scholarly journals Managing incidental findings and research results in genomic research involving biobanks and archived data sets

2012 ◽  
Vol 14 (4) ◽  
pp. 361-384 ◽  
Author(s):  
Susan M. Wolf ◽  
Brittney N. Crock ◽  
Brian Van Ness ◽  
Frances Lawrenz ◽  
Jeffrey P. Kahn ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Genomic Research ◽  
Data Sets ◽  
Research Results ◽  
Archived Data

scholarly journals Understanding Incidental Findings in the Context of Genetics and Genomics

2008 ◽  
Vol 36 (2) ◽  
pp. 280-285 ◽  
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.

scholarly journals International Policies on Sharing Genomic Research Results with Relatives: Approaches to Balancing Privacy with Access

2015 ◽  
Vol 43 (3) ◽  
pp. 576-593
Author(s):  
Rebecca Branum ◽  
Susan M. Wolf
Keyword(s):  
Genetic Risk ◽  
Incidental Findings ◽  
Research Community ◽  
Genomic Research ◽  
Return Of Results ◽  
Research Results ◽  
International Policies

Debate over return of results and incidental findings to participants in genetic and genomic research has exploded over the last decade. At this point, there is wide agreement that investigators have a responsibility to anticipate discovery of findings that may warrant return, to incorporate in protocols a plan for evaluating such findings, and to offer at least some of these results to participants consenting to such return. However, the issue of how to handle questions from a participant’s genetic relatives about their own risk, or whether investigators should alert relatives to a genetic risk they may share, has garnered much less attention. Only recently has the genomic research community begun to debate these questions and offer recommendations.

Attitudes of Researchers to the Return of Incidental and Targeted Genomic Findings Obtained in a Research Setting to Participants

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2069-2069
Author(s):  
Conrad V Fernandez ◽  
Denise Avard ◽  
Bartha Knoppers ◽  
Colleen O'Connell ◽  
David Malkin ◽  
...  
Keyword(s):  
Genetic Counselling ◽  
Incidental Findings ◽  
Clinical Utility ◽  
Genomic Research ◽  
Data Set ◽  
Research Results ◽  
Ethics Review ◽  
Institutional Ethics ◽  
Wide Range ◽  
Genomic Results

Abstract Abstract 2069 Background: The use of genomic research has exploded in recent years. Various guidelines recommend disclosure of significant, clinically validated findings to participants. Continued debate in this area has led to calls for stakeholder involvement to inform policy. In particular, the attitudes of genomics researchers are salient yet relatively unexplored with respect to how the sharing of both targeted and incidental findings should be accomplished. Methods: All 107 researchers affiliated with two large-scale Genome Canada projects [Canadian Pediatric Cancer Genome Consortium (CPCGC) and the Finding of Rare Genes Canada Consortium (FORGE)] were surveyed using a mailed, validated 32-item questionnaire that had been pilot tested with genomics researchers. The survey was designed to cover a wide range of topics including attitudes of researchers to the return of incidental and targeted research results, the need for genetic counselling, responsibilities to participants over time, to child participants and to siblings of participants, and institutional ethics review. Two reminders were sent to non-respondents. Data were analyzed with descriptive statistics. Results: 74/107 (69%) responded. Most were between 41–55 yr of age (n=40, 54%) and had their most senior training inNorth America (n=67, 91%). The majority were experienced researchers (n=58, 78%) and felt comfortable in discussing genomic results with participants (n= 66, 89%). Respondents did not feel a strong responsibility to look for meaningful incidental results in the genomic data set they created (n=27, 37%). However, once potentially significant results were identified, researchers indicated that participants had a strong or very strong right to receive analytically validated genomic results irrespective of whether these results were incidental findings (n= 50, 68%) or primary targets of the research (n= 64, 87%). Most indicated that results with clinical utility that were actionable should be offered to participants (n=54, 73%) although some indicated that research results should not be returned under any circumstances (n=6, 8%). The majority felt that a research result should be confirmed in a clinical lab prior to return to participants (n=51, 69%). Most indicated that genetic counselling should be provided either almost always or frequently prior to genomic research participation (n=48, 64%). Respondents indicated that siblings of genomic research participants had a strong or very strong right to be informed of results (n=46, 62%), and this was especially true if an intervention to ameliorate the identified condition is feasible (n=56, 76%). A minority of researchers felt personal responsibility to ensure genomic research results obtained on a child of potential clinical utility were eventually communicated to him/her when the child became an adult (n=10, 14%). A slim majority felt the parents or health care provider should be responsible (n=38, 51%). Some researchers reported encountering incidental findings of clinical utility (n=25, 34%) and had offered them to participants. However, the minority reported that their institutional ethics review boards either always (n=10, 14%) or sometimes (n=24, 32%) required an offer of results. Only 16 (22%) indicated that their ethics board had a detailed process on how to do so. Conclusions: Researchers in general support the offer of return of targeted and incidental genomic research results to participants. A minority strongly oppose such action. There is typically a high degree of support for the offer of genomic research findings to siblings, especially if actionable. Given the new developments in genomics and resulting incidental findings, researchers describe little specific guidance about the process that should be followed in returning results to participants. Greater policy guidance would be of assistance in providing a consistent approach to the offer of incidental or targeted genomic research results. Acknowledgments: Funded by Genome Canada and the Canadian Institutes of Health Research. Disclosures: No relevant conflicts of interest to declare.

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

2015 ◽  
Vol 43 (3) ◽  
pp. 440-463 ◽  
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.

scholarly journals Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?

2015 ◽  
Vol 43 (4) ◽  
pp. 827-842
Author(s):  
Anya E.R. Prince ◽  
John M. Conley ◽  
Arlene M. Davis ◽  
Gabriel Lázaro-Muñoz ◽  
R. Jean Cadigan
Keyword(s):  
Medical Record ◽  
Medical Records ◽  
Genomic Research ◽  
Research Results ◽  
Research Participants ◽  
Difficult Question ◽  
Automatic Placement ◽  
Study Participants ◽  
Research Studies

The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher’s duty to facilitate a participant’s follow-up clinical care by placing research results in the participant’s medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies — enrolling patients as participants — boldly address the question with protocols dictating that researchers place research results directly into study participants’ existing medical records, without participant consent. Such privileging of researcher judgment over participant choice may be motivated by a desire to discharge a duty that researchers perceive themselves as owing to participants. However, the underlying ethical, professional, legal, and regulatory duties that would compel or justify this action have not been fully explored.

The Development of a Preference-Setting Model for the Return of Individual Genomic Research Results

2015 ◽  
Vol 10 (2) ◽  
pp. 107-120 ◽  
Author(s):  
Phoebe L. Bacon ◽  
Erin D. Harris ◽  
Sonja I. Ziniel ◽  
Sarah K. Savage ◽  
Elissa R. Weitzman ◽  
...  
Keyword(s):  
Genomic Research ◽  
Research Results

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

2016 ◽  
Vol 5 (1) ◽  
pp. 3 ◽  
Author(s):  
Emmanuelle Souzeau ◽  
Kathryn P. Burdon ◽  
David A. Mackey ◽  
Alex W. Hewitt ◽  
Ravi Savarirayan ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Genomic Research ◽  
Ethical Considerations
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