October 31, 2007, Introduced by Reps. Donigan, Brown, Byrum, Simpson, McDowell, Bieda, Vagnozzi, Valentine, Corriveau, Polidori, Leland, Hopgood, Dean, Miller, Alma Smith, Lemmons, Wojno, Kathleen Law, Constan, Accavitti and Hammel and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
(MCL 333.1101 to 333.25211) by adding part 96A.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
PART 96A. CLINICAL TRIALS – HUMAN SUBJECT RESEARCH
Sec. 9651. As used in this part:
(a) "Clinical trial" means a clinical investigation approved
by the federal food and drug administration that involves any
experiment to test the safety or efficacy of a drug or biological
product and 1 or more human subjects and is intended to be
submitted to, or held for inspection by, the federal food and drug
administration as part of an application for a research or
marketing permit.
(b) "Department" means the department of community health.
(c) "Human subject" means a living individual about whom an
investigator conducting research obtains data through intervention
or interaction with the individual or obtains identifiable private
information.
(d) "Institutional review board" means any board, committee,
or other group formally designated by a person to review, to
approve the initiation of, and to conduct periodic review of,
biomedical research involving human subjects.
(e) "Manufacturer" means a person who prepares, produces,
derives, propagates, compounds, processes, packages, or repackages
a drug or device salable on prescription only, or otherwise changes
the container or the labeling of a drug or device salable on
prescription only, and who supplies, distributes, sells, offers for
sale, barters, or otherwise disposes of that drug or device and any
other drug or device salable on prescription only, to another
person for resale, compounding, or dispensing.
(f) "Person" means an individual, partnership, corporation,
association, governmental entity, or other legal entity, public or
private.
(g) "Research" means a systematic investigation, including
research development, testing, and evaluation, designed to develop
or contribute to general knowledge.
Sec. 9653. (1) The department shall adopt rules to incorporate
by reference federal statutes and regulations on clinical trials
and the protection of human subjects. The department may adopt
amendments to those statutes and regulations that are not
inconsistent with those statutes and regulations. A manufacturer or
other person that does business in this state shall not conduct a
clinical trial unless that research is conducted in compliance with
this part and rules promulgated pursuant to this part.
(2) A manufacturer or other person who does business in this
state shall report to the department as prescribed under section
9655 any clinical trial that it conducts or sponsors and shall make
the results of the clinical trial available to the department and
the public.
Enacting section 1. This amendatory act does not take effect
unless all of the following bills of the 94th Legislature are
enacted into law:
(a) Senate Bill No.____ or House Bill No. 5395(request no.
02308'07).
(b) Senate Bill No.____ or House Bill No. 5392(request no.
02311'07).
(c) Senate Bill No.____ or House Bill No. 5393(request no.
02312'07).
(d) Senate Bill No.____ or House Bill No. 5391(request no.
02313'07).
(e) Senate Bill No.____ or House Bill No. 5394(request no.
02314'07).