II. HEALTHCARE AND RESEARCH ISSUES

The early ethical debates regarding the AIDS epidemic were largely driven by the concerns of the politically active, primarily white, homosexual or bisexual men in the United States in whom the disease was first identified. Because of severe discrimination against HIV/AIDS patients, early activists argued for special confidentiality protections for HIV information. Because infection at that time was almost always fatal, patients also demanded access to experimental treatments, which offered the only chance of survival. Over the 1980s and 1990s, however, the epidemic changed, as did many of the ethical issues.

The global impact of HIV/AIDS in the twenty-first century dominates ethical and policy debates. In late 2001 an estimated 40 million people worldwide were HIV infected, with approximately 5 million new infections and 3 million deaths that year. More than 95 percent of new infections are in developing countries. AIDS is the leading cause of death in sub-Saharan Africa and the fourth leading cause of death worldwide. Although Africa has been particularly hard hit by the AIDS epidemic, with about 70 percent of HIV-infected persons and new infections, the looming epidemic in other developing areas, particularly China and India, may surpass it. Failure of governments to acknowledge the threat of HIV may be exacerbating the epidemic.

In the United States, HIV/AIDS remains a serious public health problem. Spread primarily through sexual transmission and injection drug use, the epidemic in the United States increasingly affects poor people of color. In 2001 an estimated 800,000 to 900,000 people in the United States were HIV-infected, with over 300,000 diagnosed with AIDS. But as a result of the introduction of highly active antiretroviral therapy, as well as prevention and education efforts, the number of AIDS deaths in the United States has fallen dramatically.

This entry discusses ethical issues regarding HIV testing, confidentiality of HIV information, HIV infection in women and children, end-of-life issues for HIV-infected patients, and access to healthcare for HIV disease. This entry also discusses clinical research issues, with particular attention to international HIV research and HIV vaccine research.

Healthcare Issues

Fear and social stigma may be barriers to seeking HIV testing or care. In the United States, special procedures, protections, and programs have been developed to encourage testing and to provide care.

TRANSMISSION AND PREVENTION. HIV is transmitted by direct contact with bodily fluids that contain the virus. The major modes of transmission are sexual contact and injection drug use (through sharing needles and drug paraphernalia). HIV can also be transmitted from mother to infant during pregnancy or through breast-feeding. Prevention measures, such as safer sex education, condoms, needle exchange, and methadone maintenance, have proven effective at preventing HIV transmission.

Nevertheless, these prevention efforts often meet with strong resistance. Some object that providing condoms and discussing safer sex techniques inappropriately encourage sexual behaviors outside of heterosexual marriage. Similarly, some object that providing clean needles fosters illegal and harmful injection drug use. From a population perspective, however, such preventive measures reduce the incidence of a serious, often fatal illness. Empirical studies do not demonstrate an increase in high-risk behaviors after these preventive interventions.

HIV TESTING. Because of the sensitivity surrounding HIV, testing for the disease is treated differently from most other medical tests.

Special procedures for HIV testing. Because the physical risks are minimal, in the United States, blood tests typically do not require extensive informed-consent discussions, and consent often is implied rather than explicit. Early in the AIDS epidemic, however, HIV testing was recognized as different from other blood tests because it presented serious psychosocial risks, such as familial rejection, employment discrimination, and/or loss of healthcare, insurance, and housing. Moreover, because there was no proven treatment at that time, the benefits of early diagnosis to individual patients were uncertain. In recognition of these circumstances and to encourage voluntary testing, special procedures were adopted for obtaining consent for an HIV test, such as pretest counseling and specific informed consent. Special protections for confidentiality of HIV test results also were enacted. For the most part, these special requirements remain in effect. Numerous states require pretest counseling, and the majority of states require specific (often written) informed consent to HIV testing.

Availability of anonymous testing. Because of the serious stigma and potential psychosocial risks associated with HIV testing and to further encourage voluntary testing, most states offer anonymous HIV testing. At special, anonymous test sites, individuals are not required to provide their names or other identifying information. Upon testing, they are given a unique code to use to obtain results. People identified as HIV-infected at these sites are not reported to public health officials.

