What Are the Reporting Requirements for the Inclusion Across the Lifespan Policy?

The Inclusion Across the Lifespan policy requires submission of de-identified individual-level participant data, including participant age at enrollment, in progress reports. Wondering how to provide individual-level inclusion data? Use the template file provided on the Inclusion Enrollment Report in the Human Subjects System. Continue reading

NIH Will Continue to Accept Preliminary Data as Post-Submission Material Through May 2021 Council

The ability to submit preliminary data as post-submission materials for applications submitted for the January 2021 council (NOT-OD-20-123) has been extended to apply to the May 2021 council (NOT-OD-20-163). This is a temporary flexibility due to the effects of the COVID-19 pandemic. Continue reading

NIH Helps Small Businesses Change the World

Did you know that the NIH’s small business programs (SBIR and STTR) invest over 1 billion dollars into life science and healthcare companies each year? The newly-created Small business Education and Entrepreneurial Development (SEED) office provides grantees with many of the valuable entrepreneurship and commercialization services we have discussed in previous blogs to help them thrive. Continue reading

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 … Continue reading

Institute and Center Award Rates and Funding Disparities

In 2011, Ginther et al. first demonstrated that African American and Black applicants to the National Institutes of Health received grant awards at a lower rate than their white counterparts (Ginther 2011). Since then, multiple studies have reproduced and extended this finding (Ginther 2011; Ginther 2016; Hoppe 2019; Erosheva 2020). Recently we reported that African American and Black (AAB) PIs are more likely to propose research on topics that are less likely to be funded (Hoppe 2019). We found that topic choice has little or no effect on whether an application is chosen for discussion, but after considering a number of confounders, it accounts for over 20% of the gap in funding success for applications that are discussed. Continue reading

Save the Date: Fall 2020 NIH Virtual Seminar on Program Funding and Grants Administration!

If you’re new to working with the NIH grants process as an investigator or administrator, then mark your calendar for Tuesday, October 26 – Friday, October 30 for a unique opportunity to learn, share and meet virtually with NIH and HHS experts. The NIH is offering a virtual seminar that you won’t want to miss! Continue reading

Inclusion Across the Lifespan II Workshop: September 2, 2020

Planning clinical research studies? Tune in to the Inclusion Across the Lifespan (IAL) II virtual workshop for evidence-based practical advice for meeting the new IAL policy, with a focus on pediatric and geriatric populations. Discussions will include considerations for special populations (e.g. racial/ethnic minorities, people with disabilities, rural/isolated populations, language minority individuals, pregnant and lactating women, people with co-morbidities, sexual and gender minorities, and other groups). Continue reading

Leveraging Standardized Clinical Data to Advance Discovery

Opportunity knocks for NIH researchers, who will be able to leverage clinical data from electronic health record (EHR) systems with increased frequency and consistency. The recently published final rule, which went into effect on June 30, 2020, and requires electronic health record (EHR) systems to provide the clinical data necessary for nationwide, interoperable health information exchange through the adoption of the U.S. Core Data for Interoperability (USCDI) standard. Continue reading