What research with stored samples teaches us about research with human subjects.
There is widespread discussion concerning the safeguards appropriate for human research subjects. Less discussed is the fact that the safeguards one deems appropriate depend, in large part, on the model of research participation that one assumes. Therefore, to determine what safeguards are appropriate, it is necessary first to clarify the competing models of research participation. The ostensibly obscure debate over informed consent for research on stored biological samples is of particular interest in this regard because such research can involve varying subsets of the three central elements of research involvement. As a result, analysis of this debate provides an opportunity to identify the competing models of research participation. Based on this analysis, this paper describes a new model of research participation that is emerging, and considers its implications for clinical research.
Wendler
David
D
Department of Clinical Bioethics, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD, USA 20892. wendler@nih.gov
D018070:Biological Specimen Banks; D035843:Biomedical Research; D004813:Epidemiology; D035082:Federal Government; D036281:Genetic Research; D006801:Humans; D007258:Informed Consent; D026684:Personal Autonomy; D035842:Research Subjects; D009927:Tissue and Organ Procurement