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Opinion 2.08 - Commercial Use of Human Tissue

The rapid growth of the biotechnology industry has resulted in the commercial availability of numerous therapeutic and other products developed from human tissue. Physicians contemplating the commercial use of human tissue should abide by the following guidelines:

(1) Informed consent must be obtained from patients for the use of organs or tissues in clinical research.

(2) Potential commercial applications must be disclosed to the patient before a profit is realized on products developed from biological materials.

(3) Human tissue and its products may not be used for commercial purposes without the informed consent of the patient who provided the original cellular material.

(4) Profits from the commercial use of human tissue and its products may be shared with patients, in accordance with lawful contractual agreements.

(5) The diagnostic and therapeutic alternatives offered to patients by their physicians should conform to standards of good medical practice and should not be influenced in any way by the commercial potential of the patient’s tissue. (II, V)

Issued June 1994 based on the report "Who Should Profit from the Economic Value of Human Tissue? An Ethical Analysis," adopted June 1990.