IAVI Vaccine Literacy Library: Module 6

The ethics and regulation
of clinical trials

This module highlights the principles of ethics that govern medical research. It provides an overview of the ethical and regulatory standards that vaccine trials follow to ensure that each participant’s health, dignity, and well-being are protected.

Contents

Summary Points

1. Introduction
2. Principles of Ethical Research
   1. Value
   2. Scientific Validity
   3. Fair Participant Selection
   4. Favourable Risk/Benefit Ratio
   5. Independent Review
      • Review by Regulatory Authority
      • Review by an Independent Ethics Review Committee
      • Local Ethics Committees
      • Data and Safety Monitoring during Clinical Research
      • Data Safety Monitoring Boards
      • Protocol Safety Review Teams (PSRTs)
      • Community Advisory Boards (CABs)
   6. Trial Guidelines
      • International Council for Harmonisation (ICH)
      • Good Clinical Practice (GCP)
      • Good Participatory Practice (GPP)
      • Specific Guidance
   7. Informed Consent
      • Informed Consent and Specific Populations
      • Vulnerable Populations
      • Women
      • Adolescents
   8. Respect for Participants
      • Welfare
      • Confidentiality
3. Community Outreach