Guidelines for Ordering Human Fetal Tissue

Requirements and Procedures

The following conditions must be met in order to obtain Human Fetal Tissue for research purposes:

1. Investigators must obtain OHSRP or IRB review/approval (Attestation forms) prior to submitting a request to obtain human fetal tissue. Intramural Investigators are expected to maintain a copy of Attestation I (OHSRP) and/or Attestation II (IRB) as part of their NIH research records.
2. NIH Institute and Center purchasing agents must receive a copy of Attestation Form prior to ordering material and must maintain the Attestation Form with related transaction records. Purchasing agents must be aware of financial restrictions associated with obtaining human fetal tissue research (U.S.C. §§289g-2)*.
3. A Materials Transfer Agreement (MTA) or Collaborative Agreement (CA) containing approved language**, must be executed for human fetal tissue obtained from an academic institution, clinic, or hospital.
4. All suppliers of research material must provide documentation indicating they are in compliance with the applicable Federal, local, and state laws and policies, or provide information on comparable restrictions in force in their country. IRP Investigators must keep a record of this documentation.

*§289g–2. Prohibitions Regarding Human Fetal Tissue

1. Purchase of tissue
   It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.

** 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 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.