Md. Code Regs. 10.25.11.08

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.25.11.08 - Suspension or Termination of IRB Approval

A. The Commission shall require an applicant to file periodic progress reports concerning any aspect of the use of data released under this chapter.

B. The Commission may:

(1) Investigate use made of data released under this chapter; and

(2) Require an applicant to provide information necessary to assist the Commission in its investigation.

C. The Commission may delegate the function listed in §B of this regulation to the IRB.

D. If an applicant fails to make use of the data in accordance with IRB requirements, including IRB data security and confidentiality requirements, the Commission, at the recommendation of the IRB or on its own motion, may:

(1) Immediately suspend or terminate its approval of the data release; and

(2) Require the applicant to:

(a) Return to the Commission, or

(b) Destroy previously released data.

E. The applicant is entitled to a post-suspension or termination hearing in front of the IRB to show cause why the suspension or termination should be rescinded. Following the hearing, the IRB shall make a recommendation to the Commission concerning reinstatement of the applicant's use of the information.

Md. Code Regs. 10.25.11.08