Exceptions to informed consent. States may permit HIV testing without informed consent under limited circumstances. For example, many states permit testing of patients without their permission after emergency response workers or healthcare workers are exposed to their blood or other fluids. Nevertheless, the patient's permission must be requested even though it is not required. In addition, some states permit the testing of prisoners and persons accused of sex crimes without their consent. Two states also require HIV testing of newborns, which indirectly reveals maternal HIV status.

Conventional versus rapid testing. Conventional HIV test results typically are not available for one to two weeks because initial positive tests must be confirmed with more sophisticated and accurate tests. In the United States, such testing is required to avoid mistakenly informing someone that they are HIV-infected based on a falsely positive test. However, this approach can be problematic when there is time urgency, such as when women first seek medical care when in labor and without a previous HIV test, or when people are unlikely to return for results, such as in clinics for sexually transmitted diseases. Effective interventions cannot be implemented without timely test results.

Rapid HIV tests are available that provide test results within hours of testing. Rapid testing is commonly used in developing countries. Because of the high prevalence of HIV in this setting, the risk of false positive results is lower than in the United States. In addition, several different rapid tests can be used to improve accuracy. In this setting, the benefits of identifying an infected individual using a rapid test are considered to outweigh the risks of false positive results.

CONFIDENTIALITY. Although medical information generally is considered confidential, there are additional requirements that apply to HIV-related information.

Protections. In the United States, physicians and healthcare organizations have ethical and legal obligations to preserve the confidentiality of all medical information. Because of the sensitivity of HIV-related information, many states in the United States have adopted laws that provide additional protection to HIV-related medical information. For example, many states require specific authorization from patients to disclose HIV-related information to third parties. Such protections are particularly important where stigma associated with HIV infection is high. Although the U.S. Supreme Court determined that HIV infection can be a disability under the Americans with Disabilities Act of 1990 (Bragdon v. Abbott, 1998), HIV-infected individuals still experience negative effects, such as ineligibility for certain governmental jobs (e.g., Peace Corps, foreign service, Job Corps, and the military) and limitations on international travel.

Exceptions. There are a number of exceptions to the legal and ethical rules of HIV-related confidentiality. First, healthcare providers in the United States have a duty to report AIDS cases and, in most states, HIV infections to public health authorities. The public health benefits of this reporting justify overriding the duty to maintain confidentiality. Reporting of AIDS cases includes the patient's name and other identifying information. Although reporting of HIV infections initially was not done by name, there has been a recent and controversial movement in the United States toward confidential name-based reporting of HIV infection. Supporters of name-based reporting argue that because antiretroviral therapies successfully delay progression to AIDS, the reporting of names is needed for more accurate epidemiological information. This information can be used for better planning and funding of HIV-related programs. Other proponents support name-based reporting because it would facilitate partner notification. Opponents of name-based reporting argue that it will deter testing and increase the risk of discrimination. Opponents contend that reporting of HIV infection can be effectively accomplished using codes, rather than names. Because of the potential psychosocial consequences associated with HIV infection, anonymous testing continues to be offered in states that require name-based reporting.

Second, healthcare providers may be permitted to inform an infected patient's sexual or drug-sharing partner of the patient's HIV infection. In some states, such as California, a healthcare provider must first inform the patient of the intended disclosure. Such a breach of confidentiality is justified on the grounds that it is the only means of preventing serious harm to an identifiable person and that the breach of confidentiality is minimized. Public health officials may also carry out partner notification. Although notification is typically conducted confidentially, it may inadvertently reveal the identity of the source patient.

Third, U.S. policy recommends that an expert panel review the cases of any HIV-infected healthcare workers who perform invasive procedures that might lead to transmission of HIV/AIDS. The panelists have to decide if an HIV-infected healthcare worker should be permitted to continue to perform such procedures, or if doing so would constitute too great a risk to the patients to be permitted. Additionally, the panel should decide if it is necessary to inform the healthcare worker's patients of any risk of infection, so that the patients can make an informed decision about whether they wish to continue in the healthcare worker's care. There is wide variation in state law and not all states require disclosure of HIV infection.

HIV INFECTION IN WOMEN AND CHILDREN. Worldwide, mother-to-child transmission is a major public health crisis. In parts of Africa, 45 percent of pregnant women are HIV-infected. Their children contract HIV in 25 to 45 percent of cases, resulting in some 540,000 perinatal cases annually. In the United States, the introduction of antiretroviral therapy has significantly reduced mother-to-child HIV transmission in the United States; by the early 2000s there were fewer than 300 perinatal HIV cases annually.

United States. To take advantage of the proven effectiveness of antiretroviral therapy for preventing perinatal HIV transmission, women must know that they are HIV-infected. U.S. policy strongly encourages HIV testing of all pregnant women, but at the same time U.S. policy embraces the state-based requirements for specific informed consent. Because many women are not offered and do not receive HIV testing during pregnancy, several consensus guidelines from professional societies have recommended that HIV testing should be made a routine part of prenatal care for all pregnant women. Notification that an HIV test will be performed, along with other prenatal blood tests, would be required, but specific consent to the HIV test would not. This proposal raises several concerns. First, women may not have enough information to know that they may refuse testing. Second, routine HIV testing in the prenatal context may undermine pretest counseling and informed consent for HIV testing in other clinical contexts. Third, because it forgoes certain opportunities for education and counseling, routine testing may undermine prevention efforts. Despite these concerns, the clear benefits of prenatal antiretroviral therapy in reducing the risk of mother-to-child HIV transmission may justify routine universal prenatal HIV testing.

Developing world. In developing countries, to date, the high cost of antiretroviral therapy to reduce the risk of mother-to-child HIV transmission has prevented the vast majority of women from receiving it. Even if antiretroviral therapy were to become affordable, the full protocol followed in the United States, which includes administration of antiretrovirals to the woman during the third trimester of pregnancy and during labor and delivery and administration to the infant after birth, may not be achievable because many women in the developing world do not receive prenatal care or deliver their babies in the hospital. Nevertheless, a single dose of nevirapine to the woman during labor and the infant after delivery has proven effective at significantly reducing mother–child HIV transmission. This simpler preventative regimen is more feasible, and some governments have committed to providing it.

Transmission from mother to child may also occur after birth through breast-feeding. A randomized clinical trial has shown that bottle-feeding instead of breast-feeding reduces the risk of transmission. Nevertheless, bottle-feeding is not a feasible option in many countries because of lack of access to clean water and cost. Moreover, some women may resist bottle-feeding, even if it were safe, because, unlike in the United States, breast-feeding is the norm in many developing countries and may play an important symbolic role in conveying social status to mothers. In such cultures, failure to breast-feed may indirectly reveal HIV status, which could subject women to risk of physical harm or loss of housing and support, particularly when there is a history of domestic violence. Women need to know about the steps they can take to reduce the risk of HIV transmission to their infants so that they can assess the risks and benefits in light of their own circumstances and make informed decisions.

END-OF-LIFE ISSUES. Early in the U.S. epidemic, before antiretroviral therapy was available, HIV infection often quickly progressed to a terminal illness. In many cases, AIDS patients were unable to make medical decisions for their care as a result of complications from their disease. There was uncertainty, however, as to who should serve as a patient's surrogate decision-maker. In the absence of a written advance directive from the patient, the law and physicians typically look to family members for surrogate decisionmakers. But many homosexual men with AIDS were estranged from their family. These patients often would have preferred to give decision-making authority to committed partners or friends with whom the patient had discussed his wishes. Because the availability of highly active antiretroviral therapy has prolonged survival, end-of-life care in HIV infection has become a less prominent issue in the United States.

In the developing world, where antiretroviral therapy is generally not available, palliative care, which focuses on relief of suffering, is often the only tenable goal. Severe resource constraints may make it difficult to provide palliative measures such as opioids for pain control or dyspnea (difficult breathing). Under these circumstances, care may be limited to psychosocial support and helping patients make plans for such practical issues such as burial or child custody and support.

ACCESS TO HEALTHCARE FOR HIV DISEASE. Access to healthcare for HIV disease remains an important issue both domestically and internationally.

