Language for Intramural Agreements that Involve Fetal Tissue

Language to Consider for Intramural Agreements That Involve the Transfer of Human Fetal Tissue

• The Parties will not knowingly acquire, receive, or otherwise transfer any human fetal tissue that is the subject of this agreement for valuable consideration. The term “valuable consideration” does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of the human fetal tissue.
• PROVIDER represents that it has followed all applicable legal requirements, including the expectation of consent for use of material to be used for reserch in obtaining and providing the Material.

Additional Language to Consider for Such Agreements That Also Involve Research Collaboration

• RECIPIENT will comply with all applicable laws, regulations, and policies related to the handling and use of the Material, which may include the following:
  • 45 CFR §46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material
  1. Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.
  2. If information associated with material described in paragraph (a) of this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.