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).
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| Name | Type |
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| 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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| Title | Authors | Journal | Year | Link |
|---|---|---|---|---|
| Genetic analysis and reporting from whole-exome sequencing data in 1052 patients with intellectual disability. | Pan X et al. | β | 2026 | β |
| Return of health research findings in Nigeria-perspective of potential research participants. | Chukwukelu VN et al. | β | 2026 | β |
| Returning Individual-Level Urgent or Emergent Research Results to Participants: The Project Baseline Health Study Experience. | Pagidipati N et al. | β | 2025 | β |
| Return of health research findings in Nigeria-perspective of potential research participants | Chukwukelu V et al. | β | 2025 | β |
| "We know what to do for you, but we can't do it:" How actionability is coordinated and contested in genomics research. | Mayes EC | β | 2025 | β |
| Deep learning and predictive modelling for generating normalised muscle function parameters from signal images of mandibular electromyography. | Farook TH et al. | β | 2024 | β |
| Expert Stakeholder Perspectives on Emerging Technology for Neuroimaging Research with Highly Portable MRI: The Need for Guidance on Ethical, Legal, and Societal Issues. | Madzelan MK et al. | β | 2024 | β |
| Far from Home: Managing Incidental Findings in Field Research with Portable MRI. | Wolf SM et al. | β | 2024 | β |
| Informing cognitively healthy research participants of modifiable dementia risk factors: Ethical implications. | Graham M et al. | β | 2024 | β |
| Applying Genetic and Genomic Tools to Psychiatric Disorders: A Scoping Review. | IItis AS et al. | β | 2023 | β |
| Attitudes and beliefs regarding race-targeted genetic testing of Black people: A systematic review. | Iltis AS et al. | β | 2023 | β |
| Consent Codes: Maintaining Consent in an Ever-expanding Open Science Ecosystem. | Dyke SOM et al. | β | 2023 | β |
| Effects of Interventions to Prevent Work-Related Asthma, Allergy, and Other Hypersensitivity Reactions in Norwegian Salmon Industry Workers (SHInE): Protocol for a Pragmatic Allocated Intervention Trial and Related Substudies. | HΓΆper AC et al. | β | 2023 | β |
| GBA/GBN-position on the feedback of incidental findings in biobank-based research: consensus-based workflow for hospital-based biobanks. | Geiger J et al. | β | 2023 | β |
| Immortal data: a qualitative exploration of patients' understandings of genomic data. | Lyle K et al. | β | 2023 | β |
| Old and new challenges regarding comparable and viable data sharing in population-scale genomic research. | Raz A et al. | β | 2023 | β |
| Return of Results in Genomic Research Using Large-Scale or Whole Genome Sequencing: Toward a New Normal. | Wolf SM et al. | β | 2023 | β |
| Communicating and Using Dementia Risk Evidence. | Rosen AC | β | 2022 | β |
| [Diagnosis of genetic disorders in childhood with next-generation sequencing]. | MenyhΓ‘rt O et al. | β | 2022 | β |
| Evolution of biobanks and ethical governance for the emerging applications in biomedical research. | Chandrashekar C et al. | β | 2022 | β |
| Identification and Assessment of Risks in Biobanking: The Case of the Cancer Institute of Bari. | De Palma G et al. | β | 2022 | β |
| Informed consent, genomic research and mental health: A integrative review. | Kilkku N et al. | β | 2022 | β |
| Perspectives on returning individual and aggregate genomic research results to study participants and communities in Kenya: a qualitative study. | Kisiangani I et al. | β | 2022 | β |
| Preferences for return of germline genome sequencing results for cancer patients and their genetic relatives in a research setting. | Best MC et al. | β | 2022 | β |
| The return of individual genomic results to research participants: design and pilot study of Tohoku Medical Megabank Project. | Kawame H et al. | β | 2022 | β |
| Actionable secondary findings in arrhythmogenic right ventricle cardiomyopathy genes: impact and challenge of genetic counseling. | Abicht A et al. | β | 2021 | β |
| A systematic approach to the disclosure of genomic findings in clinical practice and research: a proposed framework with colored matrix and decision-making pathways. | Matsui K et al. | β | 2021 | β |
| Biobanking and risk assessment: a comprehensive typology of risks for an adaptive risk governance. | AkyΓΌz K et al. | β | 2021 | β |
| Biorepositories and Databanks for the Development of Novel Biomarkers for Genitourinary Cancer Prevention and Management. | Wagner H et al. | β | 2021 | β |
| Content and Method of Information for Participants in Clinical Studies With Induced Pluripotent Stem Cells (iPSCs). | Orzechowski M et al. | β | 2021 | β |
| DNA-based screening and personal health: a points to consider statement for individuals and health-care providers from the American College of Medical Genetics and Genomics (ACMG). | Bean LJH et al. | β | 2021 | β |
