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Human tissue samples are stored in a variety of tissue banks including blood banks, umbilical cord blood banks, and forensic DNA banks, to name a few, for a variety of purposes, including research. These banks do not conduct research, but the tissue samples often become a source of research material.1
Scientists who conduct research with human tissues may need to obtain informed consent from subjects or may qualify for a waiver or exemption from the institutional review board (IRB). If the researcher obtains private identifiable information from the subjects, then the human subjects must provide informed consent for the use of their tissue.
When consent is obtained, several issues must be addressed in the consent form. These include
* tissues that will be collected and who will collect them
* types of research that will be performed on the tissue, including genetic analysis
* potential risks of information disclosure (insurance coverage, employment, and emotional discomfort)
* potential benefits and, if any, results will be disclosed to the subject
* types of processes in place to protect confidentiality
* with whom the sample may be shared, if known
* whether the sample will made unidentifiable, and if so, how and when
* commercial applications of the research
* whether the subject can have the tissue destroyed upon withdrawal from the study
* length of time the sample will be kept1
The consent process for human tissue, however, has to be tailored to the specific circumstances and may be subject to a waiver under 45 CFR 46.116 (d) if 4 conditions are met. These conditions are that
* the research involves no more than minimal risk to the subjects.
* the waiver will not adversely affect the rights of the subjects.
* the research could not be carried out with the waiver.
* whenever appropriate, the subjects will receive additional pertinent information after participation.1
Application of these conditions may be difficult. Although most IRBs have traditionally believed that human tissue research carries minimal risk, there are possible implications for employment and insurance coverage. Some IRBs believe that subjects' rights have been violated especially if the consent is waived when human tissue from distinct cultural communities is used. Once tissue specimens have been obtained, it may be difficult to contact subjects about additional pertinent information.2
Research with tissue samples may be exempt from IRB review and informed consent if the research involves samples that have already been collected and are publicly available but unidentifiable. A recent ruling has established that if the link between the sample and the individuals is maintained by the tissue bank, and the investigator has no access to that link, the sample may be considered unidentifiable and therefore exempt. However, if new tissues are added to those already in the tissue bank, informed consent is requisite.
Human tissue may be subject to multiple IRB reviews, particularly when the sample is collected at one institution, stored in a tissue bank, and transferred to another institution for study. The IRB at each institution is responsible for federal oversight compliance, including privacy and informed consent.
One controversial issue surrounding human tissue is who has property rights to the specimens and to any products developed from the tissue. In the case of Moore v Regents of the University of California,3 tissue taken from John Moore, who had hairy cell leukemia, was used to develop a product line for fighting several diseases. Mr Moore sued; the California Supreme Court ruled that he did not have property or legal rights to products developed from his cells.
Many states still do not have statutes regarding the ownership of tissues, but many investigators believe that "any ownership you might have in your tissues vanishes when they are removed from your body, with or without consent."4 The use of human tissue in research studies is a complex issue that continues to evolve and require legal interpretation.
1. Dunn CM, Chadwick GL. Protecting Study Volunteers in Research: A Manual for Investigative Sites. 3rd ed. Boston, MA: Thomson Centerwatch Publishers; 2004. [Context Link]
2. Amdur R, Bankert E. Institutional Review Board: Management and Function. Sudbury, MA: Jones & Bartlett; 2002. [Context Link]
3. John Moore v the Regents of the University of California. 1990. http://en.wikipedia.org. Accessed March 1, 2008. [Context Link]
4. Skloot R. Taking the least of you: the tissue-industrial complex. New York Times. http://www.nytimes.com/2006/04/16/magazine/16tissue.html. Accessed April 16, 2006. [Context Link]
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