1.1 	A bill for an act
1.2 	relating to health; providing for clinical trial
1.3 	registration; providing civil penalties; proposing
1.4 	coding for new law in Minnesota Statutes, chapter 144.
1.5 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.6 	Section 1. [144.6601] CLINICAL TRIALS REGISTRATION.
1.7 		Subdivision 1.Definitions. For purposes of this section:
1.8 	(1) "clinical trial" means a clinical investigation as
1.9 	defined by the federal Food and Drug Administration that
1.10 	involves any experiment to test the safety or efficacy of a drug
1.11 	or biological product with one or more human subjects;
1.12 	(2) "clinical trial registry" means a publicly available
1.13 	data bank;
1.14 	(3) "institutional review board" means an independent body
1.15 	constituted of medical, scientific, and nonscientific members,
1.16 	whose responsibility it is to ensure the protection of the
1.17 	rights, safety, and well-being of the human subjects involved in
1.18 	a clinical trial; and 
1.19 	(4) "sponsor" means:
1.20 	(i) the manufacturer of a drug or biological product;
1.21 	(ii) if the manufacturer provides no monetary support for
1.22 	the clinical trial, the person who provides the majority of
1.23 	monetary support; or 
1.24 	(iii) when the majority of monetary support comes from a
1.25 	state or federal agency, the principal investigator.
2.1 		Subd. 2.Requirements for institutional review board
2.2 	approval. An institutional review board shall not approve any
2.3 	clinical trial unless the sponsor certifies in writing that:
2.4 	(1) the clinical trial will be registered in a clinical
2.5 	trial registry at or before the time that patient enrollment
2.6 	begins;
2.7 	(2) the clinical trial registry includes, at a minimum:
2.8 	(i) a unique identifying number for each registered trial;
2.9 	(ii) a statement of the interventions and comparisons
2.10 	studied;
2.11 	(iii) a statement of the study hypothesis;
2.12 	(iv) definitions of the primary and secondary outcome
2.13 	measures;
2.14 	(v) eligibility criteria;
2.15 	(vi) key trial dates;
2.16 	(vii) the target number of subjects;
2.17 	(viii) identification of the funding source; and 
2.18 	(ix) contact information for the sponsor;
2.19 	(3) the clinical trial registry is accessible to the public
2.20 	at no charge, open to all prospective registrants, managed by a
2.21 	not-for-profit organization, and electronically searchable and
2.22 	contains a mechanism to ensure the validity of the registration
2.23 	data; and 
2.24 	(4) upon conclusion of the clinical trial, the results of
2.25 	the clinical trial will be published in a clinical trial
2.26 	registry that meets the requirements of clauses (2) and (3).
2.27 		Subd. 3.Review of prior approvals. An institutional
2.28 	review board shall not approve any clinical trial if the sponsor
2.29 	failed to comply with subdivision 2 for a prior clinical trial
2.30 	that was approved by the same or another institutional review
2.31 	board under this section.  Prior to approval, the institutional
2.32 	review board shall review the sponsor's record of compliance
2.33 	with subdivision 2 for prior clinical trials approved by the
2.34 	same or another institutional review board.
2.35 		Subd. 4.Penalties. A sponsor in violation of this
2.36 	section is liable for a civil penalty of $20,000 per violation.
3.1 	Each day a sponsor is in violation is considered a separate
3.2 	violation.  The attorney general or a district attorney, county
3.3 	attorney, or city attorney may bring an action against a sponsor
3.4 	for a violation of this section.