Consent for Testing

Updated April 22, 2009

HIV Prevention Program 971-673-0181

Is Informed Consent Necessary to Test Patients for HIV in Oregon?

Except in pregnant patients (Oregon Revised Statute [ORS] 433.017), research situations in which the patient is not identified (ORS 433.055), or circumstances of occupational exposure where the source patient refuses voluntary testing (ORS 433.080) (See, ORS 433). ORS 433.045 requires that informed consent be obtained prior to testing a patient for HIV. Informed consent must be conducted in a manner consistent with ORS 677.097. This statute mandates that a physician or surgeon explain in general terms the procedure or treatment to be undertaken, the alternative procedures, if any, and the risks, if any, to the procedure. The physician should further inquire whether the patient needs additional explanation. If the response is affirmative, the physician must explain the procedure, risks, and alternatives in “considerable” detail.

Is Written Informed Consent Required before Testing for HIV in Oregon?

As noted above, informed consent is required for HIV testing in Oregon. If the person or entity collecting the specimen is a licensed health care provider or licensed health care facility, nothing in Oregon statute (ORS 677.097; ORS 433.017, 045, 080) or administrative rule (OAR 333-012-0265) requires that this consent be "written" (although most of us would say that good practice dictates at least noting the consent in the medical record). If the person or entity collecting the blood is not a licensed provider or licensed health care facility, it must collect and retain a written consent form. Written consent forms should be substantively equivalent to the model consent form available on the Oregon State Public Health Division, HIV Program website.

Are clinical laboratories that do not receive state or federal HIV prevention funds for HIV testing required to collect evidence of informed consent before testing specimens for HIV?

No, clinical laboratories that do not receive state or federal HIV prevention funds for testing are not required to collect evidence of informed consent. This is a change from previous requirements in Oregon. Until January 16, 2007, Oregon Administrative Rule (OAR 333-018-0030) required laboratories to collect an HIV Report Form (OHD 49-03) on which the doctor or other clinician signed an attestation to the fact that the patient had provided informed consent for testing. (OAR 333-018-0030) no longer mandates collection of the form. The change is effected by the deletion of former language requiring the testing form. OAR 333-018-0030 currently requires laboratories to provide quarterly aggregate reports of total numbers of HIV antibody tests and confirmed positives by sex and age group.

Are laboratories (i.e. Oregon State Public Health Laboratory) that receive federal or state HIV prevention funds for HIV testing required to collect evidence of informed consent before testing specimens for HIV?

No. As noted above collecting specific informed consent for HIV testing continues to be required in Oregon, but language requiring laboratories verify that informed consent was done before proceeding with testing was stricken from administrative rule in 2007. The HIV Prevention Program of the Oregon State Public Health Division continues to require that test submitters remit a test form with all specimens that includes information about HIV risk behaviors, preliminary rapid testing and reason for test. This form will be replaced with a new version in May of 2009. The form (OHD 44) is available in a triplicate version from the Oregon State Public Health Laboratory (503-693-4100).