Author: Kherlen Martin

Embedding ethics throughout the research process is essential to the conduct of science in service of society. At NIH, we are committed to this principle as identifying ethical issues early on can help researchers anticipate and prospectively address potentially important challenges that may impact public trust or uptake of research findings. Additionally, by developing practices, informed by lessons from bioethics studies, researchers can design more meaningful studies to achieve scientific and public health goals.

OSP has long promoted an integrated bioethics vision and strategy across NIH through a variety of mechanisms. These include hosting a symposium on the integration of bioethics and biomedical research, coordinating NIH committees on bioethics, and funding Institute and Center-supported bioethics workshops and grants. Another important mechanism is the   awarding of administrative supplements for research and capacity building related to bioethical matters. Over the past four years, NIH has awarded over 120 supplements spanning most of NIH’s 27 Institutes and Centers (ICs).  These administrative supplements have helped support bioethics research in a wide range of fields including: human genome editing, citizen science, organoids, biobanks, and many others.

Recently, NIH published a Notice of Special Interest (NOSI) for a new round of administrative supplements available in FY 2023.  This year’s funding announcement was issued by 23 NIH ICs as well as several components of the NIH Office of the Director.  In addition to describing priority areas for OSP, the NOSI also lists areas of specific interest to each IC.  Interested applicants may propose to supplement parent awards focused on bioethics or to address a component related to bioethics in a biomedical and/or health-related behavioral research study.  Applications will be accepted until February 17, 2023.  

These administrative supplements are a unique opportunity to enhance the science that researchers are conducting, and I encourage all interested investigators to apply.  The NIH administrative supplement program has already helped build a significant bioethics evidence base in multiple policy areas. As the program continues, we hope to build on this success by addressing acute policy issues and helping the broader scientific community practice the best science possible. While the terms bioethics and biomedical research might not roll of the tongue as easily as peanut butter and jelly, the pairing is certainly just as sweet.

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!