Human tissue ownership and use in research: what laboratorians and researchers should know.
BACKGROUND
The use of human blood and tissue is critical to biomedical research. A number of treaties, laws, and regulations help to guide the ethical collection of these specimens. However, there are no clearly defined regulations regarding the ownership of human tissue specimens and who can control their fate.


BACKGROUND
This review discusses the existing regulations governing human studies and the necessary components of patient consent. Legal cases that have addressed the issue of ownership of human tissue are reviewed, including recent settlements that have led to the destruction of millions of specimens of patient tissue. The unique regulations that guide the use of tissues collected postmortem are also examined. Potential changes in the future of biomedical research that uses human tissue, including genetic material, are also discussed.


CONCLUSIONS
The use of human tissue is directed by numerous laws and regulations. Awareness of these rules and of how and when to obtain meaningful informed consent from patients is essential for laboratorians and researchers, who should also be familiar with situations that have led to lawsuits and in some cases the destruction of valuable human tissue specimens.
Allen
Monica J
MJ
Office of the Executive Vice Chancellor and General Counsel, Washington University School of Medicine St. Louis, MO 63110, USA.
Powers
Michelle L E
ML
Gronowski
K Scott
KS
Gronowski
Ann M
AM
D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D010067:Ownership / Q000331:legislation & jurisprudence*; D013048:Specimen Handling; D014481:United States