Protecting Research Subjects — What Must Be Done
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...
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| Published in | The New England journal of medicine Vol. 343; no. 11; pp. 808 - 810 |
|---|---|
| Main Author | |
| Format | Journal Article |
| Language | English |
| Published |
United States
Massachusetts Medical Society
14.09.2000
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| Subjects | |
| Online Access | Get full text |
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| Abstract | 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 . . . |
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| AbstractList | 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 . . . Unfortunately, the public's confidence in all three has been seriously shaken by the death of 18-year-old Jesse Gelsinger in a gene-transfer trial at the University of Pennsylvania in which human subjects were not adequately protected and which presented the appearance of substantial financial conflicts of interest. [...]this young man's death led to the discovery by the National Institutes of Health (NIH) of many hundreds of unreported adverse events among volunteers enrolled in gene-transfer experiments. |
| Author | Shalala, Donna |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/10984573$$D View this record in MEDLINE/PubMed |
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| Snippet | 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,... Unfortunately, the public's confidence in all three has been seriously shaken by the death of 18-year-old Jesse Gelsinger in a gene-transfer trial at the... |
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| SubjectTerms | 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 |
| Title | Protecting Research Subjects — What Must Be Done |
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