Report Title:

Clinical Trials

Description:

Requires results from clinical trials conducted in hospitals and universities to be made public.

HOUSE OF REPRESENTATIVES

H.B. NO.

209

TWENTY-THIRD LEGISLATURE, 2005

 

STATE OF HAWAII

 


 

A BILL FOR AN ACT

 

relating to clinical trials.

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

SECTION 1. Chapter 324, Hawaii Revised Statutes, is amended by adding a new part to be appropriately designated and to read as follows:

"part   .    clinical trials

§ -1 Definitions. As used in this part, unless the context otherwise requires:

"Clinical trial" means a controlled test of a new drug or a new invasive device on human subjects that is conducted under the direction of the Federal Drug Administration before being made available for general clinical use.

"Department" means the department of health.

"Director" means the director of health.

§ -2 Applicability. This chapter shall apply to clinical trials conducted in:

(1) Hospitals and medical facilities, including public health facilities established under chapter 323F; and

(2) The University of Hawaii.

§ -3 Reporting requirement. Entities falling under section -2 shall not agree to conduct clinical trials unless the results will be:

(1) Made available to physicians and to the public; and

(2) Registered with the United States Department of Health and Human Services National Institutes of Health at www.clinicaltrials.gov,

before the drug or device that is the subject of the trial becomes available to the general public.

§ -4 Rules and enforcement. (a) The department shall be responsible for the enforcement of this chapter.

(b) The director shall adopt rules pursuant to chapter 91 necessary for the purposes of this chapter."

SECTION 2. This Act shall take effect on July 1, 2005.

INTRODUCED BY:

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