As noted in Chapter 2, research with human participants plays an essential role in understanding the health impacts of the environment. This chapter will focus on human participant issues that create unique or especially challenging problems in environmental health research. Before exploring these issues, it will be useful to review some of the important historical developments, ethics codes, regulations, and ethical principles pertaining to research with human participants. (Environmental health research with human and animal participants raises a number of ethical and policy issues that will not be discussed here. For a review, see Emanuel et al. 2008; Shamoo and Resnik 2009.)

BACKGROUND

Prior to World War II, there were no well-recognized international codes or guidelines concerning research with human participants. The American Medical Association had discussed drafts of potential guidelines, and a few countries, such as Germany, had developed some rules, but there was very little substantive guidance on the ethical conduct of research with human participants. Many experiments were conducted on vulnerable groups (i.e., individuals who have difficulty providing consent), such as mentally ill people, racial minorities, children, and prisoners (Lederer 1995). Informed consent was not a widely recognized principle of medical research, and doctors often experimented on their patients without their consent (Lederer 1995).