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Author: Tamera Means, Meharry Medical College
School of Medicine, Class of 2015
At times, patients enrolled into clinical studies in an
emergency setting are unable to provide consent for themselves. In
very specific circumstances, prospective consent may be waived and
the study is conducted under FDA Code 50.24,
Exemption From Informed Consent (EFIC). While EFIC has been used
for over 15 years to conduct acute care RESEARCH , little is known
about participants' attitudes and perceptions of the process and
especially if the attitudes and perceptions are effectedby the
individual's race or ethnicity, age, and gender. We predict that
participants' attitudes and perceptions about EFIC are influenced
by their race/ethnicity, age, and gender.
Methods: Our retrospective study reviewed 241
respondents' answers to a survey conducted as part of the community
consultation activities required in preparation for a clinical
trial utiliz ing EFIC. We studied how different race/ethnicity,
age, and gender groups perceive survey questions related to EFIC.
ANOVA without replication compared answers about participants' past
RESEARCH participation and whether or not they felt the
surveyor/RESEARCH ers would listen to their opinions. We also
compared opinion scale questions rating how respondents felt about
the use of exception for informed consent. Results: Survey answers
to EFIC opinion scale questions differed by race/ethnicity, and
age. Whites and respondents aged 25-50 were more accepting of EFIC.
Hispanics and the group aged below 24 were the least accepting of
EFIC. Our ANOVA analysis showed a significant difference between
racial/ethnicities (P< 0.001) and age (P<0.02), but no
difference between genders. In relation to whether or not RESEARCH
ers would listen, Asians, ages 25-50, and males responded most
positively while blacks, participants 24 and younger, and females
reacted most negatively. However, our ANOVA analysis showed no
significant difference within any categories.
Conclusion: In an urban, racially diverse
community, respondents to a survey of opinion relating to use of
exception from informed consent in clinical RESEARCH differed by
both age and race or ethnicity. These data support the need for
broad community consultation prior for studies using EFIC; and, it
supports the need to engage diverse communities in the development
of federal regulations relating to clinical RESEARCH in the
March 2015 Issue of IMpact