Table 3 Clusters and imperatives with strong consensus
From: What do international ethics guidelines say in terms of the scope of medical research ethics?
1. Scientific Validity: study’s design and methodology must be scientifically valid; study must be justified by antecedent studies and current knowledge |
2. Favorable Benefit/Risk Ratio: risks and burdens to the research participants must be minimized; the study’s risks must be justified |
3. Informed Consent: informed consent forms and procedures must be sensitive to culture, language, and context; participants have the right to be informed of the anticipated benefits and their right to withdraw without reprisal; the participants’ comprehension of the information must be ensured; that consent is voluntary must be ensured |
4. Special Populations: the authorization of the legal representative is necessary in the event that the person concerned is incapacitated to consent; for studies on children capable of assenting, that the children’s assent is secured and dissent respected |