Ethics in human experiments

• Reviews unethical human experimentation in the past that led to the need for international standards of ethics for these experimental study designs
• Focuses on the Declaration of Helsinki and its core principles as well as the more recent revisions
• Introduces current standards from WHO, ICMJE, and major journals (Nature Medicine, The Lancet, JAMA, The BMJ, NEJM) regarding ethical considerations with human participants, including AI involvement
• Reviews additional ethical guidelines used in more specific studies such as the pharmaceutical industry and vaccine research 

Research ethics committees (REC)

• Covers research ethics committees (RECs) and institutional review boards (IRBs)
• Discusses the composition of these groups and why their diversity is important for research and society
• Focuses predominantly on what RECs are evaluating in a study, and how to increase the likelihood of proposal approval
• Reviews when REC approval is necessary, as well as those study designs where it is not needed 

Informed consent

• Highlights the importance of obtaining informed consent from all participants in human studies
• Reviews why informed consent is needed for participation in a study and when consent for publication is needed for publishing certain images
• Discusses how to properly obtain verbal informed consent from certain individuals
• Discusses using vulnerable persons in human experiments and when to obtain assent in addition to consent
• Addresses informed consent considerations when AI tools are used in data collection or analysis

Standards of care and post-trial provisions

• Defines standard of care both universally and regionally and why this is important for the participants in a study
• Discusses how to apply these standards of care when designing a clinical trial, to ensure that it is ethical for human participation
• Discusses post-trial provisions for all participants and how this should be discussed with the study sponsor and participants
• Emphasises the importance of publishing the study, regardless of the outcomes