Topic overview

Start with the big picture

Ethical clinical research requires voluntary, understandable, documented consent that continues as studies evolve, along with IRB or IEC approval before human research begins. Reviewers assess whether anticipated therapeutic value justifies foreseeable harms, while researchers must take extra care with vulnerable participants and ensure fair selection. The topic also addresses privacy, injury compensation, conflicts of interest, accurate data practices, and publication of negative or inconclusive findings. It considers when placebo use may be acceptable, responsibilities for post-trial access, and safeguards for animal studies and first-in-human dosing. Broader sections introduce ethical questions in global trials, genetic and biomarker research, environmental impact, and the use of traditional or Indigenous knowledge.