as introduced - 84th Legislature (2005 - 2006) Posted on 12/15/2009 12:00am
A bill for an act
relating to health; providing for clinical trial registration; providing civil
penalties; proposing coding for new law in Minnesota Statutes, chapter 144.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
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For purposes of this section:
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(1) "clinical trial" means a clinical investigation as defined by the federal Food and
Drug Administration that involves any experiment to test the safety or efficacy of a drug
or biological product with one or more human subjects;
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(2) "clinical trial registry" means a publicly available data bank;
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(3) "institutional review board" means an independent body constituted of medical,
scientific, and nonscientific members, whose responsibility it is to ensure the protection of
the rights, safety, and well-being of the human subjects involved in a clinical trial; and
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(4) "sponsor" means:
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(i) the manufacturer of a drug or biological product;
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(ii) if the manufacturer provides no monetary support for the clinical trial, the person
who provides the majority of monetary support; or
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(iii) when the majority of monetary support comes from a state or federal agency,
the principal investigator.
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An institutional
review board shall not approve any clinical trial unless the sponsor certifies in writing that:
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(1) the clinical trial will be registered in a clinical trial registry at or before the
time that patient enrollment begins;
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(2) the clinical trial registry includes, at a minimum:
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(i) a unique identifying number for each registered trial;
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(ii) a statement of the interventions and comparisons studied;
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(iii) a statement of the study hypothesis;
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(iv) definitions of the primary and secondary outcome measures;
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(v) eligibility criteria;
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(vi) key trial dates;
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(vii) the target number of subjects;
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(viii) identification of the funding source; and
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(ix) contact information for the sponsor;
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(3) the clinical trial registry is accessible to the public at no charge, open to all
prospective registrants, managed by a not-for-profit organization, and electronically
searchable and contains a mechanism to ensure the validity of the registration data; and
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(4) upon conclusion of the clinical trial, the results of the clinical trial will be
published in a clinical trial registry that meets the requirements of clauses (2) and (3).
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An institutional review board shall not
approve any clinical trial if the sponsor failed to comply with subdivision 2 for a prior
clinical trial that was approved by the same or another institutional review board under
this section. Prior to approval, the institutional review board shall review the sponsor's
record of compliance with subdivision 2 for prior clinical trials approved by the same or
another institutional review board.
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new text begin A sponsor in violation of this section is liable for a civil penalty
of $20,000 per violation. Each day a sponsor is in violation is considered a separate
violation. The attorney general or a district attorney, county attorney, or city attorney may
bring an action against a sponsor for a violation of this section.new text end