HIV Testing in Research Guidance
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.
Version Date: July 17, 2017
Consent for HIV TestingThe 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:
- 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.
Reporting HIV Test ResultsIf 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 ReportsUnder 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.