Table 2

Principles of research ethics and entailed normative guidelines

PrincipleDefinitionNormative guidelines
JusticeThe potential benefits, risks and burdens of research participation must be distributed equitably.Fair procedures must be in place for the selection of research participants.
Vulnerable research participants are entitled to additional protections.
Respect for personsCandidates for research participation must be treated as autonomous agents, and those with diminished autonomy are entitled to protection.Informed, comprehending and free consent must be obtained from prospective research participants.
When prospective participant autonomy is diminished or lacking, informed consent must be obtained from an authorised surrogate decision maker.
Protect the confidentiality of private information.
BeneficenceResearch participants must be protected from harm and their welfare must be promoted.Therapeutic procedures must satisfy equipoise.
Any risks of non-therapeutic procedures must be minimised consistent with sound scientific design, and reasonable in relation to the knowledge to be gained.