Md. Code Regs. 10.25.11.06

Current through Register Vol. 51, No. 12, June 14, 2024

Section 10.25.11.06 - Commission Review of IRB Recommendations

A. The Commission shall review:

(1) All IRB recommendations for approval of applications; and

(2) IRB denials of applications only for good cause shown by the applicant, which shall consist of evidence demonstrating that the IRB failed to follow the process set forth in this chapter.

B. In order to secure Commission review of an IRB denial, an applicant shall file an appeal of the denial with the Commission, together with any supporting memoranda and documentation, within 15 days of the date of receipt of the IRB denial.

C. In reviewing an IRB recommendation, the Commission shall consider all relevant factors and render its decision in a timely fashion. In reviewing an IRB recommendation to deny an application, the Commission shall affirm the IRB's decision or, if the evidence warrants, remand the case to the IRB for further consideration. In remanding the matter to the IRB, the Commission shall inform the IRB of the basis for its decision and instruct the IRB concerning any remedial measures which the IRB must take on remand.

D. A request for data from the data base is not a contested case under the Administrative Procedure Act.

Md. Code Regs. 10.25.11.06