ETHICAL CONSIDERATIONS, CONFIDENTIALITY ISSUES, RIGHTS OF HUMAN-SUBJECTS, AND USES OF MONITORING DATA IN RESEARCH AND REGULATION

Biomarkers are potentially powerful tools for use in research and regu lation. Their derivation from biologic specimens collected from human subjects does, however, present many ethical implications. Ethical iss ues are relevant in almost each facet of human biomarker research stud ies: design, identification and recruitment of subjects, handling and use of the data, and interpretation and communication of results. Rese archers also face a number of dilemmas when considering the use of hum an biologic specimens and new biomarkers. The mere fact that such mark ers are the result of measurements in human specimens gives the appear ance of being more accurate than traditional sources of information su ch as questionnaires or environmental monitoring; yet, this may not al ways be the case. The meaning of the results of biomarker studies may be unclear because the purpose of the study is usually for research ra ther than clinical purposes. There generally are no established normal ranges for biomarkers and the interpretation of findings are often di fficult. Researchers may not communicate these results to subjects or consider followup action because the task may be too difficult or unde fined, or the reaction of the subject cannot be anticipated. A wide ra nge of practices in this regard exists among researchers. Many questio ns remain unanswered about the use of biologic specimens. These includ e questions of ownership and access to specimens. Related to this is t he question of whether specimens collected for one research purpose ca n be used for an entirely different research purpose. This is still an open question. Researchers and regulators may not be aware of the pot ential for biomarker information to affect the lives of subjects and t heir families without sufficient protection of personally identifiable data and regulation of its use. it is incumbent on researchers to con sider these human subject questions whenever they are using human spec imens or biomarkers.