Tag: Biosafety

NIH Issues New Resources for Implementing the NIH Policy for Data Management and Sharing

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NIH continues to work with the research community to ensure we address resource needs associated with the NIH Data Management and Sharing Policy. Today we are releasing a new set of FAQs on questions we have heard over the past year, and we are also seeking public comment on a new resource for researchers that promotes responsible management and sharing of American Indian/Alaska Native (AI/AN) participant data.

To learn more about the NIH approach to implementing the DMS Policy and next steps, please see the latest “Under the Poliscope” blog post by Dr. Lyric Jorgenson: Gearing Up for 2023: Implementing the NIH Data Management and Sharing Policy

For questions, contact the NIH Office of Science Policy at [email protected].  Also, you can follow us on Twitter: @NIH_OSP

Gearing Up for 2023: Implementing the NIH Data Management and Sharing Policy

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Frequent readers of this blog will remember that back in October 2020, NIH issued its Data Management and Sharing (DMS) Policy to further our commitment to making the research we fund available to the public. Our strategic decision to make the effective date for the Policy approximately two years later led some to ask NIH “why wait so long?” while others asked “why not give us more time?” Fortunately, the answer to both these questions is the same. Our goal is to lead a cultural shift that makes data sharing the norm. The degree of that shift, for some, may vary.  For example, many data sharing policies are already in place and researchers currently sharing data will likely not need to significantly alter their approach. But prospective planning for how to share data (i.e., developing plans, requesting NIH funds) may be new for some. As such, it seemed reasonable that two years was the right balance of time to lay the groundwork  for implementation. Today I am excited to provide an update on what NIH is doing to make our data management and sharing efforts a success on the one-year mark prior to the Policy’s effective date.

Since the Policy’s release, NIH has continued its approach of meeting and seeking feedback from its stakeholders. For example, in April 2021, NIH supported a two-day National Academies workshop to share strategies for successful data management and sharing and identify areas of additional need for seamless policy implementation. Thanks to the success of this workshop, we were able to continue engaging the public on multiple related resources and issues, such as consent for data sharing, harmonizing the NIH Genomic Data Sharing Policy with the DMS Policy, and the discoverability of our data resources.  We also have been partnering with our colleagues in the NIH Office of Extramural Research to provide implementation updates at extramural-focused meetings such as last year’s Virtual Seminar.

As you may recall, when the DMS Policy was released, we asked the community what other types of information would be of value to help with implementation. Based on the feedback we received, we are releasing additional resources today and have plans for continuing to release more throughout 2022.

Today, NIH is:

Over the course of 2022, you can expect to hear more from us regarding resources, including:

  • Helpful tips for developing budgets in Plans describing data management and sharing
  • Updated information on principles for protecting research participant privacy and de-identification to help guide sharing of research participant data
  • Educational resources including webinars and potentially sample Plans
  • Plans for further harmonizing NIH’s data management and sharing expectations, particularly with reducing duplicative plan submissions

In addition to the above, during 2022 NIH will also continue providing supplemental funding for grantees to:

  • Improve the FAIR and Artificial Intelligence/Machine Learning-Readiness of their NIH-Supported Data
  • Align existing data repositories with FAIR and TRUST principles and evaluate usage, utility, and impact

This is definitely an exciting year for NIH, and we look forward to continuing our engagement with the stakeholder community throughout 2022. Make sure to stay tuned –there is plenty more to come as we work together to accelerate scientific discovery through effective data management and sharing.

Posted by Dr. Lyric Jorgenson, January 25, 2022

Lyric Jorgenson, PhD
NIH Associate Director for Science Policy
About Lyric
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Refreshing NIH’s Genomic Data Sharing Policy

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We’ve all heard the ancient expression that “the only constant in life is change.” While this phrase was first spoken about 2500 years ago, it is a remarkably insightful way of describing the most important aspect of policymaking; being able to adapt to a changing landscape.

NIH strives to ensure our policies keep pace with the science we support, and as policy professionals we work hard to anticipate the future while developing meaningful policies capable of supporting the present.  Naturally, this is easier said than done.  Complicated issues rarely are resolved on the first go-round and scientific opportunity and community expectations evolve over time.  Nuance, flexibility, and community experience are all necessary ingredients in evaluating the impact of a policy and its future course.  An interesting case study to illustrate this point can be found in the 2014 NIH Genomic Data Sharing (GDS) Policy.

For those of you who have been in the game for a while, you will remember that the GDS Policy was born out of the successes of the 2007 NIH Genome-Wide Association Study Policy.  In the roughly seven years between the release of the GWAS Policy and the formulation of the GDS Policy, much had changed.  Genome sequencing burgeoned and repositories for accepting and sharing genomic data proliferated. Additionally, the intrinsic value of one’s genome became increasingly apparent, and more protections were afforded through two landmark laws (the Genetic Information Non-Discrimination Act and the Affordable Care Act). When NIH looked at the impact of the GWAS policy, we saw substantial productivity as an important result.  At that point we began asking ourselves “how do we leverage these results to meaningfully improve health?” From there, the GDS Policy was born.

