on January 6th, 2015 No Comments
Much biomedical research relies on the idea of “de-identification.” The Common Rule, the federal regulation on human subjects research, applies, as a general matter, if the researchers make some kind of intervention with the research subject or if they use “identifiable private information” about the research subject. But the “Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”
De-identification doesn’t mean that no one will recognize the research subjects’ identity. Federal regulation says the researchers must not be able to ascertain it readily.
If the private information was not collected by the researcher (it comes from someone’s medical record or was collected as part of someone else’s research) and the research subject’s identity is not known to and cannot “readily be ascertained” by the researcher, it doesn’t count. No consent is required, no IRB review is required – it isn’t “human subjects research.”
And why should it be? If no one knows it is you, you cannot be hurt, or so the argument goes.
[Last Friday], the New York Times published an extraordinary article entitled “Dying in the E.R., and on TV Without His Family’s Consent” by Charles Ornstein, a reporter for ProPublica. It recounted how Anita Chanko, a 75-year-old widow, watching an ABC reality television show, NYMed, suddenly realized that she was watching her husband’s death in the emergency room. More than a year earlier, the 83-year-old man had been hit by a garbage truck while crossing the street and had died in the NewYork-Presbyterian hospital. The televised version blurred his face, but not the face of the surgeon, the description of the accident, or the sound of her late husband’s voice, asking “Does my wife know I’m here?”
At no time were any of the family told that Mr. Chanko’s treatment was being filmed or asked their consent to its use on television.
The dead man’s widow and children were traumatized. One of their sons wrote in a complaint “I had to unnecessarily relive my father’s death at your hospital a second time, while knowing that the public at large was able to — and continues to be able to — watch my father’s passing, for the purposes of what can only be described as drive-by voyeuristic ‘entertainment.’ ”