Who Owns the Rights to Human Tissue?
Thursday, June 15, 2006
The news was released by the House Energy and Commerce Committee, along with details of a nearly $300,000 collaboration involving the NIH’s National Institute for Mental Health and Pfizer, spanning several years.
The government spent $6.4 million to obtain 3,500 samples that went to Pfizer to study how Alzheimer’s disease progressed in 538 patients. An interesting point of contention related to tissue samples that this article doesn’t address is whether subjects have property rights to their tissues or products developed from their tissues. As the editor of CenterWatch’s book Protecting Study Volunteers in Clinical Research, I know it would be valuable to share a passage about this issue here…
“…at least one state has, by statute, provided individuals a property right to their DNA. In the majority of states there is no legal precedent on the issue. Many sponsors and investigators try to ask subjects to waive their rights to the tissue and the products developed from this tissue as part of teh informed consent process. However…, both FDA and the Common Rule regulations state that ‘no informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence’ (45 CFR 46.116,21 CFR 50.20). Some have argued that this language is limited by the term ‘exculpatory’ to waivers of blame for injury. However, both the OHRP [Office for Human Research Protection] and the FDA have issued guidance that interprets this regulatory language to apply to all legal rights, including property rights in tissue. This is a complex issue that continues to evolve and involves conflicting legal interpretation issues. However, unless the OHRP and FDA alter their guidance, investigators will be wise to avoid any waivers of legal rights.”