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.

View latest version | View original version
View status on official RI website

Subscribe to email updates


Changes since original draft

  • 2019 – H 5540
  • ========
  • LC001226
  • ========
  • 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

RIBIT does not have any votes for this legislation yet.
(Vote tracking on RIBIT is still a work-in-progress, so make sure to check the official RI website, too!)