FDA Should Build Greater Public Consensus on Appropriate Use of EFIC, Study Finds

Over the past two decades, the US Food and Drug Administration (FDA) has allowed more than 40 trials to use what’s known as the exception from informed consent (EFIC) pathway whereby some emergency trials where an immediate intervention is necessary can enroll patients without informed consent.

As part of such studies, FDA mandates that EFIC investigators consult with communities in which the clinical investigation will be conducted and from which the subjects will be drawn. And according to guidance from 2013, FDA encourages institutional review board members to attend community consultation activities in order to hear the perspectives and concerns of the communities.

According to a new study published Wednesday in JAMA, which looked at 27 trials that have been granted an EFIC, public attitudes about EFIC varied, with 58% approving of EFIC in principle, 69% approving of family member enrollment, 73% approving of personal enrollment and 87% approving of community inclusion. But the study also found that the surveys varied substantially by question type, and those who were surveyed as part of a community consultation did not necessarily reflect the demographics of those who were enrolled in EFIC trials.

“Groups surveyed with higher proportions of African American and male respondents had lower rates of EFIC approval, and these groups were underrepresented in surveys relative to their enrollment in EFIC trials,” the authors from Harvard Medical School wrote.

They also explained the challenge of analyzing the survey data because they are not presented in a standard format, and the authors called on FDA to require future survey data to be submitted according to an agreed-on format, including individual-level responses.

“FDA could take further steps to build public trust by delineating the desired extent of community consultation, clarifying the steps that investigators should take in light of survey results, and requiring that investigators submit documentation of how trial protocols are amended, if at all, based on community concerns,” the study says.

First author William Feldman of Harvard Medical School told Focus: "Our study found that, for each question-type (personal, family, community, and general), there was a substantial minority of people who opposed EFIC. In addition, groups that were surveyed with higher proportions of African Americans and men were more likely to oppose EFIC. The FDA and researchers could strengthen the EFIC pathway by working to build broader public consensus around its use—particularly by educating people more about EFIC, further justifying to the public why EFIC is necessary, and identifying uses of EFIC that may have especially wide public support."

JAMA Network Open