June 2025

In Maryland, informed consent is required before performing HIV testing, in accordance with Health-General Article, §18-336. This means the individual must be informed verbally or in writing about: (i) HIV testing will be performed on a specimen obtained from the individual unless the individual refuses HIV testing; (ii) includes an explanation of HIV infection and the meaning of positive and negative test results (may be accomplished with use of a video that explains the information); (iii) offers the individual an opportunity to ask questions and decline HIV testing; and (iv) if the individual refuses HIV testing, document in the medical record the individual's decision. Consent can be included as part of general consent for medical care in the same category as other screening and diagnostic tests, and a separate consent form is not required. 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 Informed Consent and Agreement to HIV Testing form provided by the Maryland Department of Health is still available to clinicians and researchers.  Researchers who conduct research that involves HIV testing have the following options to meet state requirements for documentation of testing:

1.   The research team may use the Informed Consent and Agreement to HIV Testing 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 this Department of Health form to meet documentation requirements.

2.   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 Department of Health form. If this option is selected, 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 was 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 2 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.