About the Author
Proxima CRO Team
Stephanie Mull
Sr. Director of Clinical Operations
Stephanie has over 20 years of clinical research experience working from the site, CRO, and sponsor perspectives.

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 comply with 21 CFR 50.

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