by Josh Glickenhaus, Swarthmore College senior and PRIM&R intern
In my few months working for PRIM&R, I must confess that, at times, the field of research ethics has felt somewhat academic. The field is rich with past atrocities that led to its creation—Nuremberg, the US PHS Syphilis Study, the Willowbrook hepatitis study—but those sometimes feel like ancient history. Today we’re aware of the ethical hazards intrinsic to clinical research, and have established a sophisticated system of ethics review to prevent them. Informed consent must be secured. Participants must not be subjected to more risk than necessary. Adverse events must be appropriately monitored. And so on. Though you hear about the occasional study gone awry, blatant violations of basic ethical principles should be a thing of the past. Right?
So imagine my surprise upon picking up The Boston Globe on July 2 and seeing the headline, “Journal to Scrutinize Hip Fracture Study: Inquiry Follows Allegation of Ethical Breach”* on the front page of the Metro section. Apparently, a team of Harvard researchers conducted a study to determine whether special padded underwear was likely to reduce the risk of hip fractures in nursing home residents. Their study design used underwear padded only on one side to make comparisons between the padded and un-padded sides easier to draw. The underwear turned out to be very hazardous. Seniors were fracturing their hips on the padded side with significantly greater frequency; data quickly suggested that this was because they were falling toward the padded side more often. Despite the emergence of this compelling data, the study continued and was eventually published in the Journal of the American Medical Association (JAMA) in 2007.
Now JAMA is reviewing the study amid claims that researchers knowingly misled patients and officials as to the increased risk of falls on the padded hip. A significant increase in falls on the padded side is relevant information by any standard, and should have been reported to the IRB overseeing the study. If reviewers found the data to be unacceptable, they might have shut the study down early. At the very least, the increased risk should have been disclosed to future research subjects. Either way, a significant number of seniors could have been spared broken hips without compromising the science of the study.
Covering up data and failing to disclose significant risks to research subjects is just wrong, and these are practices that the modern IRB system should prevent. Yet the Harvard research team responsible for this study seems to have gotten away with just such practices until four years post-publication. It’s this sort of story, plastered in big letters across the front of The Boston Globe, that helps to make research ethics real for me. When people continue to be hurt by this type of fundamental ethical breach, it’s just one more reminder that research ethics is not a thing of the past, and that we must keep on our collective toes to continue to make the system better and keep these stories out of the headlines.
*Lazar, Kay, Chelsea Conaboy and Neena Satija. “Journal to Scrutinize Hip Fracture Study: Inquiry Follows Allegation of Ethical Breach.” The Boston Globe. 2 Jul., 2011. B1-3.