| Genetic Contribution to Metastatic Prostate Cancer. | Sokolova AO et al. | β | 2021 | β |
| Reflections on dynamic consent in biomedical research: the story so far. | Teare HJA et al. | β | 2021 | β |
| Returning actionable genomic results in a research biobank: Analytic validity, clinical implementation, and resource utilization. | Blout Zawatsky CL et al. | β | 2021 | β |
| Return of results in a global survey of psychiatric genetics researchers: practices, attitudes, and knowledge. | LΓ‘zaro-MuΓ±oz G et al. | β | 2021 | β |
| Systematic Review of the Economic Evaluation of Returning Incidental Findings in Genomic Research. | Fontes Marx M et al. | β | 2021 | β |
| Taking it to the bank: the ethical management of individual findings arising in secondary research. | Graham M et al. | β | 2021 | β |
| The Exposome Approach in Allergies and Lung Diseases: Is It Time to Define a Preconception Exposome? | LΓ³pez-Cervantes JP et al. | β | 2021 | β |
| The impact of reporting magnetic resonance imaging incidental findings in the Canadian alliance for healthy hearts and minds cohort. | Luu JM et al. | β | 2021 | β |
| To disclose, or not to disclose? Perspectives of clinical genomics professionals toward returning incidental findings from genomic research. | AlFayyad I et al. | β | 2021 | β |
| Whether, when, how, and how much? General public's and cancer patients' views about the disclosure of genomic secondary findings. | ClΓ©ophat JE et al. | β | 2021 | β |
| A proposal on the first Japanese practical guidance for the return of individual genomic results in research settings. | Aizawa Y et al. | β | 2020 | β |
| Assessing the Intention to Provide Human Genetic Resources: An Explanatory Model. | Qin Q et al. | β | 2020 | β |
| Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis. | Schickhardt C et al. | β | 2020 | β |
| Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics. | Wolf SM et al. | β | 2020 | β |
| Navigating the Intersection between Genomic Research and Clinical Practice. | Daly MB | β | 2020 | β |
| Pilot Study of Return of Genetic Results to Patients in Adult Nephrology. | Nestor JG et al. | β | 2020 | β |
| Preferences to receive unsolicited findings of germline genome sequencing in a large population of patients with cancer. | Bijlsma R et al. | β | 2020 | β |
| Psychiatric genomics researchers' perspectives on best practices for returning results to individual participants. | Kostick K et al. | β | 2020 | β |
| Reporting Genetic Findings to Individual Research Participants: Guidelines From the Swiss Personalized Health Network. | Blasimme A et al. | β | 2020 | β |
| Returning Results of Stored Biological Samples and Biobanks: Perspectives of Saudi Arabian Biomedical Researchers. | Alahmad G et al. | β | 2020 | β |
| Return of Individual Research Results: A Guide for Biomedical Researchers Utilizing Human Biospecimens. | Sobel ME et al. | β | 2020 | β |
| A Belmont Reboot: Building a Normative Foundation for Human Research in the 21st Century. | Brothers KB et al. | β | 2019 | β |
| A FAUSTIAN BARGAIN THAT UNDERMINES RESEARCH PARTICIPANTS' PRIVACY RIGHTS AND RETURN OF RESULTS. | Evans BJ et al. | β | 2019 | β |
| Ethical and Policy Considerations for Genomic Testing in Pediatric Research: The Path Toward Disclosing Individual Research Results. | Wong CS et al. | β | 2019 | β |
| Evaluation of the cost and effectiveness of diverse recruitment methods for a genetic screening study. | Milo Rasouly H et al. | β | 2019 | β |
| Genomic Contextualism: Shifting the Rhetoric of Genetic Exceptionalism. | Garrison NA et al. | β | 2019 | β |
| Implementation of genomics in medical practice to deliver precision medicine for an Asian population. | Bylstra Y et al. | β | 2019 | β |
| Issues in the Use of Human Tissues to Support Precision Medicine. | Grizzle WE | β | 2019 | β |
| Managing "incidental findings" in biobank research: Recommendations of the Taiwan biobank. | Lin JC et al. | β | 2019 | β |
| Personalized Medicine and the Power of Electronic Health Records. | Abul-Husn NS et al. | β | 2019 | β |
| Physicians' perspectives on receiving unsolicited genomic results. | Pet DB et al. | β | 2019 | β |
| Preferences for Return of Genetic Results Among Participants in the Jackson Heart Study and Framingham Heart Study. | Joffe S et al. | β | 2019 | β |
| Prodromes and Preclinical Detection of Brain Diseases: Surveying the Ethical Landscape of Predicting Brain Health. | Ahlgrim NS et al. | β | 2019 | β |
| Responsible Conduct of Human Subjects Research in Islamic Communities. | Al-Khatib A et al. | β | 2019 | β |
| Return of genetic and genomic research findings: experience of a pediatric biorepository. | Papaz T et al. | β | 2019 | β |
| Return of individual genomic research results: are laws and policies keeping step? | Thorogood A et al. | β | 2019 | β |
| Should Researchers Offer Results to Family Members of Cancer Biobank Participants? A Mixed-Methods Study of Proband and Family Preferences. | Gordon DR et al. | β | 2019 | β |
| THE GENETIC INFORMATION NONDISCRIMINATION ACT AT AGE 10: GINA'S CONTROVERSIAL ASSERTION THAT DATA TRANSPARENCY PROTECTS PRIVACY AND CIVIL RIGHTS. | Evans BJ | β | 2019 | β |
