Who handles Human Tissue Transfer Agreements at Stanford?
ICO handles standalone tissue transfer agreements.
What if the PI is providing human tissues to a clinical research/trial sponsor?
A Human Tissue Transfer Agreement is not required if the transfer is clearly addressed in the clinical research/trial agreement. If not, a Human Tissue Transfer Agreement is needed, unless the sponsor prefers to amend the existing agreement.
What about sending human specimens to colleague for patient diagnosis/clinical purposes or a second opinion?
A Human Tissue Transfer Agreement is not required -- this is considered a part of clinical care.
When paying a service provider to analyze human samples – the provider is not using the tissues for research -- is a Human Tissue Transfer Agreement needed?
May a PI charge a fee for providing human samples that have been banked or collected over time?
The PI may be reimbursed solely for expenses incurred in preparing and shipping the human samples.
Companies sometimes ask investigators to collect human samples from a specific population of patients for the company’s research, which the investigator will participate in. How are these agreements handled, with a flat fee or otherwise?
Collecting tissues for research that includes the investigator is considered sponsored research and requires a sponsored research budget. Stanford does not enter into fee-for-service agreements where the fee covers the provision of human specimens and there is no research participation by the Stanford faculty.
A company has asked an investigator to collect human specimens for the company’s research purposes. The investigator will not participate in the research. How is this handled?
Unless there is an approved scientific justification for Stanford researchers, the transfer of human samples to a for-profit company solely for its research purposes, with or without a fee, is not allowed.
For questions about Human Tissue Transfer Agreements:
Call ICO at 650-723-0651, or email firstname.lastname@example.org.