FDA, OHRP have little to say on tissue protection
Here’s their guidance in brief
IRBs that are addressing policy regarding informed consent in cases where research uses human tissue should take note of the small amount of guidance offered by the U.S. Food and Drug Administration and the Office for Human Research Protections (OHRP). Here’s what the agencies say:
The FDA, in an IRB information sheet that can be found on-line (www.fda.gov/oc/ohrt/irbs/faqs.html#Informed) mentions the topic of specimens only once, and that is question 52:
Q: Is it acceptable for the consent document to say specimens are "donated"?A: What about a separate donation statement? It would be acceptable for the consent to say that specimens are to be used for research purposes. However, the word "donation" implies abandonment of rights to the "property." 21 CFR 50.20 prohibits requiring subjects to waive or appear to waive any rights as a condition for participation in the study. Whether or not the wording is contained in "the actual consent form" is immaterial. All study-related documents must be submitted to the IRB for review. Any separate "donation" agreement is regarded to be part of the informed consent documentation, and must be in compliance with 21 CFR 50.
The OHRP at a Cooperative Oncology Group Chairpersons Meeting on Nov. 15, 1996, wrote this about "Exculpatory Language" in Informed Consent:
No informed consent, whether oral or written, may include any exculpatory language through which the subject 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.
Examples of exculpatory language:
• By agreeing to this use, you should understand that you will give up claim to personal benefit from commercial or other use of these substances.
• I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. government and hereby relinquish all right, title, and interest to said items.
• By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research.
• I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
Examples of acceptable language:
• Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur.
• By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above.
• This hospital is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research.
• This hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge.
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