6 курс / Кардиология / Kartikeyan_HIV and AIDS-Basic Elements and Properties
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23.5.1 – Family Life Education and the Law
Lack of family life education and ignorance about sexual matters, even among educated individuals, is another factor that contributes to the spread of HIV infection. Family life education is known by various names, such as “sexuality education”, or “family life skills” or “reproductive health education” or “responsible parenthood education” in some countries (WHO, 1985). Family life education helps in knowing one’s body, structure and function of reproductive system, changes during adolescence, sex and sexuality, factors causing marital harmony and disharmony, sexual health problems, and STIs. Family life education is compulsory in schools in China, Scandinavian countries, Germany, Czech Republic, and the Philippines. It is an elective subject in some states of the United States. It is legally prohibited in Saudi Arabia, Iran, Argentina, and Chad. In the United Kingdom and Holland, there is no legislation but family life education is a component of school education (WHO, 1985).
23.5.2 – Age of Consent to Treatment
Laws in some countries stipulate that prior consent of parents/guardians must be obtained before adolescents/minors receive health care. An individual ought to have sufficient experience and intelligence to meet the basic requirements of consent. However, laws set an arbitrary age (usually 18 or 21 years) as age of attaining adulthood as if all individuals magically develop maturity on their 18th or 21st birthday. The minimum age of consent varies from country to country, depending on gender of the individual and purpose of the consent. The minimum age of consent varies for marriage, criminal responsibility, voting rights, military service, consent to sexual intercourse, and consent to health care (WHO, 1985).
In the United States, the Joint Commission of Institute of Judicial Administration and American Bar Association has recommended that parental consent should be waived when “the social utility of medical care outweighs the negative impact of not taking parental consent” (Joint Commission, 1979).
Some nations follow the emancipated minor rule, which upholds that adolescents who are nearing the age of majority and who are independent in lifestyle and finance should be able to give consent to health care. This rule recognises the fact that older adolescents have sufficient experience and intelligence to meet the basic requirements of consent. In some countries, minors do not require parental consent for treatment of STIs and drug abuse, contraceptive services, and health care in pregnancy (WHO, 1985). According to the Kenyan National VCT Guidelines issued in 2001, “mature minors” do not need parental consent. Mature minors include those individuals younger than 18 years who are “married, pregnant, parents, engaged in behaviour that puts them at risk, or are child sex workers”. Although the HIV test results are to be disclosed only
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to the client, the Kenyan guidelines say that counsellors should encourage those younger than 18 years to inform their parents about the results (NASCOP, 2001).
23.6 – CONFIDENTIALITY
Keeping client-related information confidential is a legal and ethical obligation. Besides health care professionals, this duty also pertains to professions such as psychotherapy, psychiatry, legal practice, and social work. The individual’s “right to privacy” enforces the ethical duty of confidentiality (UNAIDS/WHO, 2000). Professional codes of conduct need to be drafted and enforced to penalise breaches in confidentiality and informed consent. In view of the HIV epidemic, an increasing number of countries have enacted laws that prevent health care personnel from disclosing patient-related information acquired in the course of their duties (Magnusson, 1994). Health care providers have a legal obligation to take all reasonable steps to prevent disclosure of HIV-related information (Magnusson et al., 1997).
It is absolutely essential to protect HIV-related information because an epidemic of discrimination and social stigma has accompanied the HIV epidemic. Since HIV status is a sensitive issue, health care providers should be careful in protecting HIV-related information. In the context of HIV infection, “confidentiality” also includes the expectation of an HIV-infected person that his or her status will not be disclosed without his or her consent (UNAIDS/WHO, 2000).
Unless an individual is hospitalised, request forms for HIV test should not contain information that can identify the individual. It is recommended that HIV test request forms use a four-letter name code constructed from the first two letters of surname, followed by the first two letters of first name. The same name code should be used on pathology forms. In countries where notification to public health authorities is compulsory, anonymous codified notification is used (Magnusson et al., 1997).
Extending VCT services to urban slum dwellers, rural populations, and socially marginalised groups such as homosexuals, hijras, and prison inmates, will enable clients learn about their HIV status and receive support, if necessary (NACO, Training Manual for Doctors).
23.6.1 – Justification for Confidentiality
●Respecting confidentiality protects the privacy of clients/patients and breach of confidentiality can result in discrimination, harassment, and vilification (Magnusson et al., 1997).
●A client, who is convinced of confidentiality, is more likely to confide personal information. Public health interventions are effective only if they are based on good provider–client relationship.
