RESUMO
Advances in genomics have led to calls for developing population-based preventive genomic sequencing (PGS) programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the sequencing or analysis of specific genomic conditions (the menu approach) or whether PGS should be implemented using an all-or-nothing panel approach. We conclude that any responsible scale-up of PGS will require a menu approach that may seem impractical to some, but that draws its justification from a rich mix of normative, legal, and practical considerations.
Assuntos
Comportamento de Escolha/ética , Doenças Genéticas Inatas/prevenção & controle , Predisposição Genética para Doença , Testes Genéticos , Metagenômica/ética , Autonomia Pessoal , Prevenção Primária , Análise de Sequência de DNA , Doenças Genéticas Inatas/genética , Predisposição Genética para Doença/genética , Privacidade Genética/ética , Testes Genéticos/economia , Testes Genéticos/ética , Testes Genéticos/métodos , Genômica/ética , Humanos , Metagenômica/legislação & jurisprudência , Paternalismo , Prevenção Primária/ética , Prevenção Primária/métodos , Saúde Pública/ética , Saúde Pública/tendências , Análise de Sequência de DNA/economia , Análise de Sequência de DNA/éticaRESUMO
Study of ethical, legal, and social implications (ELSI) of human microbiome research has been integral to the Human Microbiome Project (HMP). This study explores core ELSI issues that arose during the first phase of the HMP from the perspective of individuals involved in the research. We conducted semi-structured in-depth interviews with investigators and NIH employees ("investigators") involved in the HMP, and with individuals recruited to participate in the HMP Healthy Cohort Study at Baylor College of Medicine ("recruits"). We report findings related to three major ELSI issues: informed consent, data sharing, and return of results. Our findings demonstrate that investigators and recruits were similarly sensitive to these issues yet generally comfortable with study design in light of current knowledge about the microbiome.
