You may submit data as post-submission material under the special exception for the COVID-19 pandemic. Read on for directions and reminders.
We are pleased to announce that the new NIH COVID-19 website launched earlier this week. The site provides a central location for trusted, up-to-date, accurate information about NIH research and our strategic role in COVID-19 research. The site complements information made available on our COVID-19: Information for NIH Applicants and Recipients of NIH Funding webpage.
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Looking back on 2020 includes seeing how well we have done to capture your interest with our Open Mike blog posts. Did we hit the mark? Here we analyze page views on the Open Mike blog. Similar to what we did for 2018, below we show the top ten blog posts from 2020 based on overall page views. Posts on topics that are directly related to grant funding were the ones that were viewed the most.
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In recognition of the fact that COVID-19 may still be adversely affecting the ability of applicants to generate preliminary data, NIH will continue to accept a one-page update with preliminary data as post-submission materials for applications submitted for the August/October 2021 council (beginning with applications submitted for the January 25, 2021 due date for Summer 2021 review meetings), ONLY if the Funding Opportunity Announcement (FOA) used for submission allowed preliminary data in the application.
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From struggles to successes, 2020 deserves a look back. Right before the holidays, I sat down with Dr. David Kosub from the NIH Office of Extramural Research’s communication shop to reflect on 2020 and what may be in store for the year ahead. I invite you to watch our conversation and hope you have a happy, healthy, and safe new year!
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“The [NIH Inclusion Across the Lifespan] policy, and the review and reporting requirements associated with it, should help ensure that children and older adults are not inappropriately excluded from clinical studies. The policy also has the potential to provide a more robust understanding of the full spectrum of participants recruited into clinical studies.”
Together with my NIH colleagues Drs. Marie Bernard and Janine Clayton, we made this point in a 2018 JAMA opinion piece following the inaugural NIH Inclusion Across the Lifespan workshop. Fast forward, we revisited this issue at the NIH’s Inclusion Across the Lifespan 2 workshop held this past September. You can watch the videocast here. The report covering the event was posted today, and I wanted to share some of my takeaways.
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FAQs now available to clarify our recent guidance on the ability to direct charge personal protective equipment (PPE) costs to clinical trials and clinical research awards (NOT-OD-20-164).
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NIH grant applications should NOT include contingency plans that would outline steps needed to recover from temporary, emergency situations, or institutional return-to-the-workplace plans, resulting from the COVID-19 pandemic. Contingency plans will not be considered in peer review but, if needed, COVID-19 contingency plans will be requested and carefully considered by NIH staff before funding.
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How will study sections meet in the future? NIH peer review depends on robust meetings where groups of scientists, through vigorous discussion, identify the applications of highest merit. For the last 75 years, until last March, nearly all chartered review committee meetings were held in-person. Today, in response to the pandemic, 90% of all CSR review meetings are run as video (“Zoom”) meetings. CSR is taking steps now so that when all options are back on the table, we can make informed choices about how best to convene review meetings.
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It’s been over eight months since the COVID-19 pandemic crisis struck, changing every facet of life as we knew it. The U.S. biomedical research enterprise was not spared, as lockdowns and severe restrictions on activities took hold across the country. At the time, we offered our perspectives on efforts we could take to cushion the shock. Since that time, much has happened. COVID-19 research has blossomed with impressive results including FDA approval of a therapeutic agent (remdesivir, which was found to have value in a large-scale NIH-funded trial), development of several candidate vaccines that have already made to pivotal Phase 3 trials, and the rapid development of a variety of diagnostic testing platforms. However, research unrelated to COVID has seen a different picture.
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