Tag: Science Policy Coordination

Thomas Edison had a famous saying.  No, not the one about inspiration and perspiration.  I am talking about the one that goes “there is a way to do it better – find it.”  No one can really argue with the results that the Wizard of Menlo Park achieved from living his life by that motto.  While Edison died some 25 years prior to the discovery of the double helix, his words echo as a clear directive to the way we should approach biomedical research.  

NIH unambiguously believes that animal models are critically important to biomedical research.  At the same time, we also continue to support the development of methods that capitalize on new technological approaches that can complement and supplement what we learn from animal studies.  These novel alternative methods (NAMs) can complement traditional animal models and in some cases, may help refine or replace the need for animal models in certain types of research studies. 

NIH has an increasingly expanding investment in the development and use of NAMs in multiple ways.  Examples include 3D tissue culture models and the use of computational methods, such as machine learning.  NAMs are used to explore a wide range of areas, including cancer, diabetes, cardiovascular disease, Alzheimer’s disease, mental illness, infectious disease, rare diseases, and other basic and clinical research. The use of NAMs has many important potential benefits including, speeding up drug development, predicting drug safety and efficacy in humans, and improving understanding of biological mechanisms in isolation.  Importantly, the NAMs can help us see complex problems through a different lens, potentially catalyzing amazing scientific discovery.

Supporting NAMs is not new for NIH.  For over two decades, the National Toxicology Program, led by the NIEHS Director, has provided resources for alternatives to animal use in toxicology testing. The use of NAMs by the biomedical research community has expanded beyond toxicology into the research funded and conducted by nearly every Institute and Center at the NIH. In recognition of this, we recently convened a cross-NIH working group to further explore the use of NAMs across NIH. More recently, the NIH Intramural Research Program (IRP) has been exploring its own capabilities to support NAMs to complement animal research.  There are also a number of collaborative NAMs efforts underway between NIH ICs and the FDA involving topics such as toxicological research and tissue chips. 

If you watched today’s meeting of the Advisory Committee to the NIH Director (ACD), you will already be in the know about an exciting new development—the creation of a new ACD working group.  This new working group is being set up to explore NAMs options and to make recommendations on where NAMs are positioned to be most applicable or beneficial, especially in terms of advancing our understanding of human health.  The establishment of this working group acts on the recommendation included in the ACD Working Group on Enhancing Rigor, Transparency, and Translatability in Animal Research’s June 2021 report.

As one of the co-chairs of this newly established working group, I am very excited to get started with our work as NAMs hold tremendous promise to help complement the research landscape. The working group will also be seeking stakeholder input on this issue and robust community engagement will be key to the working group’s success.

I started this blog ignoring Thomas Edison’s most famous quote.  However, after thinking a bit about it, I think there will be lots of inspiration and perspiration in my future.

Last week was a busy one for OSP.  Just to name a few of the OSP team’s accomplishments, we released two new resources to assist in implementation of the NIH Policy for Data Management and Sharing (DMS), we hosted Part II of a webinar series on the DMS Policy, and we hosted a meeting of the National Science Advisory Board for Biosecurity (NSABB) to advance responsible research with potential biosecurity implications.

In case you missed it, the NSABB meeting was the Board’s first opportunity to discuss its working group’s preliminary assessment of the scope and implementation of the OSTP Policy Guidance (and subsequent HHS Framework) for research involving enhanced potential pandemic pathogens (for a refresher on the WG’s charge, see here). Preliminary findings discussed included:

• Modifying the P3CO scope to include pathogens with high transmissibility and low/moderate virulence as well as those with low transmissibility and high virulence;
• Removing exclusions for vaccine development and surveillance work;
• Formalizing roles and responsibilities for investigators and institutions in P3CO identification and oversight;
• Developing additional U.S. government (USG) guidance/education material; and
• Increasing public transparency into the P3CO review process and decision-making.

It is important to note that draft findings and recommendations discussed last week are still preliminary. The NSABB will continue its discussions, taking the input received in this meeting into account along with all the other information gathered during their deliberations and through public input, before making final recommendations to the USG.

At this meeting, the NSABB also heard from experts focused on implementing effective strategies for responsibly communicating dual use research of concern (DURC) methods and results. An age-old question – how do we promote the highest level of transparency in research when there are potential security implications? The question itself hasn’t changed much since our biosecurity polices were developed, but the ways in which information is shared most certainly have. While scholarly publications remain a bedrock of information dissemination, we are seeing an increasing role of social media and preprint servers. Perspectives may differ, but there was general agreement amongst experts that identification of DURC earlier in the research continuum offered more, and potentially better, options for managing potential risks in its communication.

