Ethics, Equity & Informed Consent

Continuing Review and Annual Renewal: IRB/IEC Expectations and Common Pitfalls Continuing Review and Annual Renewal: IRB/IEC Expectations and Common Pitfalls In clinical research, continuous oversight is paramount to ensure that the rights and welfare of participants are protected. This is where the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) plays a crucial role….

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Understanding IRB/IEC Applications in Clinical Trials The importance of Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) in clinical trials cannot be overstated. These bodies play a critical role in protecting the rights and welfare of research participants. In the United States, IRBs are governed by the FDA regulations, while in the UK and…

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IRB and IEC Submission Dossiers: Core Elements, Timelines and Best Practices The process of submitting regulatory documents to an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is fundamental in safeguarding participant rights while ensuring compliance with ethical standards in clinical research. This article explores the core elements of IRB and IEC submission dossiers,…

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Building an IRB/IEC Submission Calendar Linked to Study Milestones Building an IRB/IEC Submission Calendar Linked to Study Milestones The initiation of any clinical trial involves navigating a complex regulatory landscape, especially when it pertains to ethics approval by Institutional Review Boards (IRB) or Independent Ethics Committees (IEC). The construction of a well-organized IRB/IEC submission calendar…

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Deviations, Noncompliance and IRB/IEC Reporting Pathways In the realm of clinical research, particularly in the context of worldwide clinical trials inc, maintaining compliance with regulatory standards is paramount. Understanding the pathways for reporting deviations and noncompliance to Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) is essential for clinical operations, regulatory affairs, and medical…

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Major and Minor Protocol Amendments: When and How to Notify IRBs and IECs Major and Minor Protocol Amendments: When and How to Notify IRBs and IECs Effective management of protocol amendments is crucial in ensuring the integrity of clinical trials and the protection of trial participants. This guide provides a comprehensive overview of the procedures…

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Digital Portals and e-Submissions: Streamlining IRB/IEC Workflows Digital Portals and e-Submissions: Streamlining IRB/IEC Workflows In the dynamic landscape of clinical research, particularly in psoriatic arthritis clinical trials, it becomes critical to ensure efficient and compliant processes for Institutional Review Board (IRB) and Independent Ethics Committee (IEC) submissions and continuing reviews. The advent of digital portals…

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What IRBs and IECs Look for in Risk–Benefit Justifications Understanding IRB and IEC Expectations for Risk–Benefit Justifications As clinical trials evolve in their complexity and methodology, the role of Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) has become increasingly critical in assessing the ethical validity of proposed research. For clinical operations, regulatory affairs,…

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