Everything You Wanted to Know About OSP (But were afraid to ask…)

The NIH Office of Science Policy (OSP) is part of the Office of the Director of NIH. Our primary purpose is to advise the NIH Director on biomedical research policy issues that are of significance to the agency, the research community, and the public, as well as to work with stakeholders within and outside of NIH to develop policies that promote progress in the life sciences. OSP is organized into three divisions – the Office of Biotechnology Activities, the Office of Clinical Research and Bioethics Policy, and the Office of Scientific Management and Reporting. Collectively, they represent a wide range of policy issues relevant to the mission of NIH. But, what does OSP do exactly? I’ve outlined a few of our key functions below:

Policy Development: OSP is frequently the incubator for policies that are ultimately implemented through the terms and conditions of grant awards funded by NIH. For example, NIH issued the NIH Genomic Data Sharing (GDS) Policy to facilitate data sharing while ensuring data are used in a way that respects the privacy and wishes of participants.  Research with genomic data increasingly demands resources that only cloud computing platforms can provide, OSP collaborated with cloud computing experts to develop appropriate best practices that support use of this technology.  The GDS Policy is part of a broader effort by NIH to increase access by researchers, clinicians, and the public to the results of NIH-funded research.

Other areas in which OSP plays a critical role in policy development include the protection of human research subjects, the conduct and reporting of clinical research and clinical trials, privacy and confidentiality in research, stem cells and regenerative medicine, biosecurity, biosafety, genetic testing, health services research, and sharing of and access to research results. Working closely with other agencies and the NIH Institutes and Centers, as well as the research community, OSP crafts the policies that facilitate research advancement and responsible conduct of research.

Review of Emerging Technologies: In some instances, OSP is directly involved in creating the policies related to oversight and review of research involving cutting edge or novel biotechnologies. An example is the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, which have become a national biosafety standard and have been used as a model for the development of biosafety standards in many other countries. In fact, this year is the 40th anniversary of the Asilomar conference at which the NIH system of oversight of recombinant DNA research was established.  OSP also oversees the activities of the National Science Advisory Board for Biosecurity (NSABB) which provides advice to the U.S Government on biosecurity matters.  In addition, OSP staff play a vital role in the USG’s implementation of the new United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.

On an ongoing basis, OSP considers whether an emerging field of science, such as embryonic stem cells, genome editing, or gene drives might need new policies to facilitate progress or address bioethical or safety concerns. This might take the form of a workshop to consider the state of the science – such as a recent examination of genomic editing technologies – or the sponsorship of a National Academies study or the creation and implementation of guidance, like the NIH Guidelines for Human Stem Cell Research.

Measuring the Outputs of Research Investment: Connecting the line between research advances and health outcomes is not easy.  Research results may take years to implement into public health practice, and one vein of research may have implications for many different aspects of health.  In addition, as the largest biomedical research agency in the U.S., it is important to ensure that our federal partners, Congress, and the public are aware of NIH’s myriad research activities.  OSP works across NIH to report on the full range of NIH’s activities, coordinate NIH’s interactions with its many important partners and to analyze NIH’s contributions to the improved health of the nation.

But wait, there’s more… As you can see from this snapshot, we tackle a diverse topics of high importance, not only to the scientific community, but to society at large. Truthfully, the activities of OSP are too numerous to capture in a single blog post – it’s an exciting place to be a part of!

In the coming months I will be sharing more information with you about some of the key initiatives of the Office of Science Policy and how our programs contribute to the mission of the NIH as well as the broader goals of promoting scientific research and using the discoveries to improve public health.  In the meantime you can find additional details about our office on the web at http://osp.od.nih.gov/.  We invite you to contact us at any time!

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