In addition to consenting to participate in a study, participants can consent on whether or not they want their results (Morello-Frosch et al. 2009). (Additional discussion is found in the section, Returning Research Results.) Researchers conducting observational exposure studies are expected to seek permission from research subjects who must be informed about the goals of the research, the specific procedures involved, and the potential benefits of and risks posed by participation. That kind of communication does not end when a research subject signs a permission form or otherwise indicates his or her willingness to participate. As a study progresses and new findings are discovered, investigators are expected to communicate to research subjects any changes that have been made in the study protocol. It is through such regular communication that consent to participate is reaffirmed. If an important risk is detected, the investigators are also obliged to report it to the participants and the funding agency involved.
Typically, observational studies that do not involve efforts to mitigate human exposures present minor risks to the people who participate as research subjects. However, in addition to minor burdens associated with the collection of exposure data, without full communication such studies may also increase participants’ exposure in unintended ways, for example, by promoting an unwarranted sense of protection to subjects through their wearing of exposure-monitoring devices. Observational studies can also present risks related to the unintended disclosure of private information; for example, release of medical records might impair a person’s ability to obtain employment. To address those possible risks, investigators should strive to ensure that data are protected and that research subjects understand any potential risks associated with their participation.
The committee acknowledges in addition to observational exposure studies, there are intentional dosing studies that can involve potential increases in harmful exposures. For example, a study conducted in London, England, had asthmatic volunteers walk routes with low and high exposures to air pollution (McCreanor et al. 2007). In another study, men suffering from congestive heart failure were exposed to high concentrations of diesel exhaust, which has been linked to an increased risk of a coronary event (Mills et al. 2007). Such studies raise additional ethical considerations (see NRC 2004); but these studies fall outside the scope of this committee’s charge.
It is critical that scientists conducting research with human subjects not have conflicts of interest that may impair their ability to conduct the research ethically. Financial relationships with industry sponsors of research should be disclosed to IRBs and other research-oversight boards, such as university committees on conflict of interest. Sources of research funding should be disclosed to potential volunteers when they are approached to participate in a study, as should any financial relationships of the investigators with commercial entities that may be affected by the outcome of the research. Such disclosures can promote public trust by increasing transparency and giving study volunteers the opportunity to assess the full array of potential benefits and risks associated with their participation in the research.