NOT-OD-24-098: Update to HeLa Cell Whole Genome Sequence Data Submission and Access Under the NIH Lacks-Family Agreement

Update to HeLa Cell Whole Genome Sequence Data Submission and Access Under the NIH Lacks-Family Agreement

Notice Number:

NOT-OD-24-098

Key Dates

Release Date:

May 24, 2024

Related Announcements

October 29, 2020 - Final NIH Policy for Data Management and Sharing. See Notice NOT-OD-21-013
April 16, 2014 - Notice of NIH HeLa Genome Sequence Data Submission and Access Policy. See Notice NOT-OD-14-080
August 14, 2013 - Notice of NIH Guidance on the Family Acknowledgment and Use of HeLa Cell Whole Genome Sequence Data. See Notice NOT-OD-13-099

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

The purpose of this Guide Notice is to update previously published Guide Notices NOT-OD-13-099 (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-099.html) and NOT-OD-14-080 (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-080.html) and to clarify expectations for NIH-supported investigators and their institutions who generate HeLa cell whole genome sequence data (DNA or RNA) or that intend to access such data in NIH controlled-access data repositories. For the purpose of ensuring consistency, this Guide Notice also updates and harmonizes sharing expectations with the NIH Data Management and Sharing (DMS) Policy which requires all NIH applicants who are planning to generate scientific data to prepare a DMS Plan that describes how the scientific data will be managed and shared. Under the DMS Policy, scientific data should be shared at the time of publication or no later than the end of the performance period, whichever comes first. For more details about the DMS Policy visit: https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policies.

Background

On August 7, 2013, NIH, in collaboration with family members of Mrs. Henrietta Lacks, announced the NIH-Lacks Family Agreement (Agreement) to allow biomedical researcher access to HeLa cell whole genome sequence data (DNA or RNA), 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, NIH reaffirmed the commitment to honor the Lacks’ family preferences and privacy while responsibly advancing scientific discovery (https://www.nih.gov/about-nih/who-we-are/nih-director/statements/10-years-nih-lacks-family-partnership-holds-strong).

NIH Expectations for Upholding the NIH-Lacks Family Agreement.

Section I. Scope and Applicability

NIH’s implementation of the Agreement establishes responsibilities for the following parties:

NIH-supported investigators and their institutions, regardless of funding mechanism or amount, who generate HeLa cell whole genome sequence data (DNA and RNA) (hereafter, “HeLa cell data”).
- Whole genome sequence data is defined as sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen (45 CFR Part 46.116 (c))
Investigators, whether NIH-supported or not, seeking access to HeLa cell data in NIH controlled-access repositories.

Section II. Responsibilities for NIH-supported Investigators Generating HeLa Cell Data

NIH expects all NIH-supported investigators who propose to generate HeLa cell data to:

Include information for sharing in the NIH Data Management and Sharing Plan of their funding application. The DMS Plan should include provisions for the data to be submitted to the NIH database of Genotypes and Phenotypes (dbGaP) as a part of the “HeLa Cell Genome Sequencing Studies” (http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000640), where it will be made available to the research community only for health, medical, and biomedical research purposes.
- NIH has provided a sample DMS Plan for applicants planning to generate HeLa cell data, which can be found at https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-for-data-management-and-sharing/writing-a-data-management-and-sharing-plan#sample-plans.(see "HeLa Cell Whole Genome Sequence (DNA or RNA)").
- 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 this Notice and the sample DMS Plan and to follow the approach described therein for submitting data to dbGaP.
Submit HeLa cell data to dbGaP as a part of the HeLa Cell Genome Sequencing Studies. The submitting investigator should email HeLaGenome@nih.gov to begin the registration and submission process. In the subject line, add “Request submission to HeLa Cell Genome Sequencing Studies.” NIH staff will give additional instructions upon receipt of email.

Section III. Responsibilities for Investigators and their Institutions Seeking Access to HeLa Cell Data

Investigators and their institutions seeking access to HeLa cell data in dbGaP must submit a data access request to NIH and be approved to access those data. To request data:

Investigators should review the “Special Instructions for Preparing a Research Use Statement for Requesting Access to HeLa Cell Genome Sequence Data in dbGaP” (https://sharing.nih.gov/sites/default/files/flmngr/HeLa%20special%20instructions.pdf) to compose a data access request for NIH review.
Investigators should submit the data access request to dbGaP for NIH review following instructions detailed here: https://sharing.nih.gov/accessing-data/accessing-genomic-data/how-to-request-and-access-datasets-from-dbgap.
All requests will be evaluated by the NIH Advisory Committee to the Director (ACD) HeLa Genome Data Access Working Group , composed of bioethicists, geneticists, and members of the Lacks family, to assess whether the request aligns with the terms of use defined in the HeLa Genome Data Use Agreement (https://acd.od.nih.gov/working-groups/hlgda.html).
- Requests will be evaluated up to one week before the Working Group meets, but NIH will consider requests submitted at any time of year. See here for additional information on when to submit requests before each Working Group’s meeting: https://acd.od.nih.gov/working-groups/hlgda.html#HeLaDates.
- The Working Group's evaluations 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.

Section IV. Acknowledgment Responsibilities for Investigators

NIH expects investigators who generate HeLa cell data or who have been approved for access to such data to acknowledge Mrs. Henrietta Lacks and her family in any publications, presentations, or other public reporting of research using this sample language (or something similar):

“The genome sequence described/used in this research was derived from a HeLa cell line. Mrs. Henrietta Lacks, and the HeLa cell line that was established from her tumor cells without her knowledge or consent in 1951, have made significant contributions to scientific progress and advances in human health. We are grateful to Mrs. Henrietta Lacks, now deceased, and to her surviving family members for their contributions to biomedical research.”

Inquiries

Please direct all inquiries to:

Office of Science Policy
Email: helagenome@nih.gov
Telephone: 301-496-9838