Comment on AN20-Proposed Rule-Jeffrey David Klausner, MD, MPH

The elimination of requirements for written signed documentation of informed consent is a safe and effective policy intervention to increase HIV testing, identify persons with HIV infection and meet the CDC recommendations for HIV testing among persons age 13-64 in the United States. We have convincingly demonstrated in San Francisco that the elimination of the requirements for written signed documentation of consent was associated with substantial and sustained increase in HIV testing and HIV case identification in our medical center, the San Francisco General Hospital (please see attached report: Association Between Rates of HIV Testing and Elimination of Written Consents in San Francisco, JAMA, 2007). Further such policy changes were associated with increases in testing in both in and out-patient settings and among higher risk populations such as men and those with inconsistent housing and lack of insurance (please see attached report: Simplifying Consent for HIV Testing Is Associated with an Increase in HIV Testing and Case Detection in Highest Risk Groups, San Francisco January 2008–June 2007. Plos One, Julu 2008) We have found no evidence of harm secondary to our change in local testing policy, no evidence of an adverse impact on privacy or loss of confidentiality. We have no reports of abuse or testing without the permission or knowledge of the patient. As a practicing physician and public health expert for over 15 years, it is my professional opinion that the HIV testing policy change proposed by the VA will increase the acceptance of HIV testing, the number of HIV tests performed, the number of HIV-infected cases identified resulting in the improved health and health outcomes of VA patients. Sincerely, Jeffrey D. Klausner, MD, MPH Deputy Health Officer, Director STD Prevention and Control Services San Francisco Department of Public Health Associate Clinical Professor of Medicine University of California San Francisco