coordination;
  2. Serve as a resource for portfolio management at the programmatic level;
  3. Employ databases, analytic tools, methodologies and other resources to conduct assessments in support of portfolio analyses and priority setting in scientific areas of interest across NIH;
  4. Research and develop new analytic tools, support systems, and specifications for new resources in coordination with other NIH organizations to enhance the management of the NIH's scientific portfolio; and
  5. Provide, in coordination with other NIH organizations, training on portfolio analysis tools, procedures, and methodology.

Gain-of-function research is medical research that genetically alters an organism in a way that may enhance the biological functions of gene products. This may include an altered pathogenesis, transmissibility, or host range, i.e., the types of hosts that a microorganism can infect. This research is intended to reveal targets to better predict emerging infectious diseases and to develop vaccines and therapeutics. For example, influenza B can infect only humans and harbor seals. Introducing a mutation that would allow influenza B to infect rabbits in a controlled laboratory situation would be considered a gain-of-function experiment, as the virus did not previously have that function. That type of experiment could then help reveal which parts of the virus's genome correspond to the species that it can infect, enabling the creation of antiviral medicines which block this function.

<span class="mw-page-title-main">Kathy Hudson</span> American microbiologist

Kathy Lynn Hudson is an American microbiologist specializing in science policy. She was the deputy director for science, outreach, and policy at the National Institutes of Health from October 2010 to January 2017. Hudson assisted in the creation and launch of All of Us, the BRAIN initiative, and the National Center for Advancing Translational Sciences. She founded the Genetics and Public Policy Center at Johns Hopkins University in 2002. Hudson is an advocate for women in science.

<span class="mw-page-title-main">Lawrence A. Tabak</span> American dentist and scientist (born 1951)

Lawrence A. Tabak is an American dentist and biomedical scientist serving as the principal deputy director of the National Institutes of Health. He served as acting director from 2021 to 2023. Previously he was the director of the National Institute of Dental and Craniofacial Research from 2000 to 2010.

<span class="mw-page-title-main">Dina N. Paltoo</span> American epidemiologist

Dina Nicole Paltoo is an American epidemiologist specializing in open science, data science, and public access. She is the assistant director for scientific strategy and innovation at the National Heart, Lung, and Blood Institute.

<span class="mw-page-title-main">Carrie Wolinetz</span> American biologist

Carrie Wolinetz is the Principal and Chair of Lewis-Burke Associate's Health and Bioscience Innovation Policy Practice Group. She formerly served in the National Institutes of Health as Senior Advisor to the Office of the Director, Associate Director for Science Policy, and Chief of Staff to Francis Collins. She also led the inaugural Health and Sciences division in the White House Office of Science and Technology Policy.

References

  1. ↑ "NIH Leadership". National Institutes of Health (NIH). 2014-10-31. Retrieved 2022-08-30.
  2. ↑ Jahnke, Art (2012-07-09). "NIH: Biosafety Lab Risks Negligible". BU Today. Boston University. Retrieved 2016-08-06.
  3. ↑ Kaiser, Jocelyn (2016-01-11). "Biosecurity board grapples with how to rein in risky flu studies". Science . Retrieved 2016-08-06.
  4. ↑ Dyke, Stephanie O. M.; Philippakis, Anthony A.; Argila, Jordi Rambla De; Paltoo, Dina N.; Luetkemeier, Erin S.; Knoppers, Bartha M.; Brookes, Anthony J.; Spalding, J. Dylan; Thompson, Mark (2016-01-21). "Consent Codes: Upholding Standard Data Use Conditions". PLOS Genet. 12 (1): e1005772. doi: 10.1371/journal.pgen.1005772 . ISSN   1553-7404. PMC   4721915 . PMID   26796797.
  5. ↑ Baumann, Jeannie (2016-06-21). "NIH Finalizes Single IRB Policy for Multi-Site Studies". Bloomberg BNA. Retrieved 2016-08-06.
  6. ↑ "OSP Directory". Office of Science Policy. National Institutes of Health. Retrieved 28 September 2018.
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