Focus of findings lost in media spotlight
Real lessons learned from others’ mistakes
There are lessons to be learned from the Office of Human Research Protections’ (OHRP) recent temporary suspension of human research at Johns Hopkins Bayview Medical Center. In fact, there are three lessons taken from the OHRP report, says Robert M. Nelson, MD, PhD, associate professor of anesthesia and pediatrics at The Children’s Hospital of Philadelphia.
Johns Hopkins University Medical Institutions was suspended from human research on July 19, after a 24-year-old research participant received a lethal inhalation of hexamethonium bromide solution. Investigators reinstated the multiple project assurance on July 21. The OHRP multiple project assurance suspension and subsequent reinstatement affected the following Johns Hopkins institutions:
- Johns Hopkins University School of Medicine;
- Johns Hopkins University School of Nursing;
- Johns Hopkins Hospital;
- Johns Hopkins Bayview Medical Center;
- Gerontology Research Center of the National Institute of Aging — Bayview campus;
- Kennedy Krieger Institute;
- Applied Physics Laboratory.
The most surprising allegation in the OHRP report, however, is not the use of the hexamethonium bromide solution that the mainstream media focused on, notes Nelson. It is that the IRB failed to conduct an initial review of new protocols. "Of note, the minutes and audiotapes of IRB meetings and our discussions with IRB members and administrators indicate that no review takes place at convened meetings for most protocols undergoing initial review. Most protocols are neither individually presented nor discussed at a convened meeting of any IRB," the OHRP report states.
Learn from others’ mistakes
So what can IRBs learn from the investigation? "I take at least three lessons from the report," says Nelson. Here are the important lessons to learn from the OHRP report:
1. Conduct independent reviews.
"An IRB needs to be diligent in conducting an independent review of the safety of the interventions in any protocol," notes Nelson. Johns Hopkins officials stated that they will develop a policy about how independent reviews will take place at their facilities, including database searches, adds Nelson. "My practice is to search the medical databases when I review a new protocol and a continuing review," explains Nelson. As a result of the OHRP report, however, Nelson plans to develop a formal policy and put it into place as soon as possible.
2. Review the use of off-label drugs.
All uses of off-label or unapproved drugs should be reviewed, including chemicals, says Nelson. Also consider whether or not an investigational new drug (IND) application should be required, he adds. "My preferred approach is to assume an IND will be required and put the burden of proof on the investigators."
3. Review informed consent documents.
Consent documents should undergo more rigorous reviews to clearly identify risks to the participant, says Nelson. "The standard information for a research study should include all risks rather than a clinical consent. The assumption that the intervention is in the participant’s best interest may not — and likely will not — hold up in the research setting," explains Nelson. What someone would want to know in order to enroll in a research study, or the "reasonable volunteer," is more than what someone would want to know to accept a recommended treatment, or the "reasonable patient," says Nelson. Consent review assessments should include a comprehensive list of risk information, he adds.
"Being able to turn right on red is a good idea at most corners, but deciding to do this on our own in the absence of legislation to that effect produces chaos," says Nelson. Institutions need to be held accountable to meeting the current standards of IRB review, he adds.
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