Printed on: 12/09/2018. 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 Transplantation Research

Responsible University Officer(s):

  • Vice President for Research
  • Vice President for Clinical Affairs

Policy Owner(s):

  • Associate Vice President for Research
  • Frances Lawrenz

Date Revised:

Jan 5, 2018

Effective Date:

Dec 1, 2003

POLICY STATEMENT

University researchers (“researchers”) may conduct research on the transplantation of human fetal tissue or cell lines derived from human fetal tissue (“human fetal tissue”) for therapeutic purposes only in accordance with applicable federal and state laws and regulations and University policies and procedures.  These researchers must do all the following:

  • obtain approval for the research from the Institutional Review Board (IRB);
  • submit a fetal tissue acquisition form to the Anatomy Bequest Program (ABP) or obtain approval from ABP for the source of human fetal tissue supplied by a research sponsor;
  • register the research with the Research Compliance Office (RCO) in the Office of the Vice President for Research;
  • follow Food and Drug Administration (FDA) requirements under an approved Investigational New Drug (IND) application;
  • follow the necessary accounting standards if the research is not eligible for federal funding; and
  • use the appropriate source of funds;
  • retain the tissue only for the amount of time necessary to complete the research; and
  • notify ABP when the research is complete to arrange for disposition of any remaining human fetal tissue.

Research ineligible for federal or state funding must use only private funding.

Researchers may accept and/or use human fetal tissue for transplantation into a relative of the donor or other individual designated by the donor (i.e., donor-designated recipient) only if the tissue is obtained from a spontaneous abortion or stillbirth.

Prohibited Research

University personnel (“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.)

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

  • receive or use human fetal tissue which is obtained through an induced abortion for the purpose of transplantation into a relative of the donor or other recipient designated by the donor;
  • offer or provide payment for any costs associated with the 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

Researchers must obtain approval from the IRB to conduct human fetal tissue transplantation research. The IRB will obtain input from the Fetal Tissue Research (FTR) committee as part of the IRB review process.

Acquiring Human Fetal Tissue

Researchers must contact the Anatomy Bequest Program (ABP) prior to obtaining human fetal tissue from any source. Researchers 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 or collaborator. ABP will procure 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 tissue from abortions performed in Minnesota. ABP also may accept donations of 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

Researchers must notify ABP when the research is complete. ABP will dispose of the human fetal tissue in a dignified manner through cremation and/or burial.

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

Training

The Principal Investigator, other project staff, and departmental financial staff must obtain training from Sponsored Projects Administration relative to the financial management of costs related to research ineligible for federal funding (“ineligible study”) prior to beginning an ineligible study involving human fetal tissue transplantation research.

All personnel, including students, using human fetal issue in research 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.

Separation of Roles

Personnel who performs human fetal tissue transplantation research must be separate from the attending physician treating the person undergoing an induced abortion. 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.

Funding Restrictions

Researchers who wish to use federal funds for human fetal tissue transplantation research must meet the requirements imposed under federal law to obtain and use federal funds for this purpose. Federal funds are allowable only when:

  • the recipient of the transplant is unknown to the donor;
  • the recipient of the transplant is not a relative of the donor;
  • the recipient of the transplant has not been designated by the donor;
  • all other federal requirements are satisfied.

In situations where use of federal and/or state funds is not allowable units must charge direct costs associated with a registered study to a private source of funding. A registered study must have in place a method of separating the costs of supporting the research so that any of the facilities and administrative (F&A) costs allocable to the ineligible research are excluded from the rates established and used to charge F&A costs to federal/state funded research. In addition, the principal investigator and the responsible laboratory administrator must carefully and consistently allocate all costs of the ineligible research to a private funding source.

Administrative Procedures: Preparing to Conduct Human Fetal Transplantation Research Ineligible for Federal/State Funding and Conducting Research Using Human Fetal Tissue for Transplantation into Designated Recipients do not apply to human fetal tissue transplantation research where the recipient of the transplant is unknown to the donor and all other federal requirements are satisfied.

Exclusions

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.)

Research for non-transplantation purposes using human fetal tissue is covered in Administrative Policy: Acquisition, Use, and Disposition of Donated Human Fetal Tissue for Research (Non-Transplantation) or Teaching

REASON FOR POLICY

Research on the transplantation of human fetal tissue for therapeutic purposes shows much promise in treating serious diseases and disorders such as those amenable to blood and bone marrow transplantation (leukemia, congenital and acquired bone marrow failure syndrome, selected inborn errors of metabolic and immuno-deficiencies) and spinal cord injuries. This policy is intended to inform and assist University researchers who wish to conduct human fetal tissue transplantation research, while at the same time assuring that all such research conducted at the University meets legal, policy and funding requirements. This policy also specifies the official unit responsible for the acquisition and disposition of fetal tissue used in research, thereby reducing legal, reputational, financial and other risks to the University and researchers.

