National Institutes of Health Office of Science Policy

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 NIH Associate Director for Science Policy is Carrie D. Wolinetz, Ph.D.[1]

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 (BBEBP) Division

The BBEBP Division promotes science, safety and ethics in the development of public policies in three areas: Biosecurity and Biosafety, Human Gene Transfer, and Emerging Biotechnologies. By monitoring research and through consultation, coordination, and analysis, the office develops policies related to: 1) the conduct of clinical trials using recombinant and synthetic nucleic acids, 2) biosafety for NIH supported research, 3) biosecurity, including oversight of dual use research, 4) the use of new stem cells lines for NIH funded research, and 5) new or emerging technologies that raise novel or unique policy considerations[6][7] for the U.S. government, the biomedical research community, and the general public. Specific activities include optimizing the conduct and oversight of gene transfer research, updating and interpreting biosafety policies under the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acids, collaborating with Federal partners to develop and implement U.S. government policies regarding dual use research, and managing the NIH Stem Cell Registry. BBEBP manages two FACA committees that provide advice to NIH and HHS on these activities: the NIH Recombinant DNA Advisory Committee and the National Science Advisory Board for Biosecurity.[8] Through these activities, BBEBP seeks to advance biomedical research, foster public knowledge, and engage key stakeholders in policy development.

Clinical and Healthcare Research Policy (CHRP) Division

The CHRP Division is responsible for biomedical and behavioral research policy development in two program areas – clinical research policy and healthcare research policy. Through consultation, coordination, and analysis, the office develops NIH policy and policy positions related to: 1) the design, conduct, and oversight of clinical research, human subjects research, and bioethics; and 2) the development and implementation of health care research, outcomes research, and evidence-based medicine. Specific areas of emphasis include the harmonization of clinical research policies; bioethics research, training, and the translation of bioethics research findings into practice; policy and programmatic issues in comparative effectiveness research (CER). CHRP monitors and coordinates policy development activities with other HHS agencies to foster policy harmonization; and functions as or supports NIH’s official liaison to CMS, FDA, OHRP, and the Patient-Centered Outcomes Research Institute Board of Governors.

Scientific Data Sharing Policy Division (SDSPD)

The SDSPD Division is responsible for biomedical research policy development in two program areas: Genomics and Health; and Scientific Data Management. By monitoring the research and science policy landscape and through consultation, coordination, synthesis, and analysis, the Division develops NIH policy and policy positions and provides advice on issues related to: 1) genetic and genomic research and the integration of findings from this research into health care, public health practice, and society; and, 2) the sharing and management of scientific data to promote reproducibility and translation of research results to advance science, medicine, and public health. Specific areas of emphasis include, but are not limited to, the management and oversight of NIH’s genomic data sharing enterprise, and the development, oversight and implementation of NIH scientific data sharing and management policies. SDSPD supports a number of trans-NIH forums for programmatic and policy initiatives, including genomic data sharing and governance, big data, the Precision Medicine Initiative,[9] and the Scientific Data Council. SDSPD monitors and coordinates policy development activities with other HHS agencies to foster policy harmonization, and it supports or functions as NIH’s official liaison to other federal agencies.

Science Policy Coordination, Collaboration, and Reporting Division (SPCCR)

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: and, 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 Division (TTIP)

The TTIP Division is responsible for overseeing and serving as the NIH resource on matters involving technology transfer and innovation policies. Major activities include: 1) serve as the HHS resource on the development of policies regarding technology transfer as well as innovation that has commercial impact; 2) serve as an information resource on patenting and licensing policies, regulations and procedures to the NIH and HHS community, other Federal agencies and non-governmental entities; 3) Identifies and tracks emerging issues in technology transfer and innovation policy that are likely to have relevance to NIH and HHS; 4) serve as liaison with the NIH legislative community, keeping abreast of policy and program developments; and 5) provides assistance to NIH staff and grantee institutions regarding policies and procedures related to federally funded inventions

Staff

The NIH Office of Science Policy staff consists of approximately 65 people. The senior leadership of the Office consists of:

References

  1. ↑ "Appointment of Dr. Carrie Wolinetz as Associate Director for Science Policy, NIH". 2015-03-10. Retrieved 2016-08-06.
  2. ↑ "NIH: Biosafety Lab Risks Negligible | BU Today | Boston University". Retrieved 2016-08-06.
  3. ↑ "Biosecurity board grapples with how to rein in risky flu studies". 2016-01-11. 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 4721915Freely accessible. PMID 26796797.
  5. ↑ "NIH Finalizes Single IRB Policy for Multi-Site Studies". www.bna.com. Retrieved 2016-08-06.
  6. ↑ "Should Human Stem Cells Be Used To Make Partly Human Chimeras?". Retrieved 2016-08-06.
  7. ↑ "Federal panel approves first test of CRISPR editing in humans". Washington Post. Retrieved 2016-08-06.
  8. ↑ "U.S. advisers sign off on plan for reviewing risky virus studies". 2016-05-27. Retrieved 2016-08-06.
  9. ↑ https://www.whitehouse.gov/precision-medicine
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