The federal government has proposed changes to the Common Rule, a law designed to protect the privacy and well-being of people who participate in scientific research.
The Common Rule was originally created "to address ... egregious violations" by certain researchers, who "time and again trampled upon the legal and ethical rights of vulnerable populations in the name of science," as recently recounted in the American Medical Association's Journal of Ethics.
And while the law itself was conceived in response to famously horrifying experiments like the Tuskegee syphilis study, the recently proposed changes have attracted little attention. Rules governing scientific research may sound like a boring bureaucratic sideshow, but these changes could directly affect your life, your health, and your privacy.
No permission required
The people who drafted Federal Policy for the Protection of Human Subjects, as the Common Rule is officially called, couldn't foresee back in 1991 (when it became a law) the incredible advances in genetics that we've had since then.
Currently, the law allows your biological samples - think leftover blood from a test at the doctor's office - to be stored and used for research indefinitely as long as the sample is stripped of your personal information. (This practice was made famous by "The Immortal Life of Henrietta Lacks," a bestselling book that tells the story behind Lacks's biopsied cancer cells, which - though she was never asked - have been used for research since their collection in 1951.)
But that "stripped of your personal information" bit is tricky - and easily bungled. Researchers have shown that today, they can use genetic testing and information on the internet, for example, to re-identify samples that were supposed to be anonymous. Nobody imagined that could happen back in 1991.
The proposed changes, which aim to protect patients' privacy given these new realties without hindering progress or scientific research, include (in part - the changes are extensive):
- Require "informed consent" from a patient when their biological samples (like Lacks' cancer cells) will be used for research, even when doctors make a reasonable effort to strip personal info from those samples. Consent "could be obtained using a 'broad' consent form in which a person would give consent to future unspecified research uses," the US Department of Health & Human Services (HHS) explains on its website.
- Make sure people volunteering for research understand clearly what they're getting themselves into before they enroll by improving the information they're given in consent forms. Consent forms would not be ridiculously long documents "with the most important information often buried and hard to find," HHS writes.
- Exclude certain activities from the Common Rule if they are not technically research or "inherently low-risk."
You can read a full explanation of the proposed changes on the HHS website.
What do people think?
The final public comment period before these changes become law ends January 6, but until recently few members of the public have been commenting.
The Infectious Diseases Society of America (IDSA), for example, submitted an extensive comment worrying that requiring consent for human specimens "would have a chilling effect on many types of research" and arguing that the "logistics of implementation appear daunting and unrealistic." Rather than requiring consent in an effort to protect patient privacy, IDSA argued, HHS should "institute strong penalties against re-identification of biospecimens."
Stanford University argued that "many health care facilities serving under-represented minorities and economically-disadvantaged individuals, particularly those in rural settings, would not have the financial resources to obtain and track consent." That could mean that, increasingly, research "would be performed with biospecimens derived from a skewed population," which might "derail efforts to provide 'precision medicine' targeted to the health care needs of all citizens."
Generally speaking, scientists applauded an update to the Common Rule that accounted for recent advances, but worried that certain changes might inhibit or slow their research. Some pointed out that the changes were extremely complicated and raised too many questions to push forward on implementation without further clarification.
Rebecca Skloot, author of "The Immortal Life of Henrietta Lacks," wrote a New York Times op-ed calling attention to the proposed changes. She pointed out that people are sharply divided on the benefits and problems of the potential update to the Common Rule, and whether any potential research slowdown is a fair or even necessary trade-off.
Some researchers think requiring broad consent for all biological samples would be an "administrative burden," she writes, while others are appalled researchers didn't have to get consent already.
But it's not just an issue that affects researchers. The public should care, she argues - if only they knew what was at stake:
Lacks's story is unusual because she lost her anonymity. But I've talked to other still-anonymous donors with strikingly similar experiences. Like the Lacks family, they're proud they helped science. They believe tissue research is important, but they wish they'd been asked permission from the start, to avoid difficulties that followed: the shock of learning they were part of research, debates over who controlled samples, questions over profits.
For people who have not experienced that, it may be difficult to imagine. And of course, any issue surrounding privacy, genetic testing, scientific discoveries, and the "future of human health," as Skloot puts it, is bound to be controversial.
But as a member of the public, whose blood or cells could potentially be used in research, you have a right to weigh in. So how do you feel about it? Submit your comments here before January 6.