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
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJM200009143431112

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 in clinical trials. None of these principles is more important than the protection of research subjects by informed consent based on full disclosure of potential risks and benefits. I did not expect, or want, to complete my tenure as secretary of health and human services by raising questions about the safety of patients in clinical . . .