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.
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.
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).
December 13, 2019
ke your comments and suggestions heard as NIH plans the follow-up to the 2017 Inclusion Across the Lifespan workshop, the Inclusion Across the Lifespan II (IAL-II) workshop that will focus on the recruitment and retention of pediatric, geriatric, and other underrepresented participants in clinical studies.
July 9, 2019
Wondering where to go for information on NIH’s Inclusion policies? Visit the new Inclusion Policies for Research Involving Human Subjects landing page, where you can navigate to learn more about NIH policies on the inclusion of women and minorities and the inclusion of individuals across the lifespan.
March 25, 2019
Applicants should include a rationale for the age range of study participants and justification for age-based exclusion in the Inclusion of Women, Minorities, and Children section of the PHS Human Subjects and Clinical Trials Information Form (Section 2.4). This section will continue to have the heading “Inclusion of Women, Minorities, and Children” until the next forms update. See the instructions under Inclusion of Children in the application guide for additional information.
February 6, 2019
Effective for due dates January 25, 2019 or later, keep in mind the following changes to your applications and progress reports.