Implementing a New Human Subject and Clinical Trial Information Form

We have been talking a lot recently about NIH’s efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that “NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials.” Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.

The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human subjects that is currently scattered across a number of forms …. Continue reading

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Continuing to Clarify the NIH Definition of a Clinical Trial

A few weeks ago we released some case studies and FAQs to help clarify for our research community whether their human subjects research study meets the NIH definition of a clinical trial. These resources prompted a number of follow-on questions and thoughtful suggestions from the community that have helped us refine both the FAQs and the case studies. We are grateful for your thoughtful and constructive comments and suggestions, many of which we have incorporated into our revised documents and communications. …. Continue reading

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NIH’s Certificates of Confidentiality Policy Enhances Confidentiality of Participants Enrolled in Clinical Research Studies

A few months ago we blogged about our plan to release an updated Certificate of Confidentiality (CoC) policy. Today, we are pleased to announce that we have published the new policy (NOT-OD-17-109), which will go into effect on October 1, 2017. The new policy both enhances the privacy protections of individuals participating in NIH funded research studies and eliminates the need for NIH funded investigators to apply for a CoC. … Continue reading

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NIH’s Next Generation Researchers Policy Now Posted

Today we posted a policy (NIH Guide Notice NOT-OD-17-101) describing current plans for the Next Generation Researchers Initiative.  Since I first blogged about it in June, NIH leadership have reviewed data (see accompanying blog) and deliberated about how best to proceed.  Our goal is to increase the number of NIH-funded early-stage investigators and assure, as best we can, that funded early-stage investigators have a reasonable chance to secure stable funding during the earliest stages of their independent research careers. This new policy will supersede previous notices on new and early stage investigators (NOT-OD-08-012, NOT-OD-09-013 and NOT-OD-09-134). …. Continue reading

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4 Questions For Researchers and Institutions Involved In Human Subjects Research

Last September, and in January of this year, we wrote about a suite of initiatives aimed at improving the quality and transparency of the NIH-supported research that most directly engages human participants – clinical trials. These initiatives include dedicated funding … Continue reading

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Certificates of Confidentiality for NIH Grants

Earlier this year I wrote a post about the 21st Century Cures Act and its changes that directly affect the NIH. One part of this new legislation contains provisions to improve clinical research and privacy through certificates of confidentiality.

Currently, certificates of confidentiality (or “CoCs”) are provided upon request to researchers collecting sensitive information about research participants. Soon, CoCs will be automatically provided for NIH-supported research, as set forth in the 21st Century Cures Act. …. Continue reading

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Following Up On Interim Research Products

The role of preprints — complete and public draft manuscripts which have not gone through the formal peer review, editing, or journal publishing process – continues to be a hot topic in the biological and medical sciences. In January, three major biomedical research funders – HHMI, the MRC, and the Wellcome Trust, changed their policies to allow preprints to be cited in their progress reports and applications.

Thinking about preprints also raises questions about the broader class of interim research products, and the role they should play in NIH processes. Other interim products include products like preregistration of protocols or research methods, to publicly declare key elements of a research project in advance. While, under current policy, NIH does not restrict items cited in the research plan of an application, applicants cannot claim preprints in biosketches or progress reports.

So, in October, we issued a call for comments to get a fuller understanding of how the NIH-supported research community uses and thinks about interim research products. Today I’d like to follow up with what we’ve learned from your input, and the policy changes this feedback suggests. …. Continue reading

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Research Commitment Index: A New Tool for Describing Grant Support

On this blog we previously discussed ways to measure the value returned from research funding. Several of my colleagues and I, led by NIGMS director Jon Lorsch – chair of an NIH Working Group on Policies for Efficient and Stable Funding – conceived of a “Research Commitment Index,” or “RCI.” We focus on the grant activity code (R01, R21, P01, etc) and ask ourselves about the kind of personal commitment it entails for the investigator(s). We start with the most common type of award, the R01, and assign it an RCI value of 7 points. And then, in consultation with our NIH colleagues, we assigned RCI values to other activity codes: fewer points for R03 and R21 grants, more points P01 grants. Continue reading

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Status of Our Initiatives to Strengthen Clinical Trials

In September Dr. Carrie Wolinetz and I blogged about our policy reforms to build a more robust clinical trials enterprise through greater stewardship and transparency at each phase of the clinical trial journey from conception to sharing of results. We discussed how these efforts promise to improve the quality and efficiency of clinical trials, translating into more innovative and robust clinical trial design, and accelerated discoveries that will advance human health.

Over the past months we have continued to partner with the community to work through the implementation of these new policies, developing responses to frequently asked questions and even reconsidering the timing of our single IRB policy to give our grantees time to work through how to operationalize the change. …. Continue reading

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Improving Visibility of NIH-supported Clinical Trial Activities and Results

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 … Continue reading

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