BMJ 2016;352:i1070 doi: 10.1136/bmj.i1070 (Published 19 February 2016)
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News
NEWS Groups call for “dangerous” trial of doctors’ working hours to stop Jeanne Lenzer New York
Public Citizen, a US public interest watchdog group, and the American Medical Student Association have issued a renewed call for the Office for Human Research Protections to stop a clinical trial they say is unethical.1
The Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) study was funded by the National Institutes of Health. It will look at the effects of extended work hours for first year internal medicine resident physicians on patient mortality at 30 days.2 The researchers will compare randomized cluster groups of interns who work shifts of no more than 16 hours with those who work shifts of 28 hours or more.
Public Citizen obtained the iCOMPARE protocol and related grant applications from the National Institutes of Health under a Freedom of Information Act request. After reviewing the documents, they and the American Medical Students Association sent a letter to the Office for Human Research Protections, saying that the iCOMPARE study “forces first year medical residents to work shifts of 28 consecutive hours or more—nearly twice the current maximum number of hours allowed by the Accreditation Council for Graduate Medical Education for such residents. The research, which is being conducted without informed consent, exposes the residents to increased risks . . . and their patients to an increased risk of medical errors.”
A spokesperson for the University of Pennsylvania’s review board told The BMJ that the board waived consent under federal regulation 45 CFR 46.116(d). The regulation lets consent be waived if four criteria are met—the first is that the research must pose “no more than minimal risk to the subjects.”
Public Citizen said that other problems included the use of a non-inferiority study design and a lack of real time monitoring of deaths of patients that would result in the study being stopped if death rates increased. Instead, the number of patient deaths will be collected from Medicare claims records and other surveys.
The call came after a similar study was criticized as unethical in part because informed consent was not obtained from the doctors or patients.3 The iCOMPARE researchers did not obtain informed consent from the residents or their patients.
The spokesperson said that the trial “could be considered minimal risk in part because a large collection of prior observational studies have repeatedly demonstrated that patient mortality and other important outcomes in both medical and surgical patients have been unchanged by the 2003 or 2011 rules limiting resident duty hours. These studies provide evidence that there is no incremental risk to patients attributable to changes in duty hour rules.”
For personal use only: See rights and reprints http://www.bmj.com/permissions
They added, “Continued inaction by the OHRP, which was asked to intervene 12 weeks ago,4 makes the agency a culpable party in this unethical research.”
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Public Citizen Health Research Group AMSA. Follow-up letter to OHRP regarding the unethical iCOMPARE trial comparing standard and long work schedules for internal medicine residents. 2016. www.citizen.org/hrg2302. Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE). 2015. https://clinicaltrials.gov/ct2/show/NCT02274818. Lenzer J. Longer shifts don’t increase harm to patients, finds controversial study. BMJ 2016;352:i719. PCHR Group. Letter to OHRP regarding the iCOMPARE trial comparing standard and long work schedules for internal medicine residents 2015. www.citizen.org/hrg2283.
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/ permissions
Subscribe: http://www.bmj.com/subscribe
Page 1 of 1
News
NEWS Groups call for “dangerous” trial of doctors’ working hours to stop Jeanne Lenzer New York
Public Citizen, a US public interest watchdog group, and the American Medical Student Association have issued a renewed call for the Office for Human Research Protections to stop a clinical trial they say is unethical.1
The Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) study was funded by the National Institutes of Health. It will look at the effects of extended work hours for first year internal medicine resident physicians on patient mortality at 30 days.2 The researchers will compare randomized cluster groups of interns who work shifts of no more than 16 hours with those who work shifts of 28 hours or more.
Public Citizen obtained the iCOMPARE protocol and related grant applications from the National Institutes of Health under a Freedom of Information Act request. After reviewing the documents, they and the American Medical Students Association sent a letter to the Office for Human Research Protections, saying that the iCOMPARE study “forces first year medical residents to work shifts of 28 consecutive hours or more—nearly twice the current maximum number of hours allowed by the Accreditation Council for Graduate Medical Education for such residents. The research, which is being conducted without informed consent, exposes the residents to increased risks . . . and their patients to an increased risk of medical errors.”
A spokesperson for the University of Pennsylvania’s review board told The BMJ that the board waived consent under federal regulation 45 CFR 46.116(d). The regulation lets consent be waived if four criteria are met—the first is that the research must pose “no more than minimal risk to the subjects.”
Public Citizen said that other problems included the use of a non-inferiority study design and a lack of real time monitoring of deaths of patients that would result in the study being stopped if death rates increased. Instead, the number of patient deaths will be collected from Medicare claims records and other surveys.
The call came after a similar study was criticized as unethical in part because informed consent was not obtained from the doctors or patients.3 The iCOMPARE researchers did not obtain informed consent from the residents or their patients.
The spokesperson said that the trial “could be considered minimal risk in part because a large collection of prior observational studies have repeatedly demonstrated that patient mortality and other important outcomes in both medical and surgical patients have been unchanged by the 2003 or 2011 rules limiting resident duty hours. These studies provide evidence that there is no incremental risk to patients attributable to changes in duty hour rules.”
For personal use only: See rights and reprints http://www.bmj.com/permissions
They added, “Continued inaction by the OHRP, which was asked to intervene 12 weeks ago,4 makes the agency a culpable party in this unethical research.”
1 2 3 4
Public Citizen Health Research Group AMSA. Follow-up letter to OHRP regarding the unethical iCOMPARE trial comparing standard and long work schedules for internal medicine residents. 2016. www.citizen.org/hrg2302. Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE). 2015. https://clinicaltrials.gov/ct2/show/NCT02274818. Lenzer J. Longer shifts don’t increase harm to patients, finds controversial study. BMJ 2016;352:i719. PCHR Group. Letter to OHRP regarding the iCOMPARE trial comparing standard and long work schedules for internal medicine residents 2015. www.citizen.org/hrg2283.
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/ permissions
Subscribe: http://www.bmj.com/subscribe
