In the end, the family decided that it wanted the data to be available under a restricted-access system similar to the NIH dbGaP database, which links individuals’ genetic make-up to traits and diseases. Researchers would apply for permission to acquire the data and agree to use them for biomedical research only, and would not contact Lacks family members. A committee that includes family members will handle requests, and papers that use the data will recognize Henrietta Lacks and her kin. The first of these papers, the NIH-funded paper, is published in this issue (see page 207).
In discussing HeLa cells and the agreement forged with the family, Collins and others often use the word “unique”. No other human sample matches the cell line for ubiquity, notoriety or celebrity (Oprah Winfrey is producing a film based on the story). The NIH does not see the deal with the family as a guide to handling other human samples. “It’s not going to be a precedent,” says Collins’ chief adviser Kathy Hudson.
But it will probably inform other cases, she adds. The US government is redrafting rules that govern the relationship between federally funded researchers and participants. New rules aim to give subjects greater say in how their tissues and personal data are used. “Going forward, I’m very much of the mind that the most appropriate way to show respect for persons is to ask,” Collins says. “Ask people, ‘Are you comfortable having this specimen used for future genomic research for a broad range of biomedical applications?’ — if they say no, no means no.”
As for the myriad other tissues out there that were obtained without consent, Collins says that it would slow science too much to ban their use. Laura Rodriguez, a policy official at the NIH who works on guidelines for genome sequencing, says that there is a low risk of donors of such samples being identified. But in January, researchers working on a genomics project showed that it is possible to identify anonymous participants — and their families — by cross-referencing their genomes with genealogy DNA databases.
Hank Greely, a biotechnology lawyer at Stanford University in California who has advised the EMBL group, says the HeLa agreement is a “good solution”, but applying it to other unconsented cell lines and data would be unwieldy and impractical. “The one thing we really should be doing is making sure everything we collect from here into the future is acceptable.”
Lacks-Whye has similar advice. Researchers can make major breakthroughs, she says, while still respecting the wishes of patients and their families. “Have them involved,” she says. “That’s not only for HeLa sequences, but anybody who participates in research.”