Printed on: 05/24/2018. Please go to http://policy.umn.edu for the most current version of the Policy or related document.

ADMINISTRATIVE POLICY

Acquisition, Use, and Disposition of Donated Human Fetal Tissue for Research (Non-Transplantation) or Teaching

Responsible University Officer(s):

  • Vice President for Research

Policy Owner(s):

  • Associate Vice President for Research

Policy contact(s):

Date Revised:

Jan 5, 2018

Effective Date:

Feb 22, 2016

POLICY STATEMENT

University personnel (“personnel”) may use human fetal tissue or cell lines derived from human fetal tissue ("human fetal tissue") for purposes of non-transplantation research and teaching only in accordance with applicable federal and state laws and regulations, and University policies and procedures.   This policy does not apply to the use of cell lines derived from human fetal tissue that historically have been available and are widely used and distributed on a national basis.

Requirements that Apply to Research

Researchers who wish to conduct research studies involving human fetal tissue must:

  • obtain approval for the research from the Fetal Tissue Research (FTR) committee if the research does not meet the criteria for review by the Institutional Review Board (IRB); and
  • obtain approval for the research from the IRB if the researcher obtains identifying information about the person donating the human fetal tissue or meets other criteria for IRB review.

If the research requires IRB approval, the IRB will obtain input from the FTR as part of the IRB review process.

Requirements that Apply to Research and Teaching

All personnel who use human fetal tissue in research or teaching must:

  • submit a request for human fetal tissue to the Anatomy Bequest Program (ABP) or obtain approval from ABP for the source of human fetal tissue supplied by a research sponsor;
  • participate in mandatory training provided by ABP;
  • retain the human fetal tissue only for the amount of time necessary to complete the research or teaching use; and
  • notify ABP when the research or teaching use is complete to arrange for disposition of any remaining human fetal tissue.

Prohibited Activities

Personnel  may not perform research on a human fetus which meets the definition of a living human conceptus under Minnesota law (shows the presence of evidence of life, such as movement, heart or respiratory activity, or the presence of electroencephalographic or electrocardiographic activity), except to protect the life or health of the fetus.

Personnel leaving the University may not transfer human fetal tissue to other institutions. Similarly, personnel cannot distribute acquired human fetal tissue to an internal or external researcher without the advance approval of the FTR and notification to the ABP.

In addition, personnel, regardless of source of funding, cannot:

  • offer or provide payment for any costs associated with a donor's induced abortion; nor
  • buy or sell human fetal tissue, except reasonable payments are permitted associated with the transportation, implantation, processing, preservation, quality control or storage of human fetal tissue.

Approval of Research Prior to Acquiring Human Fetal Tissue

Except for research that meets the criteria for review by the Institutional Review Board (IRB), the FTR must review and approve all research with human fetal tissue or cell lines derived from human fetal tissue, before the research begins.

The FTR has authority to approve, require modifications to or disapprove proposed research, and to suspend or terminate approved research for serious non-compliance or unanticipated problems.

The FTR will consider whether alternatives to human fetal tissue would be sufficient for the research and will require researchers to provide a written explanation of the need for human fetal tissue from induced abortions and whether alternatives, including non-aborted human fetal tissue, can be used for the research. The FTR will submit its decisions to the University’s Institutional Review Board (IRB) for review by the IRB to ensure all alternatives have been considered.

Acquiring Human Fetal Tissue

Personnel must contact the Anatomy Bequest Program (ABP) prior to obtaining human fetal tissue from any source, and must either: 1) obtain the human fetal tissue through (ABP); or 2) obtain approval from ABP for the source of human fetal tissue supplied by a research sponsor, collaborator or other source.  ABP will acquire human fetal tissue from tissue procurement organization or clinics outside Minnesota that operate in compliance with federal law and applicable state laws and certify they do not obtain human fetal tissue from abortions performed in Minnesota. ABP also may accept donations of human fetal tissue obtained from a stillborn infant, or an embryo or fetus that died of natural causes in utero as authorized under applicable state laws.

