Managing incidental findings and research results in genomic research involving biobanks and archived data sets.
paper
Cited
Public
- Authors
- Wolf, Susan M; Crock, Brittney N; Van Ness, Brian; Lawrenz, Frances; Kahn, Jeffrey P; Beskow, Laura M; Cho, Mildred K; Christman, Michael F; Green, Robert C; Hall, Ralph; Illes, Judy; Keane, Moira; Knoppers, Bartha M; Koenig, Barbara A; Kohane, Isaac S; Leroy, Bonnie; Maschke, Karen J; McGeveran, William; Ossorio, Pilar; Parker, Lisa S; Petersen, Gloria M; Richardson, Henry S; Scott, Joan A; Terry, Sharon F; Wilfond, Benjamin S; Wolf, Wendy A
- Year
- 2012
- Journal
- Genetics in medicine : official journal of the American College of Medical Genetics
- PMID
- 22436882
- DOI
- 10.1038/gim.2012.23
- PMCID
- PMC3597341
Biobanks and archived data sets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to manage incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors (using "biobank" here to refer both to collections of samples and collections of data). This article reports recommendations from a 2-year project funded by the National Institutes of Health. We analyze the responsibilities involved in managing the return of incidental findings and individual research results in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). We suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When reidentification of individual contributors is possible, the biobank should work to enable the biobank research system to discharge four core responsibilities to (1) clarify the criteria for evaluating findings and the roster of returnable findings, (2) analyze a particular finding in relation to this, (3) reidentify the individual contributor, and (4) recontact the contributor to offer the finding. We suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and are clinically actionable should generally be offered to consenting contributors. This article specifies 10 concrete recommendations, addressing new biobanks as well as those already in existence.
Depiction of primary researchers, biobank, and secondary researchers β a biobank research system. As noted, collection of data and samples from contributors may occur at Stage 1 research and collection sites, or at the biobank itself.
Roles and responsibilities for return of IFs and IRRs in a generic biobank research system (contributors not depicted).
| Name | Type |
|---|---|
| 23andMe | cohort |
| Abnormal blood pressure local | phenotype |
| Alzheimer's disease | phenotype |
| apoE | gene |
| Atherosclerotic disease local | phenotype |
| Best Practices for biorepositories local | cohort |
| Biobank network local | cohort |
| Biobank research system local | cohort |
| Biobank Research System local | cohort |
| biobanks | cohort |
| Biorepositories local | cohort |
| BioVU | cohort |
| blood pressure | phenotype |
| brain abnormalities | anatomy |
| BRCA2 | gene |
| BRCA2 variant local | variant |
| breast cancer | phenotype |
| caHUB | cohort |
| cancer Human Biobank | cohort |
| cancer-related findings local | phenotype |
| CLIA-certified Lab local | drug |
| CLIA-certified labs local | drug |
| Clinical personnel local | drug |
| ClinSeq local | cohort |
| CollectionSite local | cohort |
| Collection sites local | cohort |
| Collection Sites local | cohort |
| Colon cancer | phenotype |
| commonly used drug local | drug |
| Contributor local | cohort |
| contributor population local | cohort |
| Contributor Population local | cohort |
| contributors local | cohort |
| Contributors local | cohort |
| Coriell Personalized Medicine Collaborative local | cohort |
| DAA local | drug |
| DAC local | cohort |
| Data Access Committee local | cohort |
| Databases local | cohort |
| dbGaP | cohort |
| de-identification local | drug |
| deletion | variant |
| diagnosis | phenotype |
| discrepant diagnosis local | phenotype |
| disease | phenotype |
| donors | cohort |
| DUA local | drug |
| eMERGE network | cohort |
| eMERGE sites local | cohort |
| Environmental exposure information local | drug |
| environmental exposures | drug |
| Fabsitz et al. local | cohort |
| Framingham Heart Study | cohort |
| Genes, Environment and Health Initiative local | cohort |
| Genetic and genomic research results local | phenotype |
| Genetic counselors local | drug |
| Genetic IFs local | phenotype |
| genetic or genomic findings local | phenotype |
| genetic variant associated with catastrophic reaction to a commonly used drug local | variant |
| genetic variants | cohort |
| Geneva | cohort |
| HealthCareSetting local | cohort |
| Hospital local | cohort |
| Human Research Participant local | cohort |
| human subjects | cohort |
| ICOB local | cohort |
| ICOBs local | cohort |
| IFs local | phenotype |
| IFs/IRRs local | phenotype |
| Incidental Finding local | phenotype |
| incidental findings local | phenotype |
| Incidental findings local | phenotype |
| Incidental Findings local | phenotype |
| Incidental Findings Committees local | cohort |
| Incidental Findings Files local | cohort |
| Incidental findings (IFs) local | phenotype |
| Incidental Findings (IFs) local | phenotype |
| incidental research results local | phenotype |
| Incidental research results (IRRs) local | phenotype |
| Incidental Research Results (IRRs) local | phenotype |
| Individual Research Result local | phenotype |
| individual research results local | phenotype |
| Individual research results local | phenotype |
| Individual Research Results local | phenotype |
| Individual Studies local | cohort |
| Institutional Sources local | cohort |
| IRB local | cohort |
| IRRs local | phenotype |
| ISBER local | cohort |
| Kaiser Permanente Research Program on Genes, Environment, and Health local | cohort |
| life-threatening condition local | phenotype |
| Mayo biobank local | cohort |
| Mayo Clinic | cohort |
| Medical information local | drug |
| MTA local | drug |
| Myeloma Bank on a Cureβ’ local | cohort |
| National Cancer Institute | cohort |
| National Childrenβs Study local | cohort |
| neuroimaging scans local | anatomy |
| neuroimaging scans local | drug |
| NIH | cohort |
| NIH intramural biobanks local | cohort |
| Non-genetic IFs local | phenotype |
| non-U.S. biobanks local | cohort |
| Northwestern NUgene local | cohort |
| pancreatic cancer | phenotype |
| participants | cohort |
| pathology | phenotype |
| Personal Genome Project local | cohort |
| Personalized Medicine Project at Marshfield Clinic local | cohort |
| pharmaceutical company local | cohort |
| phenotype | phenotype |
| physicians | cohort |
| population | cohort |
| population biobanks local | cohort |
| Population of Contributors local | cohort |
| Primary Research local | cohort |
| PrimaryResearch local | cohort |
| Primary Researcher local | cohort |
| Primary researchers local | cohort |
| Primary Researchers local | cohort |
| Primary Research Sites local | cohort |
| private biobank local | cohort |
| public biobank local | cohort |
| re-identification local | drug |
| reproductive importance local | phenotype |
| Researchers local | cohort |
| Research Networks local | cohort |
| research participants | cohort |
| Returnable Findings local | phenotype |
| Returnable IFs/IRRs local | phenotype |
| Return of Results Committees local | cohort |
| REVEAL Study local | cohort |
| Secondary Research local | cohort |
| Secondary researchers local | cohort |
| Secondary Researchers local | cohort |
| Secondary researcher sites local | cohort |
| Secondary Research Sites local | cohort |
| serious health condition local | phenotype |
| sources local | cohort |
| Specimen pathology local | phenotype |
| study cohort | cohort |
| trait | phenotype |
| Trusted intermediary local | cohort |
| Trusted Intermediary local | drug |
| tumor specimens local | phenotype |
| UK Biobank | cohort |
| University of Connecticut Behavioral Gene Bank local | cohort |
| U.S. biobanks local | cohort |
| Vanderbilt BioVU local | cohort |
| Wolf et al. local | cohort |
| Working Group local | cohort |
| Yale University IRBs local | cohort |
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