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●On the other hand, if patients fear breach of confidentiality, they are unlikely to come forward for HIV testing, counselling, and HIV-related services. Studies reveal that assurance of privacy encourages voluntary HIV testing (Fehrs et al., 1988; Hirano et al., 1994).
23.6.2 – Breach of Confidentiality
The principle of confidentiality is not absolute and may be breached if
1.There is a need for sharing information or discussion among health care providers for care, treatment, and counselling of the client/patient. The details should remain confidential and restricted to that group only (UNAIDS/ WHO, 2000; Chapman, 1997).
2.Disclosure to public health authorities is permitted if a patient places “health of the public at risk” through irresponsible behaviour (Fehrs et al., 1988). Such legal provisions may vary from state to state within the same country, but they do not clarify whether a patient’s spouse or sexual partner falls within the definition of “the public” (Chapman, 1997).
3.A Court of Law orders such information to be disclosed (Chapman, 1997).
4.As per directives of the Supreme Court of India, all HIV-infected individuals need to be encouraged to disclose their HIV status to their spouse/sexual partners. This is to be done only after counselling of spouse/sexual partners. Partner counselling has been included as a component of India’s National HIV Policy (NACO, Training Manual for Doctors).
5.Disclosure to spouse/sexual partner is permitted in many countries if failure to disclose HIV status may harm an innocent third party (Chapman, 1997). In such situations, ethical principle of “confidentiality” may be in conflict with the ethical principle to “do no harm”. It is necessary to weigh the potential harm and benefits to the parties involved, before opting for the future plan of action (UNAIDS/WHO, 2000).
23.6.3 – Consequences of Breach of Confidentiality
Except in the circumstances mentioned above, disclosure of a client’s HIV status without his or her consent is hazardous and is fraught with social and legal consequences, which may ultimately jeopardise health-related activities.
Social Consequences: These include social ostracism and rejection. Female clients have very valid reasons such as physical violence, harassment, or abandonment, for fearing to disclose their HIV status to their husbands/partners (United Nations, 1998; Gielen et al., 1997)
Legal Consequences: In countries where privacy is protected by law, a person can sue a health care provider who has disclosed his or her HIV status. The legal aspects are complicated since laws pertaining to HIV-related information and HIV medicine may differ from state to state within the same country (Fehrs
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et al., 1988). In some countries, migrant workers may face termination of employment and deportation if their HIV-positive status is revealed.
Effect on other Health-Related Activities: Besides HIV-related activities, registration for antenatal care and blood donation would also be hindered because individuals would be afraid of getting tested if they fear that the results will be disclosed against their will (UNAIDS/WHO, 2000).
23.6.4 – Problems
Modern medical management uses a team approach that requires rapid transfer of patient-related information between members of a team (doctors, nurses, psychologists, and physiotherapists). Patient records are centralised and widely available. This amplifies the risk of breach of confidentiality. There are numerous glaring examples of disclosure of sensitive patient-related information to persons not involved in patient care (Magnusson, 1994). It is the counsellor’s duty to conceal the identity of the client, and to ensure support, to prevent family disruption, violence, and desertion by spouse (WHO/UNAIDS, 1999). Some organisations have created separate systems for HIV-related records with protocols for access, while others keep separate HIV-related records that are never filed in the centralised hospital record. Ultimately, it is self-discipline on part of health care providers that will protect the privacy of patients (Magnusson et al., 1997).
23.7 – INFORMED CONSENT
Health care providers must obtain informed consent before subjecting an individual to HIV testing, or disclosing HIV status to others (see exceptions), or initiating health care interventions. In most countries, the law views medical treatment as an interference with the patient’s body. Informed consent must be obtained from a mentally competent patient, over a certain age (varies from country to country), before any treatment is administered. A provider, who fails to do so, may be liable for charges of assault (van Reyk, 1997). Obtaining informed consent is not obligatory only under exceptional circumstances
(a)When the law provides for mandatory testing, as in some countries (UNAIDS/ WHO, 2000)
(b)When testing donors of blood, organs, tissues, semen for artificial insemination, and ova for in vitro fertilisation (Joint Commission, 1979; NACO, Training Manual for Doctors)
(c)During anonymous unlinked testing of blood samples for epidemiological purposes (van Reyk, 1997).
23.7.1 – Beneficial disclosure
This is the disclosure about a client’s HIV status, with the informed consent of the client (UNAIDS/WHO, 2000). It is voluntary in nature, and respects the
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autonomy and dignity of the affected individual, and maintains confidentiality. The merits of beneficial disclosure are discussed below:
(a)Helps affected individual, spouse/sexual partner, and family
(b)Promotes greater openness in the community about HIV
(c)Meets ethical obligations to prevent onward transmission of HIV infection
(d)An increase in number of people, who are willing to disclose their HIV status, will lead to an increase in the “critical mass” of people who are openly involved in combating the epidemic and will diminish discrimination, stigma, and secrecy
(e)Protects those not yet infected and provide more care and support for those who are already infected (UNAIDS/WHO, 2000).
