HF 1668

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:

Section 1.

new text begin [144.6601] CLINICAL TRIALS REGISTRATION.
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new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin For purposes of this section:
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new text begin (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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new text begin (2) "clinical trial registry" means a publicly available
data bank;
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new text begin (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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new text begin (4) "sponsor" means:
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new text begin (i) the manufacturer of a drug or biological product;
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new text begin (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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new text begin (iii) when the majority of monetary support comes from a
state or federal agency, the principal investigator.
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new text begin Subd. 2. new text end

new text begin Requirements for institutional review board
approval. new text end

new text begin An institutional review board shall not approve any
clinical trial unless the sponsor certifies in writing that:
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new text begin (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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new text begin (2) the clinical trial registry includes, at a minimum:
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new text begin (i) a unique identifying number for each registered trial;
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new text begin (ii) a statement of the interventions and comparisons
studied;
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new text begin (iii) a statement of the study hypothesis;
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new text begin (iv) definitions of the primary and secondary outcome
measures;
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new text begin (v) eligibility criteria;
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new text begin (vi) key trial dates;
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new text begin (vii) the target number of subjects;
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new text begin (viii) identification of the funding source; and
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new text begin (ix) contact information for the sponsor;
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new text begin (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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new text begin (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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new text begin Subd. 3. new text end

new text begin Review of prior approvals. new text end

new text begin 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 Subd. 4. new text end

new text begin Penalties. new text end

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.
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