When you get surgery or have a mole removed, and there’s leftover tissue or blood, there’s a chance that it might not be discarded. It might live on in a lab somewhere, available to researchers, unbeknownst to you.
Your doctors didn’t ask you if you wanted to donate your cells. They didn’t have to. As long as your specimens are “de-identified” — meaning your name and other personal information are no longer attached to them anymore — they’re fair game.
This practice went on for decades without much controversy — until the bestselling book The Immortal Life of Henrietta Lacks by Rebecca Skloot came along in 2010. The story sparked a debate among the public, researchers, and bioethicists about whether this practice is ethical — and whether the benefits to science truly outweigh the potential harms to individuals whose donations may come back to haunt them.
A new HBO movie starring Oprah based on the book will surely reignite that debate. The movie strongly suggests the practice of using anonymous tissues in research can be nefarious and deeply disturbing for families — while at the same time great for science. And so the research community is bracing for a backlash once again.
What happens next may hinge on whether the public gets involved in the debate about reforming the consent rules around donating tissues to science — but first, more people need to know this debate is happening at all. And there’s nothing like an Oprah movie to get Americans talking.
The HeLa Story
The book and movie center around Henrietta Lacks, an impoverished Virginia tobacco farmer whose cells, leftover from a cervical cancer treatment at Johns Hopkins, were used to create the first “immortal cell line.” (Her cells, named “HeLa,” could thrive and grow outside the body, in culture in the lab — leading to a cascade of medical breakthroughs.)
Though Lacks died in 1951, HeLa cells were and still are used in labs around the world. They were used for the discovery of the polio vaccine, chemotherapy, gene mapping, and in vitro fertilization, among other medical breakthroughs. (Researchers still haven’t figured out why they’re “immortal,” but they’ve since discovered other similarly inextinguishable cell lines.)
Because of systemic prejudices in the health care system (the Lacks were poor African Americans) and the sometimes clandestine nature of research, for years after her death, the Lacks family had no idea about Henrietta’s contribution to science. While her cells multiplied in labs everywhere, helping to advance medicine and make innovators a lot of money, the family was living in poverty and didn’t have access to basic health care. Skloot, the book’s author, does a fine job of balancing the tension of the incredible contribution Lacks’s cells made to science and the damage that science did to the Lacks family.
“The thing about Lacks’s story that’s often missed in this discussion is that it’s not just about the moment the cells were taken from Henrietta,” Skloot told me in a recent interview. “It’s about the very long tale that can follow that moment if you take cells from people without consent.” Scientists went back to her children in the ’70s and did research on them without consent in order to learn more about the cells. In 2013, researchers sequenced the HeLa genome, making the family DNA public without their consent. And this could happen again today, Skloot warned.
Why scientists object to telling you they might use your anonymous tissues
Ethical guidelines called the “Common Rule” govern research on human subjects. These guidelines consider science on human tissues as somewhat separate from research on people. When a scientist interacts with a person for the purposes of research, and collects tissue in that process, the researcher’s interactions and use of those biospecimens require informed consent. But when a researcher uses anonymous tissues that have been collected for some other purpose (for a biopsy, or during surgery, say), no consent is required.
Recently, the Department of Health and Human Services (and 15 other federal departments and agencies) considered changes to the Common Rule, including, most controversially, one that would require researchers to get consent for use of even those anonymous tissues. The Lacks story helped spark a push for that revision. But while other amendments passed earlier this year, the change to consent for biospecimens was thrown out because of a backlash from the research and bioethical communities.
In interviews, researchers critical of the change outlined several reasons why suddenly mandating consent could be a threat to the advancement of science and medicine.
For starters, they say, it’d be difficult and burdensome to build systems that connect people’s decisions about consent to all the tissues that are floating around out there. “If you’re a wealthy academic institution, maybe you can build the front-end infrastructure,” said Steven Joffe, an associate professor of medical ethics and health policy at the University of Pennsylvania’s Perelman School of Medicine, who detailed his concerns in this article and Times op-ed. “But think about trying to do that at every hospital, clinic, and surgical place around the country.”
The institutions that can put these systems in place would likely be the wealthier and more urban centers, he added, which could end up biasing the pool of tissues that are available for research. “If you want to get representative samples [of tissues] all around the country, including those that serve rural areas or minority communities or less wealthy institutions,” Joffe said, this consent rule might make that difficult.
These losses could damage science, he argues. “A huge amount of what we learned about cancer comes from studying tumor specimens that were left over after people had them biopsied or taken out as part of their clinical care. That leftover tissue is medical waste. Pathology could throw it — or it could be used for research in which we are all better off.”
Holly Fernandez Lynch, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, emphasized that the benefits to society in terms of advancing knowledge and medical discovery are much greater than the risks to any individual, such as somehow re-identifying the source of the anonymous tissue.
“There haven’t been any examples of nefarious re-identification of specimens,” Lynch argues. “And even if there were, the way to go about that wouldn’t be to demand consent but to go after the people nefariously trying to re-identify and use information against you.”
Lynch and Joffe also point out that the Lacks case is more the exception than the rule: It’s very rare for a single person’s cells to make such a large contribution to science. (A lot of discovery these days is based on researchers looking at many people’s cells in aggregate.)
“We’re worried that [the Lacks story] is getting people riled up and worried about something that wasn't really risky to them,” Lynch added.
But the critics acknowledge, as Joffe puts it, that “there’s little evidence one way or the other of what a requirement for consent would do to science, and what the impact of the burdens would be.” He and others are making “predictions under uncertainty.”
The case for requiring consent for all tissue donation
That uncertainty is part of what irks supporters of a change to the consent rule. They say there’s no proof that requiring scientists to ask for permission to use anonymous tissues would hinder science — and instead, that it would make science more transparent and respectful of the contributions of research participants.
“In my view of the future of research, people will know if they or their tissues are being used in research and they will feel a true sense of participating and pride in that fact,” said Kathy Hudson, a former deputy director at the National Institutes of Health. She worked with the Lacks family to craft an agreement about sharing their genome for science. And she wants to see consent requirement for all tissue donations.
“The notion that you can harvest excess specimens and use them in research — sure that’s convenient for the random researcher, but is it good for the biomedical research enterprise?” Hudson says.
In not asking for permission, scientists diminish public trust, she argues. And de-identifying specimens also means researchers can’t go back to the participants who donated their tissues and ask follow-up questions that might aid discovery.
In the face of uncertainty about the impact requiring consent would have, it depends on how people feel about the fact that their tissues may be used for research without their permission. And Skloot points out that many people don’t even know this is going on.
“We all want this research to happen,” Skloot said. “The problem is people don’t understand a lot of about the research, and there isn’t an effort to explain it to them.” When you ask people for their consent to use tissues for research, she added, the vast majority say yes.
In a Times op-ed about this issue in 2015, she urged readers to share their comments about the changes to the Common Rule. This year, the rule was finalized after a multi-year revision process, so it’s unlikely to be altered again anytime soon. But that doesn’t mean the debate is going away — especially now that Oprah is involved.
“There are a lot of people who feel very strongly that research on tissue should require consent,” Skloot said. “The current practices aren’t what people want them to be.” With the new HBO film, the debate could heat up. Let’s just be sure we’ve carefully considered the potential harms and benefits — to ourselves and to science — in the process.