Check Case Studies on Inclusion Across the Lifespan
December 4, 2023
As you plan your human subjects research, use the Inclusion Across the Lifespan Case Studies to help you determine if your proposed study population is appropriate.
Tag: inclusion across the lifespan
FY 2021 Data on Age at Enrollment in Clinical Research Now Available by RCDC Category
April 11, 2022
We are pleased to announce that for the first time, data are now available on the age of participants in NIH-supported clinical research. The newly available information on age adds to already reported data on participant sex or gender, race, and ethnicity.
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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.
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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.
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Request for Information on Inclusion Across the Lifespan II Workshop
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.
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Have Inclusion Questions? Our Revamped Inclusion Webpages Have Answers!
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.
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Where Should I Address the Inclusion Across the Lifespan Policy in My Application?
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.
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Reminder to Address Inclusion of Individuals Across the Lifespan in Grant Applications
February 6, 2019
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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