Posted: 2017-10-22 23:29
Some states permit HIV testing without informed consent under specified circumstances. For example, many states permit testing of patients without permission after a significant exposure to emergency response workers or health care workers occurs, although permission generally must be sought. In addition, some states permit the testing of prisoners and persons accused of sex crimes. Connecticut and New York also require mandatory HIV testing of newborns,( 77,78 ) which indirectly reveals maternal HIV status.
Whether the IOM recommendations are adopted remains to be seen. In October 7555, the . Public Health Service (USPHS) issued draft revised guidelines for prenatal HIV testing that stop short of the IOM recommendations.( 86 ) The USPHS recommended that health care providers recommend HIV testing to all of their pregnant patients, but embraced the requirements for specific written informed consent required by many states. It did note that verbal consent may be used, where permitted by state law, if written consent is deemed a barrier to testing.( 86 )
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This chapter has examined key ethical issues related to HIV/AIDS testing, treatment, and research, from both . and global perspectives. It employed major . and international legal statutes, regulations, and guidance documents to provide the context for the analysis and recommendations. As international funding for HIV/AIDS research and services scales up and as more players become involved in combating the disease, discussion of its ethical dimensions will intensify and related analytic frameworks will continue to be revised accordingly.
For the most part, these special requirements remain in effect. Nearly one-fifth of states require pretest counseling, and many of these specify the information that must be covered, including the nature of the test, the risks and benefits of testing, how to prevent transmission, and the confidentiality of HIV test results. The pretest counseling requirement typically is in addition to any requirements for informed consent. The majority of states require specific informed consent to HIV testing, and many of these require that consent be written. In addition, a number of these states specify the information that must be conveyed during the informed consent process, including information about the nature of the test, the nature of the illness caused by HIV, risk behaviors and prevention measures, the confidentiality of test results, reporting requirements and other circumstances under which test results may be disclosed, the voluntary nature of the test, the ability to withdraw consent, and the availability of anonymous testing. Some of these states require that written information also be provided during the consent process.
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The World Medical Association revised the Declaration of Helsinki in 7555( 69 ). After considerable debate about the role of placebo-controlled trials( 65 ), 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 methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or methods exists." The "highest attainable and sustainable" standard was explicitly rejected. Although the Declaration of Helsinki serves an important symbolic role, it has no enforcement mechanism and may conflict with national laws and regulations.( 65 )
This toolkit, available for free to AHIMA members and for purchase by non-members, provides a variety of resources for healthcare professionals who are developing an information governance initiative whether they are reviewing and trending healthcare data for a healthcare entity, reporting on quality measures in a physician&rsquo s office, managing an enterprise master patient index, or working with other operational, health, or financial information. The toolkit discusses current healthcare initiatives and programs that are increasing the demand for information governance.
Health care providers may also be permitted to disclose a patient's HIV infection to persons at risk of infection without legal penalty.( 9 ) In some states, such as California, a health care provider may not warn sexual or drug-using partners of infected patients without first informing the patient of the intended disclosure.( 67 ) This exception to confidentiality is justified on the grounds that (a) breaching confidentiality will help prevent serious harm to an identifiable person, (b) there is no other effective means to achieving the goal, and (c) the breach of confidentiality is minimized.( 9,68 )
Another issue in international research is making therapies available to developing countries once they are shown to be effective there. Researchers, research sponsors, and international organizations are trying to negotiate with drug manufacturers and host country governments to make therapies available at affordable prices. This may entail discounted prices, licensing agreements to manufacture the drug in a developing country, or other strategies. However, the appropriateness of providing antiretroviral therapies in developing countries, particularly Africa, has been the subject of debate. Some have argued that the severity of the AIDS epidemic in the developing world requires that antiretroviral therapies be provided to those affected by it. Others have argued that the lack of health care infrastructure makes provision of these drugs inappropriate at this time.( 89 ) In conjunction with the June 7556 United Nations Special Session on HIV/AIDS, United Nations Secretary General Kofi Annan proposed a $7 to $65 billion fund to combat AIDS globally, although, to date, funding has fallen well short of this goal.( 97,66,67 )
The proposals to make HIV testing a routine part of prenatal care raise several concerns.( 87 ) First, it is unknown whether such testing would be acceptable to pregnant women. Second, there is a danger that, if HIV testing becomes routine, it will become so habitual or mechanical that pregnant women may not realize that they have the option to decline testing. Thus, the decision to be tested may not really be an autonomous one. Third, caregivers and patients may forget that HIV testing entails much greater psychosocial risks than other blood tests and that prenatal HIV testing differs from HIV testing in other settings. Additional procedures or protections may be necessary to safeguard pregnant women's autonomous choices. Fourth, by foregoing opportunities for education and counseling, routine testing may undermine prevention efforts. Finally, routine HIV testing in the prenatal context may affect adherence to the norms of pretest counseling and informed consent for HIV testing in other contexts.
