Ethical Considerations for the Return of Incidental Findings in Ophthalmic Genomic Research

AbstractBackground:Genomic sequencing plays an increasing role in genetic research, also in psychiatry. This raises challenges concerning the validity and type of the informed consent and the return of incidental findings. However, no solution currently exists on the best way to obtain the informed consent and deliver findings to research subjects.Aims:This study aims to explore the attitudes among potential stakeholders in psychiatric genomic research toward the consenting procedure and the delivery of incidental findings.Methods:We developed a cross-sectional web-based survey among five groups of stakeholders. A total of 2637 stakeholders responded: 241 persons with a mental disorder, 671 relatives, 1623 blood donors, 74 psychiatrists, and 28 clinical geneticists.Results:The stakeholders wanted active involvement as 92.7% preferred a specific consent and 85.1% wanted to receive information through a dynamic consent procedure. The majority of stakeholders preferred to receive genomic information related to serious or life-threatening health conditions through direct contact (69.5%) with a health professional, i.e. face-to-face consultation or telephone consultation (82.4%). Persons with mental disorders and relatives did not differ in their attitudes from the other stakeholder groups.Conclusion:The findings illustrate that the stakeholders want to be more actively involved and consider consent as a reciprocal transaction between the involved subjects and the researchers in the project. The results highlight the importance of collaboration between researchers and clinical geneticists as the latter are trained, through their education and clinical experience, to return and explain genomic data to patients, relatives, and research subjects.

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Raising Genomic Citizens: Adolescents and the Return of Secondary Genomic Findings

The Journal of Law Medicine & Ethics ◽

10.1177/1073110516654123 ◽

2016 ◽

Vol 44 (2) ◽

pp. 292-308 ◽

Cited By ~ 12

Author(s):

Maya Sabatello ◽

Paul S. Appelbaum

Keyword(s):

Exome Sequencing ◽

Policy Development ◽

Incidental Findings ◽

Pediatric Research ◽

Genomic Research ◽

Whole Genome ◽

Research With Children ◽

Intense Debate

Whole genome and exome sequencing (WGS/WES) techniques raise hope for a new scale of diagnosis, prevention, and prediction of genetic conditions, and improved care for children. For these hopes to materialize, extensive genomic research with children will be needed. However, the use of WGS/WES in pediatric research settings raises considerable challenges for families, researchers, and policy development. In particular, the possibility that these techniques will generate genetic findings unrelated to the primary goal of sequencing has stirred intense debate about whether, which, how, and when these secondary or incidental findings (SFs) should be returned to parents and minors. The debate is even more pronounced when the subjects are adolescents, for whom decisions about return of SFs may have particular implications. In this paper, we consider the rise of “genomic citizenship” and the main challenges that arise for these stakeholders: adolescents' involvement in decisions relating to return of genomic SFs, the types of SFs that should be offered, privacy protections, and communication between researchers and adolescents about SFs. We argue that adolescents' involvement in genomic SF-related decisions acknowledges their status as valuable stakeholders without detracting from broader familial interests, and promotes more informed genomic citizens.

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Informed consent for return of incidental findings in genomic research

Genetics in Medicine ◽

10.1038/gim.2013.145 ◽

2013 ◽

Vol 16 (5) ◽

pp. 367-373 ◽

Cited By ~ 42

Author(s):

Paul S. Appelbaum ◽

Cameron R. Waldman ◽

Abby Fyer ◽

Robert Klitzman ◽

Erik Parens ◽

...

Keyword(s):

Informed Consent ◽

Incidental Findings ◽

Genomic Research

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Understanding Incidental Findings in the Context of Genetics and Genomics

The Journal of Law Medicine & Ethics ◽

10.1111/j.1748-720x.2008.00270.x ◽

2008 ◽

Vol 36 (2) ◽

pp. 280-285 ◽

Cited By ~ 91

Author(s):

Mildred K. Cho

Keyword(s):

Incidental Findings ◽

Human Subjects ◽

Association Studies ◽

Human Migration ◽

Genomic Research ◽

Human Subjects Research ◽

Research Results ◽

Yield Information ◽

Individual Research Results ◽

Genetics And Genomics

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. However, no consensus exists as yet on the responsibilities of researchers to disclose individual research results to participants in human subjects research. “Genetic and genomic research” on humans varies widely, including association studies, examination of allele frequencies, and studies of natural selection, human migration, and genetic variation. For the purposes of this article, it is defined broadly to include analysis of DNA collected from humans that has implications for human health (even if the purpose of the study is not medical). This paper addresses both research results of individual research participants that may be an intended product of the research, as well as unanticipated, “incidental” findings.

