September 15, 2005, Introduced by Reps. Gaffney, Mortimer, Hune and Accavitti 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 research involving human subjects
that is conducted for the primary purpose of determining whether or
not a particular drug or medical treatment is safe and effective.
(b) "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.
(c) "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.
(d) "Person" means an individual, partnership, corporation,
association, governmental entity, or other legal entity, public or
private.
(e) "Research" means a systematic investigation, including
research development, testing, and evaluation, designed to develop
or contribute to general knowledge.
Sec. 9653. A person shall not conduct a clinical trial unless
that research is conducted in compliance with this part and in
accordance with federal rules and regulations on the protection of
human subjects.
Sec. 9655. An institutional review board for a hospital or a
university located in this state shall not approve a clinical trial
funded in whole or in part with state funds unless the person
agrees to make the results of the research available to the public
and to register the clinical trial with the clinical trials data
bank maintained by the United States department of health and human
services pursuant to section 113 of the food and drug
administration modernization act of 1997, Public Law 105-115, 111
Stat. 2296, 42 USC 282.