Tag: Biosafety

This is a guest blog from Susan K. Gregurick, Ph.D. Dr. Gregurick is the Associate Director for Data Science and Director of the Office of Data Science Strategy (ODSS).  More information about ODSS can be found at: https://datascience.nih.gov/

A $500,000 prize purse, rewarding data sharing and reuse in biomedical research, is a new, innovative strategy for supporting the research community. The DataWorks! Prize highlights the role of data sharing and reuse in scientific discovery while recognizing and rewarding researchers who engage in these practices. This prize, which launched on May 11, 2022, is a partnership between the NIH Office of Data Science Strategy and the Federation of American Societies for Experimental Biology (FASEB).

The future of biological and biomedical research hinges on researchers’ ability to share and reuse data. Sharing and reuse had a sizable, catalytic impact on the development of COVID-19 vaccines and treatment protocols. The DataWorks! Prize is an opportunity for the research community to share their stories about the practices, big and small, that lead to scientific discovery.

To participate, research teams share their stories through a simple two-stage application. Through narrative prompts, teams share details of the practices they used, the scientific impact of their achievements, and the potential for replicating their practices for further scientific research. This year, the DataWorks! Prize purse is up to $500,000 across 12 monetary awards including two $100,000 grand prize awards.

Beyond monetary awards, the DataWorks! Prize is an opportunity for the research community to learn from peers and apply those lessons to their research practices. The innovative approaches and tools from prize winners will be highlighted in a symposium 2023 and made available to support community learning.

As implementation of the NIH Data Management and Sharing Policy draws near, consider the broader intent of this policy: building a culture of data sharing and reuse in the biomedical research community. Incentives are a major part of culture change and we are excited to provide a space for the community to share their achievements and learn together. Through initiatives like the prize and the launch of the new sharing.nih.gov website, we are taking new steps to support the future of biological and biomedical research at the center of the NIH’s Data Management and Sharing Policy.

The DataWorks! Prize is currently open for submissions. Participants must register to participate by June 28, 2022 – visit Challenge.gov for more information and to apply.

Sequels are all the rage these days.  I figure if Marvel can make endless “Avengers” movies, I could start making blog sequels.  Back in the beginning of the year, I wrote Part I of this blog series about how NIH is working to implement the new NIH Data Management and Sharing Policy (DMS Policy).  I mentioned at that time that additional resources were forthcoming.

I should note that when we started to receive comments on what was to become the NIH DMS Policy, one thing in particular stood out to us.  Many commentors told us it would be helpful to have clear information on how to protect the privacy and respect the autonomy of participants when sharing data.  Now, we all know that cliffhangers build anticipation, so without further delay, I want to share with you some of the tools NIH has been working on to answer that call.

First, if you have seen the Avengers movies, you likely will have noticed that they tend to introduce a new villain that the team needs to battle with either new tools (think of OSP with Thor’s Stormbreaker axe) or the help of new superheroes like Captain Marvel. While not exactly a new villain, the lack of consistent consent language to facilitate secondary research with data and biospecimens is certainly a challenge many of our stakeholders have raised and one that we thought we could help address.

NIH has a long history of developing consent language and, as such, our team worked across the agency – and with you! – to develop a new resource that shares best practices for developing informed consents to facilitate data/biospecimen storage and sharing for future use.  It also provides modifiable sample language that investigators and IRBs can use to assist in the clear communication of potential risks and benefits associated with data/biospecimen storage and sharing.  In developing this resource, we engaged with key federal partners, as well as scientific societies and associations.  Importantly, we also considered the 102 comments from stakeholders in response to a RFI that we issued in 2021.

As for our second resource, we are requesting public comment on protecting the privacy of research participants when data is shared. I think I need to be upfront and acknowledge that we have issued many of these types of requests over the last several months and NIH understands the effort that folks take to thoughtfully respond.  With that said, we think the research community will greatly benefit from this resource and we want to hear your thoughts on whether it hits the mark or needs adjustment.

When reviewing the document, please bear in mind that the main purpose is to provide researchers with information on:

• Operational Principles for Protecting Participant Privacy when Sharing Scientific Data
• Best Practices for Protecting Participant Privacy when Sharing Scientific Data
• Points to Consider for Designating Scientific Data for Controlled Access

Comments on the draft will be accepted until June 27, 2022, full information and how to submit a comment can be found here.

Finally, every sequel needs a twist ending! In November 2021, NIH published a request for comments on the future directions of the NIH Genomic Data Sharing Policy.  We are still reviewing the many points and perspectives that were raised, but while we consider next steps, the comments we received are now available on the OSP website.  Okay, so maybe that twist wasn’t as big as, say, Darth Vader revealing he is (spoiler alert) Luke’s father in The Empire Strikes Back, but it’s still pretty good for the science policy world.

With a little more than half a year left until the implementation date of the NIH DMS Policy, we will continue to provide updates and resources over the next several months.

Followers of this blog are probably keenly aware that the last few months have seen a flurry of activity related to biosecurity and biosafety policy. If you haven’t been following, it is worth a reminder that back in February, the Acting NIH Director reconvened the National Science Advisory Board for Biosecurity (NSABB) to help the U.S. government (USG) proactively ensure our biosecurity oversight framework keeps pace with rapid advances in scientific research. To help inform these deliberations, NIH hosted a virtual meeting and listening session on April 27 to hear stakeholder perspectives regarding USG oversight of research involving enhanced potential pandemic pathogens (ePPPs). With all this activity, I wanted to take a few moments to share my reflections on last week’s meeting and forecast what we hope to hear more about in the coming months.

First, I want to reiterate my gratitude to the speakers and public commenters who participated in this informative meeting. Given its technical nature, it was great to see that there were over 400 individuals viewing the meeting on the NIH Videocast, reinforcing the importance and timeliness of this engagement. If you weren’t able to join us last week, please bear in mind that this was only the first in a series of NIH meetings/listening sessions; you will have additional opportunities to participate and have your voice heard.

A significant focus for this meeting was to hear from experts about whether the scope of the oversight framework for ePPP research still hits the mark–are we still appropriately capturing what should be in and what should be out? Some stated that it would be beneficial to craft a more precise definition of ePPP and build in routine assessments to make sure the definition remains current. Others emphasized that a definition with built in flexibility is a better approach for evolving with new scientific discoveries. While there was no agreement on a bright line for defining the scope of ePPP, most emphasized the importance of transparency in how decisions about ePPP research are implemented. One thing is clear—continued discussions regarding this issue will be necessary.

We also heard from participants about potential strategies for balancing security measures with transparency. Something that particularly resonated with me was that many participants reinforced the importance that policymakers, researchers, and members of the public must work in tandem to achieve a successful path forward. It also was evident from the conversation that reasonable people may not perfectly agree on the path forward, but all agreed that having an open conversation about how decisions are being made and who is making them must be a priority. In a similar vein, there were some calls for increased communication regarding ePPP risk assessments, as well the specific outcomes of these assessments. However, as with all conversations around biosecurity, some of this research and information is sensitive, and some participants noted the importance of protecting the security of relevant research and the individuals conducting it.

As the last two years have shown, pandemics are a reality. We will need to continue our investment in biomedical research to bolster our readiness for, and capability to address, future potential pandemic threats. Make no mistake, the U.S. has a comprehensive biosafety and biosecurity oversight system that is based on identifying and assessing benefits and risks, and appropriately mitigating risks. However, we must also acknowledge that as science evolves, our policy framework might need to as well. We look forward to continuing these conversations with the community and working with the NSABB and across the government to preserve the critical advances of life sciences research while appropriately managing the potential risks.