The upcoming HBO movie of The Immortal Life of Henrietta Lacks reminds us that biomedical research has a complex legacy, when it comes to informed consent and people of color.

A paper from Emory investigators, published in AJOB Empirical Bioethics, touches on related current issues. The paper examines how race and close experience with traumatic brain injury affect study participants’ views of informed consent in clinical research.

This emerged from a study of community consultation for EFIC (exception from informed consent), in connection with a nationwide clinical trial of progesterone for traumatic brain injury (TBI). EFIC describes clinical research performed when the normal process of obtaining patients’ informed consent is not possible, because of emergency conditions such as seizures or TBI. Before such studies can be undertaken, the FDA calls for protective procedures and community consultation.

In this case, researchers surveyed 2612 people at 12 sites involved in the TBI study. The survey asked about attitudes toward the EFIC aspects of the study and also asked if they had personal experience with traumatic brain injury – either themselves or someone close to them. How that personal connection affected their responses was influenced by race.

Key paragraph from discussion:

Among white participants, increased levels of acceptance of EFIC were found among those with any connections to TBI. On the other hand, among participants identifying as black or other nonwhite races, there was decreased acceptance of EFIC enrollment among TBI patients and no increase in acceptance among those with a family member/loved one with TBI. The fact that black and white participants with no personal TBI experience or with a more distant connection to TBI had similar acceptance rates suggests that baseline acceptance of EFIC among these two groups is fairly similar and that the experience with the condition itself plays a role in driving the observed differences…

Part of Table 5 from the AJOB Empirical Bioethics paper

The authors write that the study does not provide specific information about why experience with the disease seemed to affect attitudes differently, but mention that different, and perhaps undesirable, experiences with past treatment for TBI may be one reason. They go on to discuss that the findings reinforce the importance of involving minority communities in community consultation efforts, and of awareness of these issues in communicating with patients about EFIC trials.

The lead author was medical student Victoria Scicluna, who presented the data at the 2016 AHA Resuscitation Science meeting in November and received a Young Investigator Award. The senior author was cardiologist Neal Dickert, who also recently published an analysis of how individual clinical outcomes affect views of EFIC.

Related links:

Large-scale clinical studies of progesterone for traumatic brain injury have been disappointing, in that efficacy was not apparent. Emory brain injury researcher Don Stein last year wrote this analysis of why most TBI studies fail for The Scientist, with suggestions on how to design clinical trials so that they are better able to detect whether treatments for TBI make a difference.