NIH All About Grants Podcast Mini-Series: Inclusion Plans – From Application to Post-Award

April 15, 2022

Inclusion plans. You have questions. We have answers. Join us for this NIH All About Grants podcast miniseries to learn about preparing inclusion plans as part of your application (Part 1) and what happens during peer review and post-award (Part 2).

Designing Analyses by Sex or Gender, Race, and Ethnicity in NIH-defined Phase 3 Clinical Trials

March 10, 2022

NIH-defined phase 3 clinical trials are required to conduct and report analyses by sex or gender, race, and ethnicity for each primary outcome. These analyses, referred to as “valid analyses” are unbiased assessments that on average, yield the correct estimate of the difference in outcomes between two groups of participants.

Ensuring Smooth Submission of Inclusion Data

December 20, 2021

NIH requires participant-level data in progress reports for all clinical research that come in on applications for due dates January 25, 2019 or later (see our Inclusion Across the Lifespan policy).  Grantees use the Inclusion Enrollment report template provided through NIH’s Human Subjects System (HSS) to provide the required data. To successfully submit the report, obtain the template by selecting the Download Participant Level Data Template button on the Inclusion Enrollment Report screen.

Some Thoughts Following the NIH Inclusion Across the Lifespan 2 Workshop

December 10, 2020

“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.

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

August 26, 2020

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.

Inclusion Across the Lifespan II Workshop: September 2, 2020

July 31, 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).

Inclusion Reporting and FORMS-F

July 1, 2020

Consistent with the Inclusion Across the Lifespan policy, recipients are now required to submit participant-level data on sex/gender, race, ethnicity, and age at enrollment in progress reports. This applies to applications submitted for due dates January 25, 2019 or later. Recipients must upload participant-level data in the Human Subjects System (HSS) using the template provided. … Continue reading “Inclusion Reporting and FORMS-F”