As you may have heard, the Office of Management and Budget (OMB) announced a March 28, 2024 update of Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity. There is no action for you at this time – changes must be implemented by March 28, 2029.
On June 25, 2024, the modernized ClinicalTrials.gov will become the singular website experience. This major milestone is part of National Library of Medicine’s multi-year ClinicalTrials.gov modernization effort, which has been guided by stakeholder engagement, input from the NLM Board of Regents Public Service Working Group, and a user-centered design approach.
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To avoid the pitfalls that inconsistent use of terms can lead to, NIH and FDA developed a glossary of terms related to clinical research that could be used to assist the research community in effectively communicating about clinical trials. NIH and FDA are most interested in hearing community feedback on the utility of the glossary in its goal of promoting effective communications. Comments will be accepted until June 24, 2024.
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For a subset of NIH-funded basic experimental studies with humans (BESH) research, NIH has announced that we are further extending certain interim policy flexibilities for registration and results reporting.
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We’ve heard that there is some confusion about exempt human subjects research and expedited IRB review. Expedited review is not the same as exempt research. Here are a few points to provide clarity.
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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.
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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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If your next new or competing renewal application includes human subjects research, take advantage of NIH’s new Single IRB (sIRB) Requirement Determination Workflow to help determine whether your project is subject to the single institutional review board (IRB) requirements.
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Have you encountered warnings or errors when working in the Human Subjects System (HSS)? Not to worry, a guide is now available to help Principal Investigators and Signing Officials who enter data into HSS resolve common warnings and errors
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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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