Building a Solid Policy Foundation Through Meaningful Engagement

If you have visited the OSP website in the last month, you’ve likely noticed it has a new look and feel.  Of course, a few changes were aesthetic, but most were made with one purpose in mind: making information easier to find and use. Hopefully you’ll agree that we’ve achieved that goal with our new design. 

Transparency is a word we use in government quite a bit but putting it into action can be tough. The internet is a big place – simply posting documents online fulfills the transparency mandate but does it actually provide value to users? To understand more about providing value to our users, and as a team of folks committed to evidence-based decision-making, we reached out to a variety of individuals in different positions and roles and asked them to test drive our website. We are grateful for their time and their honesty, as we received candid feedback about their experience on our site. 

I’d like to highlight two significant changes we made based on some of the feedback we heard. First, while the organization and flow may be common sense to those of us with a nuanced understanding of governmental lingo and structure, it was less intuitive to those seeking policy information. Now you will find policies front and center, grouped thematically under policy areas. In doing so we removed redundant clicks. And for those of us who just like to google and see exactly what we need, we put a lot of our efforts into making the search feature highly responsive. The second thing we heard is that getting involved in policymaking still can feel like a black box. I firmly believe engaging your government is a civic duty, so I took this one to heart. Now you will find a new “Get Involved” page which contains information on open requests for information, compiled comments for previous requests, as well as information on upcoming meetings where the public can participate.  

Our approach to our website reflects our approach to policy-making: meaningful engagement and transparency is the key to success. 

You’ll see we are trying new engagement approaches in a variety of settings. For example, as part of the NExTRAC’s latest charge experts are engaging communities across the US to understand community values and preferences about sharing personal health data to inform NIH’s future policy efforts on this topic. No small feat as individual preferences are just that – individual. But how do we consider all these varying perspectives when making policy? Step one is making sure we hear them.  

To put it succinctly, making policy must be a shared experience.  OSP wants to hear from all communities that are potentially affected by the policies we are developing.  The unique perspectives diverse audiences bring to the table will help us ensure we are making the best, most-informed decisions.  Whether it is our website or a major policy relating to the latest scientific breakthrough, OSP is committed to making the voice of the community heard.

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

How Bioethical Principles Are the Foundation of Great Research

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.

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

Catalyzing Research with Novel Alternative Methods

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.

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

ICYMI: The Download from the September 21 NSABB Meeting

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!

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