Maintaining Informed Consent Validity During Lengthy Research Protocols‪.‬

Valid informed consent is a cornerstone of ethical clinical research. A great deal of work has been undertaken to improve the informed consent process for clinical research, largely targeting the adequacy of consent at the time of a subject's enrollment in a protocol. (1) Less attention has been paid to research subjects' ability to maintain that knowledge over the course of participation in protocols that extend over substantial periods of time. (2) Many clinical trials are lengthy and easily confused with ordinary treatment. (3) Federal regulations governing research with humans (4) are silent on the extent to which information disclosed during the consent process must be retained for subjects' continued participation to be warranted, and there is no consensus on this (and little explicit consideration) in the research ethics literature. (5) There is ample evidence that participants in clinical studies frequently are unable to retain study information for the duration of their involvement in the research. Poor memory for information disclosed during the initial consent process has been observed in medically ill patients participating in research on cancer, (6) HIV, (7) hypertension, (8) and other types of research. (9) Participants in these studies exhibit poor knowledge of such protocol elements as risks, procedures, and the general purpose of the research. In some cases they exhibit confusion about the conceptual difference between the assignment of study medications or procedures and the individualized treatment decisions their own doctors would make. Some study participants report uncertainty about whether they were enrolled in research at all.