23.8 – HIV TESTING AND REPORTING
Counselling is essential before and after HIV testing. It would be unethical to test an individual’s HIV status and leave him or her in the lurch by not providing any advice (Vas & de Souza, 1991). If reporting of HIV infection to public health authorities is essential for epidemiological purposes, confidentiality should be scrupulously maintained. Otherwise, individuals may refuse HIV testing for fear of disclosure. Some countries have recently considered whether they should implement a policy of “named HIV case reporting”. Under such a policy, health care providers would be required to report by name, all HIV cases diagnosed by them, to a health authority (UNAIDS/WHO, 2000). Other forms of case reporting include:
(a)Sending reports without patient-identification information
(b)Using a code, also called “unique identifier”, for each patient (UNAIDS/WHO, 2000)
Neither the policy of reporting of HIV-infected persons, nor that of reporting AIDS cases, has been useful in low-income countries, largely because less than 10 per cent of HIV-positive persons have been tested for HIV. Thus, most people are unaware of their HIV status. Many people are reluctant to get tested for HIV due to social stigma, discrimination, and lack of access to services including ARV therapy, if they test positive. In countries where “named case reporting” is adopted, health care providers are required to report cases by name. This may lead to breach of confidentiality and privacy. There is also a problem of underdiagnosis and under-reporting. Where “unnamed case reporting” (also called “anonymous case reporting”) is employed, multiple reporting of the same cases is a problem. This is because HIV-infected individuals tend to disbelieve their HIV test report and may get the HIV test repeated at different laboratories hoping for a negative test result. Resource-poor countries lack sufficient capacity or infrastructure for maintaining confidentiality. Case reporting requires expensive infrastructure and trained manpower. By itself, case reporting does not necessarily improve access to supportive services, nor does it lead to any additional benefit for either the client or the community. It may divert
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resources from more cost-effective strategies such as public information campaigns, VCT, and education of youth (UNAIDS/WHO, 2000).
23.9 – ISSUES PERTAINING TO TREATMENT
The physician’s primary responsibility is to treat the patient without discrimination if the condition is within the physician’s current domain of competence. All human experimentation (related to clinical trials of drugs or vaccines) should strictly follow guidelines laid down in the Declaration of Helsinki (WMA, 1964). The motto to be followed is primum non nocere (Latin: “first, do no harm”). Respect for confidentiality, privacy, human rights, and dignity is essential (Vas & de Souza, 1991). Ethically and legally, each patient has a right to be treated with all available resources till his or her death. But, the best available palliative care may not provide pain relief for some patients. Some may decide to forego palliative care in hospitals and prefer care by family members (van Reyk, 1997).
23.10 – ISSUES PERTAINING TO DYING
Health care providers may come across patients in terminal stages of AIDS who may harbour thoughts about their impending death. Some may accept reality and want to talk about it, while others may deny that they are dying. Health care providers ought to strive to create an environment in which issues pertaining to death can be freely discussed (van Reyk, 1997). Desire to talk about death may be caused by depression (which should be diagnosed and treated by a specialist), concern about becoming a burden to family members, feeling of guilt, and dissatisfaction with the care received (van Reyk, 1997).
Euthanasia (Greek: eu = good; thanatos = death) refers to voluntary euthanasia in which, a doctor or other person acts directly to end a suffering person’s life when the person specifically requests death (van Reyk, 1997). In most countries of the world including India, euthanasia is illegal. In PAS, a doctor provides the means and information necessary for a person to commit suicide (van Reyk, 1997). The attitude of psychiatrists to PAS and euthanasia also seems baffling. Although a significant number of psychiatrists endorsed their support for PAS, only a small minority of them were willing to get involved in assessing patients requesting for PAS (Ranjan et al., 2005). The legal status in several countries is given below:
Australia: In some states of Australia, laws stipulate conditions under which a health provider can agree to a patient’s request to stop or withhold “futile treatments” (van Reyk, 1997). In Northern Territory, euthanasia is legal under specified circumstances (van Reyk, 1997). As per Australian law, it is not a crime to attempt or to commit suicide. But inciting or counselling someone to commit suicide is a crime. Australian law does not specify as to what constitutes “inciting” or “counselling” (van Reyk, 1997).
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Switzerland: Assisted suicide has been legal since the 1940s. In December 2005, a hospital allowed assisted suicide rather than at the home of the terminally ill patient (DNA, 2006).
