Procedures for Obtaining Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH

1. All NIH intramural investigators must be fully aware of and in compliance with all applicable legal requirements, including laws that govern research using human fetal tissue and research involving transplantation of fetal tissue. A summary of relevant laws and policies are described within the Policies on the Acquisition and Use of Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH section of the NIH Sourcebook. All experiments using human fetal tissue must be reviewed and approved in advance either by the NIH Office of IRBO or the NIH IRP IRB (NIH Intramural Institutional Review Board), which entails approval by the Scientific or Clinical Director.
   1. For de-identified tissue (that will not be covered on an IRB-approved protocol), NIH Intramural Investigators must:
      1. Submit a request for a determination of “Not Human Subjects Research (NHSR) Determination” in the electronic IRB (eIRB) submission system, including donor consent for the use of tissue in research.
      2. Attach the completed Investigator Attestation I form in the eIRB system for review and certification.
   2. For identifiable tissue, tissue for which the NIH researcher is aware of the identity of the donor OR when the tissue will be used as part of an IRB-approved protocol, NIH Intramural Investigators must:
      1. Submit a new protocol or an amendment to an existing protocol, including donor consent for the use of identifiable human fetal tissue for the research, if applicable (see Subpart B of 45 CFR 46), for IRB approval, in the eIRB system.
      2. Attach the completed Investigator Attestation II form (identifiable tissue) or Investigator Attestation I form (de-identified tissue) in the eIRB system for review and certification.
2. NIH Intramural Investigators must obtain HFT, as determined by the needs of their specific research projects, in a manner consistent with all applicable legal requirements.
3. For HFT provided from commercial suppliers:
   1. NIH Intramural Investigators must request the tissue with involvement from an NIH Institute and Center purchasing agent.
   2. Investigators must provide purchasing agents with a copy of the appropriate Attestation (I or II) prior to ordering materials.
   3. Purchasing agents must be aware of applicable legal requirements associated with acquiring and obtaining HFT (U.S.C. §§289g-2) and maintain the Attestation I or II with related transaction records.
   4. Investigators must collect documentation that the commercial supplier has complied with the applicable Federal laws and policies and keep a record of this documentation.
4. For HFT obtained from an academic institution, clinic, or hospital:
   1. Investigators must ask their Technology Transfer Office to execute an MTA or Collaborative agreement.
   2. The MTA/CA includes a statement, that NIH expects informed consent to have been obtained from the donor for any NIH-supported research using HFT. Intramural Investigators must obtain proof of consent from the external institution and keep a record of this documentation.
   3. As part of the request, they should complete and submit an Investigator Attestation for MTA/DTA/CA and include the executed Attestation I or II (see below for attestations).
   4. Investigators must collect documentation that the external institution is in compliance with the applicable Federal laws and policies or information on comparable restrictions in force in their country, when applicable, and share it with Tech Transfer.
5. NIH Intramural Investigators are required to maintain a copy of all documentation mentioned above in their research records and submit it to their SD and to the NIH Intramural Compliance Officer including:
   • A copy of the appropriate Attestation Form (I and/or II; MTA/DTA/CA, if applicable)
   • A copy of the “Not Human Subjects Research” Determination or IRB protocol approval letter with a précis
   • A copy of all documentation from the supplier of the research material
6. NIH Intramural investigators will be required to indicate on the annual Biospecimen Report whether HFT was acquired, used or stored for a specific research project in the current fiscal year.
7. Scientific Directors will be required to provide additional information on the use of human fetal tissue, and the transplantation of human fetal tissue, in the annual Management Control Survey.

Attachments

• Investigator Attestation I
• Investigator Attestation II