Tag: Collaboration

‘Twas the Night Before Hanukkah (and Christmas) at NIH

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‘Twas the night before Hanukkah and at OSP,

We were lighting menorahs and trimming the tree,

sIRB policy was all tucked in its bed,

In hopes that the deadline extension will alleviate dread.

Wondering whether the Common Rule soon will appear,

Perhaps we will see it in the coming New Year?

The RAC’s streamlined process is now put in place,

To focus on biotech moving at rapid pace.

With 21st Century Cures passed and signed,

On implementation, we’ll spend lots of time.

More rapid than eagles, precision medicine soars,

And we juggle the policy issues that still lay in store.

Now CRISPR! Now data! Now Select Agents in vials!

On chimera! On privacy! On clinical trials!

Speaking of which, we continue to move,

Policies to help clinical trials improve.

From the start of the project! To training and checking!

To the reporting of results we now are expecting!

To protocol templates we hope you will use,

And have you seen our GCP FAQs?

The Moonshot is launched, NSABB report’s been released,

Research with chimps now has been ceased.

Your thoughts on data sharing we still want to hear,

RFI’s been extended until early next year.

Genomic Data Sharing – it’s still running along!

HeLa cell review – it’s still going strong!

While it’s hard to believe this year’s almost over,

We’ll be highlighting biosafety again, next October.

Time to start thinking about next year’s plans,

Because good science and good policy, go hand in hand.

And our policy wonks all just want to say,

“To the NIH world, have a fine holiday!”

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The What and How of Data Sharing

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In a recent BMJ article, Milton Packer highlights the value of data sharing using iconic scientific figures: Copernicus, whose heliocentric theory of the universe was built using others’ data; his rival, Brahe, who hoarded data for fear of confirming Copernicus’ theory; and Kepler, whose famous laws of planetary motion depended on data sharing.  The National Institutes of Health (NIH) has long been a leader in data sharing, and there is a clear clamor for more and better data sharing by NIH and other federal agencies. There is little doubt that sharing biomedical research and health-related data plays a key role in advancing knowledge of human health and well-being. But data sharing is not without cost, and data shared in ways that are not useful to the research enterprise can waste, rather than maximize, resources. This is why we need help from you, the research community, to help us shape our data sharing strategies for the future.

Consistent with federal initiatives promoting open data and open science, NIH continues to be committed to ensuring that, to the maximum extent possible, the results of federally-funded scientific research are made publicly to support reuse, reproducibility and discovery. In order to move forward with ongoing commitments to the data sharing enterprise, we are considering priorities for data management and sharing and how to expand upon existing data sharing policies, such as our 2003 Data Sharing Policy. However, we recognize that many factors must be considered when determining what, when, and how data should be managed and shared including, for example, the purpose for sharing, supporting data re-use and reproducibility, maturity of the science, the infrastructure uniqueness of the data, and ethical considerations.

Today we are publishing a Request for Information (RFI) related to strategies for data management, sharing, and citation.  Through this RFI, we are seeking stakeholder feedback on considerations pertaining to what types of data should be shared, the costs and benefits of sharing different types of data, and standards for citation of data and software. Your feedback will help us to prioritize our thinking in data sharing stewardship and be considered as we move forward in developing new NIH policies in this area.

We need to hear from data users, data generators, and data scientists. By assisting us in this request for information, you can help ensure that NIH has the most robust set of information on hand when making future decisions in this important arena.  I encourage all interested stakeholders to review the RFI and provide us with their thoughts.  Comments on the RFI will be accepted until December 29, 2016.

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The Institutional DURC Policy – One Year Later: An Invitation for Stakeholder Input

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Maximizing the benefits of life sciences research while minimizing the potential risks associated with conducting that research is an important and ongoing topic of conversation within the science policy community. For example, developing lifesaving treatments for infectious diseases often requires working directly with infectious pathogens. This presents inherent risks to lab workers, which can be managed with proper biocontainment and safety practices. Scientific information can also pose risks if communicating the research involves findings that could be misused for nefarious purposes.

All research has some “dual use” potential, but so-called dual use research of concern (DURC) is legitimate research with the greatest potential for generating information that could be misused and result in significant harmful consequences. Recognizing the need for oversight of DURC, the U.S. government issued two policies aimed at managing risks associated with this small universe of research. One policy, issued in 2012 focuses on the responsibilities of federal funding agencies to identify DURC and manage risks accordingly. The other, and the focus of this blog, was issued in 2014 and focuses on the responsibilities of research institutions. Together, these complementary policies establish a system of shared responsibility for DURC oversight among federal funding agencies, institutions, and researchers.

