Common Rule - Geunim – Law Together

The Legal Guide to Informed Consent in Medicine & Research

META DESCRIPTION: Essential Guide Informed consent is the foundational ethical and legal requirement for all medical procedures and research participation. This post breaks down the three core elements—capacity, disclosure, and voluntariness—and explores the distinct legal standards governing healthcare and clinical trials under frameworks like the Common Rule. Understand your rights and the legal obligations of […]

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The Essential Legal Guide to Research Ethics Compliance

Post Overview Topic: Research Ethics Law Audience: Academic Researchers preparing studies for ethical and regulatory approval. Tone: Professional and informative. For academic researchers, navigating the complex intersection of scientific inquiry and legal compliance is paramount. Research ethics law is not merely a set of best practices; it represents a legally binding framework designed to protect

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The Regulatory Framework of US Clinical Trial Law

Meta Description: Understand the core legal and ethical requirements governing clinical trials in the United States, including FDA regulations, the Common Rule, Informed Consent mandates, and mandatory registration with ClinicalTrials.gov. Essential reading for sponsors, researchers, and compliance professionals. Navigating the Complexities of Clinical Trial Law in the U.S. Clinical trials are the cornerstone of advancing

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The Essential Guide to US Clinical Trial Compliance

META DESCRIPTION & KEYWORDS Navigate the complex legal landscape of US clinical trials. This professional guide covers FDA regulations (IND/IDE), the Common Rule for human subject protection, Good Clinical Practice (GCP), and compliance requirements for sponsors and investigators. Understand the critical legal framework safeguarding patient rights and ensuring data integrity in drug and device development.

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