Evaluating the quality of informed consent.
BACKGROUND
Although informed consent is a critical means of protecting the rights and interests of participants in clinical research, effective and efficient means of evaluating the quality of consent are needed. Having such means will be important to monitoring consent and testing potential improvements in the consent process.


OBJECTIVE
To develop and test a practical and general means of evaluating the quality of informed consent for clinical research. Methods We developed and tested the Brief Informed Consent Evaluation Protocol (BICEP), a short telephone-based assessment of informed consent. As soon as patient-participants completed the informed consent process for a participating VA Cooperative Studies Program clinical trial they called an interviewer who administered the BICEP.


RESULTS
632 participants completed BICEP, representing eight ongoing studies from 14 VA and one non-VA medical centers across the country. Site coordinators reported little to no difficulty implementing BICEP. The average duration of BICEP was 8.8 minutes (SD 3.6). Overall, patient-participants evaluated the informed consent process positively. A reliable coding system was then developed to analyze the verbatim responses of the final 191 participants. An Informed Consent Aggregate Score (ICAS) had a mean score of 8.23 (SD 1.17) with a range of 0-10, with 10 a perfect score; and a Therapeutic Misconception Aggregate Score (TMAS) had a mean of 1.62 (SD 0.93) with a range of 0-5, with 5 a perfect score.


CONCLUSIONS
The BICEP is an efficient means of evaluating informed consent that is acceptable to research participants and research personnel. While participants tend to be satisfied with the informed consent process, the BICEP indicates there is room for improvement in the informed consent process for research.
Sugarman
Jeremy
J
Phoebe R. Berman Bioethics Institute, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA. jsugarm1@jhmi.edu
Lavori
Philip W
PW
Boeger
Maryann
M
Cain
Carole
C
Edsond
Robert
R
Morrison
Vicki
V
Yeh
Shing Shing
SS
D032962:Consent Forms; D006805:Human Experimentation / Q000592:standards*; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D007407:Interviews as Topic; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012108:Research Personnel; D035842:Research Subjects; D014481:United States; D014493:United States Department of Veterans Affairs