August 16, 2018
We have written several blogs and articles over the past two years about our efforts to enhance stewardship and transparency in clinical trial research. Indeed, earlier this year Congress applauded our efforts thus far and reaffirmed its commitment to ensuring public access to the results of the NIH-funded clinical trials through timely registration and results information reporting on ClinicalTrials.gov. However, we have heard concern about how the NIH’s Policy on the Dissemination of NIH-Funded Clinical Trial Information applies to fundamental studies involving human participants.
March 15, 2018
NIH has, for many years, been concerned about the increasing burden of applying for, reporting on, and the costs faced by researchers when complying with requirements on federally-funded research grants— so much so that it is even called out in our strategic plan as an area to address. Today, as we continue to implement the 21st Century Cures Act, NIH is requesting public feedback on some proposed approaches to reduce administrative burden on investigators use of laboratory animals in biomedical research (NOT-OD-18-152 and Federal Register Notice 2018-05173). Together with our colleagues at the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA), we are looking for constructive and thoughtful feedback on this topic from individuals, research institutions, professional societies, animal advocacy organizations, and other interested parties. Input will be accepted electronically during a 90-day comment period, that is until June 12, 2018.
March 5, 2018
To capitalize on the opportunities presented by advances in data science, the National Institutes of Health (NIH) is developing a Strategic Plan for Data Science. This plan describes NIH’s overarching goals, strategic objectives, and implementation tactics for promoting the modernization of the NIH-funded biomedical data science ecosystem. As part of the planning process, NIH has published a draft of the strategic plan, along with a Request for Information (RFI) to seek input from stakeholders, including members of the scientific community, academic institutions, the private sector, health professionals, professional societies, advocacy groups, patient communities, as well as other interested members of the public.
March 31, 2016
I’d like to call your attention to an opportunity to provide comments on a proposed clinical trial protocol template, developed by the FDA and NIH, and informed by the guidance set forth by the International Conference on Harmonisation (ICH) E6 Good Clinical Practice. The template provides a standard format, and corresponding instructions and sample text, for…
November 24, 2015
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.
August 14, 2015
Understanding what you need to know and do to apply for a grant can be a challenge. NIH’s application instruction guide is long, with lots of background information that you may only occasionally need. On top of that, funding opportunity announcements have instructions that often add to those in the application instruction guide. ….
July 30, 2015
NIH is beginning the process of developing a 5-year strategic plan, at the request of Congress. NIH developed a framework to identify crosscutting areas of research ….
April 2, 2015
An important, recurring discussion topic on our blogs is ways to maximize the impact and sustainability of NIH-funded biomedical research. In 2011, a Rock Talk post on managing NIH’s budget in fiscally challenging times solicited many comments and led, in part, to an NIH-wide policy on special council review for applications from PIs who have more than $1 million in NIH funding. We have also implemented new programs that provide more stable support for investigators over longer time periods. A more recent example of the “maximizing impact and sustainability” theme is an NIGMS Feedback Loop post that discussed ideas for how to optimize the biomedical research ecosystem. ….
February 3, 2015
From enhancing diversity to supporting training in emerging fields, over the past three years NIH has continued to examine the needs of the biomedical workforce and create initiatives that will sustain the amazing work being performed by you, the extramural research community. Our efforts place a lot of focus on trainees and early stage investigators through policy changes and new programs, but there are two sides to every equation. We have many well-established research programs run by senior investigators. We want to explore how ….
July 17, 2014
In these times of tight budgets and rapidly evolving science, we must consider new ways to invest biomedical research dollars to achieve maximum impact—to turn scientific discoveries into better health as swiftly as possible. We do this by thinking strategically about the areas of research that we support, as well as the process by which we fund that research. …. We often hear from investigators at all career stages that they spend a significant portion of their careers writing grant applications, consuming precious time that could otherwise be spent conducting research. ….
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