by Dr. Yashashwini Reddy | Sep 26, 2025
Case Study: HeLa Cells & Informed Consent In 1951, Henrietta Lacks, an African-American woman, was treated for cervical cancer at Johns Hopkins Hospital. Without her knowledge or consent, doctors collected her tumor cells, which turned out to be the first human...
by Dr. Yashashwini Reddy | Jun 30, 2025
🧪Evaluating the Potential Risks and Benefits of the Research for Participants 🔍 1. What is Risk-Benefit Assessment in Clinical Research? Risk-Benefit Assessment is a critical ethical and scientific evaluation process in which researchers, sponsors, and ethics...
by Dr. Yashashwini Reddy | Jun 30, 2025
🧾 Informed Consent in Clinical Research 🔍 1. What is Informed Consent? Informed Consent is a process by which a clinical trial participant voluntarily confirms their willingness to participate in a particular trial, after having been informed of all...
by Dr. Yashashwini Reddy | Jun 30, 2025
📢 Reporting Complaints Related to FDA-Regulated Clinical Trials 🔍 1. Why Report a Complaint? Reporting complaints helps ensure: Protection of participant rights and safety Maintenance of ethical and regulatory standards Detection of misconduct, fraud, or GCP...
by Dr. Yashashwini Reddy | Jun 30, 2025
⚖️ Clinical Investigations Compliance & Enforcement in Clinical Research 🔍 1. What is Clinical Investigations Compliance? Clinical investigations compliance refers to the adherence to ethical, regulatory, and scientific standards during the planning, conduct,...
