Showing results for IRB

On Tech Ethics Podcast - The Essential Role of Bioethics in HBCU Medical Schools
Season 1 - Episode 34 - The Essential Role of Bioethics in HBCU Medical Schools Discusses the need for bioethics departments in HBCU medical schools....
Seven Elements of an Effective Compliance Program: What Research Administrators Need to Know
Presented by: Andra M. Popa, JD, LLM - CITI Program Learning Objectives: Identify the seven key elements of an effective compliance program fo...
Research Involving Prisoners
Describes the special requirements for conducting research with prisoners. The learner is provided with a review of why incarcerated individuals need ...
Research Involving Pregnant Women, Fetuses, and Neonates
Discusses the historical exclusion of women of childbearing potential and the special requirements for conducting research involving pregnant women an...
FDA Releases Draft Guidance about Form FDA 1572
On 20 May 2021, the FDA released a draft information sheet guidance for sponsors, clinical investigators, and institutional review boards (IRBs) entit...
New OHRP Incident Reporting Form and Instructions
The regulations at 45 CFR 46 for nonexempt research conducted or supported by the U.S. Department of Health and Human Services (HHS) require prompt re...
Phase I Research: Protecting Phase I Subjects
Reviews U.S. Food and Drug Administration (FDA) requirements for initiation of phase I research studies following non-clinical studies. Describes IRB ...
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