September 30, 2019
NIH is currently accepting public comments on the use of standards for capturing, integrating, and exchanging clinical data for research purposes (NOT-OD-19-150). This is a great opportunity to hear more from the community on ways to strengthen approaches that find, share, and access high-quality patient data, while also making it more interoperable and reusable. Such goals align with long-standing NIH data sharing policies and what was also called for in a related NIH strategic plan on data science.
December 7, 2018
The 21st Century Cures Act requires federal agencies to “review applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research finding and protection of research animals.” This past March we requested feedback from the public on ways to reduce regulatory burden while also maintaining the highest standards for protecting animal welfare and scientific integrity. You responded with constructive and helpful feedback with more than19,000 comments. Generally, many responses supported the actions initially proposed in the request, but they were balanced with concerns from animal advocacy and other groups.
October 11, 2018
When world famous cellist, Yo-Yo Ma, visited the NIH campus, he shared a story from the history of music, in which the peak of stringed instrument quality occurred in the late 17th century at a time of great collaboration and sharing of knowledge. When instrument makers began to compete, all of that changed: secrets of craftsmanship were held close and the quality of instruments plummeted. This decline lasted, according to Ma, until the 20th century, when again the free-flow of knowledge resumed. NIH Director Francis Collins noted, “There’s a lesson here about science.”
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. ….
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. ….