Communicating their individual results to participants in an environmentalexposure study: Insights from clinical ethics

The objective of this study was to formulate a framework for determining wh at information to communicate to individual subjects of a study measuring b iomarkers of exposure, consistent with the principles of ethical clinical a nd research practice. Methods consisted of review of the scope of environme ntal exposure studies, including the use of biomarker measurement in clinic al medicine and environmental research and the relevant principles of clini cal ethics and research practice. An exposure biomarker study is designed t o elucidate constitutional, behavioral, and environmental determinants of t issue concentrations of exogenous substances, Of itself, it is not designed to measure risk relations, those being the relation between biomarker leve ls and health outcomes. In many settings, measured tissue biomarker concent rations fall below those known or reasonably predicted to cause disease. Et hical clinical and research practice, aiming to maximize autonomy and benef icence and to minimize harm, requires that study findings concerning the de terminants of exposure be communicated to study participants. In addition, investigators should reference clinical action levels beyond which individu al biomarker results are routinely communicated to participants, When bioma rkers have no known. relation to risk, or when levels fall below action lev els, it may be preferable not to communicate individual results, if this ar rangement has been formalized at the time of informed consent, (C) 1999 Aca demic Press.