A Data Sharing Renaissance: Music to My Ears!

When world famous cellist, Yo-Yo Ma, visited the NIH campus, he shared a story from the history of music, in which the peak of stringed instrument quality occurred in the late 17th century at a time of great collaboration and sharing of knowledge. When instrument makers began to compete, all of that changed: secrets of craftsmanship were held close and the quality of instruments plummeted. This decline lasted, according to Ma, until the 20th century, when again the free-flow of knowledge resumed. NIH Director Francis Collins noted, “There’s a lesson here about science.”

Data sharing is important. It is critical to continued progress in science, to maximize our investment in research, and to ensure the highest levels of transparency and rigor in science. But data sharing is a means to an end, not itself an end goal and, as such, needs to be done thoughtfully, in a way that fulfills the vision and mission of NIH and continues the advancement of treatments for disease and improvement of human health. NIH has long been on the forefront of making access to the results of our research accessible and has described our vision for expanding access to publications and data both in the 2015 NIH Plan for Increasing Access to Scientific Publications and Digital Scientific and in the 2018 Strategic Plan for Data Science.

The generation, analysis, and publication of data relates to the core function of NIH’s role as a biomedical research agency. Therefore, policies related to the management and sharing of data can have great impact across the agency and the research community. As such, it is critically important that we engage stakeholders on this complex topic. We began the conversation with the 2016 request for information on Strategies for NIH Data Management, Sharing, and Citation, and a 2017 joint workshop with the National Science Foundation that focused on the value of data sharing. Now we want to share with the community our current thinking about potential next steps in data management and sharing policy and seek your feedback on the best path forward.

Today, NIH released a notice in its Guide to Grants and Contracts that seeks public input on the key policy provisions that NIH is considering for inclusion in a future draft policy aimed at replacing NIH’s existing Data Sharing Policy. By obtaining robust stakeholder feedback we can help ensure that the future NIH policy will promote opportunities for data management and sharing while allowing flexibility for various data types, sharing platforms, and strategies.  The information stakeholders provide can also assist us in developing streamlined approaches that could potentially reduce unnecessary administrative burdens.

While we appreciate and will consider any and all feedback our stakeholders provide, we are specifically interested in your thoughts on these key items:

  • The definition of scientific data to be covered within these plans,
  • The elements of required data management and sharing plans, and
  • The optimal timing, including possible phased adoption, for NIH to consider in implementing various parts of a new data management and sharing policy, as well as how possible phasing could relate to needed improvements in data infrastructure, resources, and standards.

You can view our request for information, the key provisions and provide your comments by visiting Previously Compiled Public Comments. Comments will be accepted until December 10, 2018.  In addition, NIH will also be hosting a webinar on the proposed provisions on November 7, 2018.  Interested participants can find more details and register for the webinar here.

I often hear that policies seem to emerge from NIH fully formed, with little opportunity for the expertise and thoughts of the research community to come to come to bear. This RFI represents an opportunity to join the conversation before policy decisions are made. In the spirit of collaboration, embodied by 17th century Italian instrument makers, let’s work together to get this right.

Recommendations for Moving to a Process for Returning Research Results

I have become the human subjects police. No, I’m not talking about regulations or compliance. I mean that whenever I hear someone use the term “human subject,” I immediately correct them: “research participant.” This compulsion reflects a larger trend in biomedical research, in which people who volunteer for research studies are considered to be essential partners in the process. As part of this partnership, it is important that we consider the interests and values of our partners, such as the growing recognition that research participants might want the individual results of the research in which they participated returned to them.

Yesterday, the National Academies of Sciences (NAS) released the report of the Committee on Returning Individual-Specific Research Results from Research Laboratories, titled “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.” As I wrote last year, NIH, FDA, and CMS collaborated to sponsor this study in recognition of the increasing challenge for the research enterprise posed by determining how and when to provide research participants with their individual-level research results and data, and whether the current regulatory environment is conducive to returning such results.

In the course of their work, the committee considered the justification for the return of individual-specific research results and found that while no single ethical principle requires the return of results, they assessed the potential benefits of returning individual-specific research results to generally be understated and the harms overstated. True to its title, the report recommends a broad shift in the research enterprise towards greater return of individual-specific research results than is currently common practice. The committee stressed, however, the need for quality in returning research results, and more broadly, for all research results. They conclude that greater return of research results and adoption of enhanced quality control measures would both strengthen the research enterprise by increasing the value for participants while improving scientific rigor and reproducibility.