| The Responsibility to Recontact Research Participants after Reinterpretation of Genetic and Genomic Research Results. | Bombard Y et al. | β | 2019 | β |
| APPLaUD: access for patients and participants to individual level uninterpreted genomic data. | Thorogood A et al. | β | 2018 | β |
| Approaches to carrier testing and results disclosure in translational genomics research: The clinical sequencing exploratory research consortium experience. | Porter KM et al. | β | 2018 | β |
| Aspects of Modern Biobank Activity - Comprehensive Review. | Paskal W et al. | β | 2018 | β |
| Attitudes Toward Return of Genetic Research Results to Relatives, Including After Death: Comparison of Cancer Probands, Blood Relatives, and Spouse/Partners. | Radecki Breitkopf C et al. | β | 2018 | β |
| Beyond Recommendation: Requiring Returning Findings to Research Participants. | Wurst T et al. | β | 2018 | β |
| Development of a consensus approach for return of pathology incidental findings in the Genotype-Tissue Expression (GTEx) project. | Lockhart NC et al. | β | 2018 | β |
| Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience. | Fossey R et al. | β | 2018 | β |
| Impact of Receiving Secondary Results from Genomic Research: A 12-Month Longitudinal Study. | Wynn J et al. | β | 2018 | β |
| Large-Scale Genomic Biobanks and Cardiovascular Disease. | Small AM et al. | β | 2018 | β |
| Opportunities and Challenges for Genetic Studies of End-Stage Renal Disease in Canada. | Kalatharan V et al. | β | 2018 | β |
| Paediatric genomics: diagnosing rare disease in children. | Wright CF et al. | β | 2018 | β |
| Patients' Attitudes Towards the Return of Incidental Findings After Research with Residual Tissue: A Mixed Methods Study. | Vermeulen E et al. | β | 2018 | β |
| Perceptions of legislation relating to the sharing of genomic biobank results with donors-a survey of BBMRI-ERIC biobanks. | Brunfeldt M et al. | β | 2018 | β |
| Reconsidering the duty to warn genetically at-risk relatives. | Rothstein MA | β | 2018 | β |
| Research use of electronic health records: patients' perspectives on contact by researchers. | Brelsford KM et al. | β | 2018 | β |
| Return of results and data to study participants. | Wolf SM et al. | β | 2018 | β |
| Thought leader perspectives on benefits and harms in precision medicine research. | Beskow LM et al. | β | 2018 | β |
| Towards precision nephrology: the opportunities and challenges of genomic medicine. | Nestor JG et al. | β | 2018 | β |
| Translating Biobank Science into Patient-Centered Language. | Coors ME et al. | β | 2018 | β |
| What information and the extent of information research participants need in informed consent forms: a multi-country survey. | Karbwang J et al. | β | 2018 | β |
| Clinical genome sequencing and population preferences for information about 'incidental' findings-From medically actionable genes (MAGs) to patient actionable genes (PAGs). | Ploug T et al. | β | 2017 | β |
| Clinical verification of genetic results returned to research participants: findings from a Colon Cancer Family Registry. | Laurino MY et al. | β | 2017 | β |
| Defining categories of actionability for secondary findings in next-generation sequencing. | Moret C et al. | β | 2017 | β |
| Engaging MΔori in biobanking and genomic research: a model for biobanks to guide culturally informed governance, operational, and community engagement activities. | Beaton A et al. | β | 2017 | β |
| Ethical Legal and Social Issues of Biobanking: Past, Present, and Future. | Bledsoe MJ | β | 2017 | β |
| Expect the unexpected: screening for secondary findings in clinical genomics research. | Mackley MP et al. | β | 2017 | β |
| "Forward-Thinking" in U.S. Biobanking. | Cadigan RJ et al. | β | 2017 | β |
| From Sequence Data to Returnable Results: Ethical Issues in Variant Calling and Interpretation. | Holm IA et al. | β | 2017 | β |
| Identifying public expectations of genetic biobanks. | Critchley C et al. | β | 2017 | β |
| Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators. | Kost RG et al. | β | 2017 | β |
| Moral Duties of Genomics Researchers: Why Personalized Medicine Requires a Collective Approach. | Vos S et al. | β | 2017 | β |
| Navigating social and ethical challenges of biobanking for human microbiome research. | Chuong KH et al. | β | 2017 | β |
| Pathogenic variants in the healthy elderly: unique ethical and practical challenges. | Lacaze P et al. | β | 2017 | β |
| Pediatric Issues in Return of Results and Incidental Findings: Weighing Autonomy and Best Interests. | Holm IA | β | 2017 | β |
| Population-based biobank participants' preferences for receiving genetic test results. | Yamamoto K et al. | β | 2017 | β |
| Preferences for the Return of Individual Results From Research on Pediatric Biobank Samples. | Christensen KD et al. | β | 2017 | β |
| Returning Results in Biobank Research: Global Trends and Solutions. | De Clercq E et al. | β | 2017 | β |
| Returning Results: Let's Be Honest! | Elger BS et al. | β | 2017 | β |
