79R3338 UM-D

By:  Rodriguez                                                    H.B. No. 1029



A BILL TO BE ENTITLED

AN ACT

relating to approval procedures of institutional review boards for 
certain clinical trials.
	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:                        
	SECTION 1.  Subtitle A, Title 6, Health and Safety Code, is 
amended by adding Chapter 442 to read as follows:

CHAPTER 442.  INSTITUTIONAL REVIEW BOARD PROCEDURES
	Sec. 442.001.  DEFINITIONS.  In this chapter:                           
		(1)  "Clinical drug trial" means a research study in 
human volunteers designed to evaluate the safety and effectiveness 
of a drug.
		(2)  "Institutional review board" means a board, 
committee, or other group formally designated by an institution or 
authorized under federal or state law to review or approve the 
initiation of or conduct periodic review of research programs to 
ensure the protection of the rights and welfare of human research 
subjects.
	Sec. 442.002.  REQUIRED APPROVAL PROCEDURE.  An 
institutional review board may not approve a clinical drug trial 
unless the person conducting the trial agrees to:
		(1)  register the clinical drug trial with the National 
Institutes of Health website for clinical trials; and
		(2)  publish the results of the clinical drug trial in 
electronic format on the Internet in a manner readily understood by 
the public.
	SECTION 2.  The change in law made by this Act applies only 
to a clinical drug trial approved on or after the effective date of 
this Act.   A clinical drug trial approved before the effective date 
of this Act is covered by the law in effect when the clinical drug 
trial was approved, and the former law is continued in effect for 
that purpose.
	SECTION 3.  This Act takes effect September 1, 2005.