PROCEDURES

FORMS/INSTRUCTIONS

APPENDICES

FREQUENTLY ASKED QUESTIONS

CONTACTS

SubjectContactPhoneEmail/FAX
Primary Contact Frances Lawrenz 612-625-2046 lawrenz@umn.edu
Anatomy Bequest Program (APB) Angela McArthur 612-625-0618 mcarthur@umn.edu
 Institutional Review Board (IRB) Debbie Dykhuis 612-626-5654 irb@umn.edu
Funding/Accounting Questions Associate VP for Research, Sponsored Projects Administration 612-624-1648 612-626-6949
http://www.ospa.umn.edu

DEFINITIONS

Cell Line
A mass of cells descended from the original, sharing their genetic characteristics. Batches of cells can then be separated from the cell line and distributed to researchers.
Designated Recipient
A relative of the donor or other individual designated by the donor
Electrocardiographic Activity
The presence of electric currents produced by the contraction of the heart muscle as recorded and displayed on an instrument called an electrocardiograph.
Electroencephalographic Activity
The presence of electric currents in the brain as recorded and displayed on an instrument called an electroencephalograph.
Human Fetal Tissue Transplantation Research
A form of experimental clinical research where human fetal tissue obtained from a spontaneous or induced abortion or stillbirth is transplanted into a human recipient to treat a serious disease or disorder.
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. For purposes of this policy, human fetal tissue includes cell lines derived from a dead human embryo or fetus after a spontaneous or induced abortion or after a stillbirth IF they are used or intended for transplantation into a human recipient. 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.
Ineligible Research
Human fetal tissue transplantation research where the intended recipient is a relative of the donor or other individual designated by the donor and thus, cannot be supported, directly or indirectly, with federal funds or funds from the State of Minnesota.
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 human fetal cells that might lead to therapies in the future.

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 for transporting the tissue for studies. Arrange for cremation and disposition of human fetal tissue remains.
Department Head
Attend training session regarding financial management of costs related to research ineligible for federal funding.
Department Administrator and Accounting Personnel
Attend training session regarding financial management of costs related to research ineligible for federal funding. When using ISO, verify that rate does not include federal funds. When preparing financial transactions, include complete documentation. Notify Sponsored Projects Administration of changes to project.
Institutional Review Board
Route applicable forms to Sponsored Projects Administration. Confirm education status of project personnel before approving IRB application. Review and act on IRB applications for human fetal tissue transplantation research.
Office of the General Counsel
Provide advice to University researchers and administrators on the laws, regulations and University policy requirements related to human fetal tissue transplantation research.
Researcher/Principal Investigator
Prepare proposal budget. Disclose intended human fetal tissue transplantation research. Obtain FTR, IRB and FDA approval. Use the APB to obtain the human fetal tissue or obtain approval from the ABP if the fetal tissue has been supplied by a research sponsor. Register research with the Research Compliance Office. Attend training session regarding financial management of costs related to research ineligible for federal funding. Notify the ABP when the remaining fetal tissue may be disposed of.
Project Personnel (co-investigators, laboratory staff, student workers)
Attend training session regarding financial management of costs related to research ineligible for federal funding.
Research Compliance Office (RCO)
Carry out oversight responsibilities related to these projects.
Sponsored Projects Administration
Obtain information about the proposed project. Register project with the RCO. Review project records during project period. (Assoc. Director of F&A Costs). Schedule and conduct training session regarding financial management of costs related to research ineligible for federal funding.

RELATED INFORMATION

HISTORY

Amended:
December 2017 - Comprehensive Review, Major Revision. 1. Includes language addressing the new UMN requirements as determined by legislative changes to Minnesota § 137.47. 2. Clarifies responsibilities of UMN staff. 3. 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.
Amended:
February 2016 - Comprehensive Review, Major Revision. 1. Incorporates a new requirement to procure and dispose of human fetal tissue, through the Anatomy Bequest Program. 2. Specifies that the Institutional Review Board (IRB) will obtain input from the Stem Cell Research Oversight (SCRO) Panel when reviewing research involving the transplantation of human fetal tissue into human recipients.
Amended:
December 2014 - Reference to A-21 changed to OMB Uniform Guidance in Related Information.
Amended:
April 2014 - Comprehensive Review. Minor Revision. The policy and procedures were updated to reflect change in ownership and, align with Vice President for Research current organizational structure. The other changes were minor enhancements to the language.
Effective:
December 2003
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