| Review: Genetic research on alcohol use outcomes in African American populations: A review of the literature, associated challenges, and implications. | Dick DM et al. | β | 2017 | β |
| The Continuing Evolution of Ethical Standards for Genomic Sequencing in Clinical Care: Restoring Patient Choice. | Wolf SM | β | 2017 | β |
| The Right to Know and the Right Not to Know Revisited: Part One. | Brownsword R et al. | β | 2017 | β |
| The science behind One Health: at the interface of humans, animals, and the environment. | Murtaugh MP et al. | β | 2017 | β |
| Tissue lithography: Microscale dewaxing to enable retrospective studies on formalin-fixed paraffin-embedded (FFPE) tissue sections. | Cors JF et al. | β | 2017 | β |
| Which Results to Return: Subjective Judgments in Selecting Medically Actionable Genes. | LΓ‘zaro-MuΓ±oz G et al. | β | 2017 | β |
| A Clinical Service to Support the Return of Secondary Genomic Findings in Human Research. | Darnell AJ et al. | β | 2016 | β |
| Aggregate penetrance of genomic variants for actionable disorders in European and African Americans. | Natarajan P et al. | β | 2016 | β |
| Allocation of Resources to Communication of Research Result Summaries. | Richards JE et al. | β | 2016 | β |
| An eMERGE Clinical Center at Partners Personalized Medicine. | Smoller JW et al. | β | 2016 | β |
| Association of Arrhythmia-Related Genetic Variants With Phenotypes Documented in Electronic Medical Records. | Van Driest SL et al. | β | 2016 | β |
| A Systematic Review of the Management of Incidental Findings in Genomic Research. | Ewuoso C | β | 2016 | β |
| Bioethics in Iceland. | Γrnason V | β | 2016 | β |
| Building the Partners HealthCare Biobank at Partners Personalized Medicine: Informed Consent, Return of Research Results, Recruitment Lessons and Operational Considerations. | Karlson EW et al. | β | 2016 | β |
| Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study. | Pulford DJ et al. | β | 2016 | β |
| Defining Ourselves: Personal Bioinformation as a Tool of Narrative Self-Conception. | Postan E | β | 2016 | β |
| Defining the Clinical Value of a Genomic Diagnosis in the Era of Next-Generation Sequencing. | Strande NT et al. | β | 2016 | β |
| Family decision maker perspectives on the return of genetic results in biobanking research. | Siminoff LA et al. | β | 2016 | β |
| Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe? | Budin-LjΓΈsne I et al. | β | 2016 | β |
| Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era. | Chalmers D et al. | β | 2016 | β |
| Incidentalome from Genomic Sequencing: A Barrier to Personalized Medicine? | Jamuar SS et al. | β | 2016 | β |
| Lay Attitudes Toward Trust, Uncertainty, and the Return of Pediatric Research Results in Biobanking. | Lynch J et al. | β | 2016 | β |
| Personal Genome Sequencing in Ostensibly Healthy Individuals and the PeopleSeq Consortium. | Linderman MD et al. | β | 2016 | β |
| Pharmacogenomic incidental findings in 308 families: The NIH Undiagnosed Diseases Program experience. | Lee EM et al. | β | 2016 | β |
| Return of individual genomic research results: what do consent forms tell participants? | Pereira S et al. | β | 2016 | β |
| Samples and data accessibility in research biobanks: an explorative survey. | Capocasa M et al. | β | 2016 | β |
| The Advantages and Challenges of Testing Children for Heritable Predisposition to Cancer. | Kesserwan C et al. | β | 2016 | β |
| Views of Cohort Study Participants about Returning Research Results in the Context of Precision Medicine. | Hyams T et al. | β | 2016 | β |
| A critical analysis of cancer biobank practices in relation to biospecimen quality. | Rush A et al. | β | 2015 | β |
| Adolescent perspectives on the return of individual results in genomic addiction research. | Coors ME et al. | β | 2015 | β |
| An update to returning genetic research results to individuals: perspectives of the industry pharmacogenomics working group. | Prucka SK et al. | β | 2015 | β |
| Attitudes of the general public towards the disclosure of individual research results and incidental findings from biobank genomic research in Australia. | Fleming J et al. | β | 2015 | β |
| Attitudes toward molecular testing for personalized cancer therapy. | Yusuf RA et al. | β | 2015 | β |
| Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice? | Prince AE et al. | β | 2015 | β |
| Biobanking for Personalized Medicine. | Liu A et al. | β | 2015 | β |
| Collectivizing rescue obligations in bioethics. | Garrett JR | β | 2015 | β |
| Communicating results in post-Belmont era biomonitoring studies: lessons from genetics and neuroimaging research. | Morello-Frosch R et al. | β | 2015 | β |
| Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research. | Ortiz-Osorno AB et al. | β | 2015 | β |
| DataSHIELD: an ethically robust solution to multiple-site individual-level data analysis. | Budin-LjΓΈsne I et al. | β | 2015 | β |
| EngageUC: Developing an Efficient and Ethical Approach to Biobanking Research at the University of California. | Garrett SB et al. | β | 2015 | β |
