Consent to Clinical Research

Informed consent practices have evolved over time after instances were documented in which research participants were not treated fairly or respectfully, were not informed, or were subjected to unnecessary harm. Current federal regulations support the ethical treatment of persons in the research setting in that the participation is voluntary, that the risks outweigh the benefits, and that all people are given an equal chance to participate. When a researcher invites a participant into the research setting, the researcher is required to provide the necessary information, to ensure that the participant fully understands the information, and to stop the research if it is felt that these standards have not been met. Prior to enrollment in a research study, that candidate must provide valid consent for participation. That is, the participant must be fully informed about the research purposes, risks, benefits, freedom to withdraw consent, and other relevant information; must enter voluntarily into the research; and must be capable of making an informed decision. Informed consent to clinical research is important in the field of psychology and law, because psychological researchers must be aware of the requirements of conducting research and must protect themselves and also their research participants from any ethical breaches. Clinical research refers to studies conducted in a setting where clinical conditions, either medical or psychiatric, are diagnosed and treated. This entry provides a historical basis for the evolution of informed consent, the requirements of informed consent, and will end with a brief discussion of the capacities of potentially vulnerable individuals who may have compromised ability to give a valid consent by virtue of impaired capacity or lack of voluntariness.