probable benefits outweigh its risks. These include voluntary informed consent; fair selection and recruitment of potential research participants, including fair payment for their participation; and compensation, including the provision of medical care, for research-related injuries.2 The chapter concludes with recommendations regarding whether and, if so, how the Environmental Protection Agency (EPA) should use ethically tainted data.

The aim of this chapter is to formulate standards of ethical acceptability of intentional human dosing studies. Because some standards identify a minimum that must be met in any such study, while others point to ideals that should guide such research, it is important to distinguish what is ethically unacceptable from what falls short of ethical ideals.

Federal regulations would not be applicable to many third-party intentional dosing studies, because although EPA has accepted the Common Rule, which governs the research that it conducts or funds, this rule does not apply to privately funded toxicant research. Also, EPA has not adopted Subpart B (fetuses, pregnant women, and human in vitro fertilization), Subpart C (prisoners), or Subpart D (children). In addition, although the Common Rule provides a framework for the ethical review of research involving humans, it does not fully and completely specify what should be done in key areas, such as risk-benefit analysis and assessment, the selection of research participants, informed consent, remuneration for research participation, compensation for research-related injuries, and the use of ethically tainted data, all of which are discussed in this chapter.3

The committee’s ethical analysis therefore draws on many different sources in addition to the Common Rule, including the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (National Commission, 1979), Good Clinical Practice (GCP) guidelines (FDA, 2003), the Declaration of Helsinki (WMA, 2002), bioethics literature, recent studies by the National Academy of Sciences/Institute of Medicine, a report by the National Bioethics Advisory Commission (NBAC, 2001), a report by the National Human Research Protections Advisory Committee on research with children,4 and policies and practices


Informed consent and review by an Institutional Review Board (IRB) are considered the major pillars in the system for protecting the rights and welfare of participants in research (NBAC, 2001).


This report does not address all the ethical considerations that are relevant to the evaluation of intentional dosing studies. Instead, it concentrates on the ethical considerations that are especially unclear or controversial in intentional dosing studies, while presupposing the other ethical conditions, such as confidentiality.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement