The State of Maryland law regarding consent requirements for HIV testing changed on July 1, 2008. The requirement to use the State’s informed consent document for HIV testing performed in a health care facility was revised. Use of the State form is not required if there is documentation in the medical record that informed consent was obtained from the individual who was asked to have HIV testing. Documentation in the medical record must state that the individual tested received pre and post-test counseling and was informed she/he had the right to refuse HIV testing without penalty.
The State HIV testing form is still available to clinicians and researchers. The Organization has determined that researchers who conduct research that involves HIV testing have the following two options to meet State requirements for documentation of testing.
- The research team may continue to use the State form to document the requirements for informing potential research participants of the pre- and post-testing counseling required in the State of Maryland.
- If a research participant does not have a medical record, the research team must use the State form to meet documentation requirements.
- If a research participant does have a medical record, the research team may decide to document the HIV testing requirements in the medical record instead of using the separate State form. If this option is followed, the written medical record must contain a statement that includes the following details:
a. “The research participant (name) was asked to have an HIV test performed and provided with information about the test. He/she agreed to testing. The participant was provided with pre and post testing counseling in accordance with Maryland law.”
b. “The research participant was informed she/he had the right to refuse HIV testing without penalty.”
c. “A positive HIV test result must be reported to the health department.”
A PI should provide in the recruitment process section of the eIRB application specific information on which option will be used to meet the required documentation for HIV testing. Question 13, Recruitment Information, should explain when option 3 is to be used for the research-required HIV test, that pre-and post test counseling will be provided, and the required documentation will be added to the medical record for the participants.
Questions regarding the requirements for documentation of HIV testing should be directed to the Office of Human Subjects Research.