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Minnesota Legislature

Office of the Revisor of Statutes

HF 21

as introduced - 85th Legislature (2007 - 2008) Posted on 12/15/2009 12:00am

KEY: stricken = removed, old language.
underscored = added, new language.

Bill Text Versions

Engrossments
Introduction Posted on 01/08/2007

Current Version - as introduced

Line numbers 1.1 1.2 1.3 1.4
1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12 1.13 1.14 1.15 1.16 1.17 1.18 1.19 1.20 1.21 1.22 1.23 1.24 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17 2.18 2.19 2.20 2.21 2.22 2.23 2.24

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.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin For purposes of this section:
new text end

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;
new text end

new text begin (2) "clinical trial registry" means a publicly available data bank;
new text end

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
new text end

new text begin (4) "sponsor" means:
new text end

new text begin (i) the manufacturer of a drug or biological product;
new text end

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
new text end

new text begin (iii) when the majority of monetary support comes from a state or federal agency,
the principal investigator.
new text end

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:
new text end

new text begin (1) the clinical trial will be registered in a clinical trial registry at or before the
time that patient enrollment begins;
new text end

new text begin (2) the clinical trial registry includes, at a minimum:
new text end

new text begin (i) a unique identifying number for each registered trial;
new text end

new text begin (ii) a statement of the interventions and comparisons studied;
new text end

new text begin (iii) a statement of the study hypothesis;
new text end

new text begin (iv) definitions of the primary and secondary outcome measures;
new text end

new text begin (v) eligibility criteria;
new text end

new text begin (vi) key trial dates;
new text end

new text begin (vii) the target number of subjects;
new text end

new text begin (viii) identification of the funding source; and
new text end

new text begin (ix) contact information for the sponsor;
new text end

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
new text end

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).
new text end

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.
new text end

new text begin Subd. 4. new text end

new text begin Penalties. new text end

new text beginA 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