2060. The Efficacy of
Informed Consent in a Large Clinical Trial
JM Griffin, CCDOR, HB Rubins, CCDOR, JK Struve, CCDOR, A Liu, CCDOR, DB Nelson, CCDOR
Objectives: The goal of
the informed consent process is for potential research participants to have a
comprehensive understanding of the purpose for the study, the method of data
collection, and the possible risks and benefits before making a voluntary
decision to participate. Little is
known about how efficacious the process is, especially in large clinical trials,
which, when conducted over a number of years, require a high degree of
commitment from participants. This
study’s objective was to determine the long-term efficacy of informed consent
in a large clinical trial and to evaluate how efficacy varies by participant
completing a multi-center VA cooperative studies program trial (VA-HIT) were
asked three multiple-choice questions to assess their knowledge about the
purpose of the study and its risks approximately 5 years after providing
informed consent. Participants were asked: 1) the purpose of the study; 2) the
study medication; and, 3) possible side effects from the medication. Demographic
data were also collected. Answers were coded as correct or incorrect.
Multiple logistic regression models were used to estimate the relative
odds of answering each question correctly, given the participants’ age,
education, race, marital status, and their clinical site.
85% of the 2113 eligible participants completed the exit interview questions
(n=1789). The majority of the
sample knew the main purpose of the study (51%) and the study medication (62%).
Only 25% knew the main side effect of the medication. In multivariate analyses, older and less educated
participants had significantly lower odds of correctly answering questions about
the study’s purpose and medication. Non-whites also had lower odds of
correctly identifying the study’s purpose. Demographic characteristics did not
differentiate clearly those who did and did not correctly answer question 3.
Conclusions: Older and
less-educated participants were less likely to know the basic purpose and
medication used in the study after five years of involvement. Non-whites were
also less likely to know the purpose of the study.
Impact: Different types of presentation methods and materials, using simple, non-technical language is necessary to assure comprehension. Study participation requirements, risks, and benefits should also be addressed regularly throughout the course of a research study.