Protecting Research Subjects — What Must Be Done

• Published in: The New England journal of medicine Vol. 343; no. 11; pp. 808 - 810
• Main Author: Shalala, Donna
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 14.09.2000
• Subjects: 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

As we race toward the as yet unimagined scientific and medical triumphs of the 21st century, no one is more hopeful about the journey than I am. Nevertheless, moving ahead with cutting-edge research must not mean leaving behind well-established international standards for protecting human subjects i...