Contract table of contents

ARTICLE H.18. HUMAN MATERIALS

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

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****(USE BELOW, WHEN THE CONTRACTOR WILL BE RECEIVING HUMAN MATERIALS FROM AN OUTSIDE SOURCE, ANOTHER CONTRACT OR FROM A SUBCONTRACTOR.)****

ARTICLE H.19. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self designated form, provided that it contains the information required by the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly Optional Form 310).

243

****(USE BELOW IN SOLICITATIONS AND CONTRACTS THAT INCLUDE RESEARCH INVOLVING HUMAN FETAL TISSUE.)****

ARTICLE H.20. RESEARCH INVOLVING HUMAN FETAL TISSUE

Research involving human fetal tissue must be conducted in accordance with applicable Federal, State and local laws, regulations, and policies. 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 

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."
   

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)
 

1. 
   No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
   
2. 
   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
   
3. 
   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.

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.
   

 The full text of the HHS Regulations for the Protection of Human Subjects is available at: http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf.
Furthermore, per NOT-OD-16-033, when obtaining primary human fetal tissue for research purposes, NIH expects contractors to maintain appropriate documentation, such as an attestation from the health care provider or a third party supplier, that informed consent was obtained at the time of tissue collection.
 

 Research using human fetal tissue must be in compliance with all applicable federal, state, or local laws, regulations, and policies, including 42 USC 289g-1 and g-2, the HHS Regulations for the Protection of Human Subjects (45 CFR 46 Subparts A and B), and NOT-OD-16-033. NIH defines "human fetal tissue" as tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion or stillbirth. This definition does not include established human fetal cell lines.

 As applicable, the Contractor shall make available, for audit by the Secretary, HHS, the physician statements and informed consents required by 42 USC 289g-1(b) and (c), or ensure HHS access to those records, if maintained by an entity other than the Contractor.

 

 

 

 

 

 

 

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****(USE BELOW IN SOLICITATIONS AND CONTRACTS THAT INCLUDE RESEARCH INVOLVING RECOMBINANT DNA OR SYNTHETIC NUCLEIC ACID MOLECULES (INCLUDING HUMAN GENE TRANSFER RESEARCH)****