This 2-year renewal project builds on our previous NHGRI-funded project on """"""""Managing Incidental Findings in Human Subjects Research"""""""" (#1 R01 HG003178-01A1). Using that project's outcomes as a foundation, we now propose a 2-year renewal project to address one of the most pressing issues facing genomic research: What information, if any, about incidental findings (IFs) and individual research results (IRRs) should be offered back to the individuals whose DNA and data are collected and housed in genomic biobanks and archived datasets? We will convene a multidisciplinary Working Group in order to develop normative consensus recommendations on managing IFs and IRRs in genomic research using biobanks and large archives. There are 10 components to this project: (1) identification of U.S. biobanks (defined in this project to include datasets and DNA samples archived for reanalysis) and websites where available;(2) collection of the relevant literature, guidelines, law, and regulations, including international guidelines and statements on biobank management;(3) collection and content analysis of biobank websites (including policy statements, consent forms, FAQs answers, and other informative material) to analyze approaches to IFs and return of IRRs;(4) collection and content analysis of relevant documents by emailing the manager or director of biobanks identified, including those with no or uninformative websites;(5) collection and content analysis of relevant non-U.S. documents from the websites of major international (non-U.S.) biobanks with websites in English and by email to the manager or director of each biobank;(6) development of normative consensus recommendations providing guidance on how to handle IFs and return of IRRs in genomic biobank research and soliciting feedback;(7) authorship of targeted analyses of this problem and the legal aspects;(8) presentation of consensus recommendations and targeted analyses at a public conference for feedback;(9) publication as a symposium in a prominent journal;and (10) development of a publicly available website containing tools for biobanks, their ethics oversight bodies, IRBs, researchers, research participants, scholars, and others on managing IFs and return of IRRs, including an annotated bibliography with web links. To accomplish this, the project will involve 3 methodologies: (A) a normative process to reach consensus on how IFs and IRRs should be managed in genomic research involving biobanks and archived samples and data, supported by (B) empirical and analytic research systematically collecting the relevant literature, guidance documents, regulations, and law, with structured content analysis of (a) the policy, informational, and consent documents publicly available on biobank websites, and (b) additional documents collected by email query from biobank managers and directors, and (C) international comparison of the policies on return of IFs and IRRs among major DNA biobanks with English-speaking websites.

Public Health Relevance

In order to understand the genetic contribution to a host of diseases and conditions of great importance to public health, scientists are increasingly assembling large biobanks archiving many individuals'DNA and health information for scientific reanalysis over time. However, there is no clarity about what individual health information, if any, should be given back to those people generous enough to donate;some prominent biobanks are giving back none at all. This project will convene leading experts on bioethics, genomics, biobanking, and law to recommend ethical policies and practices on return of both incidental findings and individual research results that may have importance for the donor.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Research Project (R01)
Project #
5R01HG003178-04
Application #
7938783
Study Section
Special Emphasis Panel (ZRG1-HOP-J (90))
Program Officer
Mcewen, Jean
Project Start
2004-07-01
Project End
2011-07-31
Budget Start
2010-08-01
Budget End
2011-07-31
Support Year
4
Fiscal Year
2010
Total Cost
$496,018
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Type
Other Domestic Higher Education
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
Krier, Joel B; Green, Robert C (2015) Management of Incidental Findings in Clinical Genomic Sequencing. Curr Protoc Hum Genet 87:9.23.1-16
McGuire, Amy L; Joffe, Steven; Koenig, Barbara A et al. (2013) Point-counterpoint. Ethics and genomic incidental findings. Science 340:1047-8
Green, Robert C; Berg, Jonathan S; Grody, Wayne W et al. (2013) ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med 15:565-74
Wolf, Susan M (2013) Return of results in genomic biobank research: ethics matters. Genet Med 15:157-9
Krier, Joel B; Green, Robert C (2013) Management of incidental findings in clinical genomic sequencing. Curr Protoc Hum Genet Chapter 9:Unit9.23
Green, Robert C; Lupski, James R; Biesecker, Leslie G (2013) Reporting genomic sequencing results to ordering clinicians: incidental, but not exceptional. JAMA 310:365-6
Johnson, Gina; Lawrenz, Frances; Thao, Mao (2012) An empirical examination of the management of return of individual research results and incidental findings in genomic biobanks. Genet Med 14:444-50
Beskow, Laura M; Burke, Wylie; Fullerton, Stephanie M et al. (2012) Offering aggregate results to participants in genomic research: opportunities and challenges. Genet Med 14:490-6
Richardson, Henry S; Cho, Mildred K (2012) Secondary researchers' duties to return incidental findings and individual research results: a partial-entrustment account. Genet Med 14:467-72
Scott, Christopher Thomas; Caulfield, Timothy; Borgelt, Emily et al. (2012) Personal medicine--the new banking crisis. Nat Biotechnol 30:141-7

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