Human Tissue Agreements
Human Tissue Agreements (HTAs) govern the transfer of tissues and other biological materials (ex. blood, saliva, hair samples, etc.) extracted from human subjects to outside researchers. Per Stanford's policies, human tissue transfers are only allowed for research purposes and such transfers need to be accounted for in the consent form.
If Personal Identifiable Information or Personal Health Information, as defined by HIPAA, is transferred with human tissues, Stanford Privacy Office review may be required.
Before an HTA can be signed, approval from the appropriate compliance offices must be secured.
For a template HTA, please contact ico@stanford.edu.
Frequently Asked Questions
1. What is the difference between an MTA and an HTA?
HTAs specifically cover human materials transfers from Stanford to a different entity. MTAs cover transfers of all other types of tangible materials.
2. Can I send or receive human materials without an agreement?
No, an agreement is required for all human material transfers.
3. Is Stanford IRB approval required for transferring de-identified human materials?
Stanford IRB approval is not required for incoming de-identified human materials to Stanford. However, IRB approval is always required when sending human materials outside of Stanford, even if they are de-identified.
4. Are human cell lines considered human materials?
According to the IRB, human derived cell lines are not considered human materials.
5. Is an agreement required when sending human materials to a company for analysis?
If Stanford is paying the company to analyze the materials, an HTA is not required. The company may require a service agreement, which can be handled by the Procurement office. Requests to the Procurement office can be submitted through iProcurement.