Disposing of Human Fetal Tissue

Personnel must notify ABP when the research or teaching use is complete. ABP will dispose of the human fetal tissue in a dignified manner through cremation, burial or other lawful disposition method.

Personnel must contact the ABP if the intended use of the human fetal tissue changes or if the study or teaching use will take longer than anticipated.

Training

All personnel, including students, using human fetal issue in research or teaching must complete the training provided by ABP. The training will cover applicable federal and state laws, University policies and procedures, and other professional standards related to the respectful, humane, and ethical treatment of human fetal tissue used in research or teaching

Separation of Roles

Personnel who perform human fetal tissue research must be separate from the attending physician treating the person undergoing an induced abortion. The personnel may have no part in any decisions on the timing, method or procedures used to end the pregnancy and may have no part in determining fetal viability.

Required Reporting

The University will submit an annual report to the Minnesota Legislature, no later than January 15th of each year, providing information about human fetal tissue research at the University as mandated by the Legislature in a 2017 law.

Exclusions

This policy excludes the use of cell lines derived from human fetal tissue that historically have been available and are widely used and distributed on a national basis. In addition, this policy does not address the acquisition or use of excess in vitro fertilization human embryos or embryonic stem cells or stem cell lines derived from such embryos, (see Administrative Policy: Conducting Research with Human Embryos or Embryonic Stem Cells.)

Personnel conducting research with human fetal tissue for the purpose of transplantation must follow Administrative Policy: Acquisition, Use, and Disposition of Donated Human Fetal Tissue for Transplantation Research.

REASON FOR POLICY

Research and education using human fetal tissue or cell lines derived from human fetal tissue for therapeutic purposes shows much promise for treating serious diseases and disorders such as diabetes, sepsis, HIV/AIDS, spinal cord injuries and neurodegenerative diseases. This policy is intended to inform and assist University personnel who wish to use human fetal tissue in research or teaching, while at the same time assuring that all such activity conducted at the University meets legal and policy requirements. This policy also specifies the official unit responsible for the acquisition and disposition of fetal tissue used in research or teaching, thereby reducing legal, reputational, financial, and other risks to the University and researchers.

PROCEDURES

FORMS/INSTRUCTIONS

APPENDICES

FREQUENTLY ASKED QUESTIONS

CONTACTS

SubjectContactPhoneEmail
Primary Contact(s) Frances Lawrenz 612-625-2046 lawrenz@umn.edu
Anatomy Bequest Program (APB) Angela McArthur 612-625-0618 mcarthur@umn.edu
Funding/Accounting Questions Associate VP for Research, Sponsored Projects Administration 612-624-1648 612-626-6949
ospa.umn.edu
Fetal Tissue Review Committee ( FTR) Greg Park 612-625-5193 parkx479@umn.edu
Institutional Review Board (IRB) Debbie Dykhuis 612-626-5654 irb@umn.edu

DEFINITIONS

Cell Line
A mass of cells descended from the original, sharing its genetic characteristics. Batches of cells can then be separated from the cell line and distributed to researchers.
Disposition Records
An accurate, continuous and current record used to track the acquisition, use and disposal of a human fetal tissue.
Human Fetal Tissue
Tissue, cells, or organs obtained from a dead human embryo or fetus after a spontaneous or induced abortion or after a stillbirth. Human fetal tissue does not include tissue or cells obtained from a placenta, umbilical cord or amniotic fluid.
Induced Abortion
Premature ending of a pregnancy brought about purposefully by drugs or surgical means. Induced abortion is distinguished from a spontaneous abortion, which is a naturally occurring loss of the fetus, usually before the 20th week of gestation, and a stillbirth, which is the delivery of a fetus dead at birth, usually after the 20th week of gestation.
Non-aborted fetal tissue
Term used under Minnesota law 137.47, defined as: “fetal tissue that is available as a result of a miscarriage or stillbirth, or fetal tissue from a living unborn child.” Fetal tissue from a living unborn child may not be used in research except to protect the life or health of the fetus. See Prohibited Activities above.
Research
Systematic investigation, including development, testing and evaluation designed to develop or contribute to generalizable knowledge.
Research for Therapeutic Purposes
Research intended to develop new medical therapies and/or administer such therapies to patients/research participants or in the basic science and biology/physiology of fetal cells that might lead to therapies in the future.
Tissue Procurement Organization
An organization that procures human fetal tissue for medical research.

