Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects.
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....
| Publicado en: | Science & Engineering Ethics Vol. 21; no. 4; pp. 1049 - 1065 |
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| Autores principales: | , , , |
| Formato: | Artículo |
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Springer Nature
Aug2015
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| Materias: | |
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=hlh&AN=103737044&site=ehost-live header: @attributes: shortDbName: hlh uiTerm: 103737044 longDbName: Humanities International Complete uiTag: AN controlInfo: bkinfo: jinfo: jid: 13533452 GNI jtl: Science & Engineering Ethics issn: 13533452 maglogo: N pubinfo: dt: Aug2015 vid: 21 iid: 4 pid: 237 pub: Springer Nature artinfo: ui: 103737044 10.1007/s11948-014-9579-z ppf: 1049 ppct: 16 formats: fmt: @attributes: type: P size: 417KB tig: atl: Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects. aug: au: Evers, David Fowler, Carol Mason, Jeffrey Mimnall, Rebecca affil: Veterans Affairs Maryland Health Care System, Research Service, 10 North Greene Street Baltimore 21201 USA Office of Research and Development, Veterans Health Administration, Washington USA su: Human research subjects Volunteers Institutional review boards Medical experimentation on humans Pathogenic microorganisms Evaluation sug: subj: Human research subjects Volunteers Institutional review boards Medical experimentation on humans Pathogenic microorganisms Evaluation keyword: Deliberate infection Duty of care Exaggerated benefits Healthy human subject research Intentional infection Maximum risk Microbial challenge experiments ab: 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. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: Y custom: Science & Engineering Ethics is a copyright of Springer, 2015. All Rights Reserved. item: Science & Engineering Ethics holder: Springer Nature dt: @attributes: year: 2015 holdings: @attributes: islocal: N |
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