Informed consent for the research use of human biological materials

New medical developments have increased the use of human tissue, especially for research purposes. The attention of lawyers concerned with research has traditionally focused on the protection of research subjects and on data-protection. Legal aspects of the secondary research use of human tissue are still unclear. On an international level consensus is growing that sources of tissue should consent to the secondary use of their tissue. We offer some guidelines for drafting consent forms for the research use of human biological materials, elaborating in a more concrete manner the rule of consent for the secondary use of tissue. Topics covered concern amongst others layered consent, new findings, protection of informational privacy, withdrawal of consent and commercialiZation.