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Compliance & Policies

Commercial Sale of Blood and Tissue Samples Policy

Effective: December 4, 2002

Background

Human blood and tissue samples obtained through research, clinical or pathological procedures provide a critical foundation for many areas of biomedical research. Sharing these samples with other investigators at Washington University and other research institutions has a very long history, fosters collaborative research and increases the potential for scientific discovery. While, by extension, sharing these samples with industry or other for profit entities may also lead to collaborative research efforts, these interactions pose some vexing ethical problems, which this policy addresses.

Most often blood and tissue samples* are obtained under the auspices of WUSM faculty clinical practice on an out-patient basis. In this situation, the samples belong to the University and the investigator should follow the University procedures described below (for samples obtained from in-patients see footnote below**). Samples gathered under WUSM faculty clinical practice are derived from humans who have signed informed consent forms, which generally state that the blood and tissues may be used by the investigator for all research programs directed by him or her. These consent forms do not include the right to sell tissues to other entities strictly for profit. To do so without informed consent is wrong and unethical, but there are many other problems, including liability issues, ownership of intellectual property, and serious fiscal/tax issues for the institution. Thus, there is a need for the policy described below.

Policy

Washington University principal investigators or tissue repository staff are permitted to share blood and tissue samples with other investigators at Washington University, investigators at different research institutions and private industry for research purposes, but only after appropriate informed consent has been obtained from the patients involved. If required, investigators are allowed to recoup the actual costs incurred in preparing and transporting the samples, but in no case should a profit be generated.

  1. Informed Consent
    Investigators wishing to share blood and tissue samples with other investigators, institutions or private industry must include that intent in the protocol submitted to the Human Subjects Committee. Furthermore, investigators intending to share samples with other institutions or private industry must follow proper informed consent procedures as outlined by the Washington University School of Medicine Human Subjects Committee. Briefly:

    1. If the samples are not anonymous the investigator must obtain proper informed consent from the donor. In the case of samples obtained through an autopsy, consent must be obtained from the individual assigned with durable power of attorney, or in cases where no such individual has been named, the nearest surviving relative should provide informed consent. Durable power of attorney is defined as the legal authority to act on behalf of another, regardless if the individual becomes incapacitated in the future.
    2. If the samples are anonymous, it is possible for the investigator to obtain the samples without informed consent. Samples are anonymous only if it is impossible under any circumstances for anyone to identify the tissue source. However, the investigator must request exemption from the informed consent process by submitting an application to the Human Subjects Committee.
       
    3. No informed consent, whether oral or written, may include any exculpatory language through which the subject is made to waive any of the subject's legal rights, release or appear to release the investigator or Washington University from liability for negligence.
       
  2. Materials Transfer Agreement

    Investigators who leave the University are prohibited from taking tissue specimens (defined as the entire tissue entity derived from the patient, e.g. a tumor biopsy), blood or tissue samples, or the resultant data with them unless they have prior written approval from the Vice Chancellor for Research. Investigators will be required to complete a Materials Transfer Agreement and submit it to the Office of Technology Management before the transfer can take place. The Vice Chancellor for Research will consider such a request in conjunction with the appropriate dean and department head along with the advice and consent of the Banked Tissue Sample Committee, which will be chaired by the Vice Chancellor for Research. This standing committee will include at least two senior faculty members familiar with the science and specimens or database.

    Newly employed investigators wishing to bring blood or tissue samples with them must be able to document ownership and have a formal agreement with the institution where the samples originated.

* Defined as any biological product or byproduct obtained from a living or deceased individual that is sufficient in type and quantity to permit an analysis of its physical or biochemical properties.
** Note to investigators: Human blood or tissue samples are often collected at Barnes-Jewish hospital to ascertain pathology (e.g. clinical surgery). These samples belong to the hospital and the investigator should get clearance from both WUSM and Barnes-Jewish hospital.
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