To achieve this transformation, the report provides a series of recommendations, including specific regulatory and policy changes that would enable greater return of individual-specific research results while promoting greater quality, as well as articulating a process for determining whether and how to return results. Although some of the recommendations are directed at policymakers, they will also be of interest to investigators, institutions, Institutional Review Boards (IRBs), and research participants.

We are grateful to the NAS and the Committee members for their thoughtful treatment of the complex issues they were tasked with addressing. NIH will be reviewing and considering these recommendations with our federal partners and in conversation with the research community.

And as you can probably guess from Recommendation 12G, when it comes to the choice of “subject” or “participant,” this Committee is on trend.

A Match Made in Science Policy Heaven

Everyone knows someone who has dived fearlessly into the world of online dating and found the perfect match.  But did you know that the American Association for the Advancement of Science (AAAS) plays matchmaker between federal agencies and scientists who are interested in getting their feet wet in the science policy arena?

Here at NIH, we host up to 40 AAAS Science and Technology Policy Fellows each year.  This one-year fellowship provides the opportunity for scientists from a wide range of disciplines and career levels to experience the (science policy) sausage making process à la NIH, while at the same time bringing a wealth of scientific and analytical expertise to the table.  Since this is the time of year when all the action happens, it seemed like an ideal time to tell you about how this program works.

As you can imagine, the whole operation requires considerable coordination, and OSP is responsible for managing NIH’s involvement in the program.  In February and March, the Fellowship cycle begins, and we work to recruit offices from across NIH who are interested in potentially hosting a Fellow. One of the most challenging parts of our job comes next during April’s placement week.  During that week, Fellowship finalists converge on Washington en masse, and dash from agency-to-agency to participate in interviews with potential host offices (think of a cross between speed dating and a steeple chase!).  This all culminates in a matching process, where we work with AAAS to place finalists within NIH host offices.As you might imagine, only the best matches are placed across NIH’s Institutes and Centers, as well as within the Office of the NIH Director.  Fellows find homes in a range of different NIH offices that are engaged in policy, planning, communication, outreach, legislative affairs, program administration, and evaluation, to name but a few.

Once matching has concluded, the real work can then begin.  OSP works with the host offices, AAAS and the incoming Fellows, to begin the onboarding process in preparation for the Fellow’s first day in September.  When the Fellows arrive, OSP provides an NIH orientation to bring everyone up-to speed and then assists throughout the year in making the Fellows and host offices aware of the various AAAS and NIH program requirements.

Having worked closely with many of the AAAS Fellows (as well as having several OSP staff as alumni of the program) I see the Fellowship as a valuable tool in advancing NIH’s mission by fostering productive relationships between federal policy makers and scientific professionals.  I like to look at the OSP role in this as making sure that the relationships forged through this program begin and remain strong!  For more information about our involvement with the program please visit the OSP website.

Seasons Greetings from OSP!

‘Twas the middle of Hanukkah, and across OSP,

We’re thinking deep thoughts on NIH policy.

Talented experts working on the agency’s behalf,

While their Director’s moonlighting as Acting Chief of Staff…

There’s clinical trials, a suite of to-dos,

Designed to work together, stewardship to improve.

If you’ve got a trial, use our new FOA,

Or try the protocol template developed with FDA!

Gain of function research, now where did time go?

That term’s so last year, now we’ve P3CO!

As sIRB, finally goes into effect.

Certificates of confidentiality, our participants protect.

We celebrated 40 years since forming the RAC,

Results from research, how to give them back?

As for data sharing, in the New Year you’ll find,

A request for feedback, to help us draw policy lines.

On CRISPR! On HeLa! On emerging tech!

To transforming research, built on participant respect!

On stem cells! On rigor! On validated LDTs!

To solving the opioid crisis and burden of disease!

From privacy to march-in, from chimeras to gene drives,

Science policy to support research, that extends all our lives…

So to scientists and policy wonks, we wish you good cheer!

Happy holidays to all, and a healthy New Year!