Protecting Research Subjects — What Must Be Done - Shalala, Donna (The New England journal of medicine, 2000)
Keywords: Biomedical research; Clinical trials; Clinical Trials as Topic - legislation & jurisprudence; Clinical Trials as Topic - standards; Conflict of Interest - legislation & jurisprudence; Disclosure; Ethics Committees, Research; Genetic Therapy - legislation & jurisprudence; Genetic Therapy - standards; Government Regulation; Guidelines as Topic; Health facilities; Human Experimentation - legislation & jurisprudence; Human subjects; Humans; Informed Consent - legislation & jurisprudence; Medical research; National Institutes of Health (U.S.); Patient safety; Patient Selection; R&D; Reporting requirements; Research & development; United States; United States Dept. of Health and Human Services; United States Food and Drug Administration; United States; Legal Approach; Biomedical and Behavioral Research