Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects

TitleDeliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects
Publication TypeJournal Article
Year of Publication2015
AuthorsEvers, D, Fowler, C, Mason, J, Mimnall, R
JournalScience & Engineering Ethics
Date Published2015
Publication Languageeng
ISBN Number13533452
KeywordsDeliberate , duty , Exaggerated , healthy , Institutional , Intentional , Maximum , Medical , MICROBIAL , PATHOGENIC , research , Volunteers
AbstractHere 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. 
NotesEvers, David 1; Email Address: Fowler, Carol 1 Mason, Jeffrey 1 Mimnall, Rebecca 2; Affiliation: 1: Veterans Affairs Maryland Health Care System, Research Service, 10 North Greene Street Baltimore 21201 USA 2: Office of Research and Development, Veterans Health Administration, Washington USA; Source Info: Aug2015, Vol. 21 Issue 4, p1049; Subject Term: RESEARCH subjects (Persons); Subject Term: RESEARCH; Subject Term: VOLUNTEERS; Subject Term: INSTITUTIONAL review boards (Medicine); Subject Term: MEDICAL experimentation on humans -- Evaluation; Subject Term: PATHOGENIC microorganisms; Author-Supplied Keyword: Deliberate infection; Author-Supplied Keyword: Duty of care; Author-Supplied Keyword: Exaggerated benefits; Author-Supplied Keyword: Healthy human subject research; Author-Supplied Keyword: Intentional infection; Author-Supplied Keyword: Maximum risk; Author-Supplied Keyword: Microbial challenge experiments; Number of Pages: 16p; Document Type: Article