Reflections from A Community Conversation “For the Greater Good, Please Share Your Brain with Us” September 23rd

On a very wet Tuesday night, members of our community gathered to learn about and discuss a proposed emergency research study to improve survival and neurological function following traumatic brain injury (TBI). Dr. Eileen Bulger, Chief of Trauma at Harborview Medical Center, provided an overview of her team’s proposed research that relies on an Exception from Informed Consent to investigate the effectiveness of tranexamic acid (TXA) when administered in the field by first responders to patients with TBI. TXA is well studied in both animals and people, and has been used for other bleeding conditions since the 1960’s.

Warming their hands around lattes and mochas, Community Conversation attendees discussed the crux of this proposed study: how can researchers conduct the study to hopefully decrease mortality and increase brain function in TBI patients while respecting the autonomy of those who are enrolled?

One of the hallmarks of research involving human beings is the process of informed consent. The research community, and Dr. Bulger’s team, agrees that this process is critical to ensure that potential volunteers fully understand what their participation might mean and to understand their rights if they do volunteer. But the process of informed consent looks different, by necessity, when patients are unconscious and suffering from TBI. In this study, taking place at 9 other sites in the US and Canada, people who are eligible for the study, not wearing ‘opt out’ medical bracelets, and not accompanied by family members who can be immediately consulted, are automatically enrolled to either the control or study arms. As soon as is practical, patients and family members are informed and given the opportunity to continue participating in the study or not.

The focus of the discussion was partly on the need for advanced community notification, which is required for studies like these. Some thought it was impossible to alert enough of the community (and what constitutes ‘enough’) about the study since it enrolls patients for an unpredictable injury; others were pleased that the research team has worked hard to inform groups at high risk for TBI—cyclists and the elderly. To do: people need to talk to their family and friends about their wishes regarding research and medical treatment so they have a better chance of experiencing research and care according to their wishes.

At my small group table, we spent quite a bit of time wondering if the bar for research conducted under the Exception from Informed Consent was too high. Once he learned that the application process has been over one year, one person exclaimed there is a “greater risk of harm that research is delayed and new treatments are not implemented as soon as possible.” Dr. Bulger countered that there is no such thing as the bar being too high. She emphasized the importance of research standards being unassailable so that people can be assured that the studies are being done at the highest, most trustworthy level.

The discussion was attended by at least three people who had experienced TBI. One was reluctant to agree to the study and was considering an opt-out bracelet. After his concerns were heard by the study team, mainly around a misunderstanding of the inclusion criteria, he decided not to opt out. While attendees can understand the concerns about enrolling someone without their direct consent, many nodded vigorously when one person said, “it really comes down to relationships and trust.”  Read more about this event at UW NewsBeat!

If we, the public, are to have positive relationships and trust with our community researchers and health care teams, then we need proof of maximum personal care, maximum research standards, and maximum contact with those conducting research and our health care. I am hopeful that our readers and research teams have enjoyed this material and I challenge you to attend and/or speak up at a future Community Conversation or other public conversation.

With gratitude,

Jen Wroblewski
Public Engagement Manager


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