HIV Testing in Research Guidance
Version Date: July 17, 2017
The purpose of this document is to provide guidance for researchers on testing and reporting for HIV within the context of a research study, or for use of HIV test results for research purposes. This guidance is specific to HIV testing in Wisconsin; for a more general discussion of human subject protection issues related to communicable disease testing, please see the Communicable Disease Guidance. If the study occurs in states other than Wisconsin testing and reporting requirements may differ.
Consent for HIV Testing
The study team must inform participants
that the research includes HIV testing or use of HIV test results and the associated risks, unless the criteria for the IRB to waive informed consent are met.
Under Wisconsin law, the informed consent process for HIV testing must include a written or oral explanation or description of:
UW Health’s Health Facts for You #4421 titled “HIV/AIDS: General Information”
- HIV infection
- HIV test results
- requirements for reporting to the State epidemiologist
- treatment options for a person who has a positive HIV test result; and
- services provided by AIDS service organizations and other community-based organizations.
contains the required information, and may be used in conjunction with the research consent form to convey the legally required information.
: Subjects must be informed if test results will be placed in their medical record.
Reporting HIV Test Results
If a research participant tests positive for HIV/AIDS, a report must be made to the state epidemiologist. If identifiable specimens are provided to the University of Wisconsin Hospital and Clinics (UWHC) laboratory or the Wisconsin State Laboratory of Hygiene (WSLH), the UWHC laboratory or WSLH will make required reports to the state epidemiologist. If only coded specimens are provided to the UWHC laboratory or WSLH, the study team is responsible for making all required reports.
For information and forms specific to HIV or AIDS case reporting, see the DHS AIDS/HIV Resources for Clinicians
Maintaining Records of HIV Tests and Reports
Under Wisconsin Statute Chapter 252.15(4)
, a health care provider who obtains a specimen of body fluids or tissue from a person for the purpose of an HIV test shall maintain in the person’s health care record all of the following:
- A record of whether the person or his or her authorized representative consented to or declined the HIV test;
- A record of any authorization for disclosure of HIV test results that the person or his or her authorized representative has made;
- A record of the results of an HIV test administered to the person.
Additionally, for purposes of verifying compliance with Wisconsin reporting laws, the study team should maintain records of any report made to local health departments or the state epidemiologist, but may de-identify such forms to protect subjects' privacy.
Use of HIV Test Results From Medical Records
HIV test results are confidential but may be revealed without test subject's authorization for the purpose of research, if the researcher is affiliated with a health care provider, has obtained permission to perform the research from an institutional review board, the information will be used only for the approved research and will not be released to a person not connected with the research, and the final product will not include identifying information. Wis. Stat. § 252.15(3m)(d)10