Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women

Wang, Catharine; Bertrand, Kimberly A.; Trevino-Talbot, Michelle; Flynn, Maureen; Ruderman, Maggie; Cabral, Howard; Bowen, Deborah J.; Hughes‐Halbert, Chanita; Palmer, Julie R.

doi:10.1016/j.cct.2023.107309

Contemporary Clinical Trials

2023

DOI: 10.1016/j.cct.2023.107309

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Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women

Catharine Wang¹,

Kimberly A. Bertrand²,

Michelle Trevino-Talbot³

et al.

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2024

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Cited by 2 publications

References 66 publications

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Ethical, Legal, and Social Implications of Gene‐Environment Interaction Research

Calluori,

Heimke,

Caga‐anan

et al. 2024

Genetic Epidemiology

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Many complex disorders are impacted by the interplay of genetic and environmental factors. In gene‐environment interactions (GxE), an individual's genetic and epigenetic makeup impacts the response to environmental exposures. Understanding GxE can impact health at the individual, community, and population levels. The rapid expansion of GxE research in biomedical studies for complex diseases raises many unique ethical, legal, and social implications (ELSIs) that have not been extensively explored and addressed. This review article builds on discussions originating from a workshop held by the National Institute of Environmental Health Sciences (NIEHS) and the National Human Genome Research Institute (NHGRI) in January 2022, entitled: “Ethical, Legal, and Social Implications of Gene‐Environment Interaction Research.” We expand upon multiple key themes to inform broad recommendations and general guidance for addressing some of the most unique and challenging ELSI in GxE research. Key takeaways include strategies and approaches for establishing sustainable community partnerships, incorporating social determinants of health and environmental justice considerations into GxE research, effectively communicating and translating GxE findings, and addressing privacy and discrimination concerns in all GxE research going forward. Additional guidelines, resources, approaches, training, and capacity building are required to further support innovative GxE research and multidisciplinary GxE research teams.

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Ethical, Legal, and Social Implications of Gene‐Environment Interaction Research

Calluori,

Heimke,

Caga‐anan

et al. 2024

Genetic Epidemiology

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The Answer ALS return of results study: Answering the duty to disclose

Roggenbuck,

Kaschalk,

Eustace

et al. 2024

Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

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Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women

Cited by 2 publications

References 66 publications

Ethical, Legal, and Social Implications of Gene‐Environment Interaction Research

Ethical, Legal, and Social Implications of Gene‐Environment Interaction Research

The Answer ALS return of results study: Answering the duty to disclose

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