Henrietta Lacks had no control when doctors at Johns Hopkins Hospital used her cells 62 years ago in research that led to groundbreaking medical advances. But now her descendants will.
The National Institutes of Health said Wednesday that it had reached an agreement with Lacks' family that requires scientists to get permission from the government agency to use her genome, or genetic blueprint. It was derived from cells taken from the 31-year-old from Turners Station after she died from an aggressive form of cervical cancer in 1951.
One of her grandsons and a great-granddaughter will sit on the working group that will help make the decision.
The partnership comes after years of unauthorized use of the cells, which were the first to live outside the body in a glass tube. The so-called HeLa cells have become ubiquitous in labs across the country; the most widely used human cells that exist today in scientific research. Vaccines, cancer treatments and in-vitro fertilization techniques were all a result of Henrietta Lacks' cells.
Lacks' story garnered national attention after Rebecca Skloot wrote a best-selling book, "The Immortal Life of Henrietta Lacks," which is being made into a movie by Oprah Winfrey. It told the story of a poor black woman taken advantage of by a larger medical institution.
After the book's release, Hopkins pointed out that when Lacks was treated, there was no established practice of seeking consent to take patients' tissue samples for research.
The new agreement requires researchers who get NIH funding to use a database of her genome that they can only access by applying through the federal agency. A panel that includes the two Lacks relatives, who live in Baltimore, will help decide who has access to the genome.
NIH officials are also asking biomedical researchers not funded by the agency to abide by the agreement, but acknowledge that the new restrictions are limited. Someone could create a map of her genome using data on HeLa cells already available. The cells have been the subject of more than 74,000 studies.
Still, NIH officials said the agreement strikes an important balance in protecting the privacy of those who participate in scientific studies and preserving important research. NIH Director Francis S. Collins called the agreement novel and historic.
"This agreement will protect the family's interest and advance our shared commitment to biomedical research," Collins said in a conference call Wednesday.
The Lacks family members said they are glad to finally play a part in what happens with the genetic information.
The Lacks were never compensated financially by the institutions that used the cells, according to Skloot, who set up a foundation for the family. The family will be reimbursed for expenses related to serving on the NIH working group, but will not receive pay.
"The main goal was science and being part of the conversation," said David Lacks Jr., a grandson who will sit on the working group with Henrietta Lacks' great-granddaughter Veronica Spencer.
NIH officials said the working group keeps the family in the loop.
"They are now in a position to know what research is proposed with the HeLa genome and to be able to actively participate in the review of research that furthers Henrietta Lacks' legacy," said Kathy L. Hudson, NIH deputy director for science, outreach and policy.
The Lacks story made news again in March when a German research team posted the genome made from the HeLa cells on a public database available through the European Bioinformatics Institute and the NIH's National Center for Biotechnology Information.
The genome is not identical to Lacks' original genome and posting the data did not violate any laws, but the action raised concern from the family, which again felt that their biological information was being unfairly used and distributed. They were never told about the database.
"It was like her medical records were out there to view with just a click of a button," said granddaughter Jerri Lacks Whye of Baltimore. "It was like history was repeating itself."
The family also found out that a study at the University of Washington sponsored by the National Institutes of Health was close to being published in the journal Nature. Once again, the Lacks family did not know about the renewed interest in the cells until Skloot informed them.
The Lacks said they were most concerned about what DNA information in the genome could reveal about family members, particularly if gene mapping continues to advance.
"The genome reveals a lot of information, but we don't know what information is out there," said David Lacks Jr. "It would be a free-for-all."
He compared the potential future of the genome to the advancement of the cellphone, pointing out how clunky and basic they were in the 1987 movie "Wall Street" compared to today's sleek models that are minicomputers.
NIH officials met with Lacks family members, Skloot and those in academia at Hopkins over the past four months to address family concerns. They laid out three options: free access to the data, no access or restricted access.
The family members agreed to restricted access because they support science. As part of the agreement, they ask researchers to acknowledge the family and the contributions of Henrietta Lacks in any research papers.
The Lacks case has stirred debate about consent in medical research. Cell samples may be used in gene sequencing without permission of the person as long as they cannot be identified. But as technology advances, it is unclear whether somebody's identity could be traced unintentionally. For instance, a scientist could run the genome of an anonymous subject through a database where it could link to another database where the person is identified.
"There are lots of topics that are being very actively discussed right now about how to deal with the ethics of what we can do with a biological sample from a human being going forward," said Alexander Caprone, the Scott H. Bice Chair in Healthcare Law, Policy and Ethics at the University of Southern California's Gould School of Law. "We haven't figured that out."
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Collins of the NIH said he has used HeLa cells in his lab and that more needs to be done to protect the privacy of those who donate genetic material.
"Frankly, the science has moved faster than the consent process, and maybe it is time to catch up," he said.
NIH officials said they do not expect the partnership with the Lacks family to set precedent because it is a unique case. The Lacks case occurred when there were no consent laws. Because the case, and as an extension the family, has become widely known, it has created more potential for privacy issues.
One bioethicist says the decision by NIH will have broader implications beyond influencing NIH-funded researchers.
"Anything that NIH does has a profound effect on the rest of the scientific community," said Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics, who will serve on the new working group and was part of the discussions with the Lacks family. "For NIH to take a step like this is huge, and it needs to be underscored that it will have implications not just on NIH grant-funded scientists but beyond as well."