""
UC Davis Medicine - Logo
The institution's principal publication for alumni, friends and physicians.
""
Horizontal boundary
""
""
"" "" ""
  A L U M N I  
"" "" ""
"" ""
"" ""
   
"" ""
"" ""
"" ""
"" ""
"" ""
   
"" ""
   
"" ""
Vertical Seperator Line
""
""
ALUMNI
""
 
""

CONSENT TO HIV SCREENING: A MOVE FROM INFORMED CONSENT TO NOTICE TO TEST

History of informed consent

 "" Ben A. Rich, J.D., Ph.D., UC Davis School of Medicine Bioethics Endowed Professor
  ""
Ben A. Rich, J.D., Ph.D., UC Davis School of Medicine Bioethics Endowed Professor
"" ""

Until recently, the general approach to HIV screening in the United States required informed consent. In 1999, an Institute of Medicine (IOM) panel recommended that universal HIV testing become a routine element of prenatal care. Patients would be advised that HIV testing is just one of a number of screening tests usually and customarily performed during the delivery of prenatal care. Thus, unless the patient refused HIV testing, it would be performed. The American College of Obstetrics and Gynecology and the American Academy of Pediatrics endorsed the IOM panel's recommendations.

In 2001, the Centers for Disease Control and Prevention (CDC) included universal prenatal HIV testing in revisions to its prenatal HIV testing guidelines, but only with informed consent and pretest HIV counseling. By 2006, the CDC issued "Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings." A salient passage in these recommendations reads as follows:

"CDC recommends that diagnostic HIV testing and opt-out HIV screening be a part of routine clinical care in all health care settings while also preserving the patient's option to decline HIV testing and ensuring a providerpatient relationship conducive to optimal clinical and preventive care."

In 2007, the California legislature passed and the Governor signed into law AB 682, the California Routine HIV Screening Bill, sponsored by the AIDS Healthcare Foundation, the California Medical Association, and the Health Officers Association of California.

The new legislation removes the prior requirement of written informed consent to HIV testing, replacing it with a requirement that the patient be informed that the test is planned, what it involves, the treatment options for patients who test positive, the need for continuing routine testing for those with a negative test, and the individual's right to decline the test.

The new approach to consent is characterized as an "opt-out." With much fanfare, AB 682 was hailed as "the most important change in public HIV/AIDS policy in years."

Ethical issues

The doctrine of informed consent originated in the crucible of the courts. The requirement of informed consent to the participation of human subjects in clinical research first appeared in the Nuremberg Code of 1947. Ten years later, in the case of Salgo v. Stanford University, a California court became the first to articulate a duty of clinicians to obtain the prior written consent of patients to treatment.

Eventually, informed consent came to be generally recognized as the most effective means of ensuring that a core bioethical principle – respect for patient autonomy – consistently characterized both patient care and clinical research.

A truly informed consent was one in which the patient understood the nature of the procedure, treatment, or protocol, the anticipated risks and benefits, the alternatives available as well as their risks and benefits (including doing nothing or not participating as a research subject). Implicit in the concept of informed consent is informed refusal, for without the ability to "just say no," genuine patient autonomy could not be achieved.

Recent editions of the American Medical Association's "Code of Medical Ethics" have included a section on the patient's right to informed consent generally, as well as a section specific to HIV testing. The latter indicated that both specific informed consent to testing and pretest counseling concerning the potential consequences of HIV test results on the patient's job, housing, insurability and social relationships was necessary because "consent for HIV testing cannot be inferred from a general consent to treatment."

Policy shift

The shift in policy concerning the nature of the consent that is appropriate as a matter of sound clinical practice and public policy appears to attach great significance to the fact that the earlier, more stringent requirements were an artifact of the era when HIV/AIDS was first recognized. Effective treatments were unavailable, and the disease was viewed as almost entirely confined to those who engaged in homosexual sex or IV drug use.

Now, so the argument runs, the demographics of the HIV/AIDS epidemic have changed in that a higher percentage of infected persons than ever before are under 20 years of age, women, members of racial or ethnic groups, those living in non-urban areas, and heterosexual men and women. Given these new demographics, from a public health perspective, it is no longer reasonable to direct screening measures only to certain narrowly circumscribed high-risk groups.

While it may be the case that the demographics of and the prognosis for those individuals diagnosed with HIV/AIDS may have changed significantly in the last 20 years, it is not necessarily true that personal attitudes and social practices concerning those who are infected have changed commensurately.

Discrimination protection

A plausible argument can be made that the risk of discrimination and other psychosocial harms is much greater for HIV/AIDS than other infectious diseases or serious medical conditions. Concerns have been expressed in particular about prenatal HIV testing pursuant to the more relaxed consent strategy.

To its credit, California has been one of the few states to provide special protection to women who receive prenatal HIV testing in recognition of their vulnerability should others become aware of their infected status.

It may seem to many that a change from express written informed consent to notice of intent to test with a right to refuse is quite subtle and hardly merits the amount of attention that some are giving it.

Perhaps only years of experience with the new approach will tell us how dramatic the change really is, and whether it will have the significant positive impact on public health that its proponents predict.

""
Vertical Seperator Line
"" "" ""
  "Implicit in the concept of informed consent is informed refusal, for without the ability to ‘just say no,‘ genuine
patient autonomy could not be achieved." — Ben Rich  
""
""   Vertical Seperator Line "" Vertical Seperator Line ""
"" "" Vertical Seperator Line
""
""

UC DAVIS SCHOOL OF MEDICINE
PUBLIC AFFAIRS
4900 Broadway, Suite #1200
Sacramento, CA 95820

ucdavismedicine@ucdmc.ucdavis.edu

© 2008 UC Regents. All rights reserved.

Vertical Seperator Line ""