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

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

Request for Information on Inclusion Across the Lifespan II Workshop

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. Continue reading

Have Inclusion Questions? Our Revamped Inclusion Webpages Have Answers!

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. Continue reading

Where Should I Address the Inclusion Across the Lifespan Policy in My Application?

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. Continue reading