Research programs. Licensure. Regulations. Fees.

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(a) The Commissioner of Consumer Protection may approve a research program if such research program will (1) be administered or overseen by (A) a hospital or health care facility licensed by the Connecticut Department of Public Health pursuant to chapter 368v, (B) an institution of higher education, as defined in section 10a-55, (C) a licensed producer, or (D) a licensed dispensary, and (2) have institutional review board oversight and, if the research program involves the use of animals, have an institutional animal care and use committee.

(b) Except as provided in subsection (c) of this section, no person may act as a research program employee or represent that such person is a licensed research program employee unless such person has obtained a license from the Commissioner of Consumer Protection pursuant to this section.

(c) Prior to the effective date of regulations adopted under this section, the Commissioner of Consumer Protection may issue a temporary certificate of registration to a research program employee. The commissioner shall prescribe the standards, procedures and fees for obtaining a temporary certificate of registration as a research program employee.

(d) The Commissioner of Consumer Protection shall adopt regulations, in accordance with chapter 54, to (1) provide for the approval of research programs and licensure of research program employees, (2) establish standards and procedures for the termination or suspension of a research program, (3) establish standards and procedures for the revocation, suspension, summary suspension and nonrenewal of a research program employee license, provided such standards and procedures are consistent with the provisions of subsection (c) of section 4-182, (4) establish a (A) fee for research program review and approval, and (B) license and renewal fee for each research program employee, provided the aggregate amount of such fees shall not be less than the amount necessary to cover the direct and indirect cost of approving research programs and licensing and regulating research program employees pursuant to the provisions of this chapter, and (5) establish other licensing, renewal and operational standards deemed necessary by the commissioner.

(e) Any fees collected by the Department of Consumer Protection under this section shall be paid to the State Treasurer and credited to the General Fund.

(P.A. 16-23, S. 12.)


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