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NIH, Lacks family reach understanding to share genomic data of HeLa cells

New policy requires researchers to apply for access to the full genome sequence data

8/8/2013, 1:42 p.m.
Multiphoton fluorescence image of cultured HeLa cells with a fluorescent protein targeted to the Golgi apparatus (orange), microtubules (green) and counterstained for DNA (cyan). NIH-funded work at the National Center for Microscopy and Imaging Research. Tom Deerinck

“The sequencing and posting of the HeLa genome brought into sharp relief important ethical and policy issues,” said Dr. Collins. 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.”

The HeLa Genome Data Use Agreement

The new controlled access policy for full genome sequence data from HeLa cells will give the Lacks family the ability to have a role in work being done with the HeLa genome sequences and track any resulting discoveries. Under the policy, biomedical researchers who agree to abide by terms set forth in the HeLa Genome Data Use Agreement will be able to apply to NIH for access to the full genome sequence data from HeLa cells. Along with representatives from the medical, scientific, and bioethics communities, two representatives of the Lacks family will serve on NIH’s newly formed, six-member working group that will review proposals for access to the HeLa full genome sequence data. In addition, 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 through this process.

The database study page will be accessible after the embargo lifts at this url: http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000640.v1.p1. Other investigators will be encouraged to respect the wishes of the family and do the same. Importantly, all researchers who use or generate full genomic 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.

Whole Genome Sequencing: Privacy, Consent and Further Reform

It is increasingly apparent that engaging the public as a partner is critical to scientific advancement. The Obama Administration is exploring fundamental reforms to human subjects protections—actions that are being driven in part by the fact that technological advances, especially 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 generation of whole genome sequence data without the knowledge or permission of the people providing the sample, so long as, for example, the researcher cannot identify that person.

The History of HeLa Cells

Henrietta Lacks, an African-American woman who was 31 at the time of her death, was being treated for cervical cancer at Baltimore’s Johns Hopkins Hospital in 1951. Cells were extracted from the biopsy of her tumor sample for use in research without her knowledge or consent. At the time, there were no federal regulations or restrictions on the use of patients’ cells in research. Although Lacks died shortly afterwards from her aggressive disease, scientists were able to keep her cancer cells alive and replicating under laboratory conditions.

The circumstances surrounding the HeLa cell line are unique because the identities of the source of the cell line and her descendants are public and widely known. Because hers were the first human cells cultured continuously for use in research, Lacks’ identity was revealed in a scientific journal in 1971 in reference to the landmark accomplishment. Subsequently, her story was told in a BBC documentary in 1997, and in the 2010 bestselling book, “The Immortal Life of Henrietta Lacks” by Rebecca Skloot. As a result, the Lacks family has been propelled into the spotlight to an extraordinary degree.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.