Tag: Collaboration

‘TwasThe Night Before…..

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‘Twas the night before Christmas,
When policy wonks take,
For 48 hours, a much needed break.
Although even at rest, thoughts still run deep.
Because NIH science policy never really sleeps.
And come Wednesday morn, OSPeeps and I,
Will be reading responses to each RFI.
For from the community we heard lots of chatter,
How you share data really does matter!
But that barely compares with the receiving of flack,
From those who worry we might do away with the RAC.
But worry not, friends, you’ve nothing to fear.
The next iteration of RAC soon enough will appear.
To help us work through biotech that’s emerging,
Which meetings in Hong Kong make feel slightly more urgent…
While return of results is still under discussion,
Genomic summaries now available, with not too much fussin’
No longer will gene therapy have oversight times two

And sIRB resources are available now, too!

Certificates of confidentiality now required by law,

More Common Rule delay, as you probably saw.

On, rigor! On, CRISPR! On, dual use, too!
On, research protections! On, fetal tissue review!

To a scientific culture where harassment is ended,

Where female researchers are protected and defended.

To a data sharing policy, beloved by all!

(Although perhaps that’s an order just a bit too tall…)

As GDPR and Plan S across the pond fly,

And clinical trial policies raise great hue, and great cry,

OSP never forgets, as we read every letter,

Our enterprise is great, but it can always be better…

Together we stand, as the NIH thrives,

Fulfilling the mission to improve people’s lives.

In the New Year, we look forward to working with you,

To make biomedical research the best we can do.

And as we shape policies, to get this thing right…

Happy holidays to all, and to all, a good night!

Posted by Dr. Carrie D. Wolinetz, December 21, 2018

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A Data Sharing Renaissance: Music to My Ears!

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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.

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The Behavioral and Social Clinical Trials Template: A New Resource!

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In May 2017, NIH and FDA released the final version of a template document aimed at assisting NIH-funded investigators in preparing Phase 2 and 3 IND/IDE clinical trial protocols. Additionally, at that time, NIH also released the electronic Protocol Writing Tool (e-Protocol Tool) which was based on the NIH-FDA protocol template. The way we like to describe the e-Protocol Tool is that it is like a Turbo TaxTM for developing clinical trial protocols.   We think it can be safely said that both of these products have been an unmitigated success! In fact, the e-Protocol Writing Tool is one of the most frequently visited pages of the OSP website, drawing on average over 1,000 visitors per month.

Almost immediately, we began to think of how NIH could leverage this platform and expand to other clinical research areas that do not involve a drug or medical device intervention. Taking into consideration the recent NIH policies that have expanded the requirements of clinical trials beyond those that are FDA-regulated, it seemed most appropriate to develop a template specifically aimed at studies involving social and behavioral interventions. Most NIH Institutes and Centers (ICs) fund behavioral and social science clinical trials, so it makes perfect sense to have a resource available that aims to help investigators conducting these types of trials.

Today, the NIH released  a request for public comments on the Draft Behavioral and Social Clinical Trials Template.  This template was created to guide investigators through the systematic development of a comprehensive clinical protocol. The template will be especially helpful to investigators who are less familiar with the information and the level of detail that is required in a clinical protocol. The template retains much of the content and structure of the NIH-FDA Phase 2 and 3 IND/IDE clinical trial protocol template but has been tailored specifically for studies involving a social or behavioral intervention. Given the variations of intervention approaches and designs in the behavioral and social sciences, the NIH wants to encourage comments from a broad and diverse range of investigators on this draft protocol template.

It is important to note that the NIH Clinical Trials policies do not require the use of these protocol templates when submitting a protocol to clinicaltrials.gov or to the NIH Institute that funds the project and provides oversight. For basic or mechanistic studies subject to the clinical trials policies, some components of the template may not be applicable. However, use of the template will help ensure that investigators are writing a protocol consistent with the guidelines outlined in the International Council on Harmonisation (ICH) E6 Guidelines for Good Clinical Practice, which are intended to ensure research integrity and the protection of human research participants.

Comments on the draft protocol template can be made by visiting: Previously Compiled Public Comments. While members of the public are free to comment on any aspect of the template, we are most interested in comments about its utility and the clarity of the instructional text. Comments on the template will be accepted until October 11, 2018.

We have also saved the best news for last. Once NIH has considered all of the comments we receive, we will then integrate the final behavioral and social sciences protocol template into the existing e-Protocol Writing Tool! Investigators will then have a true one-stop (electronic) shop for all of their needs when it comes to preparing Phase 2 and 3 IND/IDE clinical trials documents and comparable behavioral/social science clinical trials.

Please help make the draft behavioral and social clinical trials template the best it can be by reviewing and providing your feedback!

This blog was co-authored by Dr. William Riley, Director of the NIH Office of Behavioral and Social Sciences Research (OBSSR). More information about OBSSR can be found at https://obssr.od.nih.gov.

William Riley
Director of the NIH Office of Behavioral and Social Sciences Research
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Recommendations for Moving to a Process for Returning Research Results

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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.

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