摘要：Objectives. I evaluated the effects of written informed consent requirements on HIV testing rates in New York State to determine whether such consent creates barriers that discourage HIV testing. Methods. New York streamlined its HIV testing consent procedures on June 1, 2005. If written informed consent creates barriers to HIV testing, then New York's streamlining exercise should have reduced such barriers and increased HIV testing rates. I used logistic regression to estimate the effects of New York's policy change. Results. New York's streamlined consent procedures led to a 31.4% (95% confidence interval [CI] = 20.9%, 41.9%) increase in the state's HIV testing rate. In absolute terms, 7% of the state's population had been tested for HIV in the preceding 6 months under the streamlined procedures, whereas only 5.3% would have been tested under the original procedures. These estimates imply that the streamlined consent procedures accounted for approximately 328 000 additional HIV tests in the 6 months after the policy change. Conclusions. Written informed consent requirements are a substantial barrier to HIV testing in the United States.There may be a trade-off between efforts to increase HIV testing rates and efforts to improve patient awareness. In 2006, the Centers for Disease Control and Prevention (CDC) endorsed a shift from targeted HIV testing of high-risk groups to broad-based screening of the general population. 1 The CDC called for opt-out HIV screening of all patients in health care settings and argued that written informed consent procedures that are separate and distinct from general consent to medical treatment procedures should not be required for HIV testing. 1 The CDC recommendations reflect concerns that HIV testing rates are too low in the United States because a large number of people do not learn about their infection until it is too late for treatment to be effective. Opt-out screening has increased testing rates in other settings, including genitourinary clinics in the United Kingdom, and there is little doubt that it would increase HIV testing in the general population. 2 , 3 The effect of informed consent regulations on HIV testing rates is less clear. The CDC claims that such regulations create administrative and social barriers that discourage HIV testing. 1 There is also some evidence that written informed consent regulations represent a legal impediment to the implementation of opt-out testing. 4 Such concerns might also explain the CDC's advocacy of informed consent repeal. Critics of the recommendations argue that separate informed consent promotes important ethical and clinical objectives in public health policy and that removing informed consent regulations could lead to a more coercive HIV testing environment. 5 – 8 In summarizing the controversy, Bayer and Fairchild argued that the CDC's informed consent recommendations signal an end to the practice of HIV exceptionalism, which leads the medical establishment to approach HIV/AIDS issues differently than it approaches other health conditions. 9 It is difficult to estimate the effects of informed consent regulations on HIV testing rates because variations in state consent requirements may be correlated with state-level characteristics that themselves predict testing rates; that is, state populations are not randomly assigned to different informed consent policies. Zetola et al. reported the best evidence to date. They found that monthly testing rates increased from 13.5 to 17.9 HIV tests per 1000 patients in a set of institutions in San Francisco after that city's department of public health eliminated written informed consent requirements. 5 However, the Zetola et al. study lacked a comparison group, which would have alleviated concerns that the increases observed were associated with underlying trends and changes in HIV testing that occurred in the same time frame as the San Francisco policy change. In addition, Zetola et al. relied on administrative data, for which observations were conditional on patients' visits to particular institutions. It is possible that HIV testing rates among patients who visited these institutions were different than testing rates in the general population. As a result of such problems, it is difficult to generalize the effects of the San Francisco policy change on HIV testing rates in particular institutions to testing rates in the general population. A careful decision on whether to repeal or maintain written informed consent requirements in HIV testing depends on estimates of the effects of the regulations in terms of both testing rates and the physical and psychological risks to patient well-being. It also requires normative judgments regarding the relative importance of these effects in terms of public welfare. 10 In this study, I investigated the CDC's claim that informed consent regulations lead to reductions in HIV testing rates. I used data from the Behavioral Risk Factor Surveillance System (BRFSS) to examine HIV testing rates in New York State and a set of comparison states before and after the introduction of streamlined HIV test consent procedures in New York. The policy change in New York generated a natural experiment that helps address many of the challenges associated with evaluating the effects of consent procedures on testing rates.
