2019 -- H 5540 | |
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LC001226 | |
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STATE OF RHODE ISLAND | |
IN GENERAL ASSEMBLY | |
JANUARY SESSION, A.D. 2019 | |
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A N A C T | |
RELATING TO HEALTH AND SAFETY - DEPARTMENT OF HEALTH - CLINICAL | |
TRIALS WEBSITE | |
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Introduced By: Representatives McNamara, Ackerman, Shanley, Newberry, and | |
Date Introduced: February 27, 2019 | |
Referred To: House Health, Education & Welfare | |
It is enacted by the General Assembly as follows: | |
1 | SECTION 1. Chapter 23-1 of the General Laws entitled "Department of Health" is |
2 | hereby amended by adding thereto the following section: |
3 | 23-1-1.4. Rhode Island clinical trials website. |
4 | (a) The department of health shall create and maintain a website which informs the public |
5 | and potential participants, of all clinical drug, biological, or device products trials being |
6 | conducted in Rhode Island and throughout the region. |
7 | (b) The website shall be regularly updated and shall include, the following information, |
8 | but not be limited to: |
9 | (1) The identity of the clinical trial's sponsor, with street address, telephone number and |
10 | email address; |
11 | (2) The medical conditions being investigated, studied, tested or treated by the clinical |
12 | trial; |
13 | (3) Whether participants are required to have current medical insurance; |
14 | (4) Whether there are any expenses to be incurred by the participants for which they will |
15 | be reimbursed by the sponsor of the trial; |
16 | (5) Whether the participants will be paid for their participation and if so, how will that |
17 | compensation be determined; |
18 | (6) A complete listing of all requirements that a selected trial participant must meet; |
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1 | (7) Whether trial participants are entitled to receive the results of their trial; |
2 | (8) Any other information that ClinicalTrials.gov, a free service of the National Institutes |
3 | of Health provided through the National Library of Medicine, regularly includes on its website, |
4 | listing all potential clinical studies; and |
5 | (9) Any other written information the department of health deems necessary to include |
6 | before a potential participant can exercise informed consent for participation in the clinical trial. |
7 | (c) The department of health is expressly authorized to sell advertising for its clinical trial |
8 | listing website to help defray the costs incurred by the creation and maintenance of it. |
9 | SECTION 2. This act shall take effect upon passage. |
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EXPLANATION | |
BY THE LEGISLATIVE COUNCIL | |
OF | |
A N A C T | |
RELATING TO HEALTH AND SAFETY - DEPARTMENT OF HEALTH - CLINICAL | |
TRIALS WEBSITE | |
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1 | This act would require the state department of health to create and maintain a website |
2 | which contains meaningful information about clinical, drug, biological, and device products' |
3 | clinical trials currently underway in Rhode Island aimed at potential clinical trial participants. |
4 | This act would take effect upon passage. |
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