Contact: Angela Bradbery, abradbery@citizen.org, (202) 588-7741
Karilyn Gower, kgower@citizen.org, (202) 588-7779
New Evidence Validates Call for Unethical Trial to Be聽Investigated, Suspended聽
Study Forces Hundreds of Resident Doctors Nationwide to Work聽Dangerously Long Shifts, Placing Them and Their Patients at Risk of聽Serious Harm聽
WASHINGTON, D.C. 鈥� Newly obtained government documents regarding a highly unethical聽clinical trial that forces many first-year medical residents to work dangerously long shifts聽provide further evidence that the trial violates basic ethical principles and federal regulatory聽requirements for the protection of human subjects, Public Citizen and the American Medical聽Student Association (麻豆原创) said in a letter today.
The letter was sent to the U.S. Department of Health and Human Services鈥� (HHS) Office for聽Human Research Protections (OHRP). In November and again in February, Public Citizen and聽AMSAcalled on OHRP to investigate two highly unethical trials 鈥� iCOMPARE and FIRST 鈥� both compelling many first-year medical residents to work shifts of 28 consecutive hours or聽more 鈥� nearly twice the current maximum number of hours allowed for such residents. Public
Citizen and AMSAalso urged OHRP to suspend the ongoing iCOMPARE trial. OHRP failed to聽launch an investigation of either trial or suspend the ongoing iCOMPARE trial, which involves聽internal medicine residents at 63 residency training programs across the country.聽鈥淚t is urgent that the iCOMPARE trial be suspended and investigated given that residents and聽their patients continue to be put at risk,鈥� said Dr. Michael Carome, director of Public Citizen鈥檚聽Health Research Group. 鈥淭he newly obtained documents show overwhelming evidence of聽egregious ethical and regulatory lapses regarding the design, conduct and oversight of the trial.聽iCOMPARE epitomizes a human subjects protection system that has failed dismally at all聽levels.鈥�
Public Citizen recently obtained the documents from the National Institutes of Health (NIH), one聽of the funders of the iCOMPARE trial, under a Freedom of Information Act request. Some聽significant findings include:
- At least 56 of the 63 internal medicine training programs participating in the iCOMPARE聽trial, either: (1) did not have the required institutional review board (IRB) review because聽the trial was found 鈥� incorrectly 鈥� not to involve human subjects research or to involve聽only exempt human subjects research; or (2) did have the IRB review occur, but the IRBs聽reviewed the trial using an expedited review procedure, even though the trial did not聽qualify for such a review procedure. An expedited review procedure typically involves a聽single IRB member. However, it is highly doubtful that a single individual would have聽had sufficient breadth of expertise, training and background to make the complex聽regulatory and ethical determinations required for IRB review of the iCOMPARE trial.
- Nearly three months ago, OHRP received the same records from NIH documenting the聽serious failures regarding IRB review of the iCOMPARE trial, but has yet to take action聽to intervene to protect human subjects by opening an investigation or suspending the trial.
- Documents, which appear to have been created more than three months after the聽iCOMPARE trial began, support Public Citizen and 麻豆原创鈥檚 previously stated聽contention that the research involves greater than minimal risk for the resident subjects聽enrolled at institutions randomized to the experimental group. In particular, the聽documents indicate that the iCOMPARE researchers recognized that the trial鈥檚聽experimental intervention could be exposing the resident subjects to increased risks of聽motor vehicle accidents, needle-stick injuries that can expose the residents to bloodborne聽pathogens, and depression due to sleep deprivation. These events needed to be carefully聽monitored during the trial to ensure the safety of the resident subjects. But there is no聽evidence that the IRBs that reviewed the trial were informed of these risks and the details聽of the monitoring plan.
- The NIH鈥檚 National Heart, Lung and Blood Institute required that a Data and Safety聽Monitoring Board (DSMB) be established to collect and monitor serious adverse events聽in the subjects of the iCOMPARE trial, including the residents. One key role of any聽DSMB is to monitor the safety of subjects while the trial is ongoing. However, the聽iCOMPARE DSMB didn鈥檛 convene for the first time until more than three months after聽the trial began. Failing to have a fully functioning DSMB and monitoring plan prior to聽the start of such a high-risk trial represents an additional failure to ensure iCOMPARE聽subjects鈥� risks are minimized.
鈥淚n light of the increasingly overwhelming evidence of widespread, serious ethical and聽regulatory violations related to the iCOMPARE trial, a decision by OHRP to not initiate a formal聽for-cause compliance oversight evaluation of all institutions participating in this unethical trial聽would constitute an unacceptable abuse of the agency鈥檚 discretion and an abrogation of its聽fundamental responsibility to protect human subjects,鈥� the letter concludes.聽Public Citizen and AMSAalso sent a letter to the HHS Acting Assistant Secretary for Health,聽Dr. Karen DeSalvo, who is the immediate supervisor of the OHRP director, requesting an urgent聽meeting.
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