How Do I Submit Preliminary Data as Post-Submission Material Under the Special Exception During the COVID-19 Pandemic?

You may submit data as post-submission material under the special exception for the COVID-19 pandemic. Read on for directions and reminders.

Check Out NIH’s New COVID-19 Research Website

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.

Extended Guidance for Applicants Preparing Applications During the COVID-19 Pandemic

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.

Continued Impact of COVID-19 on Biomedical Research

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.

Exceptions to Use of a Single IRB During the COVID-19 Public Health Emergency

Conducting research involving human subjects during COVID? Read here for information on requesting an exception to the use of a single IRB.

NIH released a Guide Notice to inform the extramural research community how NIH is implementing the Office for Human Research Protections (OHRP)’s determination of Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

Researchers, if You Received a Survey, Please Provide Us with Your Perspective on the Impact of COVID-19

Since March, COVID-19 has greatly impacted the way we all work. NIH has been tracking how well our policies meet the needs of our research community in response to the ongoing pandemic. To get a better understanding of how COVID-19 is impacting our extramural researchers, we launched the Impact of COVID-19 on Extramural Researchers Survey in mid-October. If you received an invitation to take this survey, please take 15-20 minutes to complete it. This survey will be open until Friday, November 13th. The results from the survey will inform policy and program decisions, so participation is critical.

Seeking Your Ideas on the NIH-Wide Strategic Plan for COVID-19 Research

From shifting public health needs to the unprecedented pace of biomedical discovery, everything about the coronavirus response is evolving. This goes for the NIH-Wide Strategic Plan for COVID-19 Research as well, so too must it evolve.

We want your help on the next iteration of the Plan. A Request For Information released yesterday seeks public feedback on the current Plan (NOT-OD-21-018). You or your organization can submit ideas here by December 7, 2020.

Encouraging Participation in Upcoming NIH Surveys to Identify Impacts of COVID-19 on Extramural Research

NIH has been working diligently to support the extramural research community since the pandemic began in March. We are now preparing to reach out with surveys to gather data on how COVID-19 is impacting our extramural researchers and their institutions. If you receive such a survey, we hope that you will take the time to provide us with your perspective. The results of the surveys  will be extremely valuable to inform policy and program decisions as NIH seeks to identify ways to continue to support the biomedical research enterprise as we move forward.

Temporary Extension of Eligibility for the NIH K99/R00 Pathway to Independence Award During COVID-19 Pandemic

Due to disruptions caused by the COVID-19 pandemic, NIH will be providing up to a two-receipt cycle extension (roughly eight additional months) of eligibility for prospective applicants meeting the requirements for submission of a K99/R00 application from the June/July 2020 due dates through the February/March 2021 due dates. For more details, see the full Guide … Continue reading “Temporary Extension of Eligibility for the NIH K99/R00 Pathway to Independence Award During COVID-19 Pandemic”

Roundup of New COVID-19 Resources for NIH Applicants and Recipients: Part 3

We continue to add new resources to our COVID-19: Information for NIH Applicants and Recipients of NIH Funding webpage. We hope they are helpful in navigating this unprecedented situation. Here is a summary of what’s new since the last Nexus.