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
Allowable Costs to Improve Human Subjects Participation and Inclusion
December 4, 2023
Did you know that you can pay for childcare for your research participants while they are doing study activities? Find similar ideas to enhance your inclusion, recruitment, or retention of research participants in NIH’s new one-page tool.
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Rethinking Population Descriptors in Genetics and Genomics Studies
September 28, 2023
Assuming that biological or genetic differences relate directly to racial or ethnic categories can lead to false scientific conclusions and perpetuate bias. Misuse of population descriptors has harmed marginalized groups and promoted scientific racism. These limitations in existing population descriptors in genetics and genomics led 14 NIH Institutes, Centers, and Offices to sponsor the National Academies of Science, Engineering, and Medicine (NASEM) to establish an interdisciplinary committee of experts and explore the issue.
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Tool Tip: Age Data Table for Inclusion Enrollment Reports
July 31, 2023
If you conduct human subjects research and completed an RPPR recently, you may have noticed something new in your inclusion enrollment report. If you haven’t had a chance to see it yet, we’ve got great news: Inclusion Enrollment Reports now include a table summarizing the age data that you submit as part of the participant-level data.
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Your Questions on Human Subjects Research, Answered
January 10, 2023
If you’re conducting research with human subjects, you might have questions about HHS regulations and NIH policies and how you can prepare proposals and inclusion plans. HHS and NIH experts address many of these questions, along with resources, guidance, and case studies in a 2-part webinar series focused on Human Subjects Research Policies, Clinical Trials, and Inclusion.
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Human Subjects Research: Policies, Clinical Trials, & Inclusion on December 6-7
October 31, 2022
Are you working with human subjects in your research and wondering about how HHS regulations and NIH policies apply, how to prepare a research proposal, or how to develop inclusion plans? Join experts from the NIH Division of Human Subjects Research and HHS Office of Human Research Protections (OHRP) for answers to these questions and more at the Human Subjects Research: Policies, Clinical Trials, & Inclusion event on December 6 and 7, 2022.
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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).
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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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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.
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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.
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