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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).
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The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO
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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 March 21, 2024 the Centre for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) issued a warning letter to the New York State Psychiatric Institute (NYSPI) institutional review board (IRB). The FDA’s inspection resulted in six major observations, all of which occurred during convened IRB meetings.
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Section 3023 of the 21st Century Cures Act (Cures Act) requires harmonizing the human subject protection regulations between U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA). In efforts to harmonize with the revised Common Rule, the FDA recently published two proposed rules.
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In a recent investigator warning letter issued by the US Food and Drug Administration (FDA), an investigator was cited for failing to ensure an Institutional Review Board (IRB) that complies with the applicable regulatory requirements in 21 CFR 56 was overseeing their clinical trial. During the time where IRB approval for the protocol lapsed, the site continued to enroll and administer investigational products to study participants under that protocol. The investigator’s response to the FDA was inadequate because they explained that they did not need to report any adverse events during that timeframe.
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The US Food and Drug Administration (FDA) released a guidance, “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.” The purpose is to guide industry to consider patient and caregiver perspectives on living with a particular disease or condition and how medical devices impact their lives, as well as perspectives on how a clinical trial may impact a study participant. The guidance is part of the FDA Patient Engagement Advisory Committee (PEAC) initiative to increase patient engagement in medical device clinical trials.