Thoughts on the Recent NIH DURC Stakeholder Engagement Meeting

On Thursday, NIH held its second stakeholder engagement meeting on components of the U.S. government biosecurity oversight framework. As I prepared for this meeting and collected my thoughts around the meetings that ultimately shaped the current USG DURC policies, it struck me that it has been almost 17 years to the day since the inaugural (June 30, 2005) meeting of the National Science Advisory Board for Biosecurity (NSABB).  I couldn’t help but start to think about the technological differences between now and 2005.  For example, on the day of that first NSABB meeting, the list of things that did not exist include: smartphones, free Wi-Fi, widespread use of electronic health records, and, of course, ubiquitous use of social media.

The remarkable pace of technological development, when applied to biomedical research, is equally, if not more, staggering. As a scientist, I’ll admit I’m thrilled to see how science is being used to make our lives better. However, as a policymaker, I’m extremely cognizant of the importance of ensuring the science we support maximizes the benefits while minimizing risks. After a decade since the NSABB helped shape the first USG DURC policy, we thought it imperative to take a fresh look at our DURC policies to ensure they’ve kept pace.

As part of its series of public sessions related to biosecurity, this week NIH heard from a variety of stakeholders including institutional officials, researchers, policy experts, and other members of the public on the USG’s DURC oversight framework.  The meeting featured three sessions focused on the DURC policy scope and definition, policy implementation and effects, and potential future considerations for oversight.

For those of you who were unable to attend (and even those who were), I wanted to share a few of the major highlights of the meeting. 

  • Multiple speakers emphasized that the DURC policies provide a good overarching framework in which the degree of oversight is justifiable. There was good discussion on whether the classification of agents and experimental types was the most effective strategy moving forward.
  • Some speakers thought that the scope should be expanded to encompass non-federally funded research, and there was much discussion of how the democratization of biology necessitates consideration of bottom-up approaches to risk mitigation.
  • Communication.  Communication.  Communication.  It was very clear from the discussions and public comment portion that effective communication is critical to ensuring robust oversight of DURC and the success of these policies. Just a few ideas included sharing best practices beyond the academic institution and dedicated efforts to promote understanding and transparency in policy development.

These are just a few of the key takeaways I heard from the meeting. Importantly, this meeting is only one step in the NIH approach to engaging the stakeholder community on this issue. There will be another stakeholder engagement meeting later in 2022. All of the information we are collecting will also help inform the deliberations of the NSABB as they work on their current charge.

In case you were unable to join us earlier this week, I hope you have found this recap helpful.  If you were in attendance, please let me know if I left anything out!  Finally, a recording of the full meeting will soon be available on the NIH Videocast if you are interested in seeing the action for yourself.

Lyric Jorgenson, PhD
Acting NIH Associate Director for Science Policy
About Lyric

‘Twas the Night Before Christmas

‘Twas the night before Christmas, in a very strange year,
OSP is so quiet, because there’s nobody here!
Teleworking from home, like the whole NIH,
But science policy has hardly slowed pace!
OSP staff are masterfully juggling,
Homeschool and glitches and cat laptop snuggling!
While COVID 19 has grabbed our attention,
OSP’s 2020 still had much to mention.
At long last, it’s final, the DMSP!
(Data sharing policy, to the cognoscenti…)
Please share your data and show us your plan!
It might affect if you get your next grant…
Doesn’t go into effect until 2023,
So, look for more guidance, tell us what you need.
Advisory Committees? Why, yes, there were three:
The NSABB, the NExTRAC, and the EAB.
sIRB exception for COVID is there,
COVID trial results, we hope that you’ll share!
Bioethics funding, we hope you’ll apply!
As a working group wrestles with using gene drives.
And when we look to the horizon, what should appear?
A glimpse at what continues into the next year
On CRISPR! On DURC! On biosafety!
On clinical trials diversity!
On digital health! On genomic data!
On privacy protections, based on risk or pro rata!
From primate research conducted with rigor,
De-identity challenges growing bigger and bigger,
Despite the pandemic, we see science advance,
And so, too, goes policy! (On Zoom! In sweat pants!)
As we come to the end of the year 2020,
From across OSP, there are wishes a-plenty,
To policy wonks, friends, and family,
To stakeholders and critics and the whole USG,
Stay healthy! Stay well! Wear a mask! Hang in tight!
Happy holidays to all, and to all a good night!

Carrie D. Wolinetz, PhD
Former Associate Director for Science Policy, NIH

NExTRAC: Considerations for Gene Drives Research and an Emerging Biotechnology Framework

Last year, NIH unveiled the Novel and Exceptional Technology & Research Advisory Committee (NExTRAC), a forum for advice and transparent discussions about the scientific, safety, and social issues associated with emerging biotechnologies. Today and tomorrow, the NExTRAC will be meeting to address its first two charges: considering the safety and responsible use of gene drives in biomedical research and establishing a framework to guide NExTRAC in future deliberations of emerging biotechnologies. Amidst the continuing backdrop of the COVID-19 pandemic, the proactive consideration of science on the horizon may feel esoteric, but science continues unabated and so must our examination of the appropriate boundaries under which to continue to develop new biotechnologies to improve human health and quality of life.

