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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.
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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.
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On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.
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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).
What does that mean for the informed consent process for clinical trials?
Because the ruling considered the wording of 40 P.S. § 1303.504(a) as a basis for their understanding that a physician alone must obtain informed consent, and subsection 5 includes experimental drugs and devices, clinical trials conducted in Pennsylvania can be held to this new standard.
China Food and Drug Administration (CFDA) was accepted as a regulatory member in the International Council for Harmonisation (ICH) whose mission “is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.”
Registration now open!
Certification Exam Prep Course
Presented by: Laurin Mancour, CCRA
Date: Saturday, August 26
Time: 9:00 am – 5:00 pm
Location: Premier Research (1 Park Drive, Research Triangle Park, NC 27709)
**UPDATED EFFECTIVE DATE** The research landscape has changed over the course of the last several decades to accommodate increased complexity along with broader population samples for the assessment of new therapeutic interventions causing a new set of human subject protection challenges. Time and cost of clinical trials are always a pain point in the industry and many initiatives have been launched to address it. Here in the US research funding plays a major role in IRB selection since most institutions insist on using a local IRB for non-industry-sponsored research even as the FDA and OHRP have encouraged the use of central IRBs.
Our own SAM Sather will be in the ACRP's Northern California chapter for a discussion of the guideline updates, impact assessment, and a scalable approach to implementation of ICH-GCP E6 R2. For more information click here.