Notice Number: NOT-OD-15-143
Key Dates
Release Date: August 14, 2015
NOT-OD-16-033
Issued by
National Institutes of Health (NIH)
Purpose
This Notice is intended to remind NIH-funded grantees and contractors that research involving human fetal tissue must be conducted in accordance with applicable Federal, State and local laws, regulations, and policies, including the NIH Grants Policy Statement. Selected Federal statutes, regulations, and policies are provided below:
42 U.S.C. 289g-1 and 289g-2 set forth specific requirements and prohibitions on research involving human fetal tissue. For example, among other prohibitions, 42 U.S.C. 289g-2 provides:
Prohibitions regarding human fetal tissue
(a) 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.
The full text of 42 U.S.C. 289g-1 is available at:
http://www.gpo.gov/fdsys/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A-subchapIII-partH-sec289g-1.htm.
The full text of 42 U.S.C. 289g-2 is available at:
http://www.gpo.gov/fdsys/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap6A-subchapIII-partH-sec289g-2.htm.
Research involving human fetal tissue is also subject to the HHS Regulations for the Protection of Human Subjects (45 CFR 46 Subparts A and B). The following provisions may be specifically relevant:
46.204 Research involving pregnant women or fetuses.
~ (a) (g)
(h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
(i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and
(j) Individuals engaged in the research will have no part in determining the viability of a neonate.
46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
(a) 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.
(b) 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.
The full text of the HHS Regulations for the Protection of Human Subjects is available at: http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf.
Grantee responsibilities for the conduct of human fetal tissue research are further described in the NIH Grants Policy Statement Part 4.1.14. Contractor responsibilities are outlined in the HHS Acquisition Regulation Protection of Human Subjects Clause (HHSAR 352.270-4b), the Research Involving Human Fetal Tissue Article included in Section H of the contract, and in the Statement of Work.Inquiries
Please direct all grants related inquiries to:
Division of Grants Compliance and Oversight
GrantsCompliance@nih.gov
Please direct all contract related inquiries to:
Division of Acquisition Policy and Evaluation
Phillip.Osborne@nih.gov
and Human Services (HHS)
