Abstract

Participants in clinical studies are frequently unable to remember study information for the duration of their participation in the research. Along with a nine-member work group and a seven-member advisory group, we determined that six elements of consent are necessary to uphold the validity of consent over time: awareness of ongoing participation; understanding the right to withdraw; understanding that withdrawal will not influence other treatment options; knowledge of the general purpose of the research; knowledge of potential risks of participation; and understanding of the differences between traditional, individualized clinical care and standardized treatment during research participation. Based on these important elements, we developed an Assessment of Sustained Informed Consent as a tool to periodically review a protocol’s essential elements with its participants. We hope this will be a useful means of confirming research participants’ continued knowledge of the critical elements of consent, and of identifying those subjects who need reminding