On September 11, 2015, the National Heart, Lung, and Blood Institute (NHLBI) announced that it was stopping its Systolic Pressure Intervention Trial (“SPRINT”). The Institute’s Data Safety and Monitoring Board (DSMB) had reviewed interim data and concluded that the results demonstrated clear benefit from aggressive blood pressure lowering. The trial enrolled over 9300 adults with systolic hypertension and increased cardiovascular risk and randomized them to standard control (aiming for a target systolic blood pressure of 140 mm Hg) or to aggressive control (aiming for a target blood pressure of 120 mm Hg). ….
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. ….
Monday, in a blog post on the Feedback Loop, colleagues at NIGMS outline the recent history of NIH’s efforts that impact graduate student training, as well as recent discussions beyond NIH on how to modernize and revitalize graduation education and training.
These conversations raise an important question, “Is NIH’s support of graduate-level training keeping pace with how we do science?”. …..
In 2014, the NIH announced that it was going to distribute the NIH postdoctoral benefits survey to collect information on benefits available to postdoctoral researchers at different institutions. The survey was launched in response to a report on the biomedical research workforce from an Advisory Committee to the Director (ACD) working group. ….
As part of a wider initiative to shape the future direction of research training for the biomedical workforce as a whole, we at the NIH are actively pursuing ways to examine the physician-scientist workforce and to optimize training for clinicians seeking research careers. Physician-scientists face some challenges and career transition pathways unique to being in a clinical career track, hence the need for a specific focus on this workforce.
Three years ago, NIH created a program to enable extramural researchers to collaborate with our intramural scientists and use the exceptional resources of the NIH Clinical Center. Since then, 20 awards have been made to support projects of significant breadth, such as a trial for treatment of relapsed leukemia; a malaria vaccine trial; and a trial testing a new cardiac catheter. This is the fourth year that NIH has issued this funding opportunity. The December 15 pre-application deadline is approaching, and I wanted to remind you what this program offers. ….
In today’s New England Journal of Medicine, Richard Nakamura, the director of NIH’s Center for Scientific Review (CSR), and I published an essay titled “Reviewing Peer Review at the NIH.” As the competition for NIH research grants has become increasingly stiff, review scores often are pointed to as the reason for failure to obtain funding. Indeed, over the past few years, peer review has come under increasing scrutiny. Critics have argued that peer review fails in its primary mission – to help funding agencies make the best decisions about which projects and which investigators to support. ….
Suppose a funding agency happens to have some extra money and needs to decide how to invest it. Should it invest that extra money in a large, highly productive laboratory, so that laboratory can expand a bit more? Or should it invest that extra money in a small to moderate size laboratory? Given our inability to predict the future with great certainty, which approach represents the smarter investment strategy? Jon Lorsch, the director of the National Institute for General Medical Sciences (NIGMS), has posted an interesting video on just this question. ….
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 ….
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. ….