• IRB: ETHICS & HUMAN RESEARCH

Long-Term Recall of Elements of Informed Consent: A Pilot Study Comparing Traditional and Computer-Based Consenting

Consent forms and processes have been proposed for biobanks with no discussion about the most effective means to provide the information to potential biobank participants to enhance their knowledge and understanding to make truly informed decisions about participation. The purpose of the study described was to evaluate a computer-based consent process versus a traditional consent process for participation in a randomized clinical trial in a population-based biorepository (the Marshfield Clinic Personalized Medicine Research Project) to assess long-term recall of specific items in the informed consent process. Men enrolling in the biobank for a study of prostate cancer were randomized to traditional or computer-based consenting. Two-page questionnaires were mailed to participants six months after the consent process. Participants in the computer-based group were more likely to answer some of the knowledge questions correctly. The computer-based consenting process decreased staff time required and led to improved retention of the elements of informed consent. It has been adopted prospectively.

Catherine A. McCarty, Richard Berg, Carol Waudby, Wendy Foth, Terrie Kitchner, and Deanna Cross. “Long-term recall of elements of informed consent: A pilot study comparing traditional and computer-based consenting.” IRB: Ethics & Human Research 2015;37(1):1-5.