Advancing the Promise of Open Science: We Want to Hear from You!

Dr. Brennan
Dr. Schor
Dr. Gregurick
Dr. Lauer

This blog has been co-authored with Dr. Patricia Flatley Brennan (Director, National Library of Medicine); Dr. Nina Schor (NIH Deputy Director for Intramural Research); Dr. Susan Gregurick (NIH Associate Director for Data Science); and Dr. Michael Lauer (NIH Deputy Director for Extramural Research).

It is only February, but this has already been a busy year with respect to open science. First off, the NIH Policy for Data Management and Sharing (DMS Policy) became effective January 25, 2023! As you most likely know by now, the DMS Policy requires NIH-supported researchers to prospectively plan for how scientific data will be preserved and shared. We know that sharing scientific data accelerates biomedical research discovery, leads to cures, and supports transparency, so we see this as a huge step forward for open science.

Implementation of the DMS Policy has been a big undertaking over the last few years, and we are grateful to our colleagues throughout the scientific enterprise for your continued engagement. Your feedback has resulted in providing valuable resources to support the community at, including Frequently Asked Questions and other guidance. We also want to acknowledge our NIH colleagues who worked across the agency to seamlessly ensure that WE were ready to meet this important moment.

Open science is a priority at NIH and across the U.S. Federal Government. Earlier this year, the White House Office of Science and Technology Policy (OSTP) declared 2023 to be the Year of Open Science. This OSTP announcement included details on actions being taken across the Federal Government to advance national open science policy, provide access to the results of taxpayer-supported research, accelerate discovery and innovation, promote public trust, and drive more equitable outcomes. Keen observers on this topic will also remember that OSTP issued guidance in August 2022 on Ensuring Free, Immediate, and Equitable Access to Federally Funded Research, asking agencies to accelerate access to data and publications.

Today, we are pleased to announce that the “NIH Plan to Enhance Public Access to the Results of NIH-Supported Research” (NIH’s Public Access Plan) is now available for public review and comment. We are issuing this Plan in response to the OSTP memo and also because it is consistent with NIH’s longstanding commitment to open science. This Plan builds upon the strong foundation of the NIH Public Access Policy which, since 2008, has made over 1.4 million articles describing NIH-supported research available to the public through PubMed Central. As you will see, the Plan builds on what we currently do, and we expect to maintain many current practices. But importantly, we ultimately plan to institute a zero-embargo period on publications so that research results are freely available to the public without delay.

It is important to keep in mind that this Plan is not a proposed policy, but a roadmap of steps NIH will take to enhance access to research products.  Any future updates to the NIH Public Access Policy will, in turn, be released as a draft for public comment. Also, to loop back to the DMS Policy—we expect that the DMS Policy will meet all expectations related to data sharing in the OSTP memo.

The NIH Public Access Plan also provides preliminary considerations on the issue of metadata and persistent identifiers, as described in the OSTP memo. Persistent identifiers contribute to the findability of research products (publications, data, software, etc.) and ensure that appropriate credit for use of those products is maintained. This is another area where public input is needed to inform NIH’s future plans. We will ensure that there will be lots of opportunities to engage on this topic and others over the next months and years.

We also want to take a moment to let you know how the Intramural Research Program at NIH is doing its part to ensure that the research NIH conducts meets the expectations of open science and data sharing.  All scientists at NIH must submit and have an approved data management and sharing plan for all research studies.  Studies involving human participants must have an approved data management and sharing plan in place as a prerequisite for Institutional Review Board review.  Additionally, annual reports of studies must indicate how the investigators have complied with their approved plans.

So far 2023 has been a productive beginning to what is shaping up to be a great year for open science. NIH is fully committed to realizing the expectations of the Biden Administration when it comes to open science. We encourage anyone with an interest in this space to review the NIH Public Access Plan and provide feedback. Comments on the NIH Public Access Plan will be accepted until 11:59 PM on April 24, 2023.  Comments can be submitted via our online portal at:

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

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
NIH Associate Director for Science Policy
About Lyric

Upcoming Meeting of the NSABB

On January 27, 2023, NIH will be hosting a virtual meeting of the National Science Advisory Board for Biosecurity (NSABB).  This meeting will feature a discussion of the draft report of the NSABB Working Groups to Review and Evaluate the U.S. Government Potential Pandemic Pathogen Care and Oversight (PC3O) and Dual Use Research of Concern (DURC) Policies, which was prepared in response to the charge given by the NIH Director at the February 2022 NSABB meeting   

A draft agenda and information on how to provide comments can be found on the NSABB meeting page of the OSP Website. The report from the NSABB Working Groups will also be posted to the meeting page prior to the meeting.   

If you have any questions, please contact us at [email protected]. You can also follow us on Twitter: @NIH_OSP

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
NIH Associate Director for Science Policy
About Lyric