United States. In the United States, the average annual cost of care for an HIV-infected individual is between $10,000 and $15,000 annually. For those in the "advanced stages" of AIDS, the average annual cost of care is $34,000. In delving further into access to healthcare in the United States, it is necessary to discuss two areas: private coverage of HIV infection and coverage of HIV infection by public programs.

HIV-infected individuals may face several difficulties with private healthcare insurance. Most individuals in the United States with healthcare coverage receive it through their employers. Employers and insurers may seek to control the soaring cost of health insurance by limiting coverage for HIV infection. A 1990 federal appeals court case affirmed employers' "freedom to amend or eliminate employee bene-fits" in health insurance and allowed self-insured employers to reduce or eliminate benefits for any particular illness, even if all other medical conditions are covered (McGann v. H & H Music Company, 1991). A 2000 federal appeals court decision concluded that such limits do not violate the Americans with Disabilities Act (Doe v. Mutual of Omaha Insurance Co., 2000). Those who do not receive healthcare coverage through their employers may find it impossible to obtain private coverage for their HIV infection because, if coverage for individual applicants with HIV infection is available at all, it is very expensive or provides limited coverage.

As their disease progresses, previously employed persons cease working and lose their employment-based health insurance. About half of HIV-infected adults and 90 percent of HIV-infected children receiving medical care are covered through publicly funded sources. There are several ways to receive such coverage. First, patients may be insured through Medicaid. To be eligible for Medicaid, patients must either have AIDS or HIV-related disability and meet (low) income eligibility requirements. Second, state AIDS drug assistance programs (ADAP), which are funded through the federal Ryan White Comprehensive AIDS Resources Emergency (CARE) Act of 1990, make HIV medications available to low-income and uninsured persons. Because each state receives different funding and determines eligibility and benefits packages, Medicaid coverage and access to medications vary widely from state to state. In addition, because, unlike Medicaid, the drug assistance programs are not entitlement programs (i.e., programs in which all those who meet the eligibility criteria are entitled to receive the bene-fits), they are funded through annual appropriations, which may vary year to year. Finally, the CARE Act provides funding for HIV/AIDS services that are not covered by Medicaid or state or local government funds. Although the majority of the CARE Act funds are used for medical care (including the ADAP programs), they also provide funding for HIV/AIDS-related support services. These services include counseling, emergency housing assistance, training for clinicians who treat HIV-infected patients, and developing programs to improve treatment. States and other local governments receive CARE Act funds based, in part, on the prevalence of HIV/AIDS in their populations. Because of shifts in the epidemic and the effectiveness of antiretroviral therapies in delaying progression to AIDS, using AIDS cases to allocate funds may not accurately reflect the burden of HIV disease in the population. Reporting of HIV infection can provide essential information to ensure that funds are appropriately distributed to meet the needs of HIV-infected patients.

The shift to Medicaid and other public funding causes several problems. Because of low reimbursement levels, many physicians do not accept Medicaid patients. Thus, patients who lose private insurance may also lose access to care. As a result, emergency departments and public hospitals bear a greater burden of care. In addition, because of large budget deficits, many states and counties are finding it increasingly difficult to pay for such care.

Specific funding that provides for HIV care, but not for other fatal illnesses whose treatments are expensive, such as cancer, raises issues about equitable allocation of resources. AIDS activists exerted considerable political pressure to obtain this funding and to continue the programs supported by it. There are public policy reasons for providing special funding for HIV care. First, HIV is an infectious disease. Providing care and access to antiretroviral medications slows the progress of disease, which may decrease transmissibility and, therefore, help control the spread of the epidemic. In addition, because AIDS patients are categorically eligible for Medicaid and the overall cost of antiretroviral therapy is less than caring for a patient with AIDS, it may be more cost effective for the government to provide antiretroviral therapy to delay progression to AIDS.

