Contact: Angela Bradbery, [email protected], (202) 588-7741
Karilyn Gower, [email protected], (202) 588-7779
New Evidence Strengthens Call for Investigation and Suspension of Unethical Trial
Study Forces Hundreds of Resident Doctors Nationwide to Work Dangerous Shifts, Putting Both Doctors and Patients at Serious Risk
WASHINGTON, D.C. – Newly released government documents underscore the need to investigate and suspend an unethical medical trial that compels hundreds of resident doctors to work excessively long shifts, endangering both their own safety and the safety of their patients.
In a letter today to the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP), Public Citizen and the American Medical Student Association (AMSA) reiterated their earlier calls – made in November and February – to investigate two unethical trials: iCOMPARE and FIRST. Both studies require many first-year medical residents to work dangerously extended shifts. Despite earlier warnings, the iCOMPARE trial continues at 63 internal medicine residency programs nationwide without adequate oversight.
“It is critical that the iCOMPARE trial be immediately suspended and investigated, as residents and patients remain at significant risk,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “These newly obtained documents clearly highlight significant ethical lapses and regulatory failures associated with the trial.”
Documents acquired through a Freedom of Information Act request from the National Institutes of Health (NIH) reveal significant ethical issues:
– At least 56 of the 63 participating residency programs either bypassed required institutional review board (IRB) approval entirely or incorrectly classified the study as not involving human subjects research. In some cases, a single reviewer – lacking sufficient expertise for such complex ethical evaluations – approved the trial.
– OHRP received these NIH documents nearly three months ago, clearly detailing major failures in IRB oversight of the iCOMPARE trial. Yet, the agency has not initiated a formal compliance review.
– Documents indicate that researchers acknowledged the experimental group’s extended shifts exposed resident participants to increased risks, including motor vehicle accidents, needle-stick injuries with exposure to bloodborne pathogens, and depression due to sleep deprivation. The researchers recognized these serious risks required ongoing monitoring.
– Although a Data and Safety Monitoring Board (DSMB) was established to track serious adverse events among trial participants, it failed to hold its initial meeting until more than three months after the trial began, representing a significant failure in safeguarding the residents involved.
Given the extensive evidence of ethical and regulatory violations uncovered, Public Citizen and AMSA argue that OHRP’s continued inaction amounts to a clear neglect of the agency’s fundamental responsibility to protect human subjects.
“In light of the growing evidence of widespread and severe ethical and regulatory breaches within the iCOMPARE trial, failure by OHRP to promptly conduct a formal investigation at all participating institutions would represent a significant misuse of its authority,” the letter concludes.
Public Citizen and AMSA also requested an urgent meeting with Dr. Karen DeSalvo, Acting Assistant Secretary for Health at HHS, who oversees the OHRP director.
Read the letter to OHRP. Read the letter to the HHS Assistant Secretary for Health.
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