Md. Code Regs. 10.18.02.02

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.18.02.02 - Exemptions

A. Qualifications for Exemption. A research project that meets both of the following criteria may be eligible for exemption from the HIV reporting requirements of Regulation .06 of this chapter:

(1) The research project has been approved by an institutional review board; and

(2) The research:

(a) Is intended to determine the safety or effectiveness of a vaccine that would produce immunity against HIV; or

(b) Is not primarily intended to provide medical treatment to participants.

B. Application for Exemption. The principal investigator of a research project shall submit all of the following documents to the Department in order to apply for an exemption:

(1) A copy of the research protocol approved by the institutional review board of the institution conducting the research; and

(2) A copy of the notice stating that the protocol has been approved by the institutional review board of the institution conducting the research.

C. Approval.

(1) The Director of the Infectious Disease Prevention and Health Services Bureau or the Director's designee shall review the application submitted under §B of this regulation to determine whether the:

(a) Application is complete; and

(b) Research protocol meets the criteria specified in §A of this regulation.

(2) If the application is complete and the research protocol meets the specified criteria, the Director shall grant an exemption from the requirements set forth in Regulation .06 of this chapter for any specimen tested for HIV detection under the research project approved for exemption.

(3) The Director shall mail written notification to the applicant of an exemption under this regulation within 30 days of receipt of the application, stating whether the exemption:

(a) Has been approved;

(b) Has been denied and the reason for the denial; or

(c) Cannot be processed until further information is provided to the Department.

D. Responsibilities of the Principal Investigator. If a research project is granted an exemption under §C of this regulation, the principal investigator of the research project shall send to each laboratory to which specimens collected under the research protocol will be sent to be tested for HIV detection a copy of the notification from the Director issued pursuant to §C(3)(a) of this regulation to verify that the project has been exempted from the reporting requirements of Regulation .06 of this chapter.

E. Scope of Exemption.

(1) Except as indicated in §E(2) of this regulation, an exemption approved under §C of this regulation does not relieve the principal investigator, a laboratory director, or another individual from a reporting requirement contained in Health-General Article, §18-201.1, 18-202.1, 18-205, or 18-207, Annotated Code of Maryland, or Regulation .06 of this chapter.

(2) A principal investigator, laboratory director, or other individual is not required to report HIV detection test results if the test is done as part of the research project and the individual tested:

(a) Meets the criteria for participation in the research project set forth in the research protocol submitted under §B(1) of this regulation; and

(b) Has signed an informed consent form agreeing to participate in the research project.

Md. Code Regs. 10.18.02.02

Regulation .02 amended effective 43:5 Md. R. 385, eff.3/14/2016; amended effective 47:10 Md. R. 515, eff. 5/18/2020