Notice Number: NOT-OD-14-080
Release Date: April 16, 2014
National Institutes of Health (NIH)
The purpose of this Guide Notice is to clarify that NIH-funded investigators who have generated and submitted HeLa cell whole genome DNA or RNA sequence data to dbGaP must submit a data access request if they plan to use these data in any analyses.
As outlined in an August 14, 2013, Guide Notice (available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-099.html), NIH expects all NIH-funded investigators (e.g., grantees, contractors, and NIH intramural researchers) who propose to generate HeLa cell whole genome sequencing data from DNA or RNA to include a plan for submission of these data to dbGaP in the "Research Sharing Plan" of their funding application. The plan should include provisions for the data to be added to the dbGaP study page for HeLa Cell Genome Sequencing Studies (http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000640) and an acknowledgement that the researcher agrees to the provisions of the HeLa Genome Data Use Agreement (available at https://dbgap.ncbi.nlm.nih.gov/aa/wga.cgi?view_pdf&stacc=phs000640.v2.p1).
NIH-funded investigators who have generated and submitted HeLa cell whole genome sequence data from DNA or RNA to dbGaP must submit a data access request if they plan to use the these data in any analyses. The process for accessing these data is outlined on the HeLa Cell Genome Sequencing Studies page (available at http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000640).
Investigators who are requesting to use the data they generated and submitted should describe how they plan to use the data, and the use should be consistent with the HeLa Cell Genome Data Use Agreement (https://dbgap.ncbi.nlm.nih.gov/aa/wga.cgi?view_pdf&stacc=phs000640.v2.p1). Investigators should submit an updated request if, at any time, they change the scope of their research and the intended use of the data from that originally proposed in the data access request.
NIH Guidance on Family Acknowledgement
NIH expects investigators who have generated or used HeLa cell whole genome sequencing data from DNA or RNA maintained in dbGaP to acknowledge Henrietta Lacks and her family in any publications, presentations, or other public reporting of research using these genomic data (see sample text at: http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?document_name=HeLaAcknowledgement.pdf) and to note that their data request was approved by the NIH Director based on the recommendations of the Advisory Committee to the Director and the evaluation of its HeLa Genome Data Access Working Group.
Please direct all inquiries to:
Office of Science Policy
Office of the Director, National Institutes of Health