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FAQs on the Policy and Procedures for Research Using Human Fetal Tissue in the IRP

  1. My samples are all “de-identified.” Why do I need to submit a request for a determination?
    The NIH IRP requires investigators conducting research with human fetal tissue to obtain an OHSRP determination or IRB review and approval for the research. The request for determination verifies the research project with fetal tissue has been reviewed and approved.
  2. I have a clinical protocol that included participants with a specific congenital condition. One of my participants would like to make arrangements for a private donation of an affected fetus from a terminated pregnancy for research purposes. What do I need to do?
    In this case, the materials are associated with identifiable information, and a new protocol or amendment to the existing protocol is required. (See Subpart B of 45 CFR 46.) Attestation II (for the IRB) must accompany the amendment/new protocol.
  3. I’m collaborating with investigators on a joint project from another country who are providing human fetal tissue acquired there for the study. What agreements do I need?
    There are a variety of mechanisms that can be used to arrange for transfer of human fetal tissue to the NIH. Check with your TDC to determine which is appropriate for your project. OGC has cleared language which may be included in MTAs and Collaboration Agreements that are specific to the transfer of human fetal tissue.
  4. What are Attestations and why are they needed?
    Attestations are intended to document awareness of and compliance with relevant laws and policies pertaining to this type of research. Different forms are available for specific circumstances.
    • Investigator Attestation I: Review of Human Fetal Tissue at NIH by The Office of Human Subjects Research Protections for research using de-identified fetal tissues for research.
    • Investigator Attestation II: Review of Human Fetal Tissue Research at NIH by the Institutional Review Board (IRB), for research using materials with identifiers, to be submitted with a new or amended IRB protocols

    NOTE: If purchasing from a commercial supplier (e.g. ABR), the supplier must provide a copy of their standard affirmation of their policy for obtaining fetal materials.

The page was last updated on Tuesday, December 15, 2015 - 10:00am