Policy and Procedures for Obtaining Human Fetal Tissue for Research Purposes in the Intramural Research Program at NIH

Definition and Scope

• This policy describes the requirements and procedures for obtaining human fetal tissue for research purposes within the Intramural Research Program (IRP) at the National Institutes of Health (NIH).
• This policy defines “Human fetal tissue” as tissues or cells obtained from a dead human embryo or fetus after spontaneous or induced abortion, or after a stillbirth. This policy applies to research using human fetal tissue; however, this policy does not apply to secondary sources of tissues such as established cell lines or animal models containing human fetal tissue.

Requirements and Procedures

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 Fetal Tissue Research section of the NIH Sourcebook. All experiments using human fetal tissue must be reviewed and approved either by OHSRP or an NIH IRB.
   1. For de-identified tissue (that will not be used as part of an IRB-approved protocol), review, sign, and submit both of the following documents to the NIH Office of Human Subjects Research Protection (OHSRP) indicating that you are aware of and in compliance with the relevant laws and policies pertaining to research with human fetal tissue, including the expectation of consent for use of materials for research purposes:
      1. Request for Determination - Specimen Data Use Interview Survey or Other
      2. Investigator Attestation I: Review of Human Fetal Tissue at NIH by the Office of Human Subjects Research Protections (hereinafter referred to as “Attestation I")
   2. If the samples include identifiable information, the NIH researcher is aware of the identity of the donor, or the samples will be used as part of an IRB-approved protocol which includes consent for use of fetal tissue for research purposed (see Subpart B of 45 CFR 46).
      Institutional Review Board review of a new protocol or an amendment to an existing protocol will be required. Review, sign, and submit the following document, along with your protocol, to the IRB indicating that you are aware of and in compliance with the relevant laws and policies pertaining to research with human fetal tissue.
      1. Investigator Attestation II: Review of Human Fetal Tissue Research at NIH by the Institutional Review Board (IRB) ( “Attestation II”)
2. After obtaining OHSRP or IRB approval in order to obtain and use human fetal tissue, NIH Intramural Investigators must submit a request to their purchasing agents or completion of MTA or Collaborative agreement (See #5). A certified document, “Attestation I or II”, must accompany all such requests. (See Guidelines for Ordering Fetal Tissue). Intramural Investigators must maintain a copy of these forms as part of their NIH research records.
3. NIH Institute and Center purchasing agents must be provided a copy of the appropriate Attestation prior to ordering material and must maintain the Form with related transaction records. Purchasing agents must be aware of applicable legal requirements associated with acquiring and obtaining human fetal tissue (U.S.C. §§289g-2).
4. NIH Intramural Investigators must obtain human fetal tissue, as determined by the needs of their specific research projects, in a manner consistent with all applicable legal requirements.
5. A Materials Transfer Agreement (MTA) or collaborative agreement (CA) must be executed for human fetal tissue obtained from an academic institution, clinic, or hospital, and must provide documentation that they are in compliance with the applicable Federal laws and policies or provided information on comparable restrictions in force in their country. This includes a statement, that NIH expects informed consent to have been obtained from the donor for any NIH-supported research using human fetal tissue. IRP Investigators must keep a record of this documentation.
6. All commercial suppliers of research material must provide documentation that they are in compliance with the applicable Federal laws and policies. IRP Investigators must keep a record of this documentation.
7. NIH Intramural Investigators are required to submit all documentation regarding their use of human fetal tissue to their SD and to the NIH Intramural Compliance Officer including:
   • A copy of the appropriate Attestation Form (I and/or II);
   • A copy of the OHSRP Determination or IRB protocol approval letter with précis;
   • A copy of all documentation from the supplier of the research material
8. NIH Intramural investigators will be required to check a box on their annual report in the NIH Data Base (NIDB) indicating whether human fetal tissue was acquired and/or used for a specific research project in the current fiscal year.
9. Scientific Directors will be required to provide additional information on the use of human fetal tissue in the annual Management Control Survey.

Attachments

• Human Fetal Tissue Checklist
• Investigator Attestation I
• Investigator Attestation II