A few weeks ago we released some case studies and FAQs to help clarify for our research community whether their human subjects research study meets the NIH definition of a clinical trial. These resources prompted a number of follow-on questions and thoughtful suggestions from the community that have helped us refine both the FAQs and the case studies. We are grateful for your thoughtful and constructive comments and suggestions, many of which we have incorporated into our revised documents and communications. ….
NIH’s Certificates of Confidentiality Policy Enhances Confidentiality of Participants Enrolled in Clinical Research Studies
A few months ago we blogged about our plan to release an updated Certificate of Confidentiality (CoC) policy. Today, we are pleased to announce that we have published the new policy (NOT-OD-17-109), which will go into effect on October 1, 2017. The new policy both enhances the privacy protections of individuals participating in NIH funded research studies and eliminates the need for NIH funded investigators to apply for a CoC. …
As I reflect on the research training I received during and after medical school, I recall how lucky I was that I did not have much resulting debt and severe financial constraints that could interfere with my research career. Unfortunately, today’s aspiring physician scientists are often mired in debt. The Association of American Medical Colleges estimates that two-thirds of medical students graduate with debt, with 80% of those students owing at least $100,000.
How can we alleviate the rising debt accrued during biomedical training for those investigators seeking a foothold in the lab? The NIH loan repayment programs (LRPs), managed inside the Office of Extramural Research, is one approach the NIH is utilizing to stabilize career trajectories for talented investigators. My predecessor, Dr. Sally Rockey, understood and also championed the impact of the LRPs, and I share her enthusiasm. ….
Today we posted a policy (NIH Guide Notice NOT-OD-17-101) describing current plans for the Next Generation Researchers Initiative. Since I first blogged about it in June, NIH leadership have reviewed data (see accompanying blog) and deliberated about how best to proceed. Our goal is to increase the number of NIH-funded early-stage investigators and assure, as best we can, that funded early-stage investigators have a reasonable chance to secure stable funding during the earliest stages of their independent research careers. This new policy will supersede previous notices on new and early stage investigators (NOT-OD-08-012, NOT-OD-09-013 and NOT-OD-09-134). ….
By the 21st Century Cures Act, the Next Generation Researchers’ Initiative calls on the NIH to develop policies to increase funding opportunities for new researchers seeking to secure early independence. To put the Initiative in perspective and to extend on previous blogs we’ve posted on changing demographics in NIH-funded researchers, we thought it would be useful to explore trends according to career stage.
First, some definitions. We define “Early Stage Investigators” (ESI) as those who are within 10 years of completing their terminal degree or post-graduate clinical training and who have not yet secured independence as a PI of a substantial NIH research award. ….
The devastating effects of Hurricane Harvey cause deep concern about the health and safety of people and animals, and about the health of the biomedical enterprise in the affected areas. While everyone’s immediate efforts need to be focused on getting through this immediate crisis, we want to assure our applicant and grantee community that NIH will be doing our part to help you ensure your research continues. We issued a Guide notice reminding the community about our natural disaster policy, Reminder: NIH Natural Disaster Policy – Hurricane Harvey. To give you an idea of the ways NIH can help in these situations, our website on Extramural Response to Natural Disasters has a list of available resources, including guidance on animal welfare issues. ….
Last September, and in January of this year, we wrote about a suite of initiatives aimed at improving the quality and transparency of the NIH-supported research that most directly engages human participants – clinical trials. These initiatives include dedicated funding opportunity announcements for clinical trials, Good Clinical Practice training, enhanced registration and results reporting on … Continue reading “4 Questions For Researchers and Institutions Involved In Human Subjects Research”
At the NIH Regional Seminar this past May, I had the pleasure of giving the keynote talk and presenting different perspectives on how NIH can further the impact of our research funding. …. My staff recorded this talk and has made it available to you on the NIH Grants YouTube channel. If you’re interested in the topics covered here on the blog ….
At the Advisory Committee to the Director meeting last week, NIH Principal Deputy Director Dr. Larry Tabak presented a new NIH initiative to strengthen the biomedical workforce. This presentation followed extensive discussions with stakeholders both here through this blog, at stakeholder meetings, and at NIH advisory council meetings over the last month. We heard unequivocal endorsements for supporting early-career and mid-career researchers given the hypercompetitive funding environment —a challenge we have addressed many times in my blog posts. However, many voiced concerns about our taking a formulaic approach to capping grant funding and called on us to be more direct in enabling greater support for the next generation of biomedical researchers. For this reason, we have shifted our approach to a focused initiative to support early- and mid-career investigators. ….
Working with NIH applicants and awardees as an extramural program division director, I often shared the NIH RePORTER resource as a tool for exploring the research topics NIH supports. Learning what projects we support, using a robust database of historical and newly-funded projects (updated weekly), provides researchers valuable insight as they consider developing their own research programs and applications for funding.
Another valuable tool which you might be familiar with is Federal RePORTER, which expands the RePORTER concept to support searching over 800,000 projects across 17 Federal research agencies, with trans-agency data updated annually. As Federal RePORTER recently received an update to introduce some new functions and additional agency data we’d like to highlight some of the ways it helps both the public and scientific researchers alike ….