TAG ARCHIVES FOR IRB

21
Jun2017

In May, PRIM&R hosted the webinar Introduction to Research Misconduct for IACUC, IRB, and IBC Professionals. This webinar provided foundational knowledge in research misconduct for regulatory professionals who work in the human subjects protections and animal care and use fields. After the webinar, one of the presenters, Jim Kroll, PhD, responded to some of the attendee questions that time didn’t permit us to answer live. We’re pleased to share those answers with the readers of Ampersand. Read more

5
Apr2017

In March, PRIM&R hosted the webinar Electronic Informed Consent: Ethical, Regulatory, and Practical Implications. Presented by Cheryl Grandinetti, PharmD, a health science policy analyst at the FDA, and Christian Simon, PhD, a bioethicist at the University of Iowa who conducts research on electronic informed consent (eIC), this webinar helped attendees understand the definition of eIC, grasp its regulatory requirements and context for using it in FDA-regulated clinical trials, better anticipate the challenges and benefits associated with eIC, and recognize how investigators and IRBs can promote its ethical and effective use. The presenters were joined by additional panelists Leonard Sacks, MD from the FDA and [...] Read more

30
Nov2016

“We lost our quorum,” presenter Susan S. Fish, PharmD, MPH quipped as a few stragglers were still finding their seats after a short coffee break. I recognized her wonderful sense of humor and ability to engage the audience from last year’s IRB 101 course, and was delighted that she and her co-presenter Karen N. Hale, RPh, MPH, CIP continued to exceed expectations at this year’s AER Pre-Conference Program, IRB 201: An In-Depth Analysis of the Criteria for Review. Read more

7
Oct2016

PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.” Read more

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