Informed Consent and RCTs

Truog et al, “Is Informed Consent Always Necessary for Randomized, Controlled Trials?” NEJM 340 (10), 804-807.

Informed consent is morally necessary only when it is essential for guaranteeing that patients’ right to self-determination is respected.
The right to self-determination [is respected? not disrespected?] when conditions 1-5 are met. (NB some of these conditions have more directly to do with risk minimization than respecting self-determination.)
Therefore, informed consent is not always morally necessary.

Furthermore, requiring specific informed consent sometimes prevents small but meaningful improvements in care.

“When benefits to society and to future patients can be gained without meaningfully compromising respect for patients’ autonomy and without any serious increase in risk to those involved, blind insistence on informed consent is not only unnecessary, but also harmful.”

Tags: consent, trial design