Just want to expand on this quickly then it’s back to writing papers https://twitter.com/lachelle_dawn/status/1283771370476834822

So the study referenced in this @statnews piece is a systematic review of FDA’s “Exception from Informed Consent Pathway” and it was authored by my former co-resident William Feldman. https://www.healthaffairs.org/doi/10.1377/hlthaff.2018.0501

The article is behind a paywall, so if you want access and don't have it through your institution DM me.

So the article specifically refers to trials conducted under Exception from Informed Consent or EFIC. Started in 1996, the major gist of this process is that there are some trials where the trial cannot be conducted if you were to use normal informed consent pathways.

EFIC is used for "emergency research." Think CPR trials, use of ECMO, drugs and devices in critical care use - things like that. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research

Will's study looked at EFIC trials from '96-'17. Like I said, all of them were critical care interventions. Over half of them were interventions that started *before* the patient got to the hospital.

There is nothing intrinsically morally wrong with an EFIC study. How do you know if ECMO in the field really has better outcomes than standard field CPR if you don't study it right? The interventions are never substandard. Researchers aren't going rogue with EFIC trials.

The problem is in this table from Will's paper - look at the racial demographic breakdown and you will see that it is TOTALLY different from any clinical trial you've every read. SO. MANY. BLACK. PEOPLE!!!

So here's the issue - if the (flawed) assumption is minority mistrust and therefore unwillingness for clinical trial participation - why does that assumption disappear for EFIC studies?

If as a clinical investigator you would be hesitant to even offer a therapeutic study to a Black patient because they might get upset, trust you less, leave your practice, have Tuskegee PTSD - what is the ethical equipoise for including them in these studies?

And this overrepresentation isn't only b/c Black people are sicker or experiencing more out of hospital trauma/emergencies. The authors note the disparity persists for elements like out of hospital cardiac arrest where the crude incidence is equivalent for Black & White people.