| Ethical considerations in biobanks: how a public health ethics perspective sheds new light on old controversies. | Virani AH et al. | β | 2015 | β |
| Frequency and spectrum of actionable pathogenic secondary findings in 196 Korean exomes. | Jang MA et al. | β | 2015 | β |
| Genetic diagnosis of developmental disorders in the DDD study: a scalable analysis of genome-wide research data. | Wright CF et al. | β | 2015 | β |
| Genetic studies of quantitative MCI and AD phenotypes in ADNI: Progress, opportunities, and plans. | Saykin AJ et al. | β | 2015 | β |
| Governing the research-care divide in clinical biobanking: Dutch perspectives. | Boeckhout M et al. | β | 2015 | β |
| How Much Control Do Children and Adolescents Have over Genomic Testing, Parental Access to Their Results, and Parental Communication of Those Results to Others? | Clayton EW | β | 2015 | β |
| International Policies on Sharing Genomic Research Results with Relatives: Approaches to Balancing Privacy with Access. | Branum R et al. | β | 2015 | β |
| INTRODUCTION: Return of Research Results: What About the Family? | Wolf SM | β | 2015 | β |
| Managing the Ethical Issues of Genomic Research using Pathology Specimens. | Zeps N et al. | β | 2015 | β |
| Mapping the Ethics of Translational Genomics: Situating Return of Results and Navigating the Research-Clinical Divide. | Wolf SM et al. | β | 2015 | β |
| Participant Satisfaction With a Preference-Setting Tool for the Return of Individual Research Results in Pediatric Genomic Research. | Holm IA et al. | β | 2015 | β |
| Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease. | Prince AE | β | 2015 | β |
| Researchers' views on informed consent for return of secondary results in genomic research. | Appelbaum PS et al. | β | 2015 | β |
| Research findings with clinical implications. | Bjugn R | β | 2015 | β |
| Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations. | Wolf SM et al. | β | 2015 | β |
| Returning a Research Participant's Genomic Results to Relatives: Perspectives from Managers of Two Distinct Research Biobanks. | Petersen GM et al. | β | 2015 | β |
| Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles. | Beskow LM et al. | β | 2015 | β |
| Return of Results from Research Using Newborn Screening Dried Blood Samples. | Lewis MH et al. | β | 2015 | β |
| Sharing the Knowledge: Sharing Aggregate Genomic Findings with Research Participants in Developing Countries. | Kerasidou A | β | 2015 | β |
| Sharing with More Caring: Coordinating and Improving the Ethical Governance of Data and Biomaterials Obtained from Children. | Longstaff H et al. | β | 2015 | β |
| So rare we need to hunt for them: reframing the ethical debate on incidental findings. | Schuol S et al. | β | 2015 | β |
| Stakeholders' perspectives on biobank-based genomic research: systematic review of the literature. | Husedzinovic A et al. | β | 2015 | β |
| The development of a preference-setting model for the return of individual genomic research results. | Bacon PL et al. | β | 2015 | β |
| The EuroBioBank Network: 10 years of hands-on experience of collaborative, transnational biobanking for rare diseases. | Mora M et al. | β | 2015 | β |
| The Importance of Quality Patient Advocacy to Biobanks: A Lay Perspective from Independent Cancer Patients Voice (ICPV), Based in the United Kingdom. | Wilcox M et al. | β | 2015 | β |
| The new world of genomic testing, families and privacy. | Wolf SM | β | 2015 | β |
| Understanding patient and provider perceptions and expectations of genomic medicine. | Hall MJ et al. | β | 2015 | β |
| Using community-based participatory research principles to develop more understandable recruitment and informed consent documents in genomic research. | Skinner HG et al. | β | 2015 | β |
| A framework for analyzing the ethics of disclosing genetic research findings. | Eckstein L et al. | β | 2014 | β |
| An implementation framework for the feedback of individual research results and incidental findings in research. | Thorogood A et al. | β | 2014 | β |
| Attitudes of non-African American focus group participants toward return of results from exome and whole genome sequencing. | Yu JH et al. | β | 2014 | β |
| Attitudes of parents toward the return of targeted and incidental genomic research findings in children. | Fernandez CV et al. | β | 2014 | β |
| Autonomy, the Right Not to Know, and the Right to Know Personal Research Results: What Rights Are There, and Who Should Decide about Exceptions? | Helgesson G | β | 2014 | β |
| Biobank participants' preferences for disclosure of genetic research results: perspectives from the OurGenes, OurHealth, OurCommunity project. | Allen NL et al. | β | 2014 | β |
| Biobanks and personalized medicine. | Olson JE et al. | β | 2014 | β |
| Biobanks containing clinical specimens: defining characteristics, policies, and practices. | Edwards T et al. | β | 2014 | β |
| Can I be sued for that? Liability risk and the disclosure of clinically significant genetic research findings. | McGuire AL et al. | β | 2014 | β |
| Developing an institutional cancer biorepository for personalized medicine. | Liu A | β | 2014 | β |
