The NIH-Lacks Family Agreement

NIH Expectations for the NIH-Lacks Family Agreement

“HeLa” is a human epithelial adenocarcinoma cell line that was derived from biopsy specimens of a 31-year-old patient named Henrietta Lacks who was being treated for cervical cancer at The Johns Hopkins University Hospital in 1951. The specimens were obtained without her knowledge or consent. HeLa cells were the first human cells to be stably cultured for research and have been a vital tool in biomedical research, leading to an increased understanding of the fundamentals of human health and disease. 

On August 7, 2013, NIH, in collaboration with family members of Mrs. Henrietta Lacks, announced the NIH-Lacks Family Agreement (the Agreement) to allow biomedical researcher access to DNA or RNA HeLa cell whole genome sequence data (HeLa cell data), while also respecting the preferences and privacy of the Lacks family. The Agreement also serves to foster transparency on genomic research using HeLa cells and to raise awareness of Mrs. Henrietta Lacks’ enduring contribution to science and medicine. In August 2023, the NIH reaffirmed the commitment to honor the Lacks’ family preferences and privacy while responsibly advancing scientific discovery. NIH also has a dedicated website that serves as an accessible resource to the public, scientific researchers, and the Lacks’ family that is in keeping with the spirit of this historic agreement.  

NIH clarified expectations for NIH-supported investigators who generate HeLa cell data or that intend to access such data in NIH controlled-access data repositories in the Guide Notice Update to HeLa Cell Whole Genome Sequence Data Submission and Access Under the NIH Lacks-Family Agreement (NOT-OD-24-098). 

Below are key points from the Guide Notice:  

1. The NIH-Lacks Family Agreement applies to NIH-supported investigators, regardless of funding mechanism or amount, who generate HeLa cell data. 
2. NIH expects all NIH-supported investigators who propose to generate HeLa cell data to include a plan for submission of these data to NIH in the Data Management and Sharing (DMS) Plan of their funding application (see sample HeLa DMS Plan). The DMS Plan should include provisions for the data to be submitted to the NIH database of Genotypes and Phenotypes (dbGaP) as part of “HeLa Cell Genome Sequencing Studies”, where it will be made available to the research community only for health, medical, and biomedical research purposes. Other awards that generate HeLa cell data but are not subject to the DMS Policy or Genomic Data Sharing (GDS) Policy are strongly encouraged to review the Guide Notice NOT-OD-24-098 and the sample DMS Plan and to follow the approach described therein for submitting data to dbGaP.
3. To submit HeLa cell data to dbGaP as a part of the HeLa Cell Genome Sequencing Studies, send an email to HeLaGenome@nih.gov to begin the submission process. The email subject line should contain “Request submission to HeLa Cell Genome Sequencing Studies” and the name of the project. NIH staff will give additional instructions upon receipt of email.
4. The Agreement also applies to investigators (whether NIH-supported or not) seeking access to controlled HeLa cell data in dbGaP. Investigators seeking access to HeLa cell data in dbGaP must submit a data access request to NIH and be approved to access those data.  
5. All access requests will be evaluated by the Advisory Committee to the Director (ACD) HeLa Genome Data Access Working Group to determine whether the request aligns with the terms of use defined in the HeLa Genome Data Use Agreement. See ACD HeLa Genome Data Access Working Group for additional information on when to submit requests before each Working Group meeting. The Working Group's findings are reported to the ACD, and the ACD makes recommendations to the NIH Director about whether a request should be approved or disapproved. The NIH Director decides whether access to the data will be granted.