Netherlands: The Dutch were the first in the world to legalise both PAS and physician-unassisted euthanasia. In the Netherlands, both are approved for mentally ill patients and Dutch law does not make psychiatric assessment mandatory (DNA, 2006). As per Dutch law, the concerned patient is sent for psychiatric assessment only if the treating physician feels that the patient may be psychiatrically ill (Kissane & Kelly, 2000). Terminally ill patients who may request for PAS may also be suffering from depressed mental status, where one’s judgment can be severely impaired. Many terminally ill patients have withdrawn their request for PAS after successful treatment of their mental depression (Kelly & McLoughlin, 2002). Dutch guidelines for termination of life of mentally ill patients require an opinion from an independent psychiatrist about the incurable nature of the illness from a prognostic point of view. With the current state of medical knowledge, no one can truly claim the curability of severe mental illnesses. Currently available medications can bring about drastic improvements to the point of sustained remission. But, curability remains a distant dream (Ranjan et al., 2005).
Belgium: Belgians followed the Dutch and passed assisted dying laws (DNA, 2006).
United States: In January 2006, the US Supreme Court upheld State of Oregon’s 8-year-old Death with Dignity Act by a 6–3 vote. Under Oregon law, a doctor can prescribe a lethal dose of medication to a terminally ill patient of sound mind, who makes the request in writing in the presence of witnesses. The written request is to be repeated at least 2 weeks later. The patient has to meet a few other requirements. The patient must swallow the prescribed lethal medication and it cannot be administered by anyone. The “right to die” issue became a topic of household debate when repeated Court rulings permitted the husband of Terri Schiavo (a terminally ill Florida woman) to order the removal of her feeding tube that had kept her alive for 15 years. Most Americans disapproved of the measures taken by the US Federal Government to defy the repeated Court rulings (DNA, 2006).
23.11 – HIV AND MARRIAGE
Maintaining confidentiality is essential to any public health strategy. However, the law has recognised exception to the rule of confidentiality when public interest outweighs private or personal interest. The Supreme Court of India (8 SCC 296 of 1998) upheld the action of a physician who informed the status of a HIV seropositive prospective groom to a would-be bride, when the groom moved the Court for breach of confidentiality (Kumar, 1998; Muthuswamy, 2005). The
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Supreme Court of India also ruled that an HIV-positive man who marries and transmits the infection to the spouse would be criminally liable under Sections 269 and 270 of the Indian Penal Code – these sections pertain to negligent or malignant acts, likely to spread a disease dangerous to life. However, the Court did not lay down any protocol by which, such a disclosure was to be made. Human rights activists in India opine that the Court’s ruling has overlooked situations where HIV-infected or HIV-discordant couples wish to marry each other with the knowledge of each other’s HIV status (Shreedhar, 2002). In certain situations, such as those related to employment or insurance, privacy should be maintained. However, in the absence of anti-discriminatory legislation in most countries, discriminatory practices continue (Muthuswamy, 2005).
23.12 – ETHICAL ISSUES IN HIV/AIDS RESEARCH
23.12.1 – Background Information
In June 1964, the World Medical Association adopted the “Declaration on human experimentation” at Helsinki (Finland). This came to be known as the “Declaration of Helsinki” (WMA, 1964). The expansion of HIV/AIDS research into other developing countries has increased the awareness regarding adapting ethical standards created in the developed countries to resource-poor settings of the developing countries. The issues pertaining to standard of care and use of placebo in control arm of the trial have dominated debates on clinical trials in developing countries.
In the developed countries, any clinical trial of a new ARV drug requires the standard ARV drug in the control arm. However, when a drug trial is conducted in the resource-poor countries, a placebo is used instead of the standard ARV drug in the control arm. Apparently, placebo is used because no treatment is the norm in the resource-poor countries either because standard drugs are not available or because they are too expensive. Further, clinical trials in the resourcepoor countries were designed to use lower dosage or reduced duration of treatment to suit affordability or feasibility factor. In 1997, Marcia Angell’s article in Lancet questioned the perinatal transmission studies (to prevent MTCT of HIV infection) being conducted in Africa with US collaboration (Angell, 1997). This article generated heated debates that ultimately resulted in revision of the Declaration of Helsinki in 2000.
