Report Title:

Medical Research; Clinical Trials; Public Registry

Description:

Requires medical research subject to chapter 324, HRS, that includes prescription drugs as part of a clinical trial, research, or experimental treatment for a serious or life-threatening diseases to register the study with a public registry; public registry information shall include potential benefit and harm.

HOUSE OF REPRESENTATIVES

H.B. NO.

102

TWENTY-THIRD LEGISLATURE, 2005

 

STATE OF HAWAII

 


 

A BILL FOR AN ACT

 

relating to medical research.

 

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 . Prescription Drugs in clinical trials,

research, and experimental treatments

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

"Institutional review board" means an institutional review board established in accordance with 7 Code of Federal Regulations 1c.107, 10 Code of Federal Regulations 745.107, 14 Code of Federal Regulations 1230.107, 15 Code of Federal Regulations 27.107, 16 Code of Federal Regulations 1028.107, 21 Code of Federal Regulations 56.107, 22 Code of Federal Regulations 225.107, 24 Code of Federal Regulations 60.107, 28 Code of Federal Regulations 46.107, 32 Code of Federal Regulations 219.107, 34 Code of Federal Regulations 97.107, 38 Code of Federal Regulations 16.107, 40 Code of Federal Regulations 26.107, 45 Code of Federal Regulations 46.107, 45 Code of Federal Regulations 690.107, or 49 Code of Federal Regulations 11.107.

"Public registry" means a collection of data organized so that the information can be processed and made available for research and to inform consumers and health care providers.

§324-    Prescription drug clinical trials, research, or experimental treatments; public registry; disclosure. (a) All federal, state, or private sponsors of any medical research, including clinical trial, clinical research, or experimental treatments for serious or life-threatening diseases, that:

(1) Includes the use of prescription drugs;

(2) Is federally, state, or privately funded; and

(3) Is conducted at any facility in the State;

shall register the study with a public registry of clinical trials. Facilities include, but are not limited to, hospitals, universities, physicians' offices, or community clinics.

(b) Any medical research that includes a clinical trial, clinical research, or experimental treatments for serious or life-threatening diseases that:

(1) Includes the use of prescription drugs; and

(2) Is conducted in a facility in the State;

shall be approved and monitored by an institutional review board to ensure that risks to participants are minimal and potential benefits are reasonable.

(c) The complete results, positive and negative, of prescription drug use in any clinical trial, clinical research, or experimental treatments for serious or life-threatening diseases shall be disclosed and made available to the public within six months of the study's completion through a public registry of clinical trials of the United States National Institutes of Health, or successor organization.

(d) Notwithstanding any law to the contrary, each clinical trial, clinical research, or experimental treatment for serious or life-threatening diseases study that includes prescription drugs and is conducted in the State shall register the study with a public registry and provide information that includes: the study's purpose and objective; its design; the potential benefits, harm, and risk; and the commencement and ending dates of the study. If a study is not completed, an explanation of the reasons for its termination shall be provided in the public registry.

§324-    Public registry applicability. Any medical research subject to this chapter that includes prescription drugs as part of a clinical trial, clinical research, or experimental treatment for serious or life-threatening diseases shall register the study with a public clinical trials registry of the United States National Institutes of Health, or successor organization. Studies subject to the public registry requirement of this chapter shall be registered before the commencement of the study."

SECTION 2. This Act shall take effect upon its approval.

INTRODUCED BY:

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