NIH has announced an unprecedented privacy protocol involving the cells of the late Henrietta Lacks, whose cancer cells have been used as a basis for thousands of medical studies over the past six decades without her family's consent.
The legacy of Henrietta Lacks
In 1951—well before federal regulations requiring patient consent were established—Lacks was diagnosed with an aggressive form of cervical cancer. Doctors at Johns Hopkins Hospital in Baltimore took a biopsy of her tumor without her or her family's permission, retaining cells—called HeLa cells—that have the unique ability to continuously reproduce in laboratory cultures.
Although Lacks died shortly afterward at age 31, the HeLa cells have since become the most widely used cell lines in medicine, yielding profound insights into cell biology, vaccines, in vitro fertilization, and cancer. To date, HeLa cells have been the subject or more than 74,000 scientific papers.
However, her family had no knowledge of the HeLa research until they were contacted by a scientist seeking blood samples in 1973. The concerns of the family were largely ignored for years, according to the New York Times. However, a 2010 book published by Rebecca Skloot, "The Immortal Life of Henrietta Lacks," drew new attention to the cell line and the family's unhappiness.
Last March, researchers at the European Molecular Biology Laboratory published the genome line of the HeLa cells, making them available for public downloading. A separate study, sponsored by NIH at the University of Washington, was slated to be published in Nature. The Lacks family did not give consent for either study, the Times notes.
"I said, 'No, this is not right,'" Jeri Lacks Whye, one of Lacks' grandchildren, explained in an interview with the Times. "They should not have this up unless they have consent from the family."
Whye said, "The biggest concern was privacy—what information was actually going to be out there about our grandmother, and what information they can obtain from her sequencing that will tell them about her children and grandchildren and going down the line," such as the risk for certain hereditary diseases.
NIH, Lacks family reach privacy pact
The family's objections led to four months of negotiations that resulted in a "novel and historic agreement" to protect the family's privacy and grant researchers access to HeLa cells, according to NIH Director Francis Collins.
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Under the agreement, two members of the Lacks family will serve on NIH's six-member HeLa Genome Data Access working group, which will review proposals from researchers seeking to sequence the genomic data. The Lacks family will also be named in papers and scientific presentations based on the research done with the HeLa cells, but they will not share in any proceeds from HeLa-related products.
"We are pro scientist. We want to continue to the legacy of Henrietta," David Lacks Jr., who will serve on the panel, said at an NIH briefing on Wednesday, adding, "We just wanted to add an extra step to protect our privacy."
Medical ethicists warn of 'one-off solution'
Richard Sharp, the director of biomedical ethics at the Mayo Clinic, told the Times that the situation was "pretty well handled," but he warned that it was only a "one-off solution" to the growing tension between genome research and privacy. Convening a working group of scientists and relatives for every genome with these issues is impractical, he argued, adding, "There's absolutely a need for new policy."
Eric Lander, the founding director of the Broad Institute at Harvard and MIT, said resolving the broader issue is critical for future clinical research. "If we are going to solve cancer, it's going to take a movement of…patients willing to contribute information from their cancer genomes towards a common good," he said, adding, "We can't do it without a foundation of respect and trust" (Doucleff, "Shots," NPR, 8/7; Winslow, Wall Street Journal, 8/7; Zimmer, New York Times, 8/7).