In October 2000, the 32nd Assembly of the World Medical Association at Edinburgh (Scotland) came up with a revised declaration titled “Ethical Principles for Medical Research involving Human Subjects” (WMA, 2000). The revised declaration stipulated that all trials should aim for achieving the highest attainable standards with no placebo in the control arm, if a standard treatment was available. This declaration became instantly controversial because of sensitivities involved in HIV/AIDS research and because ground realities in developing countries cannot allow adherence to these guidelines. These debates led to development of guidelines by National Bioethics Advisory Council (USA), Nuffield Council
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(UK), and the European Union. India, the Philippines, and South Africa have devised their own guidelines to suit local requirements (Muthuswamy, 2005). These multiple guidelines indicate the dilemma faced by researchers in the developed world while collaborating with developing countries on various research programmes. The world has still not reached a consensus on this issue.
The HIV Preventive Trial Network (HPTN) Ethics guidance document prepared by HPTN Ethics Working Group of Family Health International, North Carolina, USA emphasises
(a)Protection of vulnerable groups from exploitation
(b)Non-discriminatory access to benefits of research
(c)Minimisation of research-related harms (medical, psychological, social, and economic)
(d)Improvement of local access to care and capacity building for that care so that accessibility can be sustained once the research ends (FHI, 2003)
In India, almost all ARV drugs are available in the market, but they are not provided by the public health system. In 2004, NACO announced that ARV drugs will be provided free of cost to all women who participated in prevention of MTCT studies. Use of standard ARV treatment in the control arm in a trial situation creates a dilemma. Even if the ARV drugs are provided by sponsors during the trial period, it is not known whether it will be sustained after the trial period is over (Muthuswamy, 2005).
23.12.2 – Ethical Issues in Experimental Studies
Collaborative studies could give the impression of experimentation on the population of resource-poor countries by a developed country and could invite allegations of exploitation. Debates on this issue led to the revised Helsinki declaration of 2000, but the issue is still unresolved (Muthuswamy, 2005). International collaborations need to consider
1.Needs of the host country and strategies for capacity building in host countries so that they function as equal partners with the sponsors.
2.Involving the host countries in design, implementation and monitoring of trials.
3.Distributing benefits including disseminating research findings.
4.Protecting dignity, safety, and welfare of participants in trials.
5.Respecting laws, guidelines, rules and regulations of both the host and sponsoring countries; this includes laws related to intellectual property rights, exchange of biological materials, data transfer, and protection of confidentiality (ICMR, 2000; Muthuswamy, 2005).
23.12.3 – Ethical Issues in Epidemiological Studies
●Extent of community consultation – when, where and whom to consult
●Informed consent – individual consent is to be insisted upon, in addition to consent of community leaders, tribal chiefs, or “gate-keepers”
●Privacy and confidentiality of all collected data
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●Disclosure to third parties, including partner notification
●Prevention of stigma and discrimination at all levels
●Screening high-risk groups in addition to the general population
●Screening persons with diminished autonomy – individual consent is to be taken, where possible, in addition to consent of the legal guardians (Muthuswamy, 2005).
23.12.4 – Ethical Issues Related to Behavioural Studies
Although no specific cure or preventive vaccine is available as yet, it is generally agreed that behavioural changes may alter the rate of transmission of HIV/AIDS. These behavioural changes include risk reduction measures such as condom use and single sexual partner at individual level, and promotion of social norms at community level. The ethical requirements for biomedical research also apply to behavioural studies. Mobilisation of community and mass media may help behavioural researchers in tackling psychosocial issues such as stigma and discrimination that participants may face. Participants in some behavioural studies may face legal risks in some countries. For example, MSM are liable to face criminal charges under Section 377 of the Indian Penal Code.
23.12.5 – Ethical Sssues Related to Clinical Trials on Antiretroviral Drugs
These include approval from Institutional Ethics Committee (or Institutional Review Board), clearance from regulatory bodies, informed consent and partner notification, protection of vulnerable populations, tackling discordant couples, and sustained availability of successful products.
23.12.6 – Ethical Issues Related to Clinical Trials on HIV Vaccine
In May 2000, UNAIDS released a guidance document which outlined the strategies to be adopted for capacity building, community involvement, protection of vulnerable population, inclusion of women and children with adequate safeguards, informed consent, justice and equity in selection of subjects for the clinical trials, use of placebo or any other vaccine in the control arm, continued counselling for risk reduction, and monitoring mechanisms, care and support for HIV-infection or any associated complication that may occur during the course of the trial (UNAIDS, 2000).
Continued Counselling for Risk Reduction: There is a possibility that participants in clinical trials of HIV vaccines might abandon safer sexual practices and indulge in risky behaviour due to a false sense of security. Subsequently, if the vaccine is proved to be ineffective, this may lead to increased transmission of HIV. Hence, risk reduction measures include: (a) continued counselling programme on safer sexual practices; (b) condom promotion; (c) control of RTIs and STIs;