Author: admin

What do you think of when you think of fall? Back to school? Pumpkin spice lattes? Raking leaves? That first chilly nip in the air?

Here at NIH’s Office of Science Policy, our thoughts turn to National Biosafety Month! This year’s annual event will feature an important new resource and additional opportunities for stakeholders to engage in a dialogue with NIH about biosafety. During National Biosafety Month, we encourage institutions to highlight the importance of biosafety and to undertake activities to strengthen their biosafety programs.  In past years during National Biosafety Months, NIH has promoted themes such as transparency, laboratory accountability, and public engagement. This year, our theme is “promoting biosafety through good governance.”

A recent activity of the Federal Experts Security Advisory Panel (FESAP) has been the development of a document articulating guiding principles and best practices for biosafety and biosecurity governance.  Just in time for National Biosafety Month, this document, “Guiding Principles for Biosafety Governance”, is now available.  A wealth of other resources that institutions may also find useful can be found, on the S3: Science, Safety, Security website.  I encourage you to take a look at these resources and determine what best practices might benefit your institution.

OSP has also been very active of late with respect to the future direction of biosafety oversight. This past July, we held a workshop  to examine the current biosafety oversight framework, and discuss the future direction of biosafety oversight given the emergence of new technologies in the life sciences and the evolution in our understanding of risk and safety.  In addition, OSP staff will be participating in a town hall meeting with biosafety professionals at the ABSA International 60^th Annual Biological Safety conference in Albuquerque in October to follow-up on some of themes that were raised at the workshop. Stakeholders are also encouraged to share their thoughts with us at any time by emailing [email protected].

Finally, all throughout National Biosafety Month, I will be sending out biosafety-themed tweets.  Please make sure to follow me @CWolinetzNIH.  I encourage everyone to use #NBM2017 to keep the conversation going.

Effective biosafety oversight needs cooperation and commitment from all levels – from Federal to institutional to the individual scientists who are conducting vitally important research. Hopefully, National Biosafety Month will help strengthen that commitment to biosafety, not just in the fall, but throughout the year.

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!

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!