| Disclosure of genetic research results to members of a founder population. | Anderson RL et al. | β | 2014 | β |
| Emerging issues in public health genomics. | Roberts JS et al. | β | 2014 | β |
| Ethical challenges for the design and conduct of mega-biobanking from Great East Japan Earthquake victims. | Matsui K et al. | β | 2014 | β |
| Ethical considerations of research policy for personal genome analysis: the approach of the Genome Science Project in Japan. | Minari J et al. | β | 2014 | β |
| Factors that may influence the willingness of cancer patients to consent for biobanking. | Pillai U et al. | β | 2014 | β |
| Guidelines for return of research results from pediatric genomic studies: deliberations of the Boston Children's Hospital Gene Partnership Informed Cohort Oversight Board. | Holm IA et al. | β | 2014 | β |
| Harnessing massively parallel sequencing in personalized head and neck oncology. | Jessri M et al. | β | 2014 | β |
| How do researchers manage genetic results in practice? The experience of the multinational Colon Cancer Family Registry. | Keogh LA et al. | β | 2014 | β |
| Human subjects protection: an event monitoring committee for research studies of girls from breast cancer families. | Harris D et al. | β | 2014 | β |
| Impact of non-welfare interests on willingness to donate to biobanks: an experimental survey. | Gornick MC et al. | β | 2014 | β |
| Implementing risk-stratified screening for common cancers: a review of potential ethical, legal and social issues. | Hall AE et al. | β | 2014 | β |
| Incidental findings from clinical genome-wide sequencing: a review. | Lohn Z et al. | β | 2014 | β |
| Incidental findings in medical imaging and genetic testing: opportunities and challenges. | Erickson LA | β | 2014 | β |
| Incidental findings: the time is not yet ripe for a policy for biobanks. | Viberg J et al. | β | 2014 | β |
| Informed consent for return of incidental findings in genomic research. | Appelbaum PS et al. | β | 2014 | β |
| INTRODUCTION: From the Right to Know to the Right Not to Know. | Knoppers BM | β | 2014 | β |
| Life insurance: genomic stratification and risk classification. | Joly Y et al. | β | 2014 | β |
| Managing clinically significant findings in research: the UK10K example. | Kaye J et al. | β | 2014 | β |
| Managing the ethical challenges of next-generation sequencing in genomic medicine. | Clarke AJ | β | 2014 | β |
| Models of consent to return of incidental findings in genomic research. | Appelbaum PS et al. | β | 2014 | β |
| Parents' preferences for return of results in pediatric genomic research. | Ziniel SI et al. | β | 2014 | β |
| Patient decisions for disclosure of secondary findings among the first 200 individuals undergoing clinical diagnostic exome sequencing. | Shahmirzadi L et al. | β | 2014 | β |
| Practical guidance on informed consent for pediatric participants in a biorepository. | Brothers KB et al. | β | 2014 | β |
| Processes and factors involved in decisions regarding return of incidental genomic findings in research. | Klitzman R et al. | β | 2014 | β |
| Returning findings within longitudinal cohort studies: the 1958 birth cohort as an exemplar. | Wallace SE et al. | β | 2014 | β |
| Returning individual research results for genome sequences of pancreatic cancer. | Johns AL et al. | β | 2014 | β |
| Return of genomic results to research participants: the floor, the ceiling, and the choices in between. | Jarvik GP et al. | β | 2014 | β |
| Sample and data sharing: observations from a central data repository. | Ardini MA et al. | β | 2014 | β |
| Sustainability in biobanking. | Simeon-Dubach D et al. | β | 2014 | β |
| Teaching genomic counseling: preparing the genetic counseling workforce for the genomic era. | Hooker GW et al. | β | 2014 | β |
| The challenge of informed consent and return of results in translational genomics: empirical analysis and recommendations. | Henderson GE et al. | β | 2014 | β |
| The First Amendment Right to Speak About the Human Genome. | Evans BJ | β | 2014 | β |
| The implications of familial incidental findings from exome sequencing: the NIH Undiagnosed Diseases Program experience. | Lawrence L et al. | β | 2014 | β |
| The unintended implications of blurring the line between research and clinical care in a genomic age. | Berkman BE et al. | β | 2014 | β |
| Traditional and electronic informed consent for biobanking: a survey of U.S. biobanks. | Simon CM et al. | β | 2014 | β |
| Understanding of informed consent by parents of children enrolled in a genetic biobank. | Klima J et al. | β | 2014 | β |
| Utilizing Focus Groups with Potential Participants and Their Parents: An Approach to Inform Study Design in a Large Clinical Trial. | Kadimpati S et al. | β | 2014 | β |
| Whole exome or genome sequencing: nurses need to prepare families for the possibilities. | Prows CA et al. | β | 2014 | β |
| A closer look at the recommended criteria for disclosing genetic results: perspectives of medical genetic specialists, genomic researchers, and institutional review board chairs. | Brandt DS et al. | β | 2013 | β |
| ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. | Green RC et al. | β | 2013 | β |
| Attitudes of African Americans toward return of results from exome and whole genome sequencing. | Yu JH et al. | β | 2013 | β |
| Attitudes of Canadian researchers toward the return to participants of incidental and targeted genomic findings obtained in a pediatric research setting. | Fernandez CV et al. | β | 2013 | β |
| Biobanking past, present and future: responsibilities and benefits. | De Souza YG et al. | β | 2013 | β |
| Biobanking: sample acquisition and quality assurance for 'omics' research. | YΓΌzbaΕΔ±oΔlu A et al. | β | 2013 | β |
| Biobanking: The Melding of Research with Clinical Care. | Smith ME et al. | β | 2013 | β |
| Biopsies: next-generation biospecimens for tailoring therapy. | Basik M et al. | β | 2013 | β |
| Broad consent versus dynamic consent in biobank research: is passive participation an ethical problem? | Steinsbekk KS et al. | β | 2013 | β |
| Characterizing biobank organizations in the U.S.: results from a national survey. | Henderson GE et al. | β | 2013 | β |
| Clinical analysis and interpretation of cancer genome data. | Van Allen EM et al. | β | 2013 | β |
| Clinical Correlates of Autosomal Chromosomal Abnormalities in an Electronic Medical Record-Linked Genome-Wide Association Study: A Case Series. | Jouni H et al. | β | 2013 | β |
| Clinical Correlates of Autosomal Chromosomal Abnormalities in an Electronic Medical Record-Linked Genome-Wide Association Study: A Case Series. | Jouni H et al. | β | 2013 | β |
| Dealing with the unexpected: consumer responses to direct-access BRCA mutation testing. | Francke U et al. | β | 2013 | β |
| Disclosing incidental findings in genetics contexts: a review of the empirical ethical research. | Christenhusz GM et al. | β | 2013 | β |
| Do researchers have an obligation to actively look for genetic incidental findings? | Gliwa C et al. | β | 2013 | β |
| Ethical and legal implications of whole genome and whole exome sequencing in African populations. | Wright GE et al. | β | 2013 | β |
| Ethics of genomic research. | Mathaiyan J et al. | β | 2013 | β |
| Evolving approaches to the ethical management of genomic data. | McEwen JE et al. | β | 2013 | β |
| Funding considerations for the disclosure of genetic incidental findings in biobank research. | Black L et al. | β | 2013 | β |
| Genetic incidental findings: autonomy regained? | Vayena E et al. | β | 2013 | β |
| Genetic medicine and incidental findings: it is more complicated than deciding whether to disclose or not. | Crawford G et al. | β | 2013 | β |
| Genetics professionals' perspectives on reporting incidental findings from clinical genome-wide sequencing. | Lohn Z et al. | β | 2013 | β |
| Genetic susceptibility testing for neurodegenerative diseases: ethical and practice issues. | Roberts JS et al. | β | 2013 | β |
| Genome sequencing: a systematic review of health economic evidence. | Frank M et al. | β | 2013 | β |
| Genomics: from persons to populations and back again. | Knoppers BM | β | 2013 | β |
| Genotype-driven recruitment: a strategy whose time has come? | Budin-LjΓΈsne I et al. | β | 2013 | β |
| Incidental findings in the era of whole genome sequencing? | Parens E et al. | β | 2013 | β |
| Informatics and clinical genome sequencing: opening the black box. | Moorthie S et al. | β | 2013 | β |
| 'Information is information': a public perspective on incidental findings in clinical and research genome-based testing. | Daack-Hirsch S et al. | β | 2013 | β |
| Intentions to receive individual results from whole-genome sequencing among participants in the ClinSeq study. | Facio FM et al. | β | 2013 | β |
| Interpreting secondary cardiac disease variants in an exome cohort. | Ng D et al. | β | 2013 | β |
| Let us ask better questions. | Clayton EW et al. | β | 2013 | β |
| Meeting summary: Ethical aspects of whole exome and whole genome sequencing studies (WES/WGS) in rare diseases, Tel Aviv, Israel, January 2013. | Farberov L et al. | β | 2013 | β |
| Minimizing liability risks under the ACMG recommendations for reporting incidental findings in clinical exome and genome sequencing. | Evans BJ | β | 2013 | β |
| Neglected ethical issues in biobank management: Results from a U.S. study. | Cadigan RJ et al. | β | 2013 | β |
| Overcoming the obstacles to returning genomic research results. | Lee M et al. | β | 2013 | β |
| Pediatric research 'personalized'? International perspectives on the return of results. | Knoppers BM et al. | β | 2013 | β |
| Personalized medicine: challenges and opportunities for translational bioinformatics. | Overby CL et al. | β | 2013 | β |
| Perspectives of clinical genetics professionals toward genome sequencing and incidental findings: a survey study. | Lemke AA et al. | β | 2013 | β |
| Point-counterpoint. Patient autonomy and incidental findings in clinical genomics. | Wolf SM et al. | β | 2013 | β |
| Practical, ethical and regulatory considerations for the evolving medical and research genomics landscape. | Lyon GJ et al. | β | 2013 | β |