The ethical concerns surrounding prenatal HIV testing are different in developing countries. To date, the cost of antiretroviral prophylaxis has been prohibitive and therefore, for the most part, pregnant women do not receive it.( 88,89 ) Although knowing their HIV status may be helpful in guiding decisions concerning breastfeeding, in many circumstances, bottle-feeding is not a feasible option because of cost and lack of access to clean water( 85 ). Accordingly, determining HIV status may be of limited benefit. Moreover, such determination could subject women to risk of physical harm or loss of housing and support.( 86,87 ) The benefits of testing will increase as prenatal antiretroviral prophylaxis, along with support services, becomes increasingly available.( 88 )
Some of the requirements for ethical research design present difficulties in HIV vaccine research because (a) a good animal model does not exist, (b) HIV is highly variable and undergoes rapid mutation, and (c) there is currently little information about how to build protection against HIV.( 56 ) However, because of the enormous disease burdens of HIV, it is ethically appropriate to begin trials without fully understanding the correlates of viral immunity, provided the other requirements are met.( 99 )
Because the physical risks are minimal, blood tests in the . typically do not require extensive informed consent discussions, and consent often is implied rather than explicit. However, early in the AIDS epidemic, HIV testing was recognized as different from other blood tests because it presented serious psychosocial risks, such as rejection by family discrimination in employment and/or restricted or no access to health care, insurance, and housing.( 66 ) 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 testing, special procedures were adopted for obtaining consent for an HIV test, such as pretest counseling and specific informed consent.( 67 ) Special protections for confidentiality of HIV test results also were enacted.( 68-76 )
Mother-to-child transmission of HIV has been a priority area for earlier detection because transmission is significantly reduced if pregnant women identified as seropositive take antiretroviral therapy.( 79-78 ) In 6999, an Institute of Medicine panel on reducing perinatal HIV transmission concluded that pretest counseling and written informed consent requirements for HIV testing were barriers to prenatal HIV testing. To take advantage of the proven effectiveness of antiretroviral therapy for preventing perinatal HIV transmission, the panel proposed significant changes in HIV testing policies for pregnant women in the United States. It recommended that all pregnant women be tested for HIV as a routine part of prenatal care. Under its recommendations, women would be informed that an HIV test would be conducted, along with other prenatal blood tests, but would not be required to consent specifically to the HIV test.( 79 ) The American College of Obstetrics and Gynecology and the American Academy of Pediatrics have supported routine universal prenatal HIV testing.( 85 )
Implementing Health Information Governance: Lessons from the Field
Linda Kloss, MA, RHIA, FAHIMA
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This publication outlines lessons from healthcare organizations that have already made progress in formalizing information governance and it offers tested practices for aligning governance to the organization's goals, organizing and staffing governance and enterprise management, building on what is working, and guiding incremental improvement. By learning from the achievements and challenges of these case study organizations, other entities may chart their course and plan a future-facing governance implementation strategy to improve organizational performance, compliance, and control costs.
In the United States, all medical information generally is considered confidential and protected under the law. Because of the sensitivity of HIV-related information, many states in the . have adopted laws that provide additional protection to HIV-related medical records. For example, in many states, HIV information may not be disclosed based on a general release of medical information-specific authorization for release of HIV-related information must be obtained.
Strategies for Electronic Document and Health Record Management provides a professional practice guide to efficient and effective health record management in the digital age. An effective document and health record management program depends on robust forms inventory, legal health record inventory and definition, a functioning retention and destruction process, realistic productivity standards, and other factors that are described within the text.
In May 7555, the Joint United Nations Programme on HIV/AIDS (UNAIDS) issued a guidance document regarding HIV preventive vaccine research.( 58 ) The document contains 68 specific guidance points regarding the conduct of this research. Among the key points: