Feds to Patients: Drop Dead to Prevent “Unauthorized Experiment”

A program in Michigan that saved 1500 lives over 18 months by maintaining checklists on patient care to prevent hospital infections has been shut down by the federal government.  The federal Office for Human Research Protections (OHRP) defines the concept of a medical “experiment” so broadly that keeping tabs on patient care through checklists is deemed an “experiment” that requires express permission in advance from patients and physicians.  To OHRP, it is better that patients die than that they be subjected to an “experiment” and that they and their physicians fill out elaborate forms after receiving extensive disclosures.

Dr. Atul Gawande notes that “if the government’s ruling were applied more widely, whole swaths of critical work to ensure safe and effective care would either halt or shrink: efforts by the Centers for Disease Control and Prevention to examine responses to outbreaks of infectious disease; the military’s program to track the care of wounded soldiers; the Five Million Lives campaign, by the nonprofit Institute for Healthcare Improvement, to reduce avoidable complications in 3,700 hospitals nationwide.”

Institutional Review Boards set up under OHRP regulations impede and investigate academics who use interviews to collect information needed for social science research.  OHRP apparently deems such routine information gathering to be “human experimentation” that triggers cumbersome notice and consent requirements under its regulations.