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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Updates on Addressing Rigor in Your NIH Applications

As NIH moves ahead with implementing measures to enhance rigor, transparency and reproducibility in NIH-supported research, I’d like to give a brief update on these efforts, and highlight some important timeline changes for implementation in applications for institutional training grants (T), institutional career development awards (K12), and individual fellowships (F). …. Continue reading

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What Does It Mean to Consider Sex as a Relevant Biological Variable in Your NIH Grant Application?

In 2014, NIH announced plans for policy changes to ensure that NIH-supported investigators consider relevant measures, including sex as a biological variable (SABV), in preclinical research. NIH solicited feedback through a request for information, and we invited the research community to participate in workshops and resource development. These activities led to new guidelines for addressing SABV as an aspect of rigor and reproducibility in NIH research project grant applications and mentored career development award applications due January 25, 2016, and beyond. As you prepare applications and think about addressing the new instructions we wanted to offer some reminders about the policy’s origin, and about the application and review information. In particular, we wanted to point out what including SABV does not mean. …. Continue reading

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Bolstering Trust in Science Through Rigorous Standards

Scientists have long considered the research process to be self-correcting; we trust that, even if scientists may sometimes make errors in the lab, those errors will eventually be discovered and corrected as others try to substantiate and extend original research findings. However, as stated in a commentary by NIH Director Francis Collins and NIH Deputy Director Larry Tabak, “A growing chorus of concern, from scientists and laypeople, contends that the complex system for ensuring the reproducibility of biomedical research is failing and is in need of restructuring.”
There are examples that indicate that our processes have room for improvement. For example, a 2008 study …. Continue reading

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Change is Coming: Updates to NIH Application Forms and Instructions

We periodically need to update our application forms and instructions to accommodate changing policy, new business needs, and sometimes (not often enough) to reduce the amount of information we ask of you. Given our constraints, we have been working to provide systems support to make the mechanics of these transitions easier for you. This particular set of changes implements a number of policy changes impacting applications submitted in 2016, which we announced in a series of recent NIH Guide notices. We would like to give you a quick overview of what is happening. …. Continue reading

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Proposed Changes to Human Subjects Regulations Are Open for Comment

As many in the research community know, the “Common Rule” refers to current regulations to protect individuals who participate in research as human subjects. The regulations, which have been in place since 1991, are followed by 18 federal agencies that support research – hence the name. Today I’d like to give you some background on how these regulations – and the conversation around these regulations – have evolved since 1991, and let you know about an opportunity to provide feedback on the modernization of these important rules. …. Continue reading

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