House Bill #5540 (2019)

AN ACT RELATING TO HEALTH AND SAFETY - DEPARTMENT OF HEALTH - CLINICAL TRIALS WEBSITE

Requires the state department of health to post and maintain on its website a link to ClinicalTrials.gov, a free service of the National Institutes of Health Library of Medicine.

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Changes since original draft

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

Votes

NOTE: Electronic voting records are unofficial and may not be accurate. For an official vote tally, check the House or Senate Journal from the day of the vote.

Floor vote for PASSAGE

May 21, 2019 at 4:26pm
Yeas: 61 / Nays: 0 / Not voting: 7 / Recused: 0
Legislator Vote
Rep. Abney Y
Rep. Ackerman Y
Rep. Ajello Y
Rep. Almeida NV
Rep. Alzate Y
Rep. Amore Y
Rep. Azzinaro Y
Rep. Barros Y
Rep. Bennett Y
Rep. Blazejewski NV
Rep. Caldwell Y
Rep. Canario NV
Rep. Carson Y
Rep. Casey Y
Rep. Casimiro Y
Rep. Cassar Y
Rep. Chippendale NV
Rep. Cortvriend Y
Rep. Corvese Y
Rep. Costantino Y
Rep. Craven Y
Rep. Diaz Y
Rep. Donovan Y
Rep. Edwards Y
Rep. Fellela Y
Rep. Filippi Y
Rep. Fogarty Y
Rep. Handy Y
Rep. Hawkins Y
Rep. Hull Y
Rep. Jackson Y
Rep. Jacquard Y
Rep. Johnston Y
Rep. Kazarian Y
Rep. Kennedy Y
Rep. Kislak Y
Rep. Knight Y
Rep. Lima Y
Rep. Lombardi Y
Rep. Lyle Y
Rep. Maldonado Y
Rep. Marszalkowski Y
Rep. Mattiello Y
Rep. McEntee Y
Rep. McKiernan Y
Rep. McLaughlin NV
Rep. McNamara Y
Rep. Mendez Y
Rep. Messier Y
Rep. Millea Y
Rep. Morin NV
Rep. Nardone Y
Rep. Newberry Y
Rep. Noret Y
Rep. O'Brien Y
Rep. Phillips Y
Rep. Place NV
Rep. Price Y
Rep. Quattrocchi Y
Rep. Ranglin-Vassell Y
Rep. Roberts Y
Rep. Ruggiero Y
Rep. Serodio Y
Rep. Serpa Y
Rep. Shanley Y
Rep. Shekarchi Y
Rep. Slater Y
Rep. Solomon Y