Use of Human Fetal Tissue in Research

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Policy Number:
UW-4077
Responsible Office:
Office of Research Compliance

University Policy

Rationale/​Purpose:

The purpose of this policy is to outline federal, state, and institutional requirements for the use of fetal materials in research at UW-Madison.

Definitions:
Fetus
The product of conception from implantation until delivery.
Fetal material
Includes the post-mortem fetus; or cells, material, or organs excised from a post-mortem fetus.
De-identified fetal material
Fetal material obtained by researchers that does not have a link to information that identifies or could be used to identify an individual.
Valuable Consideration
Does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal material.
Scope:

This policy applies to all university investigators using human fetal materials in research. 

Policy:
  1. All research involving human fetal material shall be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.
  2. No UW-Madison employee or agent may knowingly acquire, receive, or otherwise transfer any fetal material in exchange for valuable consideration.
  3. The portions of this policy regarding IRB review and consent process do not apply to 1) research using de-identified fetal material, 2) cell lines derived from fetal materials, 3) placental or umbilical materials and their cell lines, or 4) human embryonic stem cells and their cell lines.
  4. Research using de-identified fetal material is not considered human subjects research. Requests to obtain and use de-identified fetal material in research must be reviewed and approved by the Stem Cell Research Oversight committee chair or designee to ensure it meets informed consent requirements described in NIH policy.
  5. IRB Review
    1. If information associated with the fetal material is recorded for research purposes in a manner that living individuals (e.g. living donor(s) of the material) can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and research using the material must be submitted for IRB review and approval.
  6. Transplantation Research Using Fetal Tissue Subject to 42 U.S.C. §289
    1. Federal funds may only be used to support research involving the transplantation of fetal tissue for therapeutic purposes if all criteria in 42 U.S.C. §289g-1 for informed consent are met.
    2. Additionally, UW-Madison complies with limitations on the purchase, solicitation or acceptance of tissue set forth in 42 U.S.C. §289g-2.
Related UW–Madison Documents, Web Pages, or Other Resources:
External References:

Policy Administration

Approval Authority:
Associate Vice Chancellor of Research Policy and Compliance
Policy Manager:
Associate Vice Chancellor of Research Policy and Compliance
Contact:
Associate Director, HRPP -- Travis Doran, TRAVIS.DORAN@WISC.EDU, (608) 890-4399
Date Issued:
04-23-2019
Revised Dates:

12-11-2014, 11-07-2019, 01-06-2023

Retrieved:
11-23-2024 02:12:41