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Tag: IRB

IRB Consulting Hours

The VCU Human Research Protection Program is pleased to continue offering open IRB consulting hours. The next of these open consulting hours will be hosted VIRTUALLY using Zoom, and is sponsored by our colleagues in the Wilder School. IRB staff will be available for drop-in consultations with faculty, students, and staff from any school or department […]

IRB drop-in consulting hours

Monday, July 6th from 12:30 p.m. – 3:30 p.m. The VCU Human Research Protection Program is pleased to continue offering open IRB consulting hours. The next of these open consulting hours will be hosted VIRTUALLY using Zoom, and is sponsored by the Wilder School IRB staff will be available for drop-in consultations with faculty, students, and […]

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators

(6/2/2020) – FDA is issuing this “Guidance for IRBs and Clinical Investigators” to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19. See document here: https://www.fda.gov/media/138496/download

Replies to Inquiries to FDA on Good Clinical Practice

GCP inquiries submitted by the public to the FDA’s Good Clinical Practice Program’s gcp.questions@fda.hhs.gov e-mail account are now available online. FDA on GCP Link: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/replies-inquiries-fda-good-clinical-practice Visit this FDA page to search through years of answers to GCP related questions on: Adverse Events Inquiries Computer Questions Device Study Inquiries FDA Forms 1571 and 1572 Financial Disclosure Inquiries Foreign […]

Oct. 9 & Oct. 11: Crucial Conversations with the IRB Part II (CReSS Workshop)

Crucial Conversations with the IRB, Part II: “Oops we did it again” Unanticipated Problems, Non-compliance Register for only one of the following two sessions: Wednesday, Oct. 9, from 9 – 10:30 am; MMEC 12‐101/102 Friday, Oct. 11, from 2:30 – 4 pm; MMEC 12‐101/102 The VCU IRB will continue their conversation with research teams in […]

**Important IRB Communication**

On January 21, 2019, revisions to the Federal Policy for the Protection of Human Subjects will go into effect.  This new version of the “Common Rule,” as it is typically known, represents the first revision to the rule since its publication in 1991. Many of us in the world of Human Subjects Protection have been […]

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