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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Building Better Clinical Trials through Stewardship and Transparency

NIH is the largest public funder of clinical trials in the United States. As stewards of this research enterprise, we have been actively listening and discussing how to overcome hurdles and shortcomings that we, and others in the research community, have identified. If you’ve been following the conversation, you’ll know that NIH already has implemented some key reforms to enhance clinical trial stewardship. Today, in a Viewpoint Essay published in the Journal of the American Medical Association (JAMA), we provide an overview of how these reforms, and new initiatives, fit in to the broader picture of building a better clinical trial enterprise through better stewardship, accountability, and transparency.

Figure 1 illustrates the clinical trial “lifespan”, and key opportunities for improving the quality and efficiency of clinical trials – opportunities that translate into more innovative and robust clinical trial design, and accelerated discoveries that will advance human health. NIH is leading a multi-faceted effort that addresses shortcomings and challenges throughout this lifespan, including the application and award process; the scientific review of trial applications; post-award management and oversight; sharing of trial data; and dissemination of research results information to the public. …. Continue reading

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NRSA Postdoctoral Stipend Guidelines for FY2017

This month, NIH published the projected fiscal year 2017 stipend guidelines for postdoctoral trainees and fellows supported by National Research Service Awards (NRSAs). For NRSA-supported postdocs with less than one year’s experience, the stipend level will increase to $47,484. In keeping with the recommendation of the Biomedical Research Workforce Working Group of the NIH Advisory Committee to the Director, stipend levels then increase dependent on years of postdoctoral experience. …. Continue reading

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Accelerating Clinical Research by Streamlining Multi-site Review of Human Subjects Research

Research involving human participants is key to improving public health and advancing medicine. Oversight of such research by institutional review boards (IRBs) both protects research participants and promotes ethical science. IRB review and approval is a critical step in initiating the start of a research project and for multi-site studies, NIH is taking an important step to help streamline the process. Today, NIH is issuing the NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research (sIRB Policy) …. Continue reading

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How New US Overtime Provisions Will Affect Postdoctoral Researchers

The Fair Labor Standards Act (FLSA) is the law that contains overtime pay provisions for employees across the United States, entitling all US workers to overtime pay unless they are exempted because they are paid on fixed, preset salaries; are engaged in executive, administrative, or professional duties; and are paid at least $23,660 per year. Today, a historic change to this act has occurred – under the new rule, the overtime pay threshold will be increased to $47,476, effective December 1, 2016. …. Continue reading

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