The NIH said today it has reached an understanding with the family of the late Henrietta Lacks to allow researchers controlled access to the full genome sequence data from cells derived from her tumor, commonly known as HeLa cells—the first human cells to be successfully grown in the laboratory, and the source of the world’s most commonly used human cell lines.
Lacks is the poor African-American tobacco farmer from Virginia whose tissue had been extracted from her tumor for research purposes without knowledge or consent by either her or her family, following her death from cervical cancer in 1951, at age 31. Lacks’ identity was revealed in a scientific journal in 1971, and her story was told in a 1997 BBC documentary, as well as in Rebecca Skloot’s 2010 best-seller “The Immortal Life of Henrietta Lacks.”
The understanding was designed to balance the Lacks family’s wish to continue enabling scientific progress with the desire to publicly acknowledge Lacks’ contribution to research. Researchers will be able to apply to the NIH for access to the full genome sequence data from HeLa cells, if they agree in return to abide by the terms of the HeLa Genome Data Use Agreement. Two representatives of the Lacks family will join representatives from the medical, scientific, and bioethics communities on a new NIH-created, six-member working group that will review proposals to access the HeLa full genome sequence data.
NIH-funded researchers who generate full genome sequence data from HeLa cells will be expected to deposit their data into a single database for future sharing, accessible at http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000640.v1.p1. All researchers who use or generate full genomic sequence data from HeLa cells will now be asked to include in their publications an acknowledgement and expression of gratitude to the Lacks family for their contributions.
Earlier this year, researchers at the Heidelberg-based European Molecular Biology Laboratory published a paper describing the first sequence of the full HeLa genome, comparing the DNA of HeLa cell lines with that of cells from healthy human tissues. The paper sparked concerns voiced by researchers, patient advocates, and bioethicists that the published data violated the Lacks family’s privacy because of the potential for identifying the family’s possible disease risk. The data were removed from public view after the Lacks family expressed concern to the German researchers about the risks associated with publishing sensitive medical information.
“The sequencing and posting of the HeLa genome brought into sharp relief important ethical and policy issues,” NIH Director Francis S. Collins, M.D., Ph.D., said in a statement. “To understand the family’s perspectives, we met with them face to face three times over four months, and listened carefully to their concerns. Ultimately, we arrived at a path forward that respects their wishes and allows science to progress. We are indebted to the Lacks family for their generosity and thoughtfulness.”
Dr. Collins and Kathy L. Hudson, Ph.D., deputy director for science, outreach, and policy, announced the NIH’s accord with Lacks’ family in a Nature comment article. The article described their collaboration with the family to develop the new policies, and also examined broader questions about protection of research participants in genomics research.
According to the NIH, the Obama administration is exploring fundamental reforms to policies meant to protect human subjects, on the premise that advances in genomics and computing have made the notion of “de-identifying” a research participant’s biological sample virtually impossible. Current policy permits the research use of specimens and the generation of whole genome sequence data without the knowledge or permission of the people providing the sample, so long as the providers cannot be identified by the researchers.
The Nature issue that carries the NIH announcement also includes a whole genome analysis of the CCL-2 strain of HeLa cells, authored by a research team headed by Jay Shendure, M.D., Ph.D., of the University of Washington, Seattle. The paper—which acknowledged the contributions of the Lacks family—identified an insertion of the human papilloma virus near an oncogene that may explain the aggressiveness of Lacks’ cancer.
“She is a phenomenal woman who continues to amaze the world. The Lacks family is honored to be part of an important agreement that we believe will be beneficial to everyone,” Lacks’ granddaughter Jeri Lacks Whye, a spokeswoman for the family, said in a statement.