Comments Welcomed on the Draft Report Recommending How to Reduce Administrative Burden in Research with Laboratory Animals: A Next Step in Implementing the 21st Century Cures Act

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. Continue reading

Changes to the R15 Academic Research Enhancement Award (AREA), and Introducing the R15 Research Enhancement Award Program (REAP)

Students in institutions with significant amounts of NIH funding, whether they be undergraduate or graduate students, generally have plenty of opportunities to gain exposure to biomedical research. This early exposure is key to engendering interest in exploring careers in science and enhancing understanding of the value of the research process. Institutions with little NIH funding often offer significantly fewer opportunities for students to do hands-on research. That’s where NIH’s AREA program comes in. Continue reading

New Funding Opportunities for Basic Experimental Studies Involving Humans

Over the past year, since we published an essay in Nature Human Behaviour on “NIH policies on experimental studies with humans,” NIH has engaged in a discussion with the basic science community to find ways to meet our shared obligations to study participants and taxpayers, while respecting the unique goals and outcomes of basic science.  While we are still in the midst of that conversation, we are pleased to announce real progress in the form of new funding opportunity announcements for Basic Experimental Studies involving Humans.  Continue reading

Working Together to Protect the Integrity of NIH-funded Research

When research findings are made up from thin air, misrepresented in some way, or blatantly and without credit copied from others, we risk eroding the public’s trust, damaging institutional reputation, harming careers, incurring skepticism, misleading future research, and, arguably most importantly, hurting patients. NIH takes research misconduct seriously. We are being proactive.
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Understanding Age in the NIH Portfolio: Implementation of the NIH Inclusion Across the Lifespan Policy

Last December, NIH announced a revision to its Inclusion of Children Policy to expand the policy to individuals of all ages. The revised policy, now called the Inclusion Across the Lifespan policy, requires individuals of all ages (including children and older adults) be included in clinical research studies unless there are scientific or ethical reasons to exclude them.
A recent Viewpoint Essay published in the Journal of the American Medical Association (JAMA), co-authored by Drs. Marie Bernard (National Institute on Aging), Janine Clayton (NIH Office of Research on Women’s Health), and Michael Lauer, highlights the need for such a policy. The essay summarizes efforts by NIH to implement 21st Century Cures requirements to publish data on the age of research participants, to convene a workshop on age grouping and exclusions, and to make a determination on whether to revise inclusion guidelines on age.
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Protecting Participants, Empowering Researchers: Providing Access to Genomic Summary Results

Today, we are updating the way we manage data related to the NIH Genomic Data Sharing Policy to again allow unrestricted access to genomic summary results for most of the studies we support in order to advance health or further research purposes. These summary results are importantly distinct from other genomic research data, most notably in that they do not include individual-level information. Instead, these results come from analyzing pooled genomic data from multiple individuals together to generate a statistical result for the entire dataset. Such information can be a powerful tool for helping researchers determine which genomic variants potentially contribute to a disease or disorder. Continue reading

What Contributes to the Success of Early Career Scientists? – A NIAID Look

At NIH, we are heavily invested in our workforce and in understanding the barriers they face. What characteristics do they share? How do they compete in the current hypercompetitive environment? When do they stop applying to NIH (drop out), even after receiving their first award? Staff from the National Institute of Allergy and Infectious Diseases (NIAID) delve into these questions in a paper published recently in PLOS ONE , whose findings I’d like to highlight today. Here, Drs. Patricia Haggerty and Matthew Fenton looked at factors that may contribute to the success of early-career investigators and if these factors affect all junior researchers equally. Continue reading

A Data Sharing Renaissance: Music to My Ears!

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.”
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NIH Loan Repayment Programs: A Lifeline for Biomedical and Biobehavioral Researchers: Applications Accepted September 1 – November 15

By the time many researchers have completed their education and training, they have amassed on average $160,000 in student loan debt. The NIH Loan Repayment Programs (LRPs) are a set of programs established by Congress and designed to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers. The LRPs counteract early-career researchers’ financial pressure by repaying up to $35,000 annually ($70,000 over a two-year contract) of a researcher’s qualifying educational debt in return for a commitment to engage in research areas important to the mission of NIH. Continue reading

NIH Policies to Address Sexual and Gender Harassment in NIH-supported Extramural Research

Several months ago, we learned in the press that an NIH-supported investigator was banned from his university campus pending an ongoing investigation into allegations of sexual misconduct. The institution, which was the recipient of the awards in which this investigator was designated as principal investigator (PI), had not informed us of this situation. Once aware, we contacted senior institutional officials to discuss the need to ensure the effective stewardship of the award under these circumstances. We requested that the institution provide us with alternative plans for conducting the research given that this individual would no longer serve as PI and would have no other involvement in the NIH-funded research, and we reminded them (as we recently reminded the community and as reiterated below) that they are responsible for notifying NIH of any change in status that might affect the ability of an individual identified as key personnel to conduct NIH-supported research. Continue reading