If you plan on collecting information about or testing participants for communicable disease status, additional considerations apply. The IRB generally defines a communicable disease as:

• Health conditions that must be reported to health authorities under state and/or federal law, such as hepatitis, tuberculosis, or syphilis.
• Health conditions that may require health care providers to use contact precautions, such as gown and gloves or isolation, when interacting with an affected individual.

Your protocol or application should address why such information must be collected for your study as well as whether any test results will be disclosed to participants and what impact, if any, such testing will have on their clinical care. The informed consent document must include language informing potential participants about such testing and its impact on their clinical care.

For HIV testing, additional requirements apply, including those mandated by state law.

• Informed consent: Participants must be informed 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. If results will be placed in the participant’s medical record, they must be informed of this as well. Under Wisconsin law, the informed consent process for HIV testing must also 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.
  • Study teams can use the UW Health’s Health Facts, “HIV and AIDs” to satisfy these state law requirements.
• Reporting HIV test results: If a 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, you are responsible for making all required reports.
• Maintaining records: State law requires that a record be maintained of the following:
  • Whether the person or their authorized representative consented to or declined the HIV test;
  • Any authorization for disclosure of HIV test results that the person or their authorized representative has made;
  • 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; such forms may be de-identified to protect subjects’ privacy.
• Use of test results from the medical record: HIV test results are confidential but may be revealed without the subject’s authorization for research purposes if:
  • The researcher is affiliated with a health care provider,
  • The study has permission for the research,
  • The researcher provides written assurance to the person releasing the HIV test results that:
    • Use of the information requested is only for the purposes under which it is provided to the researcher;
    • The information will not be released to a person not connected with the study and;
    • The final research product will not reveal information that may identify the subject unless the researcher has obtained consent for disclosure from the subject.