Indeed the recent celebration of the Nobel Prize awarded to Drs. Jennifer Doudna and Emmanuelle Charpentier for development of the CRISPR gene editing technology and announcement of the World Health Organization (WHO) position on genetically modified mosquitoes, illustrate the timeliness of Monday and Tuesday’s NExTRAC workshop on biosafety guidance and considerations for field work for the use of gene drives. There are many questions to be considered in using this technology to control vector-borne diseases, like malaria or dengue fever, ranging from the practical – is current biosafety guidance adequate? – to the scientific – what is the current state of the science on risk mitigation strategies? – to policy implicating – what is the state of infrastructure for oversight and engagement? We hope that the convening of experts in the field and comments from the public will begin to bring some clarity to these questions.

Gene drives is, of course, only one of many emerging technologies on the horizon, and the Working Group to Establish a NExTRAC Framework is laying the groundwork for future considerations of these technologies by the Committee. They will be presenting a draft report describing their current thinking on identification of emerging technologies or areas of science and a deliberative process and prompts for discussing and evaluating such technologies. This framework, pending approval by the NExTRAC, will be incredibly useful for guiding the work of NExTRAC in the future.

In keeping with the commitment of the NExTRAC as a public and transparent forum for discourse, the virtual meeting can be watched live at: and will be archived for future viewing. We hope you will have a chance to tune in and public input on NExTRAC activities is always welcome at

Posted by Dr. Carrie D. Wolinetz, November 9, 2020

Carrie D. Wolinetz, PhD
Former Associate Director for Science Policy, NIH

NIH Releases New Policy for Data Management and Sharing

Today, nearly twenty years after the publication of the Final NIH Statement on Sharing Research Data in 2003, we have released a Final NIH Policy for Data Management and Sharing. This represents the agency’s continued commitment to share and make broadly available the results of publicly funded biomedical research. We hope it will be a critical step in moving towards a culture change, in which data management and sharing is seen as integral to the conduct of research. Responsible data management and sharing is good for science; it maximizes availability of data to the best and brightest minds, underlies reproducibility, honors the participation of human participants by ensuring their data is both protected and fully utilized, and provides an element of transparency to ensure public trust and accountability.

This policy has been years in the making and has benefited enormously from feedback and input from stakeholders throughout the process. We are grateful to all those who took the time to comment on Request for Information, the Draft policy, or to participate in workshops or Tribal consultations. That thoughtful feedback has helped shape the Final policy, which we believe strikes a balance between reasonable expectations for data sharing and flexibility to allow for a diversity of data types and circumstances. How we incorporated public comments and decision points that led to the Final policy are detailed in the Preamble to the DMS policy.

The Final policy applies to all research funded or conducted by NIH that results in the generation of scientific data. The Final Policy has two main requirements (1) the submission of a Data Management and Sharing Plan (Plan); and (2) compliance with the approved Plan. We are asking for Plans at the time of submission of the application, because we believe planning and budgeting for data management and sharing needs to occur hand in hand with planning the research itself. NIH recognizes that science evolves throughout the research process, which is why we have built in the ability to update DMS Plans, but at the end of the day, we are expecting investigators and institutions to be accountable to the Plans they have laid out for themselves.

I strongly suspect we will hear both from those who think we should have gone farther and required that all data resulting from NIH-funded research be shared, regardless of extenuating factors, and those who think we have gone too far in requiring all applicants to develop a Plan. Which perhaps means we’ve gotten it just right! For some investigators and disciplines, who have been at the forefront of data sharing, this will be very familiar; for others, this will be new territory. Anticipating that variation in readiness, and in recognition of the cultural change we are trying to seed, there is a two-year implementation period. This time will be spent developing the information, support, and tools that the biomedical enterprise will need to comply with this new policy. NIH has already provided additional supplementary information – on (1) elements of a data management and sharing plan; (2) allowable costs; and (3) selecting a data repository – in concert with the policy release.

As NIH Director Francis Collins notes in his Director’s Statement today, the novel coronavirus pandemic has highlighted the importance of making research data broadly accessible. But even as the world struggles with this acute global crisis, it is important to note that we are at an extraordinary time in biomedical science, where new technologies, data science, and understanding of fundamental biology are converging to accelerate the pace of discovery and medical advancement. The Final NIH Policy for Data Management and Sharing builds on those exciting opportunities, and we look forward to working with our stakeholders to fulfill its vision.

Posted by Dr. Carrie D. Wolinetz, October 29, 2020

Carrie D. Wolinetz, PhD
Former Associate Director for Science Policy, NIH