HF 1633

as introduced - 90th Legislature (2017 - 2018) Posted on 02/27/2017 04:09pm

A bill for an act
relating to higher education; imposing requirements for fetal tissue research at the
University of Minnesota; appropriating money for a program in ethical fetal tissue
research; proposing coding for new law in Minnesota Statutes, chapter 137.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [137.45] FETAL TISSUE RESEARCH.
new text end

new text begin Subdivision 1. new text end

new text begin Definition. new text end

new text begin "Fetal tissue" means any part of an unborn child or fetus,
including a body part, cell, tissue, or organ.
new text end

new text begin Subd. 2. new text end

new text begin Approval by institutional review board (IRB). new text end

new text begin The University of Minnesota
must obtain approval from an institutional review board (IRB) or stem cell oversight
committee before conducting research using fetal tissue. In its approval process, the IRB
must consider whether adult or nonhuman tissue would be sufficient for the research.
new text end

new text begin Subd. 3. new text end

new text begin Fetal tissue sources. new text end

new text begin The university must attempt to identify sources for
procurement of fetal tissues that are available due to the natural death of the fetus and are
suitable for use in academic research. The university may consider engaging an outside
consultant to assist in identifying such sources. When appropriate sources are identified,
recommendations must be made to the Board of Regents of the University of Minnesota
for updates to university policies and procedures to encourage use of these sources in all
university research activities where fetal tissue is requested to be used. Sources that are
identified must be submitted to the Association of American Medical Colleges.
new text end

new text begin Subd. 4. new text end

new text begin Legislative report. new text end

new text begin No later than January 15, 2018, the Board of Regents must
submit a report to the chairs and ranking minority members of the legislative committees
with jurisdiction over higher education policy and finance and health and human services
policy and finance. The report must describe all activities under subdivision 3, including
the identification of suitable fetal tissue sources, any recommended updates to university
policies and procedures, and whether the Board of Regents adopted the recommended
updates. The report must also contain a list of all new or ongoing fetal tissue research projects
at the university. For each research project, the list must include:
new text end

new text begin (1) the date that the research was approved by an IRB or stem cell oversight committee;
new text end

new text begin (2) the source of funding for the research;
new text end

new text begin (3) the goal or purpose of the research;
new text end

new text begin (4) the source of the fetal tissue used;
new text end

new text begin (5) references to any publicly available information about the research such as National
Institutes of Health grant award information; and
new text end

new text begin (6) references to any publications resulting from the research.
new text end

new text begin Subd. 5. new text end

new text begin Institutional review board procedures. new text end

new text begin The university shall:
new text end

new text begin (1) further develop and clarify existing university policies and procedures related to the
lawful and ethical treatment of human subjects and fetal tissue in research activities, including
enhancement of applicable penalties for violation of these policies and procedures;
new text end

new text begin (2) institute a system of frequent, random, unannounced inspections and audits of research
activities involving fetal tissue to verify compliance with applicable federal and state laws,
university policies and procedures, and other professional standards related to purchasing,
handling, and disposing of fetal tissue;
new text end

new text begin (3) conduct education and outreach programs, including instituting a required
comprehensive training program, on applicable federal and state laws, university policies
and procedures, and other professional standards related to the respectful, humane, and
ethical treatment of human subjects and fetal tissue in research, for all students and employees
engaged in these activities; and
new text end

new text begin (4) establish an anonymous reporting system to receive complaints of activities that may
violate applicable federal and state laws, university policies and procedures, and other
professional standards in research involving human subjects and fetal tissue by the university,
university students or employees, or any other person engaged in research activities in
university facilities.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 2. new text begin APPROPRIATION; CENTER FOR ETHICAL RESEARCH.
new text end

new text begin Subdivision 1. new text end

new text begin Appropriation provided. new text end

new text begin $1,000,000 in fiscal year 2018 is appropriated
from the general fund to the Board of Regents of the University of Minnesota to establish
a program in ethical fetal tissue research within the Center for Bioethics on the Twin Cities
campus.
new text end

new text begin Subd. 2. new text end

new text begin Program in ethical fetal tissue research. new text end

new text begin (a) The program in ethical fetal
tissue research must:
new text end

new text begin (1) provide oversight of all research activities at the university that request the use of
fetal tissue;
new text end

new text begin (2) ensure compliance with applicable laws and policies governing the ethical acquisition,
sale, handling, and disposal of fetal tissue;
new text end

new text begin (3) procure fetal tissue for use in applicable university research activities, provided that
the program may only purchase fetal tissue for use in research if the tissue is available due
to the natural death of the fetus; and
new text end

new text begin (4) advance research on stem cells derived from sources other than fetal or embryonic
tissue, including adult somatic cells, cord blood, and related sources.
new text end

new text begin (b) In advancing nonembryonic and nonfetal stem cell research, the program may:
new text end

new text begin (1) produce clinical grade stem cells from adult tissues, cord blood, and related materials
for use in clinical trials and therapies;
new text end

new text begin (2) facilitate the delivery of adult, cord blood, and related stem cell therapies to area
hospitals where appropriate;
new text end

new text begin (3) partner and collaborate with other institutions to foster a regional network of
physicians trained in adult, cord blood, and related stem cell therapy applications;
new text end

new text begin (4) create and maintain a database resource for physicians and patients that provides a
comprehensive global list of available stem cell clinical trials and therapies;
new text end

new text begin (5) initiate clinical trials with adult, cord blood, and related stem cells;
new text end

new text begin (6) create education modules to train and educate physicians and research scientists
about peer-reviewed adult, cord blood, and related stem cell therapy applications for patients;
new text end

new text begin (7) distribute information to physicians about methods for successful treatments with
adult, cord blood, and related stem cells through basic and clinical research; and
new text end

new text begin (8) inform the public on available adult, cord blood, and related stem cell therapeutic
options.
new text end

new text begin Subd. 3. new text end

new text begin Certification required. new text end

new text begin By the end of fiscal year 2018, the Board of Regents
must submit a report stating whether the program in ethical fetal tissue research has been
established and is operational consistent with the requirements of subdivision 2. The report
must be submitted to the chairs and ranking minority members of the legislative committees
with jurisdiction over higher education policy and finance and health and human services
policy and finance.
new text end