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Winning Abstracts from the 2014 Medical Student Abstract Competition:The effect of an Individual's Race, Age, and Gender on how they view exemption from Informed Consent.

Winning Abstracts from the 2014 Medical Student Abstract Competition:The effect of an Individual's Race, Age, and Gender on how they view exemption from Informed Consent.

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 emergency setting.

Back to March 2015 Issue of IMpact

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