Spreading the Word About Policies Impacting Human Subjects Research and Clinical Trials

Understanding the impact of the new human subject and clinical trial policies on selecting a funding opportunity announcement, developing an application, the review of applications, and reporting on grant awards will be critical in the upcoming months. …. we have made a variety of resources available to the research community to assist with institutional training and outreach….. Continue reading

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Continuing to Clarify the NIH Definition of a Clinical Trial

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. …. Continue reading

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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. … Continue reading

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Small Businesses Gather in Milwaukee for 19th Annual HHS SBIR/STTR Conference on Federal Research Funding

The Department of Health and Human Services (HHS) is pleased to present the 2017 Annual SBIR/STTR Conference: In The Heartland of BioHealth Innovation. The National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Administration for Community Living (ACL), and the Office of Inspector General (OIG) will be present to demonstrate and discuss research funding opportunities with interested entrepreneurs and innovators. …. Continue reading

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Have You Seen the Loan Repayment Program Recently? Here’s What You Missed

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. …. Continue reading

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NIH’s Next Generation Researchers Policy Now Posted

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). …. Continue reading

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Data On Trends According to Career Stage

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.  …. Continue reading

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Monitoring the Impact of Hurricane Harvey on Research

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. …. Continue reading

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