IRB: Human Fetal Transplantation Research
Policy number:
503 A
References:
UMN Administrative Policy: Conducting Human Fetal Transplantation
Research (and procedures therein)
http://www.policy.umn.edu/Policies/Research/fetalresearch.html
Date: 05/04/14
Policy Owner:
Executive Director HRPP
Cross Reference:
None
Definitions:
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.
1.0 Reason for Policy
To describe the policy for use of human fetal tissue in transplantation.
2.0 Scope of Policy
This policy is University-wide. All components of the University of Minnesota and its healthcare
components must adhere to this policy.
3.0 Policy Statement
The University of Minnesota Human Research Protection Program will follow all federal, state and
University policies, laws, and regulations concerning the use of human fetal tissue in transplantation.
Specifically, the IRB will access and follow the policies and procedures at
http://www.policy.umn.edu/Policies/Research/fetalresearch.html
when an application for approval is submitted. The IRB will follow all requirements related to donation
of tissue, designation of recipient, and all specific requirements for informed consent of all parties.
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Review of this research is to be conducted by the full convened IRB. The IRB should consider limiting
the scope of the study to a small number of subjects in the earliest stages of this research.
The IRB will assign frequent reporting and continuing review intervals for this research.
The IRB, through the Executive Director of the HRPP, will officially notify the Institutional Official that
this research has been proposed and is under review.
The IRB will coordinate its review of this research with Research Education and Oversight (REO) and
other institutional offices, including communications entities.
4.0 Required approvals for this document
Title
Executive Director HRPP
5.0 Revision History
Revision
05/04/14
08/01/09
Reason for change
Update reference to REO
New Policy
Date of release
09/02/14
08/26/09
To obtain a copy of a historical policy, e-mail IRB at irb@umn.edu or call 612-626-5654
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