Understanding Incidental Findings in the Context of 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.

Download Full-text

Attitudes of the general public towards the disclosure of individual research results and incidental findings from biobank genomic research in Australia

Internal Medicine Journal ◽

10.1111/imj.12911 ◽

2015 ◽

Vol 45 (12) ◽

pp. 1274-1279 ◽

Cited By ~ 8

Author(s):

J. Fleming ◽

C. Critchley ◽

M. Otlowski ◽

C. Stewart ◽

I. Kerridge

Keyword(s):

General Public ◽

Incidental Findings ◽

Genomic Research ◽

Research Results ◽

Individual Research Results

Download Full-text

Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations

The Journal of Law Medicine & Ethics ◽

10.1111/jlme.12288 ◽

2015 ◽

Vol 43 (3) ◽

pp. 440-463 ◽

Cited By ~ 7

Author(s):

Susan M. Wolf ◽

Rebecca Branum ◽

Barbara A. Koenig ◽

Gloria M. Petersen ◽

Susan A. Berry ◽

...

Keyword(s):

Incidental Findings ◽

Genomic Research ◽

Research Results ◽

Health Implications ◽

Multiple Contexts ◽

Important Health ◽

Reproductive Concerns ◽

Genomic Results ◽

Individual Research Results ◽

Genetic Results

The debate about how to manage individual research results and incidental findings in genetic and genomic research has focused primarily on what information, if any, to offer back to research participants. However, increasing controversy surrounds the question of whether researchers have any responsibility to offer a participant’s results (defined here to include both individual research results and incidental findings) to the participant’s relatives, including after the participant’s death. This question arises in multiple contexts, including when researchers discover a result with potentially important health implications for genetic relatives, when a participant’s relatives ask a researcher whether any research results about the participant have implications for their own health or reproductive planning, when a participant’s relative asks whether any of the participant’s results have implications for a child’s health, and when the participant is deceased and the participant’s relatives seek information about the participant’s genetic results in order to address their own health or reproductive concerns.

Download Full-text

Empirical Analysis of Current Approaches to Incidental Findings

The Journal of Law Medicine & Ethics ◽

10.1111/j.1748-720x.2008.00267.x ◽

2008 ◽

Vol 36 (2) ◽

pp. 249-255 ◽

Cited By ~ 23

Author(s):

Frances Lawrenz ◽

Suzanne Sobotka

Keyword(s):

Empirical Analysis ◽

Incidental Findings ◽

Scientific Literature ◽

Human Subjects ◽

Human Subjects Research ◽

Potential Health ◽

National Human ◽

Multidisciplinary Working ◽

Imaging Research ◽

Object Of Study

Researchers in the health sciences regularly discover information of potential health importance unrelated to their object of study in the course of their research. However, there appears to be little guidance available on what researchers should do with this information, known in the scientific literature as incidental findings (IFs). The study described here was designed to determine the extent of guidance available to researchers from public sources. This empirical study was part of a larger two-year project funded by the National Human Genome Research Institute (NHGRI) to generate guidance on how incidental findings should be managed in human subjects research, especially genetics, genomics, and imaging research. We generated empirical analysis of publicly available guidance and consent forms to help guide a multidisciplinary Working Group of experts in their formulation of normative recommendations reported in this symposium.

Download Full-text