“For the most part, doctors and civil servants simply did their jobs. Some merely followed orders, others worked for the glory of science.”
— Dr. John Heller, Director of the Public Health Service’s Division of Venereal Diseases
The first time I complied with the American Board of Pediatrics Maintenance of Certification system, the choices for “Part 4 Practice Improvement Module” credit were limited so early in the program. I asked around, and the least painful exercise was the “hand washing module”. It involved self-reporting on my hand washing technique, watching a video, and then self-reporting my improvement. It was lame, but could be completed quickly without disrupting patients during their office visits or requiring my staff to pull charts for review.
This time around, the Part 4 options have exploded and are far more complex. There are currently over 400 research projects being done on children without patient consent under the auspices of the American Board of Pediatrics “Practice Improvement Module”. Large hospital systems and institutions have created research projects that are approved for Part 4 credit. This serves two purposes for the institutions: their doctors can get MOC done within the usual research being done by the hospital and that research is exempt from patient consent because it’s “Quality Improvement” and not “research”.
It’s a bureaucratic line, to be sure. If a major research hospital does a “quality improvement study” and changes the way they care for patients, then publishes that study to show patient outcomes, it sure sounds like research to me. As a patient or a parent of a child enrolled in the study, I’d sure like to know if the study was why I had to pay for extra follow-up, extra testing, or why my child was denied care.
The American Board of Pediatrics disagrees and defends these studies, lack of consent and publishes the results with pride. The most recent example is an asthma study published this summer in Pediatrics, Effectiveness of an Asthma Quality Improvement Program Designed for Maintenance of Certification.
In exchange for Part 4 MOC credits, 56 physicians conscripted 594 patients to participate in the asthma study without consent. In addition to being a crummy study with questionable outcomes, there was no disclosure on how patients paid for the extra visits, extra time, medications and extra testing required in this study or if they ever found out they were part of a study.
When the Pediatrics Editorial Board was questioned on the ethics of “paying” doctors with MOC credit for studies done on children without consent, this was their response:
The issues that you raised about human subjects protection and quality improvement have been previously addressed by the US Department of Health and Human Services. Based on this federal guidance, there has been no ethical breach and no reason to consider retraction of this work. Please refer to: http://answers.hhs.gov/ohrp/search/results?category_id=1569
Alex R. Kemper, MD, MPH, MS
Deputy Editor, PEDIATRICS
In other words, it’s ethical because the government says it is. Sad that the nation’s leaders in pediatric research have no higher ethics than government sanction. Equally sad is that the pressure of fulfilling MOC apparently seduces good physicians to neglect human research subject’s and fundamental patient’s rights. The American Board of Pediatrics needs to come clean on these studies, allowing patients full informed consent to participate. Anything less regresses medical ethics to the time of Dr. John Heller.
The Tuskegee Experiments were sanctioned by the government as well. Out of Tuskegee came various laws, commissions and Institutional Review Boards to protect patients and require informed consent. Now, simply renaming research as “Quality Improvement” allows complete disregard for the safeguards of IRB and informed consent that came out of Tuskegee. Returning to the Tuskegee standards for patient rights doesn’t sound like Quality or Improvement to me.
Meg Edison MD is a pediatrician in private practice. You can follow Dr. Edison on Twitter @megedison
Photo by throgers