Prior to the institutional DURC Policy’s 2015 implementation date, the U.S. government held a workshop to engage stakeholders and address questions. Now, just over a year later, the U.S. Government is interested in learning more about how researchers and institutions are implementing the Policy. What are the challenges being encountered? Are there best practices for identifying DURC or managing risks? To help answer these and other questions, the National Science Advisory Board for Biosecurity (NSABB) is being asked to help the U.S. Government further solicit feedback by hosting a series of regional stakeholder meetings. These meetings will focus on how institutions are implementing the DURC policy and what challenges they are facing.

The NSABB will discuss this new task at its next full Board meeting, a teleconference on November 4th, 2016 from 12:00 pm – 3:00 pm ET. This teleconference is open to the public and time will be reserved on the agenda for public comments. If you can’t participate on Nov. 4th, there will be additional opportunities to engage the NSABB to discuss the institutional DURC policy in the coming months. Additionally, we invite interested stakeholders to submit comments to the NSABB at any time by emailing [email protected].

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Improving Visibility of NIH-Supported Clinical Trial Activities and Results Information

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In a separate post today, we provide an overview of the various reforms the NIH is leading to enhance our stewardship of clinical trials. In this post we’d like to focus a bit more on our efforts to broadly disseminate clinical trial availability and results information.

Timely dissemination of clinical trial results information has been a problem, one that has been documented more than once, and that appears to apply to NIH- as well as non-NIH funded trials. To realize the benefits of a clinical trial, the findings must be available to the public as soon as possible after the trial has concluded. This is not only responsible use of taxpayer dollars for publicly funded trials, but also fulfills our responsibility to the individuals who volunteered in these studies with an understanding that their participation would contribute to advancing medical knowledge. Today, NIH announced a new policy that will complement a new federal regulation, referred to here as the Final Rule, also released today, to improve the accessibility of information on clinical trial availability and on the outcomes and results of completed trials.

As you likely know, to carry out the laws passed by Congress, federal agencies issue regulations that govern the activities of the agency and the applicable community. The “Final Rule” announced today by the U.S. Department of Health and Human Services is the federal regulation that implements requirements in the Food and Drug Administration Amendments Act of 2007 (FDAAA) for registering and reporting clinical trials on ClinicalTrials.gov. Clinical trials that are subject to this federal regulation are, in general, trials of drug, biological, and device products regulated by the Food and Drug Administration (FDA), except phase 1 trials of drug and biological products and small feasibility studies of device products. Pediatric post-market surveillances of device products, required by the FDA, are also subject to the regulation.

In addition, NIH issued a policy today that complements the Final Rule and sets the same reporting expectations for all NIH-funded clinical trials whether or not they are subject to the regulation (to include, for example, phase 1 studies of FDA regulated products as well as studies of interventions not regulated by FDA, e.g., behavioral interventions.)Both the NIH policy and the Final Rule will take effect January 18, 2017.

The Final Rule and NIH policy will provide greater clarity and robust enforcement provisions that we anticipate will result in rapid increases in the percentage of trials that are registered and that will promote timely dissemination of main results information through ClinicalTrials.gov. Investigators and sponsors who fail to comply with the regulation will be subject to civil monetary penalties assessed by FDA. In addition, NIH will restrict clinical trial funding to grantee institutions if the agency is unable to verify adequate registration and results information reporting from all trials funded at that institution. Failure to comply with the NIH policy in accordance with the terms and conditions of an NIH award can also have consequences, including suspension of funding.

In addition to the Final Rule and NIH policy, NIH has made available a number of resources to help explain the changes, and will be rolling out more over the upcoming months. Resources available now include:

As described in the NIH Guide Notice, for the NIH extramural program, the NIH policy applies to applications for funding including for grants, other transactions, and contracts submitted on or after the policy’s effective date that request support for the conduct of a clinical trial that is initiated on or after the policy’s effective date. For the NIH intramural program, the NIH policy applies to clinical trials initiated on or after the policy’s effective date.

Any grant application or contract proposal submitted on or after the policy’s effective date (January 18, 2017) must include a plan describing how awardees will ensure the appropriate dissemination of NIH-funded clinical trial information. The contents of this plan may vary, depending on whether the NIH clinical trial falls under the Final Rule (referred to as an “applicable clinical trial”), and whether the awardee or investigator is a “responsible party” as defined in the Final Rule (42 CFR Part 11). For more details, please read the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information and the Final Rule published today.

We certainly encourage the broad dissemination of results information from all trials, both through ClinicalTrials.gov and peer-reviewed published results, even prior to the NIH policy’s effective date. Please join us in our efforts to maximize the federal investment in clinical trials as well as maximizing the impact of the contributions of the patient volunteers who are so critical to helping advance human health as a whole.

Dr. Mike Lauer is the NIH Deputy Director for Extramural Research and blogs about NIH research funding policies and data at his blog, Open Mike.

Dr. Mike Lauer
NIH Deputy Director for Extramural Research
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