Developing world. There have been many efforts to make HIV medications more available to the developing world by pressuring pharmaceutical manufacturers to reduce prices, permitting production of generic versions of effective therapies, and providing funds for drug purchases. Even though the annual cost of antiretroviral therapy has been reduced to between $500 and $1,350 for the developing world, this cost is beyond the means of many developing nations. In 2001 the United Nations secretary general, Kofi Annan, proposed a $7 billion to $10 billion fund to combat AIDS globally, although, as of 2003, funding has fallen well short of this goal. The obligation of developed nations to address the AIDS epidemic in the developing world can be justified on several grounds. First, compassion may motivate developed nations to help alleviate the suffering caused by the AIDS epidemic. Second, to the extent that good health and healthcare are basic human rights, nations who are able are obligated to contribute resources to guarantee these rights. Third, because the wealth (and health) disparities between the developed and developing world are largely a legacy of colonialism, the developed nations have an obligation to address those problems to which they contributed. Finally, it is in the self-interest of developed nations to assist the developing world. If the AIDS epidemic is not controlled in the developing world, the resulting economic and political instability will threaten the security of all nations.

Even if antiretroviral therapy can be made affordable, there are challenges in providing treatment in developing countries that have little healthcare infrastructure. Because failure to adhere to the treatment regimen may lead to drug resistance, it is important to develop treatment protocols that can be implemented effectively using existing infrastructure. Once-a-day regimens are being developed that could facilitate implementation of antiretroviral treatments in the developing world. Also being studied are programs for providing care when intensive laboratory monitoring is not available. To successfully maintain HIV treatment programs in the developing world, host-country personnel must be trained to provide and monitor the treatments.

Clinical Research Issues

Activists and the scope of the HIV epidemic forced society and scientists to reconsider fundamental questions about clinical trials of promising new therapies (Lo, 2000b).

WHAT IS THE GOAL OF THE CLINICAL TRIAL? To most scientists and to the U.S. Food and Drug Administration (FDA), the goal of clinical trials is to determine the safety and effectiveness of new drugs. Historically, clinical research has been considered dangerous for subjects. The HIV epidemic, however, caused many patients to consider clinical trials beneficial rather than risky, because they offer access to promising new treatments, closer medical follow-up, and more sophisticated laboratory monitoring than does standard care.

WHO SHOULD PARTICIPATE IN CLINICAL TRIALS? Historically, women, children, and people of color have been underrepresented in clinical trials. Usually, children are restricted from clinical trials to protect them from the risks of unproven therapies. Unlike adults, children cannot give informed consent. The rationale for excluding women of childbearing age, particularly women who are pregnant, is to protect their developing and future children from possible long-term side effects of unproven drugs. But restricting women and children from clinical trials also harms them. Unless they participate in clinical trials, the effectiveness and safety of therapies cannot be rigorously established. For example, the trials of the effect of zidovudine (also known as azidothymidine, or AZT) on mother-to-child transmission provided important information that has dramatically reduced perinatal HIV transmission. Without the participation of pregnant women in clinical trials, the effectiveness of antiretroviral therapy in preventing mother-to-child transmission of HIV would not be proven. What is more, there would be no evidence basis for enhanced public health measures and increased funding to prevent mother-to-child transmission. Similarly, the increased inclusion of minorities in trials has provided information on the efficacy and adverse effects in these populations. In addition, it is problematic to take away women's decision-making about research participation simply because they are pregnant.

INTERNATIONAL RESEARCH. Because of the great disparities of wealth between the developed and the developing world and a history of exploitation, research conducted in the developing world has been controversial. There are concerns that research that will never benefit the host country is being conducted in developing countries solely because costs are lower and the local ethical requirements are not as onerous as those in the sponsoring nation. Moreover, there are concerns that people will participate in research, regardless of the level of risk, because research participation represents the only opportunity to receive medical care. Nevertheless, unlike research associated with many other conditions, HIV-related research in developing countries typically does not involve privately sponsored trials of new drugs that are unlikely to become available to the host country. Rather, such research generally is publicly funded and designed to assess efficacy of affordable treatment regimens or behavioral interventions. Government involvement and sponsorship may result in research addressing health policy issues that are more salient to the host countries.