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INCIDENTAL FINDINGS IN BIO BANKS IN SOUTH AFRICA: ETHICAL AND LEGAL ISSUES

Obiter ◽

10.17159/obiter.v35i2.11905 ◽

2014 ◽

Vol 35 (2) ◽

Author(s):

Maureen Mswela ◽

Patricia Molusi

Keyword(s):

South Africa ◽

Incidental Findings ◽

Genomic Research ◽

Return Of Results ◽

Research System ◽

Primary Research ◽

Potential Health ◽

Secondary Research ◽

Biobank Research ◽

Legal Challenges

Biobanks have come to be essential apparatuses of genetic and genomic research as they are seen as essential tools for translational medicine in particular. Various unique ethical and legal challenges arise in the course of biobanking as biobanks generate a range of ethical and legal challenges related to privacy, informed consent, control and ownership, withdrawal of samples, commercialization, genomic sovereignty, return of results, incidental findings, and research governance. These issues have generated much policy debate within the international world, and yet in South Africa, debates on the ethical and legal challenges posed by biobanks and biobank networks still remain alienated. According to Wolf, biobanks are the dominant part of a “biobank research system,” consisting of primary research also known as collection sites, the biobank, and secondary research sites that access biobank data or samples for further research. Therefore, incidental findings could arise at several points in a biobank-research system, that is, in primary research, biobank research, and secondary research. Within the South African context literature and guidance are sparse on the handling of significant incidental findings which are identified in biobank systems. How incidental findings should be handled as well as the role of biobanks in enabling this process, are well-founded concerns. Unresolved in South Africa, is how to manage incidental findings of potential health, reproductive, environmental and medicinal risk that are of particular importance to individual contributors. With a proposal for a national biobank in South Africa, it is apparent that researchers as well as clinicians are anticipated to access data from biobanks and to this end, laws, clear public guidance and regulations on the handling of incidental findings are indispensable.

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Disclosure of incidental findings in cancer genomic research: investigators' perceptions on obligations and barriers

Clinical Genetics ◽

10.1111/cge.12540 ◽

2014 ◽

Vol 88 (4) ◽

pp. 320-326 ◽

Cited By ~ 12

Author(s):

E. Kleiderman ◽

D. Avard ◽

A. Besso ◽

S. Ali‐Khan ◽

G. Sauvageau ◽

...

Keyword(s):

Incidental Findings ◽

Genomic Research

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Dialogues, dilemmas, and disclosures: genomic research and incidental findings

Genetics in Medicine ◽

10.1038/gim.2011.72 ◽

2012 ◽

Vol 14 (3) ◽

pp. 293-295 ◽

Cited By ~ 7

Author(s):

Lynn W. Bush ◽

Karen H. Rothenberg

Keyword(s):

Incidental Findings ◽

Genomic Research

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Critical social theory approach to disclosure of genomic incidental findings

Nursing Ethics ◽

10.1177/0969733011433924 ◽

2012 ◽

Vol 19 (6) ◽

pp. 819-828 ◽

Cited By ~ 4

Author(s):

Jeffrey L Bevan ◽

Julia N Senn-Reeves ◽

Ben R Inventor ◽

Shawna M Greiner ◽

Karen M Mayer ◽

...

Keyword(s):

Informed Consent ◽

Social Theory ◽

Incidental Findings ◽

Critical Social Theory ◽

Genomic Research ◽

Theory Approach ◽

Nursing Research ◽

Related Information ◽

Health Related ◽

Critical Social

Technology has expanded genomic research and the complexity of extracted gene-related information. Health-related genomic incidental findings pose new dilemmas for nurse researchers regarding the ethical application of disclosure to participants. Consequently, informed consent specific to incidental findings is recommended. Critical Social Theory is used as a guide in recognition of the changing meaning of informed consent and to serve as a framework to inform nursing of the ethical application of disclosure consent in genomic nursing research practices.

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