Carte Blanche is the alarming tale of how the right of Americans to say "no" to risky medical research is eroding at a time when we are racing to produce a vaccine and treatments for Covid-19. This medical right that we have long taken for granted was first sacrificed on the altar of military expediency in 1990 when the Department of Defense asked for and received from the FDA a waiver that permitted it to force an experimental anthrax vaccine on (...) the ranks of ground troops headed for the Persian Gulf. Since then, the military has pressed ahead to impose nonconsensual testing of the blood substitute PolyHeme in civilian urbanities, quietly enrolling more than 20,000 non-consenting subjects since 2005. Most Americans think that their right to give or withhold consent is protected by law, but the passing in 1996 of modifications to the Code of Federal Regulations, such as statute CFR 21 50.24, now permit investigators to conduct research with trauma victims without their consent or event their knowledge. More than a dozen studies since have used the 1996 loophole to recruit large numbers of subjects without their knowledge. The erosion of consent is the result of a U.S. medical-research system that has proven again and again that it cannot be trusted. (shrink)

It is the researcher's responsibility to provide accurate, complete, and unbiased verbal and written information yet, as this essay discusses, challenges to meaningful research consent abound in the communication between researcher and subject. This discussion of these challenges is far from exhaustive, but it will flag some of the potholes that researchers must anticipate on the sometimes rocky road to eliciting meaningful consent. These include, but are not limited to, inadequate scientific literacy, poorly written consent forms, and even the deployment (...) of scientific terms and seductive acronyms like CURE and MIRACL. Studies with acronyms, for example, enroll five times as many patients as those without, are more likely to be published by prestigious journals, and have higher Jadad methodologic quality scores although they are no more likely to conclude with positive findings. Other barriers to researcher-subject communication include: widely differing beliefs and customs, semiotics, socioeconomic status, iatrophobia, and dramatically different histories of treatment in the medical-research arena. (shrink)