Overview of Normative Frameworks Applicable to Health Research Involving Humans


1. Introduction

The regulation of research involving humans has evolved over the past century. Within the last half century, it has taken the form of rules, guidelines and even state regulations. There is no single instrument that applies to all research involving humans worldwide. However, there are various instruments — some more and some less specific to research — that establish safeguards to oversee the conduct of research involving humans. This section will focus on instruments that are relevant to biomedical or health research.