At the end of the day, our policies need to anticipate ways in which science will be conducted in the future to preserve the benefits and mitigate the risks. The second panel of experts focused on this exact issue and highlighted the importance of incentivizing biosafety and biosecurity practices. Quite a bit of discussion focused on equipping the next generation of researchers with the knowledge and tools needed to identify and address dual use research issues. It is vital that all scientists, especially the next generation, review the implications of their research not only through the lens of its benefits, but also its potential risks.

Of course, nothing beats the real thing, so I encourage you to take a look at the NIH Videocast of the event so you can really take stock of the important discussions that were held.

As for next steps, the NSABB will continue to work on its charge, and we expect they will be meeting again sometime in the coming months to present draft findings and recommendations for the entirety of the charge – stay tuned!

I don’t think it would be news to anyone reading this blog to hear we are living in a digital economy. Whether at home, work, or play, the data we provide about ourselves are being collected and used to understand our preferences and shape our behaviors. A lot of the time, we freely give away this information so that we can get access to the latest app or service aimed at making life easier. For example, providing information on your location so that a charming British voice can provide you with step-by-step directions to brunch on your GPS can be a real timesaver. However, how does your calculus change when you are asked to provide data related to your health and well-being? Would you think differently about giving access to your personal health data so readily? How would you consider your family’s privacy or the potential benefit to public health?

As the leading biomedical research agency for the Nation, how people think about sharing their personal health data is key to informing policy development. It is clear that health-related apps, wearable devices, social media, and other personalized technologies can move a research study from the lab to the real world. But how this transformation takes place, especially in terms of how NIH can ensure responsible data collection, analysis, and use, requires careful consideration.

To assist NIH in thinking through these issues, NIH charged a working group of the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) to forecast areas of research in which emerging technologies might yield novel data types and sources.

The first step in tackling this problem is to identify potential studies and why they might be undertaken.  This is a vital step as any future policy must clearly balance the benefits and risks for individuals and the public. The working group has been hard at work over the last several months meeting with a variety of experts across sectors to develop a draft list of types of research questions. These questions were presented and discussed during the working group’s progress update at the meeting of the NExTRAC on July 14, 2022.

In general, key aspects of the discussion focused on:

• Emerging Data Sources: Personal health data collected from outside of the traditional healthcare system are increasingly being used to study health-related questions and predict health risks. Collection and sharing of these data has enormous potential to help people, but how these research aims affect not only individuals, but also families and communities (who might share genetic makeup or walk around the same rooms) and how we effectively communicate the broader risks and benefits require careful consideration.
• Use of Models and Algorithms: Computer-based technologies, such as artificial intelligence (AI), machine learning (ML), and automated image analysis, have the potential to revolutionize diagnostic and treatment decisions. Knowing that the accuracy of these technologies depends on the data that were used in their development, how do we responsibly deploy for early adoption or underserved populations who may not be represented in those underlying data? Lack of representation in datasets remains a pervasive challenge, which can be detrimental when used to inform healthcare decisions. These biases can be further exacerbated when datasets are combined as the biases existing in one dataset can be reflected in all the others.
• Linkage and Aggregation: Researchers have an increasing capability to link diverse datasets, such as electronic health records with genomic information, creating new opportunities and challenges. Can dataset formats be standardized so that data from different countries and healthcare systems could be aggregated, linked, and shared across populations? How can personal health libraries be used to combine individuals’ health information across multiple different data streams to inform health outcomes?

Importantly, much of the discussion emphasized the point that how we think about these technologies – and the opportunities and challenges they raise – is highly personal and context matters. This is why we need robust and representative input. Particular attention should be placed on those not traditionally engaged in the conversation, including people who may be more skeptical of sharing data for research. Accordingly, the working group discussed its plans to engage the public in the conversation to understand more about how to balance the benefits and risks in these types of research. These engagements represent a critical step in the process to ensure that participants remain partners at the center of our research efforts.

While this will not be an easy task, I’m very excited about the NExTRAC’s next steps as they will not only help us think through policy issues on the horizon, but also help chart the course for new ways of engaging the public in the policy process. In case you were unable to attend the meeting (archived here), expect to see some announcements for the working group’s engagement activities in the near future and their final recommendations to NIH some time in 2023. Emerging technology in data science continues to shape the way we conduct research, and we look forward to working with the public we serve to ensure that we balance this change for the greatest good.

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.