The 21st Century Cures Act, and Perspectives from NIH

You may have been following news of the 21st Century Cures Act, a landmark piece of legislation with provisions for healthcare, medicine, and research. Republican and Democratic lawmakers supported this bill through its development and eventual passage, and yesterday, President Obama signed the bill into law. The Act establishes a multitude of important changes to our nation’s approach to supporting and funding health care, medical interventions, and research. Readers of this blog may be particularly interested in the many changes directly relevant to NIH’s mission. A New England Journal of Medicine Perspective essay …. Continue reading

Give Us Your Feedback on Standards for Preprints, and Other Interim Research Products

Many scientific disciplines, like physics and mathematics, routinely communicate research findings through preprints — manuscripts that have not yet gone through the formal peer review, editing, or journal publishing process. However, this is still a relatively novel concept in biology and clinical research. …. we at NIH are interested in feedback from you, to get a fuller understanding of the current use of preprints in the broader NIH-supported research community, accepted preprint standards, whether preprints should be included in NIH applications and reports, and how investigators could report them. …. Not only are we interested in your current use of preprints — and other interim research products — but perhaps most importantly we’d like your feedback on the specific standards that need to be in place for their citation, particularly for citation in NIH applications and reports …. Continue reading

Join Us in Chicago to Learn About NIH Program Funding and Grants Administration

In the spring, I attended my first NIH Regional Seminar on Program Funding and Grants Administration. I greatly enjoyed meeting with a diverse group of scientists and science administrators. During two “Open Mike” sessions, I had the opportunity to engage in rich conversations with attendees on topics I frequently include on this blog. The conversations were enjoyable and insightful – there’s nothing like discussing such important issues like funding trends, research accountability, and grants policy face-to-face with new and early career scientists. …. Why am I writing about a seminar that took place in May? Because I have some good news for those of you who didn’t get a chance to come to Baltimore! NIH is hosting a second Regional Seminar this year, from October 26-28 ….. Continue reading

Honoring Recipients of the Presidential Early Career Awards for Scientists and Engineers

This week I had the pleasure of meeting the newest recipients of the Presidential Early Career Awards for Scientists and Engineers. These awards, also known as PECASE, are the highest honor given by the federal government to outstanding scientists and engineers in the early stages of their independent research careers. NIH is proud to support twenty PECASE recipients this year …. Continue reading

NIH and FDA Seek Feedback on Clinical Trial Protocol Template

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… Continue reading

NIH’s Commitment to Basic Science

Several years ago, my colleagues and I analyzed the diversity of disease research supported by NIH’s National Heart, Lung, and Blood Institute, and wrote about the importance of maintaining a diverse scientific portfolio. In times of scarce resources, it is tempting to prioritize investments that seem to offer a better promise of direct returns. In my current position as NIH’s deputy director for extramural research, I still feel strongly that maintaining a strong commitment to long-term goals and maintaining a diverse science portfolio ultimately balances risk and long- versus short-time pay-offs. Basic science is an essential component of this diverse portfolio. …. Continue reading

A Pilot Partnership to Find Private Support for Unfunded Applications

When I was an editor at JAMA, we often considered papers that were strong, received favorable reviews, and yet could not be published for lack of space. As it turned out, we had an option other than outright rejection: we could offer authors a user-friendly pathway by which their papers, and the reviews that went with them, could be forwarded for consideration at another journal (e.g. JAMA Internal Medicine). Later, when I came to NIH I wondered whether it was even theoretically possible for a funding agency to do something similar: arrange a way for highly meritorious but unfunded projects to find their way to willing, even eager, alternate private-sector sponsors. Effectively, we could develop public-private partnerships to extend the system’s ability to fund high-quality science and scientists. …. Continue reading

New to the World of NIH Grants? Attend a 2016 NIH Regional Seminar

One of my favorite “job tasks” is to spend time meeting with scientists and science administrators who are new to the NIH environment or are attempting to launch their careers in science. Invariably I’m asked, “What wisdom do you have to offer?” Of course, I’ll mention that it’s key to find a top-notch mentor (or mentors), that it’s critical to follow one’s passion, and that it’s always a good idea to work on grant proposals well in advance of deadlines, allowing ample time to seek input from colleagues and critics. But … that’s not enough. In today’s dynamic world, one in which we can not only no longer take science funding for granted (let alone increases in science funding), it’s not enough to be an outstanding scientists or an outstanding administrator. One also has to be an outstanding citizen. …. Continue reading

Setting the Course for Scientific Discovery

On Wednesday, NIH published its strategic plan for fiscal years 2016-2020. We strongly encourage you to take a look at the plan, which focuses on four objectives that will help guide NIH’s priorities over the next five years. The objectives align with many familiar themes for readers of this blog: advance opportunities in biomedical research in fundamental science, treatment and cures, and health promotion and disease prevention; foster innovation by setting NIH priorities to enhance nimbleness, consider burden of disease and value of …. Continue reading