NIH awardees must report individual-level study participant data on: 1) Sex/Gender, 2) Race, 3) Ethnicity, and 4) Age at Enrollment in annual progress reports. This individual-level data must be de-identified and submitted using the required .csv template file.
“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.
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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.
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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).
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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”
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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.
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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.
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For over two decades, NIH has required researchers to include women, members of racial and ethnic minority groups, and children in their work absent an acceptable scientific or ethical rationale for their exclusion. Now, for the first time, selected inclusion data on sex/gender and race/ethnicity are publicly available disaggregated for various research, condition, and disease areas.
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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.
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Effective for due dates January 25, 2019 or later, keep in mind the following changes to your applications and progress reports.
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