Month: July 2022

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.