HeLa Genome Data Access Working Group Report to the Advisory Committee to the Director September 17 2015 Kathy Hudson, Ph.D. Clyde Yancy, M.D. Deputy Director for Science, Outreach, and Professor in Medicine-Cardiology and Medical Policy Social Sciences National Institutes of Health Chief, Division of Medicine-Cardiology Northwestern University Feinberg School of Medicine 2 The HeLa Genome Data Use Agreement Per the agreement between NIH and the Lacks family, NIH is requesting that all researchers:  Apply for access to HeLa whole genome sequence in the database of Genotype and Phenotype (dbGaP)  Abide by terms outlined in the HeLa Genome Data Use Agreement, such as: o Data can only be used for biomedical research only; this does not include the study of population origins or ancestry o Requestors are not to make contact with the Lacks family o Requestors are to disclose any commercial plans o Requestors are to include an acknowledgment in publications and presentations  Deposit future whole genome sequence data into dbGaP 3 Role of HeLa Genome Data Access Working Group  Evaluate requests to access HeLa cell genome data in dbGaP for consistency with the terms of the HeLa Genome Data Use Agreement  Report findings to the Advisory Committee to the Director  Make recommendations to the ACD on changes to the terms specified in the HeLa Genome Data Use Agreement 4 HeLa Genome Data Access Working Group Roster Clyde Yancy, M.D. (co-chair) Ruth Faden, Ph.D., M.P.H. Professor in Medicine-Cardiology and Medical Social Sciences Philip Franklin Wagley Professor in Biomedical Ethics Chief, Division of Medicine-Cardiology Director, Johns Hopkins Berman Institute of Bioethics Northwestern University Johns Hopkins University Feinberg School of Medicine David Lacks Jr. Kathy Hudson, Ph.D. (co-chair) Representative, Henrietta Lacks Family Deputy Director for Science, Outreach, and Policy National Institutes of Health Richard Myers, Ph.D. President, Director and Faculty Investigator HudsonAlpha Institute Russ Altman, M.D., Ph.D. Professor, Bioengineering, Genetics, & Medicine Robert Nussbaum, M.D. Director, Biomedical Informatics Training Program Professor of Medicine Stanford University Chief of Division of Genomic Medicine University of California, San Francisco Lisa Cooper, M.D., M.P.H. James F. Fries Professor of Medicine and Director, Johns Hopkins Center to Eliminate Cardiovascular Health Disparities Veronica Spencer Representative, Henrietta Lacks Family Johns Hopkins University School of Medicine 5 Working Group Evaluation Criteria  Is the proposed research focused on health, medical, or biomedical research objectives? o Is the proposed research related to determining the ancestry or population origins of HeLa cells?  Are there any plans to develop intellectual property? Specifically: o Does the requestor anticipate or foresee IP or developing commercial products or services from the proposed research? o Has the requestor agreed to notify NIH if their plans for IP or commercial products change?  Are there any plans to publish or present findings? 6 Types of Findings Reported by the Working Group In evaluating a Data Access Request, the Working Group will report a finding as: • Consistent with the Data Use Agreement • Inconsistent with the Data Use Agreement • Conditional (will be consistent with the Data Use Agreement if NIH staff find that additional information obtained from the Requestor is satisfactory) • Pending (will require a re-evaluation from the Working group once additional information is obtained from the Requestor) 7 Status of Data Access Requests Number of Requests Status Evaluated by the HeLa Genome Data Access Working 43 Group 35 Approved by NIH Director 1 Disapproved by NIH Director Disapproved by NIH staff (requestors did not respond to 5 requests for clarifications regarding publication plans, IP, and/or the non-technical summary) Number of Data Downloads Status 24 Approved requestors have downloaded the data Number of Annual Reports Status 20 (Renewal Requests) Approved administratively by NIH staff Number of New Requests Status 3 Being reported to ACD today 8 Working Group Findings: Evaluation of Access Requests Since the last ACD meeting, the Working Group has found 3 requests to be consistent with the HeLa Genome Data Use Agreement: Project Title Requestor’s Affiliation Working Group Findings Human Spliceosome Structure and Function University of California Santa CONSISTENT WITH Cruz DATA USE AGREEMENT Gene Copy Number at Naturally-Variant Loci in HeLa University of Arizona, Tucson CONSISTENT WITH DATA USE AGREEMENT Integrating Epigenetic Data with Hi-C to Infer 3D University of Oslo, Norway CONSISTENT WITH Models of Genomes DATA USE AGREEMENT 9 ACD Discussion, Vote, and Recommendations 10 Working Group Findings: Evaluation of Access Requests Since the last ACD meeting, the Working Group has found 3 requests to be consistent with the HeLa Genome Data Use Agreement: Project Title Requestor’s Affiliation Working Group Findings Human Spliceosome Structure and Function University of California Santa CONSISTENT WITH Cruz DATA USE AGREEMENT Gene Copy Number at Naturally-Variant Loci in HeLa University of Arizona, Tucson CONSISTENT WITH DATA USE AGREEMENT Integrating Epigenetic Data with Hi-C to Infer 3D University of Oslo, Norway CONSISTENT WITH Models of Genomes DATA USE AGREEMENT