Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects
| Autor: | Jeffrey T. Mason, Carol B. Fowler, David L. Evers, Rebecca K. Mimnall |
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| Rok vydání: | 2014 |
| Předmět: |
Risk
Gerontology Research design Biomedical Research Health (social science) Research Subjects media_common.quotation_subject Human subject research Intention Infections Risk Assessment Ethics Research Informed consent Management of Technology and Innovation Humans Medicine Ethics Medical Duty media_common Informed Consent business.industry Health Policy Transparency (behavior) Healthy Volunteers Research Personnel Issues ethics and legal aspects Human Experimentation Clinical research Research Design Duty of care Safety business Risk assessment Social psychology Ethics Committees Research |
| Zdroj: | Science and Engineering Ethics. 21:1049-1064 |
| ISSN: | 1471-5546 1353-3452 |
| DOI: | 10.1007/s11948-014-9579-z |
| Popis: | Here we identify approximately 40,000 healthy human volunteers who were intentionally exposed to infectious pathogens in clinical research studies dating from late World War II to the early 2000s. Microbial challenge experiments continue today under contemporary human subject research requirements. In fact, we estimated 4,000 additional volunteers who were experimentally infected between 2010 and the present day. We examine the risks and benefits of these experiments and present areas for improvement in protections of participants with respect to safety. These are the absence of maximum limits to risk and the potential for institutional review boards to include questionable benefits to subjects and society when weighing the risks and benefits of research protocols. The lack of a duty of medical care by physician-investigators to research subjects is likewise of concern. The transparency of microbial challenge experiments and the safety concerns raised in this work may stimulate further dialogue on the risks to participants of human experimentation. |
| Databáze: | OpenAIRE |
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