Controversy over perinatal trials. Placebo-controlled trials testing interventions to reduce perinatal HIV transmission conducted by U.S. researchers in Africa and Asia sparked extensive debate over research in developing countries. Relying on the World Medical Association's (WMA) Declaration of Helsinki (first adopted in 1964), which stated that "[i]n any medical study, every patient—including those of a control group, if any—should be assured the best proven diagnostic and therapeutic methods" (World Medical Association, 2000), some argued that the placebo-controlled trials were unethical because zidovudine was a proven effective treatment, even though it generally was not available in the countries in which the trials were taking place because of cost, poor health infrastructure, and lack of prenatal care. Others argued that such placebo-controlled trials can be ethically justified because they provide information that responds to local needs. A developing country needs to know whether a simpler, cheaper therapeutic regimen is superior to what is currently available in the country (generally no therapy) rather than whether a simpler, cheaper treatment is comparable to the best proven treatment, which the country cannot afford.

Appropriate comparison group. The controversy over the perinatal HIV transmission trials influenced the larger debate regarding international research, particularly as the WMA revised the Declaration of Helsinki in 2000. After considerable debate about the role of placebo-controlled trials, the final version reads: "[t]he benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic methods exists" (World Medical Association, 2000). There is a growing recognition, however, that it may be ethically permissible to compare an inexpensive, simple regimen to a current practice of no therapy in developing countries when the regimen used in developed countries is not feasible. For example, the WMA issued a clarification after the 2000 revision of the Declaration of Helsinki that "a placebo-controlled trial may be ethically acceptable, even if proven therapy is available … where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method" (World Medical Association, 2001).

In its 2001 report, Ethical and Policy Issues in International Research, the U.S. National Bioethics Advisory Commission (NBAC) concluded that members of any control group should be provided with an established effective treatment, whether or not such treatment is available in the host country. NBAC also declared, however, that a placebo-controlled design may be permissible based on the health needs of the host country, but that such a design requires strong justification.

Post-trial access to treatment. There is general agreement that research in a developing country should not go forward unless there is a realistic chance that its inhabitants will gain access to the treatment after the trial. For example, HIV vaccine trials would be permissible in a developing country only if the vaccine candidate, if successful, would be made available within the host country. There is, however, disagreement regarding how far researchers' obligations extend toward assuring access and to whom the obligation is owed (i.e., trial participants only or others within the community or nation). NBAC points out that researchers are not in control of government policy and funding for clinical care. It therefore would be unfair to hold them responsible for ensuring post-trial access to therapies. NBAC suggests instead that researchers should be obligated only to make good faith efforts to make therapies available after completing a trial. Moreover, the successful results in a well-designed clinical trial may cause resources to become available to provide a new therapy, even though such resources were not available before the trial commenced.

Informed consent. U.S. federal regulations, the Declaration of Helsinki, and other international ethics guidelines all require individual consent for research participation. However, U.S. requirements regarding informed consent may present challenges for research in developing countries. Informed consent is often not the norm for clinical care in many developing nations. People may therefore be uncomfortable or even scared by being asked to provide consent. In addition, most people assume that the doctor is giving them something that is known to work. It may be difficult to overcome this presumption and to get them to appreciate the risks involved in participating in the research. In addition, women may be used to deferring decisions to husbands, fathers, or other family members. In some communities, it may not be possible to approach individuals without the community leader's permission. In such cases, although assent from the authority figure may be needed to approach people regarding the research, voluntary consent must be obtained from individual participants. Finally, in some communities, documentation of consent may be difficult because of illiteracy or because people fear that a signed document may be used against them. In such cases, it may be necessary to seek approval of the institutional review board to modify the documentation of consent to accommodate these local conditions.

Vulnerable participants. Vulnerability is particularly important in the context of HIV-related research. Those infected with HIV may be medically vulnerable from their infection. In addition, homosexuals, injection drug users, minorities, and women, who, for various reasons, may be at higher risk of HIV infection, are more likely to be socially and economically vulnerable because of historical attitudes and discrimination. This may be particularly true in the international setting, and the degree of vulnerability for these groups may vary from country to country. Accordingly, investigators conducting HIV-related research, especially internationally, must pay particular attention to vulnerability and take steps to protect potentially vulnerable research participants.