Now in the seven years since the GDS Policy has been issued, it has proven remarkably resilient in evolving with the science.  The Policy has kept pace with the increase in cloud computing, the emergence of novel methods to reduce the burden associated with accessing human genomic data, and a reassessment of the risks and benefits of sharing genomic summary results.  With that said, even the best policies can only accommodate a rapidly changing field so much through clarifying guidance documents.  The framework of the GDS Policy is continually tested by new trends in the field.

Some updates to the GDS Policy are common sense. For instance, the NIH Data Management and Sharing Policy, due to take effect in January 2023, necessitates consolidating and simplifying NIH’s data sharing expectations to minimize the burden of the compliance.  However, some are more complex. For instance, the growing demand to investigate the social determinants of health may benefit from access to data elements that NIH has not historically permitted to be submitted and shared through NIH genomic data repositories.  Additionally, new technology for preserving participant privacy while facilitating records linkage may open the possibility of matching participants’ data from genomic studies with other studies or even non-research data.

What does this all mean for the future?  This is where YOU come in.  Today, NIH released a “Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy.”  This is your opportunity to help us shape the future of the GDS Policy.  Stakeholder input is the key to ensuring that NIH strikes the right balance when updating the GDS Policy.  Comments will be accepted until February 28, 2022.  The full RFI and instructions on how to comment may be found here.  I am very excited to hear your thoughts on how we can best serve the needs of the research community!

Dr. Lyric Jorgenson is the Acting Associate Director for Science Policy and Acting Director of the NIH Office of Science Policy.  While the Under the Poliscope blog is under new authorship, it will continue to be a direct link between OSP and our stakeholders.  Please feel free to comment below on how we are doing.  Also, to learn more about Lyric, please visit here.

Posted by Dr. Lyric Jorgenson, December 1, 2021

Lyric Jorgenson, PhD
NIH Associate Director for Science Policy
About Lyric
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Sharing Our Current Thinking: Models Containing Aspects of Human Embryos

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Understanding early human development helps scientists study causes of miscarriage and search for therapies and preventions for developmental disorders. As I’ve explained before on this blog, NIH is prohibited from funding research that creates or destroys human embryos. However, models of various aspects of human embryo development represent promising alternatives.

Readers of this blog may recall that in 2019, I wrote about how NIH, as a steward of public funds, carefully considers whether the agency can support proposed research using these models on a case-by-case basis. We at NIH have been following the progress of these various research approaches, and last year my office sponsored a state of the science workshop on these model systems at the National Academies of Sciences, Engineering, and Medicine. At the workshop, leaders of the field presented their findings and future research plans with models that vary in shape and composition and mimic different aspects of actual embryos and time points in development. The researchers explained how they use these models to investigate how cells differentiate into specific cell types and organize themselves and what signals coordinate key changes during embryonic development. Models range from rings of different cell types in a single-cell monolayer to more spherical models of particular features of the human embryo. (See diagrams of several models below.)

With these new tools developed and further refinements on the horizon, I thought it would be a good time to share our latest thoughts on how we decide what research we can legally support. When NIH considers whether the agency can support a specific research proposal, we ask ourselves (and sometimes the applicants!) a number of questions. These may include:

  • What stage, or aspect, of embryonic development is being modeled?
  • What cell types, structures, and functions are present in the model? For example,
    • Does the model contain all components of the epiblast lineage (i.e. the three “germ layers” that collectively form the embryo)?
    • Does the model contain any extraembryonic lineage cell types (i.e. cells that contribute to the yolk sac, placenta, or other tissues that support development of the embryo)?
    • Are there other materials or growth factors present that might substitute for the functions of the extraembryonic lineages?
  • Is the spatial orientation of the components similar to, or different from, an actual embryo?
    • Are the cells in a single monolayer or in a more complex structure?
    • How is the shape similar to or different from that of the embryo?
  • Can the model maintain its organizational structure? Does it change to look like the next stage in normal development?
  • Would the researcher watch for any unanticipated events, such as the unexpected appearance of other cell types or structures?

Ultimately, NIH considers what is the likely developmental potential of the model. This is of course a tricky question, since the ultimate test of the potential of a model would be to study its growth in a uterine environment–an experiment that NIH would never support. Yet we know what structures and functions of an embryo and extraembryonic tissue are critical for development, so we have a framework to address this question.

Personally, it has been fascinating to witness the advancements in this field. As an agency, NIH will continue to consider applications on a case-by-case basis, and do our best to be a responsible steward of public funds.

Summary of Stem Cell Models of the Mouse and Human Embryo
From Shahbazi et al., Science 364, 948–951 (2019). Reprinted with permission from AAAS.

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