Legal Minute: 6 Crucial Mistakes in Informed Consent

We discuss six critical errors in the informed consent process: 1. Exclusion of Principal Investigator: PI was not allowed to engage in the informed consent process. 2. Lack of Detailed Discussion: Staff members did not take the time to thoroughly discuss the study's potential benefits and risks with prospective subjects. 3. Inadequate Training: Coordinators lacked knowledge about the study and lacked a research background, leading to insufficient information provided to participants. 4. Una...

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Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm -  Helping regulators see your business the way you do. We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.