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NIH INFORMED

Issue No. 9, 2021
Insights from NIH notices and reviewer comments, so you can focus.
 
SEPTEMBER TIP
 

Should I propose a multi-site interventional trial as a first-time R01 applicant?

Not if you want to be funded.

As a general rule of thumb, if you want to obtain NIH funding for trials, you might want to begin with a single-site, observational design for your first R01. Clinical trials pose their own unique set of challenges and have high compliance and regulation requirements. It takes time and skill to learn how to run them successfully. In addition, multi-site trials take a certain amount of communication and coordination to run like a unified whole. As you develop a proven track record of success, you can scale up on subsequent R01s to multi-site and interventional. Of course this is a sweeping generalization and there will always be exceptions. For example, if you have a great deal of experience leading trials that were funded outside of NIH, then reviewers might find it credible that you can successfully lead a first R01 with a more complex design. Always discuss your specific circumstances with the program officer.
 

SEPTEMBER NEWS
  1. Change to Login.gov transition timeline
  2. NCI releases FY2023 annual plan & budget proposal
  3. NIH guidance for Fall 2021 applications submitted during the COVID-19 pandemic
  4. The latest roundup of some NIH-sponsored COVID-19 research
1. Change to Login.gov transition timeline
Instead of requiring users to transition to login-dot-gov by September 15th, NIH is implementing a phased approach to the transition. Beginning on September 15th, scientific account holders should begin transitioning. All PIs and key personnel associated with an application or RPPR will be required to transition 45 days after the submission of the grant application or RPPR. Administrative accounts will transition in early 2022. For complete information, please see the NIH Notice.
2. NCI releases FY2023 annual plan & budget proposal
NCI released its fiscal year 2023 annual plan and budget proposal. The proposal’s key messages include: (1) Increasing R01 paylines to the 13th percentile, with the goal of achieving 15th percentile by 2025; (2) Seizing new opportunities in cancer research and building on progress in already-established areas; (3) Making health equity a priority by building a diverse and inclusive cancer research workforce and support disparities research; and (4) Sustaining and leveraging the opportunities created by The Cancer Moonshot initiative after funding ends in FY2023. The full report can be accessed here.
3. NIH guidance for Fall 2021 applications submitted during the COVID-19 pandemic
NIH has issued guidance for applications prepared for Fall 2021 due dates during the COVID-19 pandemic. Applicants may address effects due to the pandemic on productivity or other scoreable issues in the Personal Statement section of the Biographical Sketch. The NOT also provides information regarding guidance given to reviewers regarding COVID-19 related constraints and productivity. Details are available in the NIH Notice.
4. The latest roundup of some NIH-sponsored COVID-19 research
Over the past year, the NIH has maintained the scientific community abreast of COVID-19 developments via a website with news releases regarding research findings and clinical trials attempting to address the pandemic. As the situation evolved, so has NIH’s information. 
 
The site now lists NIH’s strategic priorities for COVID-19 research, as well as a PDF of the 2021 NIH-wide COVID-19 Strategic Plan. Additionally, there is a page outlining COVID-19 research initiatives across its centers and institutes. 
 
We’ll continue sharing COVID-19 related headlines, but we encourage you to visit the resources above. 

Here are some other COVID-19 related headlines:

Exciting News!
Our new course library platform is now live!

Margaret Bouvier received her PhD in 1995 in Biomedical Sciences from the Mount Sinai School of Medicine. After an NINDS post-doctoral fellowship, she worked as a staff writer for current NIH Director Dr. Francis Collins in the Office of Press, Policy, and Communications for the Human Genome Project and NHGRI. Since 2007, Meg has specialized in editing and advising on NIH submissions, and began offering virtual courses in 2015. She currently supports 2 of the top 3-ranked hospitals; 4 of the top 6 cancer hospitals; and 3 of the top 6-ranked medical schools for research in the country. She has helped clients land over $380 million in federal funding. Meg Bouvier Medical Writing, LLC is a woman-owned, small business.

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