커먼룰과 보관된 인체유래물에 관한 제공자의 권리

Abstract

Catalona court decided who had the rights to dispose the stored biospecimens among donors, an investigator(=Dr. Catalona), and an institute(=Washington University). According to the jurisdiction of the case,the court gave the institute rights to dispose the stored biospecimens based on the common law donation theory. However, there’s a critical opinion on this decision. Especially, it insisted that the decision violated the Supremacy Clause in the Amendment VI of the Federal Constitution. That is, the decision violated the general principle of Informed Consent that the rights of the human research subjects should not be waived by including exculpatory language. As you know, to obtain informed consent from the human research subjects is the critical element in conducting ethical research. But,according to Catalona decision, if there’s informed consent when the investigator or the institute collected the biospecimens, it’s allowed to use the stored biospecimens in any kind of research without obtaining additional informed consent from the donors. In fact, current Common Rule provided that the research could be conducted without obtaining additional informed consent from the donors if the identifiers were stripped. However,it’s necessary to consider that the complete anonymatization is not possible,especially, in the field of genomics. Changing technology in this field has dramatically increased the amount and nature of information about individuals that can be obtained from their DNA. It’s necessary to consider that the rights of donors should be protected as well. Under the Common Rule, investigators may be allowed in certain situations to obtain a general consent for future research with stored biospecimens. However, this violates HIPAA Privacy requiring that authorizations for research be study-specific. Therefore, the current Common Rule should be amended to provide the sufficient safeguards to protect the rights of donors in disposing their stored biospecimens. In order to do that, the suggestions would be helpful: the Common Rule should explicitly stipulate that it applies to research using biospecimens, the Common Rule should explicitly provide that donors retain certain rights in their biospecimens, the Common Rule should explicitly include that donors must give fully informed consent, the Common Rule should explicitly stipulate that blanket consent be prohibited, and the Common Rule should explicitly stipulate that investigators cannot anonymize a sample after its donor has requested withdrawal from research. Actually, OHRP published the Proposed Rule for the current Common Rule in the Federal Register in July 26, 2011 and received all the comments. OHRP is still working on making final rule. I hope that the final rule guarantee full informed consent of donors in research using stored biospecimens and provide additional safeguards to protect and enhance the rights of human research subjects.