The public comment period on the NPRM to revise the Common Rule has just closed, and now we wait to see what happens (if anything), and when. One of the most controversial proposals in the NPRM would require at least broad consent for secondary research with biospecimens (i.e., research on specimens originally collected for another purpose, either clinical care or a different study), regardless of whether those specimens retain identifiers. This is a substantial change from the status quo, which does not require consent for such research with de-identified specimens. How should we feel about this status quo, and the proposed change? My own view is that it’s really not so bad: the risks to individual research participants are quite low, and the current approach facilitates critically important scientific advancement. There is certainly room for improvement, e.g., to impose punishment on those who would act to re-identify de-identified specimens without permission, to inform the public that such research takes place, and to educate them about its value, perhaps allowing those who still feel very strongly that they prefer not to be included an opportunity to opt-out. But what has been actually proposed has more problems than what it would replace, and in fact, wouldn’t solve some of those it seems to be a response to.
Rebecca Skloot feels otherwise. She is the author of a book called The Immortal Life of Henrietta Lacks, which chronicles the origin of one particularly important cell line – HeLa – derived from cells that had been excised from Ms. Lacks in the course of a 1951 surgery to treat her cancer, and later used for research without her knowledge or permission. Ms. Lacks was poor, uneducated, and black, and her descendants have also faced more than their fair share of adversity. Ms. Skloot paints a compelling story of exploitation, but in my opinion, it is much more effective as a narrative about the horrible and enduring legacy of racism in this country than as proof that researchers who conduct secondary research with biospecimens without consent (as permitted under the current regulations, remember) or even without profit-sharing have behaved badly. After all, if individual risks are low and social benefits high – both true – then what’s the problem? And it is far from clear that specimen sources deserve compensation for no other reason than that their discarded material actually proves valuable to scientists. Nonetheless, the book has been used as a rallying cry by people from all walks of life who believe that they should be allowed to control whether, and potentially how, their specimens are used for research. Indeed, The Immortal Life of Henrietta Lacks is probably the single most important development that pushed the proposed revisions to the Common Rule forward, for the first time since they were released in 1991.
In a recent New York Times Op-Ed published on December 30, Ms. Skloot called for the public to weigh in on the proposed changes, raising concern that the comments the government had received so far were too one-sided from investigators, IRBs, and institutions opposed to the NPRM, rather than specimen sources (i.e., patients) who she suspects might feel differently. She points out that patients do seem to care how their specimens are used, but an important gap in her piece is to analyze whether they *ought* to care, and whether the reasons they might provide *ought* to be treated as sufficient to justify what the NPRM proposes. Again, my view is that the status quo is in need of improvement, but the NPRM takes the wrong approach – I don’t think patients ought to care what happens to their specimens so long as their privacy is protected and so long as the specimens are used for the advancement of socially-valuable science, and I don’t think they ought to necessarily be granted a right of control simply because the specimens came from their bodies. I do, however, recognize a desire to at least know that specimens may have some use once taken, and a broad attempt at public education would be very welcome – not in terms of scare tactics (“Can you believe what they’re doing without your knowledge?!”), but in terms of explaining the benefits and risks.
Ms. Skloot’s op-ed has stirred an interesting debate about how to properly frame secondary research with biospecimens, with some excellent commentary by Petrie-Flom Center alumni Michelle N. Meyer and Christopher T. Robertson.
Michelle has a fantastic piece in Forbes (where she is a regular contributor) from Dec. 31, in which she provides a robust overview of the issues at stake, and takes issue with an analogy used in the NYT op-ed, as summed up in Michelle’s title: “Donating Your Leftover Tissue to Research Is Not Like Letting Someone Rifle Though Your Phone…And even if it were, proposed new rules for tissue research wouldn’t stop it.” Check out Michelle’s analysis here.
Chris also has a great piece out in the Washington Post from Jan. 8, with his fellow Jonathan D. Loe, in which he cautions against “Learning the Wrong Privacy Lesson from Henrietta Lacks.“
There is no doubt that Rebecca Skloot has done more than anyone to bring the issue of biospecimen research into the public’s consciousness, and in many ways, her work is to be commended. Moreover, she was right to call for broad public commentary on the proposed rules – that is precisely how our administrative law system is designed to work. But I do share the serious concerns raised by Michelle and Chris that a focus on HeLa can set us down the wrong path, with serious consequences for the advancement of medicine.