Ethical considerations, confidentiality issues, rights of human subjects, and uses of monitoring data in research and regulation.
The process of conducting research on human biomarkers was reviewed, and the ethical issues that arise at each step in the process were addressed. Some potential problems which arise and stimulate attempts in discovering approaches to solve the problems were presented. Emphasis was placed on design of studies, subject recruitment and informed consent, privacy and confidentiality, interpretation and communication of test and study results, communication to control subjects, responsibilities for action, dilemmas for researchers, and implications of biotechnologic developments. In almost every facet of human biomarker research studies, ethical issues have been involved. A number of concerns also have arisen when considering the use of human biologic specimens and new biomarkers. While it may seem that use of such markers taken from human specimens should be more accurate than traditional sources of information such as questionnaires or environmental monitoring, the authors caution that this is not necessarily the case. Issues which remain to be resolved include the use of specimens for purposes other than that for which they were collected, the extent of reporting back results, ownership of specimens, and use and interpretation of results.