title: Perspectives on human microbiome research ethics.
abstract: 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.
authors: Baylor College of Medicine, Houston, TX, USA. amcguire@bcm.edu
authors: Amy L
authors: AL
authors: McGuire
authors: Laura S
authors: LS
authors: Achenbaum
authors: Simon N
authors: SN
authors: Whitney
authors: Melody J
authors: MJ
authors: Slashinski
authors: James
authors: J
authors: Versalovic
authors: Wendy A
authors: WA
authors: Keitel
authors: Sheryl A
authors: SA
authors: McCurdy
mesh_terms: D000328:Adult; D000368:Aged; D032984:Ethics, Research; D005260:Female; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent; D007407:Interviews as Topic; D008297:Male; D054892:Metagenome; D056186:Metagenomics / Q000941:ethics* / Q000331:legislation & jurisprudence; D008875:Middle Aged; D009316:National Institutes of Health (U.S.); D012108:Research Personnel; D035842:Research Subjects; D014481:United States