SPECIAL ISSUES IN HIV VACCINE RESEARCH. HIV vaccine trials present special ethical concerns. First, HIV vaccine trials must go forward with less preclinical evidence of efficacy than other interventions. This is because a good animal model does not exist, HIV is highly variable and undergoes rapid mutation, and there is little information about how to build protection against HIV. Nevertheless, because of the enormous suffering caused by HIV, such trials are ethically appropriate if there are credible scientific reasons to believe the candidate vaccine may be effective.

Second, vaccine trial participants may mistakenly believe that they will receive protection from the vaccine and, therefore, may increase risky behaviors. This issue is a particular concern because, unlike most vaccines, HIV vaccines are unlikely to confer full immunity. While researchers need outcomes (i.e., seroconversions—positive HIV tests in persons who previously tested negative for HIV) to evaluate the efficacy of the vaccine candidate, they also have an obligation to protect research participants. Accordingly, researchers must provide high-quality risk-reduction counseling and emphasize the uncertainty about the effectiveness of the candidate vaccine to all participants, even though, if such counseling were totally effective, the clinical trial would be undermined. To avoid this potential conflict, it may be necessary to have separate staff for the counseling and research aspects of the trial.

Finally, HIV vaccine trials pose unique risks to participants. Participants may be prevented from participating in future vaccine trials, and subsequently developed vaccines may be less effective for them. In addition, because participants may react positively to certain HIV antibody tests, they may be excluded from certain professions and activities, even if their seroconversion does not represent a true infection. Subjects may also face stigmatization from family or friends to whom they disclose information. Mere participation in some trials may identify the subject as someone at high risk of contracting HIV. Because of the high stakes if confidentiality is breached, researchers should take extra steps to protect the confidentiality of the information they collect in HIV vaccine trials.

Conclusion

In summary, the HIV epidemic has raised new ethical and policy dilemmas and has forced reconsideration of established guidelines and policies that apply to a much broader range of issues. In the future, controversies will likely continue to focus on addressing the global impact of HIV/AIDS and what justice requires in healthcare access and research.

bernard lo (1995)

revised by leslie e. wolf

bernard lo

SEE ALSO: Children: Healthcare and Research Issues; Confidentiality; Epidemics; Healthcare Resources, Allocation of; Homosexuality; Human Dignity; Human Rights; Life, Quality of; Public Health; Research Policy; and other AIDS subentries

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Varmus, Harold, and Satcher, David. 1997. "Ethical Complexities of Conducting Research in Developing Countries." New England Journal of Medicine 337(12): 1003–1005.

Wolf, Leslie E., and Lo, Bernard. 1999. "What about the Ethics? [HIV Vaccine Trials]" Western Journal of Medicine 171(5–6): 365–366.

Wolf, Leslie E.; Lo, Bernard; Beckerman, Karen P.; et al. 2001. "When Parents Reject Interventions to Reduce Perinatal Transmission of HIV." Archives of Pediatrics and Adolescent Medicine 155: 927–933.

World Medical Association (WMA). 2000. "Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects." Ferney-Voltaire, France: Author.

World Medical Association (WMA). 2001. "Declaration of Helsinki: Note of Clarification on Placebo-Controlled Trials." Ferney-Voltaire, France: Author.

INTERNET RESOURCES

Global HIV Prevention Working Group. 2002. "Global Mobilization for HIV Prevention: A Blueprint for Action." Available from <http://www.gatesfoundation.org/connectedpostings/hivprevreport_final.pdf>.

Joint United Nations Programme on HIV/AIDS (UNAIDS). 2000. AIDS Epidemic Update, December 2001. Available from <http://www.unaids.org/epidemic_update/report_dec01/index.html>.

Joint United Nations Programme on HIV/AIDS (UNAIDS). 2000. Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document. Available from <http://www.unaids.org/publications/documents/vaccines/>.

Joint United Nations Programme on HIV/AIDS (UNAIDS). 2001. Children and Young People in a World of AIDS. Available from <http://www.unaids.org/youngpeople/index.html>.