| Progressing the utilisation of pharmacogenetics and pharmacogenomics into clinical care. | Trent RJ et al. | β | 2013 | β |
| Pseudonymization of patient identifiers for translational research. | Aamot H et al. | β | 2013 | β |
| Researchers' views on return of incidental genomic research results: qualitative and quantitative findings. | Klitzman R et al. | β | 2013 | β |
| Research ethics in the post-genomic era. | VΓ€hΓ€kangas K | β | 2013 | β |
| Return of individual research results and incidental findings: facing the challenges of translational science. | Wolf SM | β | 2013 | β |
| Return of research results from genomic biobanks: cost matters. | Bledsoe MJ et al. | β | 2013 | β |
| Return of results in genomic biobank research: ethics matters. | Wolf SM | β | 2013 | β |
| Return of results in translational iPS cell research: considerations for donor informed consent. | Lomax GP et al. | β | 2013 | β |
| Risk terminology in biobanking and genetic research: what's in a name? | Quinn GP et al. | β | 2013 | β |
| Self-guided management of exome and whole-genome sequencing results: changing the results return model. | Yu JH et al. | β | 2013 | β |
| Stakeholder views on returning research results. | Haga SB et al. | β | 2013 | β |
| Stewardship practices of U.S. biobanks. | Henderson GE et al. | β | 2013 | β |
| The attitudes of people with sarcoma and their family towards genomics and incidental information arising from genetic research. | Young MA et al. | β | 2013 | β |
| The disclosure of incidental genomic findings: an "ethically important moment" in pediatric research and practice. | Driessnack M et al. | β | 2013 | β |
| The responses of research participants and their next of kin to receiving feedback of genetic test results following participation in the Australian Ovarian Cancer Study. | Hallowell N et al. | β | 2013 | β |
| The return of unexpected research results in a biobank study and referral to health care for heritable long QT syndrome. | Haukkala A et al. | β | 2013 | β |
| The SNPs in the human genetic blueprint era. | Giampaoli S et al. | β | 2013 | β |
| Use of human specimens in research: the evolving United States regulatory, policy, and scientific landscape. | Bledsoe MJ et al. | β | 2013 | β |
| Using AD biomarker research results for clinical care: a survey of ADNI investigators. | Shulman MB et al. | β | 2013 | β |
| Why do participants enroll in population biobank studies? AΒ systematic literature review. | Nobile H et al. | β | 2013 | β |
| Biobanks: Validate gene findings before telling donors. | Hansson MG | β | 2012 | β |
| Biospecimens, biomarkers, and burgeoning data: the imperative for more rigorous research standards. | Poste G | β | 2012 | β |
| Disclosing individual genetic research results to deceased participants' relatives by means of a qualified disclosure policy. | Bredenoord AL et al. | β | 2012 | β |
| Discontent with consent. | β | β | 2012 | β |
| High-throughput sequencing and rare genetic diseases. | Makrythanasis P et al. | β | 2012 | β |
| International normative perspectives on the return of individual research results and incidental findings in genomic biobanks. | Zawati MH et al. | β | 2012 | β |
| Mapping the inputs, analyses, and outputs of biobank research systems to identify sources of incidental findings and individual research results for potential return to participants. | Bemmels HR et al. | β | 2012 | β |
| Permission to share biospecimens. | Horn EJ et al. | β | 2012 | β |
| Recommendations for ethical approaches to genotype-driven research recruitment. | Beskow LM et al. | β | 2012 | β |
| Reporting actionable research results: shared secrets can save lives. | Hunter LE et al. | β | 2012 | β |
| Secondary researchers' duties to return incidental findings and individual research results: a partial-entrustment account. | Richardson HS et al. | β | 2012 | β |
| Secondary variants in individuals undergoing exome sequencing: screening of 572 individuals identifies high-penetrance mutations in cancer-susceptibility genes. | Johnston JJ et al. | β | 2012 | β |
| Sharing individual research results with biospecimen contributors: counterpoint. | Clayton EW | β | 2012 | β |
| Sharing individual research results with biospecimen contributors: point. | Yassin R et al. | β | 2012 | β |
| Should genetic findings from genome research be reported back to the participants? | Steinsbekk KS et al. | β | 2012 | β |
| Taking aims seriously: repository research and limits on the duty to return individual research findings. | Ossorio P | β | 2012 | β |
| The evolution of biobanking best practices. | Vaught J et al. | β | 2012 | β |
| The legal risks of returning results of genomics research. | Clayton EW et al. | β | 2012 | β |
| The new world of clinical genomics. | Biesecker LG | β | 2012 | β |
| The past, present, and future of the debate over return of research results and incidental findings. | Wolf SM | β | 2012 | β |
| The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science. | Wolf SM | β | 2012 | β |
| Biobanks and the return of research results: out with the old and in with the new? | Zawati MH et al. | β | 2011 | β |