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University of Minnesota researchers may conduct research on the transplantation of human fetal tissue for therapeutic purposes only in accordance with applicable federal and state laws and regulations, University policies and procedures and the decisions of the University of Minnesota Institutional Review Board (IRB).

Researchers who wish to use federal funds for human fetal transplantation research must meet the requirements imposed under federal law to obtain and use federal funds for this purpose. Federal funds are allowable only where the recipient of the transplant is unknown to the donor and all other federal requirements are satisfied.

No federal funding may be used, either directly or indirectly, to support human fetal transplantation research where the recipient of the transplant is a relative of the donor or has been designated by the donor. The University extends this same funding prohibition to the use of funds from the State of Minnesota.

Studies involving human fetal transplantation research ineligible for federal or state funding must be registered with the Office of Regulatory Affairs (ORA) in the Office of the Vice President for Research and will be subject to oversight by ORA. These registered studies must have IRB approval, follow the necessary accounting standards and use only private funding. In addition, researchers conducting human fetal transplantation research ineligible for federal/state funding must follow University procedures 2.1.12.1 - "Preparing to Conduct Human Fetal Transplantation Research Ineligible for Federal/State Funding," and 2.1.12.2 - "Satisfying Regulatory Requirements for Human Fetal Transplantation Research."

Direct costs associated with a registered study must be charged 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.

Regardless of the source of funding, there are circumstances where human fetal transplantation research is a crime under federal or state law and cannot be conducted at the University. University researchers cannot: (1) 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; (2) conduct research on a fetus which shows evidence of life, such as movement, heart or respiratory activity, the presence of electroencephalographic or electrocardiographic activity; and (3) 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.

Exclusions

The procedures to this policy do not apply to human fetal transplantation research where the recipient of the transplant is unknown to the donor and all other federal requirements are satisfied.

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). This policy is intended to inform and assist University researchers who wish to conduct human fetal transplantation research, while at the same time assuring that all such research conducted at the University meets legal, policy and funding requirements.

• Procedure 2.1.12.1 - Preparing to Conduct Human Fetal Transplantation Research Ineligible for Federal/State Funding
• Procedure 2.1.12.2 - Satisfying Regulatory Requirements for Human Fetal Transplantation Research

There are no forms related to this policy.

Subject	Contact	Phone	Fax/Email
Primary Contact	Jessy Thomas	612-624-2431	thoma098@umn.edu
Funding/Accounting Questions	Associate VP for Research, Sponsored Projects Administration	612-624-1648	612-626-6949 www.ospa.umn.edu
Regulatory Questions	Assistant VP for Regulatory Affairs	612-625-5914	612-626-6949

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 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 or cells obtained from a dead human fetus after a spontaneous or induced abortion or after a stillbirth.

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 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 embryonic stem cells that might lead to therapies in the future.

Principal Investigator

Prepare proposal budget. Disclose intended human fetal transplantation research. Obtain IRB approval. Attend training session.

Project Personnel (co-investigators, laboratory staff, student workers)

Attend training session.

Department Head

Attend training session.

Department Administrator and Accounting Personnel

Attend training session. 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.

Accounting Services

Identify ISOs that include federal funds in their rates and develop alternative rate if necessary.

Sponsored Projects Administration

Obtain information about the proposed project. Register project with the Office of Regulatory Affairs. Review project records during project period. (Ass't Director of F&A Costs). Schedule and conduct training.

Institutional Review Board

Route applicable forms to Sponsored Projects Administration. Confirm education status of project personnel before approving IRB application.

Sponsored Financial Reporting

Notify the Office of Regulatory Affairs when the project terminates.

Office of Oversight, Analysis, and Reporting

Perform transaction reviews.

Office of Regulatory Affairs

Register project at its start and deactivate project at its end. Review project records when project becomes active or deactivated and provide ongoing oversight of all regulatory aspects of the project.

Office of the General Counsel

Provide advice to University researchers and administrators on the laws, regulations and University policy requirements related to human fetal transplantation research.

There are no appendices for this policy.

There is no FAQ for this policy.

• Federal Office of Management & Budget - Circular A-21
• Research Subjects' Protection Programs
• National Institutes of Health, Office of Extramural Research
• Administrative Policy: Charging of Direct and Facilities and Administrative (Indirect) Costs

Effective:

December 2003

To obtain a copy of a historical policy, e-mail the U Policy Librarian at policy@umn.edu or call 612-624-4372.