The bedrock requirement to obtain informed consent before patients may be enrolled in research has been eroding. I’ve documented the different ways and different reasons for this several times over the years (“Informed Consent for Babies: When Experts Disagree,” “Informed Consent in Infant Research: Ethical Problems Remain,” “Informed Consent in Comparative Effectiveness Research,” and “The Erosion of Informed Consent in Medical Research“). The latest example is a clinical trial of severely agitated patients conducted by Hennepin Healthcare in Minnesota. Hennepin halted its research after information about lack of consent was published in the Minneapolis Star Tribune, resulting in a public uproar and criticism from local politicians.
The study’s subjects were individuals with “prehospital agitation” whom emergency medical service (EMS) workers injected with either the sedative drug ketamine or another commonly used drug, midazolam. Which drug the patients received was determined by the research protocol. The drug was administered during incidents in which individuals were perceived as severely agitated or aggressive. Although patients were not asked to consent to having the drug administered and being enrolled in the study, they were given the choice to opt out afterward. Opting out, of course, simply meant that their data would not be used in reports of the research outcomes. It was not consent for the research itself.
Your patients are rating you online: How to respond. Manage your online reputation: A social media guide. Find out how.
