Current through Register Vol. 51, No. 19, September 20, 2024
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.