RESPONSIBILITIES

Anatomy Bequest Program (ABP) Director

Facilitate acquisition of human fetal tissue. Approve source of tissue supplied by a research sponsor. Maintain a database of human fetal tissue acquisition and disposition. Arrange the transportation of human fetal tissue for research or teaching. Arrange for the lawful disposition of human fetal tissue remains. Provide training for all employees and students using human fetal tissue in research or teaching.

Draft the mandatory annual human fetal tissue research legislative report in consultation with the FTR for review by University senior officials and transmission to the Legislature.

Researcher or Instructor

Disclose intended human fetal tissue use. (For researchers: Obtain FTR approval, and IRB approval where required. Contact ABP when human fetal tissue is needed or obtain approval from ABP to use fetal tissue supplied by a research sponsor or another source. Properly track and use human fetal tissue. Maintain sufficient laboratory records documenting the acquisition, use, storage location, and processing procedures of the human fetal tissue while the tissue is in the custody of the  laboratory.  Notify the ABP when the remaining tissue is ready for disposition.

Attend the required human fetal tissue research training.  Ensure that all personnel working with human fetal tissue have received the required training. Create and maintain human fetal tissue training records for lab personnel.

Institutional Research Board (IRB)
Review research with human fetal tissue that meets the criteria for IRB review under federal regulations.  For other research that uses human fetal tissue, review FTR decisions to assure consideration of all alternatives as required under Minnesota law.
Fetal Tissue Research (FTR) committee

Review the scientific merit and ethical justification of proposed research involving human fetal tissue and cell lines derived from human fetal tissue. Consider whether alternatives to human fetal tissue would be sufficient for the research.  Determine whether to approve, require modifications to or disapprove the research.

The FTR will submit its decisions to the University’s Institutional Review Board (IRB) for review.

Research Compliance Office (RCO)
Carry out oversight responsibilities related to these projects.
Office of the General Counsel
Provide advice to University personnel and administrators on the laws, regulations and University policy requirements related to use of human fetal tissue in research or teaching.  .

RELATED INFORMATION

HISTORY

Amended:
December 2017 - Comprehensive Review.
  1. Includes language addressing the new UMN requirements as determined by legislative changes to Minnesota § 137.47.
  2. Provides new language addressing the exclusion of historical, publically available fetal cell lines from the policy.
  3. Adds language broadening the scope of the policy to include teaching uses.
  4. Clarifies responsibilities of UMN staff.
  5. Includes new language which would prevent the transfer of fetal tissue from one researcher to another, or from the UMN to another institution without advance approval of the Fetal Tissue Research committee.
  6. Modifies the title to standardize the language across all three documents.
Amended:
April 2016 - Stem Cell Research Oversight Panel (SCRO) changed to Fetal Tissue Research (FTR) committee to prevent confusion about stem cell research which is the SCRO and Fetal Tissue Research which is not about stem cells.
Effective:
February 2016 - New Policy, Comprehensive Review: 1. Incorporates a new requirement to procure and dispose of human fetal tissue, through the Anatomy Bequest Program. 2. Specifies that research using human fetal tissue must be reviewed and approved by the Stem Cell Research Oversight (SCRO) Panel unless subject to IRB review and approval. 3. Identifies research that is prohibited.
Document Feedback