Tag: Biosafety

The Deep Dish on Institutional DURC Policy: Calling All Stakeholders!

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If my time in the U.S. government has taught me anything, it is the vital importance of checking in on how the policies we craft are being implemented by our stakeholders.  Policies should not be set in stone, especially when they apply to fast moving areas of science, and we need to hear from the affected community what is or is not working.

When the U.S. government and institutional stakeholders gathered at the NIH in July 2015 to discuss the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC), it was still months until the policy would come into effect.  Yet this face-to-face exchange of questions, ideas, perceived challenges, and initial experiences with federal policy implementation was invaluable to providing investigators, institutions, and federal funding agencies with a clearer understanding of their individual and shared responsibilities to identify and manage DURC.  As productive as that meeting was, at that point, it was still impossible to predict the impact of the yet-to-be implemented institutional DURC policy.

To leverage the benefits that come with hindsight, and two years of experiences, the U.S. government is hosting a two day stakeholder workshop on September 25-26, 2017, in Chicago, Illinois to engage with boots-on-the-ground implementers of the institutional DURC policy.  The purpose of this workshop is to learn how the DURC policy is being implemented at different institutions, hear about any challenges encountered and strategies devised and, perhaps most importantly, facilitate the sharing of best practices among research institutions and investigators in order to make compliance with the policy easier.

The safety and security of life sciences research is absolutely dependent upon the shared role of scientists, research administrators, compliance officers, and oversight bodies.  Hearing about the various ways these groups function to achieve the goals of supporting beneficial research while mitigating risks associated with DURC should be a great practical resource to those institutions participating, as well as a great value to NIH and the U.S. government.  I encourage individuals and institutions with a stake in research subject to the DURC policy to register, come share their views, and be active participants in the discussions in Chicago.  I hope to see you there!

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Back to the Future: Asilomar and the Upcoming NIH Guidelines workshop

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The old expression, “the more things change, the more they stay the same” is one that is not usually applicable to science and science policy.  You could even say that our job as policymakers is to ensure things don’t stay the same and that policy evolves alongside of technology. However, sometimes you need to look back to look forward.  An example of this is the way we are taking a fresh look at the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) at an upcoming workshop, NIH Guidelines: Honoring the Past, Charting the Future.

The system of oversight for recombinant DNA research began at the International Congress on Recombinant DNA Molecules held at Asilomar, which gave rise to the NIH Guidelines and the NIH Director’s Recombinant DNA Advisory Committee (RAC).  The notion of scientists coming together to discuss oversight of their own research was a revolutionary concept, and the term “Asilomar” has become nearly synonymous with self-regulation of science.

Forty years after Asilomar, the scientific landscape has changed significantly.  The use of recombinant DNA, including in human gene transfer trials, is now routine, and the associated risks are better understood. In that same time period, we have seen the maturation of biosafety oversight and practice, as well as an evolving framework of research regulation. However, emerging technologies such as synthetic biology, novel RNA applications, and genome editing tools and techniques are raising questions about where these technologies fit within our existing biosafety paradigm.

Within this context, the aim of this workshop is to pose the following questions with respect to laboratory biosafety oversight:

  • If Asilomar were held today, what would the NIH Guidelines look like?
  • What would be the role of the RAC?
  • Where should theNIH Guidelines fit within the policy and regulatory landscape?

This workshop will be an excellent forum for attendees to discuss the above questions with scientific experts and stakeholders.  We are also honored to have Asilomar co-organizer, and Nobel Laureate, Dr. David Baltimore opening the meeting with a keynote address.

The workshop will take place on July 18-19, 2017, and will be held at the Bethesda North Marriott Hotel & Conference Center. Further information, including the agenda is on the workshop website.  I encourage all interested stakeholders to join us in July for what is shaping up to be an exciting and engaging workshop!

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Extreme Website Makeover: The OSP Edition!

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Yesterday afternoon, OSP launched its brand new website!  We are confident that visitors will find the new site both visually appealing and simple to navigate.  The new site, while providing essential information about OSP divisions and programs, also contains more information about the people who make OSP tick.  Looking for someone who can answer a question about technology transfer or biosafety requirements?  Then head to our searchable employee directory.  Curious about what contributions OSP employees have made to the scientific literature?  Well our new site has the latest publications (fully hyperlinked as well) from our team of experts.  I encourage you to take a look around the new site and drop us a line with your thoughts.  The site can be accessed at: https://osp.od.nih.gov/.

The new website is just one of the many ways OSP is continuously trying to reach out to our stakeholders.  While you are obviously familiar with the Under the Poliscope blog, OSP has additional resources to keep stakeholders informed.  The best way to get direct information is to sign up for our OSP news service.  This news service allows stakeholders to receive timely updates on policy areas including biosafety and biosecurity, clinical research, genomic data sharing, technology transfer, innovation policy, scientific reporting, and much more.  It also provides subscribers with information on upcoming OSP and trans-governmental meetings and workshops related to important science policy topics.  To subscribe, please click here and then choose the “subscribe” option. Finally, don’t forget to follow me on twitter (@CWolinetzNIH) to read my latest thoughts on the world of science policy.

These are exciting times for science policy and we are glad you are along for the ride.  Please feel free to reach out to us anytime by emailing [email protected] or by contacting a member of the staff.  We hope you enjoy the new website!

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A Fresh Look at the Rules for Returning Research Results

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As the biomedical research enterprise increasingly moves to a more participatory model of research, where research participants are treated more as partners than passive subjects, we can expect greater emphasis on returning individual-level results of research to participants. A prominent example is the All of Us Research Program. All of Us aims to recruit one million people living across the United States, and as a central tenet of the program will also make data available to those participants, as well as the findings of research that use their samples and data. Recent revisions to the Common Rule have anticipated this movement, and the changes that will take effect in 2018 include new provisions that are specific to the return of research results.

As the research enterprise works to determine how and when to provide participants access to their individual-level research results and data, questions have emerged regarding whether the current regulatory environment is conducive to such access. One such example includes the Clinical Laboratory Improvement Amendments (CLIA) which is enforced by the Centers for Medicare and Medicaid Services (CMS). The Secretary’s Advisory Committee for Human Research Protections (SACHRP) has suggested that the requirements under CLIA may, in effect, create a conflict in some situations with the right of access provided by the Health Insurance Portability and Accountability Act (HIPAA) to laboratory test results. The Food and Drug Administration (FDA) device regulations may also require certain additional measures before returning individual-level research results.

In recognition of these important considerations, NIH, FDA, and CMS are collaborating to support a study by the National Academies of Sciences, Engineering, and Medicine who will convene a committee representing a range of diverse perspectives (e.g., clinicians, laboratory directors, researchers, research participants and advocates). This committee will consider whether the current regulatory environment for the return of individual-level results from analyses of biospecimens in research laboratories adequately minimizes risks and maximizes benefits both for individuals and society. This will require the committee to, among other activities, review the current regulatory environment and the evidence of harms and benefits from returning individual-level results from research laboratories, and to consider whether alternative approaches could achieve a more appropriate balance of risks and benefits.

The proceedings of this committee are sure to raise important questions and robust dialogue. I encourage all interested stakeholders to stay tuned to the National Academies for more news on this study.

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