Toward clarity in the use of human tissue in research

The issues of ownership of human tissue and individuals' consent for its use in research are of national importance. Three influential court cases have determined that individuals do not retain a property interest in research tissues. The issue currently in question is what degree of individual understanding and informed consent is appropriate to both protect researchers from lawsuits for their use of human tissue in research, while simultaneously providing individuals and groups of individuals with the appropriate degree of understanding and informed consent. We present a 2-tiered approach that might resolve this issue.