What should research participants understand to understand they are participants in research?
To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of potential participants' informed consent. An analysis of individuals' interests suggests that potential participants need to understand three additional facts to understand that they are being invited to participate in research: 1) research contribution: those who enroll in the study will be contributing to a project designed to gather generalizable knowledge to benefit others in the future; 2) research relationship: the investigators will rely on participants' efforts to gather the generalizable knowledge to benefit others; and 3) research impact: the extent to which participating in the study will alter what participants do and what happens to them.
Wendler
David
D
NIH Clinical Center, Bethesda, MD 20892, USA. dwendler@nih.gov
Grady
Christine
C
D035843:Biomedical Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D019359:Knowledge; D035842:Research Subjects