Informed Consent

How to communicate about informed consent for HIV testing in the ED?

The CDC recommends that HIV testing be voluntary.  As such, no patient should be tested unless he or she has provided informed consent. The informed consent process ensures that the provider and the patient have communicated about information the patient needs to make an informed decision to undergo or to decline HIV testing.

While informed consent is a key part of the testing process, it should facilitate not impede patients' acceptance of HIV testing. For this reason, the CDC recommends that HIV testing in health care settings need not be linked with other HIV teaching efforts, such as prevention counseling.  However, state and local statutes govern content and procedures for informed consent, so it is important to contact your health department for clarification on informed consent requirements.

This section addresses some elements in CDC's recommended approach to informed consent, namely opt-out testing, streamlined pretest information, and general consent forms.  It also provides some approaches to delivering pretest information to patients

Streamlined Pretest Information

Streamlined pretest information disconnects risk assessment from the pretest process. In a streamlined pretest information session, patients would receive oral or written information on the meaning and ramifications of HIV testing, the risks and benefits of testing, the implications of preliminary test results, and how and when test results will be communicated to them.  Patients would also have the opportunity to raise and discuss any questions they may have. Intensive counseling and referral for further care would be employed when patients are diagnosed with HIV or when HIV testing and counseling are otherwise consistent with the medical visit, such as when the visit is related to a behavioral or clinical risk factor (e.g., substance abuse or symptoms of an STD) or when other health promotion services are usually offered (e.g., as part of comprehensive health assessments, reproductive health care, or family planning).

When undergoing rapid HIV testing, patients must be additionally advised that:

• Results of their rapid HIV test will be available quickly, within as little as 20 minutes of administering the test
• Positive rapid tests are preliminary results and a second test will need to be performed to confirm the test result

The FDA also requires that an information pamphlet on the specific rapid HIV test used be given to the patient. These are available from the test manufacturers and distributors. 

Delivering Information to Patients

Ways in which pretest information can be provided to patients include:

• One-on-one staff discussions with patients based on scripts and training
•  Fliers/posters posted throughout the emergency department with required information
• Pamphlets with required information handed out at registration or triage; these are appropriate to the patient's culture, language, sex, sexual orientation, age, developmental level, and literacy level
•  Rolling videos broadcast in waiting rooms and low urgency exam rooms
• Computer-aided, self-administered tutorials
•  Manufacturers' information pamphlets
• Handouts describing HIV transmission, the rapid test procedure, and methods to prevent transmission

Informational materials should be easily understood and made available in the languages of the ED's commonly encountered populations. The competence and availability of interpreters and bilingual staff to provide language assistance to patients with limited English proficiency must be ensured. Patients who do not read, or who do not read well (which may be a significant proportion of the ED clientele) should have the option of having information delivered orally.

See side bar for advice on delivering pretest information to patients.

Opt-out Versus Opt-in Testing

Opt-out testing means performing an HIV test after notifying the patient that the test is normally performed but that the patient may elect to decline or defer testing. Assent is then assumed unless the patient declines testing. Opt-in testing means testing is offered and the patient is required to actively give permission before it can occur. The CDC recommends opt-out testing policies in health care settings.

Note that opt-out testing does NOT eliminate the need for informed consent, which is required by medical ethics. It also might not eliminate the need to formally document the patient's consent (e.g., by having the patient sign a consent form), since that is governed by state laws and sometimes local hospital policies. For more on written consent forms and HIV testing go to Consent Forms.

Consent Forms

Some states require written informed consent for all HIV testing (but not necessarily on a separate form); others specifically exempt health care providers from this requirement; and several explicitly state that no separate consent for an HIV test is necessary when a general consent for medical care is in effect. The CDC recommends incorporating informed consent for HIV testing into the general consent for medical treatment. Specifically, separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.  However, each facility must be familiar with laws governing informed consent in its own state and carefully consider their legal meaning in light of the HIV testing objectives.  

Resources

Resources

• Streamlined "Consent to Test for HIV" script and form (DOC) 
  Highland General Hospital
• Informed consent form (PDF) 
  New York State Department of Health
• Rapid HIV Test Staff Script (PDF) 
  Detroit Receiving Hospital