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Controlled Human Inhalation-Exposure Studies at EPA (2017) / Chapter Skim
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1 Introduction
Pages 11-16

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From page 11...
... studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. In the CHIE study context, controlled refers to the aspect of experimental design intended to focus on exposure conditions (that is, the type of pollutant, concentration, and duration)
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From page 12...
... EPA conducts CHIE studies involving subjects who are healthy individuals or those with mild medical conditions who are considered unlikely to have a serious adverse health response to the controlled exposures. The regulations that govern human research at EPA provide the general requirements for informed consent the agency must follow in seeking the involvement of human subjects in a CHIE study (40 CFR 26A)
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From page 13...
... Review by an appropriately constituted IRB or its foreign equivalent. Participant Selection Criteria IRBs reviewing intentional human dosing studies should ensure that the following conditions are met in selecting research participants: a.
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From page 14...
... Human Studies Review Board To ensure that intentional human dosing studies conducted for EPA regulatory purposes meet the highest scientific and ethical standards, EPA should establish a Human Studies Review Board to ad dress in an integrated way the scientific and ethical issues raised by such studies. To the extent possi ble, this board should review in a timely manner the protocols and the justification for all intentional dos ing studies intended for submission to EPA, as well as study results when completed.
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From page 15...
... The committee was asked to assess the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. The committee also was asked to assess the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility and comment on the degree of actual risk imposed by the exposures in those studies.
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From page 16...
...  If the committee supports continued conduct of human-exposure studies, it will provide further guidance in the following areas: o Methods for estimating levels of risk in controlled human-exposure studies, drawing from rel evant approaches used in Phase I clinical drug trials, and o A template to characterize reasonably foreseeable risks, in terms of the nature, frequency, and magnitude of possible risks, which could be used in obtaining informed consent from po tential study participants. The literature on "challenge studies" should be considered in the design of the template, if applicable.
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Key Terms

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  • intentional human
  • informed consent
  • dosing studies
  • human studies

  • studies review
  • study participants
  • review board
  • air pollutants
  • controlled human

  • chie study
  • adverse events
  • human research
  • epa regulatory
  • human subjects

  • study subjects
  • continued conduct
  • regulatory purposes
  • scientific issues
  • epa human

  • studies epa
  • review chie
  • involving human
  • research studies
  • exposure studies

  • potential study
  • research facility
  • research involving
  • potential health
  • committee supports


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