Informed Consent

Need multiple seats for your university or lab? Get a quote
The page below is a sample from the LabCE course HIV Safety for Florida Clinical Laboratory Personnel. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about HIV Safety for Florida Clinical Laboratory Personnel (online CE course)
Informed Consent

Informed consent must be obtained first before an HIV antigen or antibody test can be ordered.
Informed consent must be preceded by:
  • Explanation of the test subject's right of confidentiality.
  • Notification that a positive HIV test result will be reported to county health department with enough information to possibly identify the test subject.
  • Availability and location of sites where anonymous testing is performed
Informed consent can be given by a legal guardian or other person authorized by law when the test subject is:
  • not competent,
  • incapacitated, or
  • a minor.
According to the Florida Department of Health, "In September 2016, Florida Administrative Code Rules 64D-2.002, 2.003, 2.004, and 2.006, were adopted to implement Florida's amended HIV testing law (section 381.004, Florida Statutes). This amendment removed the need for separate informed consent prior to HIV testing in health care settings. This amendment simplifies routine HIV screening in health care settings and has the opportunity to improve the identification of new or existing HIV infections. There was no change in the law regarding non-health care settings.
Summary of Changes to Section 381.004, Florida Statutes:
  • Informed consent is no longer required in health care settings in Florida prior to testing for HIV.
  • Patients must be notified either orally or in writing that they will be tested for HIV unless they decline (opt-out of) testing.
  • Notification must include information that a positive HIV test result, along with identifying information, will be reported to the county health department and of the availability and location of sites at which anonymous testing is performed.
  • If the patient opts out, it must be noted in their medical record.
  • A patient need not be notified that their blood is being tested for HIV in the event of a significant exposure for health care personnel.
  • A patient need not be notified that their blood is being tested for HIV in the event of a significant exposure for non-health care personnel during a medical emergency."