Protocols submitted to Institutional Review Boards (IRB) for genetic research are increasing in number and complexity. Further, it is now recognized that to understand genetic susceptibility, including interactions with environmental factors, research studies will require large sample sizes. The need for large studies will result in increased use of existing data from repositories and large disease registries and will present new issues with regard to IRB approval of human genetic studies. While efforts to understand public views of genetic research are underway, there is less known about the views of participants already enrolled in established registries, and whose samples will be increasingly valuable to these efforts. Data was collected through the NIH/NHGRI funded Centers of Excellence for ethical genomic research at the University of Washington in Seattle and Case Western Reserve University in Cleveland to identify issues that IRB members and genetic scientists confront in this new era of genomic research, with an emphasis on identifying areas of tension and common concern. However, a third and important component, the views of those participating in human genetic studies, were not evaluated. We hypothesize that the views and concerns of research participants, particularly those individuals with a condition or disease with a genetic component that runs in families, will differ from those of the IRB and researchers. Further, individuals with diseases with a genetic component may have different motivations for and concerns about participating in genetic research than the general population. It is important that these stakeholder views be included in discussions of protections in human genetic research studies. Thus, the primary purpose of this study is to identify the specific concerns and expectations of cancer registry participants regarding participation in genetic research. The results from the proposed project will provide critical insight into the views and concerns of individuals participating in an ongoing cancer registry whose biological samples and personal and medical history information will be increasingly valuable and sought after for genetic studies. By adding data on this important stakeholder group to data already obtained on IRB professionals and genetic researchers from a recently completed UW CEER project, the results may ultimately affect how genetic research studies are reviewed and conducted.

Public Health Relevance

The potential benefit of this project is a better understanding of the views and concerns of the individuals who are participating in research studies. By including the views of this stakeholder group, the results may ultimately affect how genetic research studies are reviewed and conducted.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project (R01)
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Ethical, Legal, and Social Implications of Human Genetics Study Section (ELS)
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Nelson, Wendy
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University of Washington
Public Health & Prev Medicine
Schools of Public Health
United States
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Goodman, Deborah; Johnson, Catherine O; Bowen, Deborah et al. (2018) A comparison of views regarding the use of de-identified data. Transl Behav Med 8:113-118
Goodman, Deborah; Bowen, Deborah; Wenzel, Lari et al. (2018) The research participant perspective related to the conduct of genomic cohort studies: A systematic review of the quantitative literature. Transl Behav Med 8:119-129
Hyams, Travis; Bowen, Deborah J; Condit, Celeste et al. (2016) Views of Cohort Study Participants about Returning Research Results in the Context of Precision Medicine. Public Health Genomics 19:269-75
Goodman, Deborah; Johnson, Catherine O; Wenzel, Lari et al. (2016) Consent Issues in Genetic Research: Views of Research Participants. Public Health Genomics 19:220-8
Condit, Celeste M; Korngiebel, Diane M; Pfeifer, Lesley et al. (2015) What Should Be the Character of the Researcher- Participant Relationship? Views of Participants in a Long-standing Cancer Genetic Registry. IRB 37:1-10
Kelly, V E; Johnson, C O; McGough, E L et al. (2015) Association of cognitive domains with postural instability/gait disturbance in Parkinson's disease. Parkinsonism Relat Disord 21:692-7
Srivatsal, Sindhu; Cholerton, Brenna; Leverenz, James B et al. (2015) Cognitive profile of LRRK2-related Parkinson's disease. Mov Disord 30:728-33
Yorgov, Daniel; Edwards, Karen L; Santorico, Stephanie A (2014) Use of admixture and association for detection of quantitative trait loci in the Type 2 Diabetes Genetic Exploration by Next-Generation Sequencing in Ethnic Samples (T2D-GENES) study. BMC Proc 8:S6
Santorico, Stephanie A; Edwards, Karen L (2014) Challenges of linkage analysis in the era of whole-genome sequencing. Genet Epidemiol 38 Suppl 1:S92-6
Cholerton, Brenna A; Zabetian, Cyrus P; Wan, Jia Y et al. (2014) Evaluation of mild cognitive impairment subtypes in Parkinson's disease. Mov Disord 29:756-64

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