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.’ ”
But it was not just the widow and the family who recognized the dying Mark Chanko:
Yet a few weeks later, Mrs. Chanko said she received a call from a woman who used to work as a pet sitter for her and her husband. “She said to me, ‘Do you watch “NY Med?” ‘ She said, ‘That was Mark, wasn’t it?’ She recognized him.”
So far, the family’s complaints have gotten the clip of their father taken down from ABC’s website and off any (new) DVDs of the show. The State of New York cited the hospital for violating Mr. Chanko’s rights but imposed no sanctions. The Chankos’ sued the hospital, the surgeon, and ABC, so far unsuccessfully. The federal government is still considering whether to take action against the hospital, presumably for a HIPAA violation.
So what does this have to do with biomedical research? This was “reality” TV, not research, and not something intended to provide the kinds of public benefits that biomedical research sometimes brings, but only momentary distraction and, perhaps, more, carefully selected, knowledge about hospitals and medicine.
The same kind of de-identification relied upon by the hospital, the surgeon, and the network as a defense against the Chankos’ complaints is used to remove much human research from any need for consent or other protections. And, as in the Chankos’ case, “de-identification” can be a myth. De-identification (also called “anonymization”) doesn’t mean that no one will recognize the research subjects’ identity – the Common Rule only says the researchers must not be able to ascertain it readily. Someone else might be able to recognize it, readily or immediately. And anyone, including the researchers, may be able to recognize it in a way that might not qualify as “readily,” but might take a little effort, though less and less effort as more information about people is available on the web. And although the Chankos were not concretely harmed by this breach of Mark Chanko’s privacy, they were hurt. Shock, grief, depression, anger, betrayal – these are harms even if they do not lead to denials of insurance, employment discrimination, or other financial damages.
Jennifer Kulynych and I just published a piece in Slate, "Every Patient a Subject," which concerns de-identification. We argue that as genomic information becomes more and more frequent in patients’ electronic medical records, those records will become irresistible temptations to biomedical researchers. Under currently accepted interpretations of current laws, “de-identification” will make everything fine. No harms possible, so no regulation needed.
Just ask the Chankos.
Hank Greely, JD, is a Stanford law professor and an expert on the legal, ethical, and social issues surrounding health law and the biosciences. He is director of the Center for Law and the Biosciences, and he chairs the steering committee of the Stanford Center for Biomedical Ethics. This post originally appeared on the law and biosciences blog.