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

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Abstract

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.

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Notes

  1. US Select Agents are defined in Title 7 Code of Federal Regulations part 331 (7CFR331), 9CFR121, and 42CFR73; the ‘Select Agent and toxins regulations’.

  2. The ‘HHS regulations’ are administered under the HHS Assistant Secretary for Health by the Office for Human Research Protections (OHRP) under 45CFR46, part A of which constitutes the US federal Common Rule. The FDA is an agency division of the HHS and ‘FDA regulations’ refers to the clinical research regulations codified in 21CFR50, 21CFR56, 21CFR312 and 21CFR812. The CDC, NIH and FDA are divisions of the PHS but OHRP is not.

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Conflict of interest

The authors are employees of the US government.

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Authors and Affiliations

  1. Veterans Affairs Maryland Health Care System, Research Service, 10 North Greene Street, Baltimore, MD, 21201, USA

    David L. Evers, Carol B. Fowler & Jeffrey T. Mason

  2. Office of Research and Development, Veterans Health Administration, Washington, DC, USA

    Rebecca K. Mimnall

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  1. David L. Evers
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  2. Carol B. Fowler
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  3. Jeffrey T. Mason
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  4. Rebecca K. Mimnall
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Correspondence to David L. Evers.

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Evers, D.L., Fowler, C.B., Mason, J.T. et al. Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects. Sci Eng Ethics 21, 1049–1064 (2015). https://doi.org/10.1007/s11948-014-9579-z

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