title: Addressing low-risk comparative effectiveness research in proposed changes to US federal regulations governing research.
authors.affiliation: Berman Institute of Bioethics and Johns Hopkins Bloomberg School of Public Health, 1809 Ashland Ave, Baltimore, MD 21205, USA. nkass@jhu.edu
authors.forename: Nancy
authors.initials: N
authors.lastname: Kass
authors.forename: Ruth
authors.initials: R
authors.lastname: Faden
authors.forename: Sean
authors.initials: S
authors.lastname: Tunis
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards; D057186:Comparative Effectiveness Research / Q000331:legislation & jurisprudence* / Q000592:standards; D028744:Ethics Committees, Research; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent; D007878:Legislation as Topic; D058991:Patient Protection and Affordable Care Act; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D014481:United States