See All Customer Reviews. Shop Books. Add to Wishlist. USD Sign in to Purchase Instantly. The issues discussed in this work reflect issues that arose on a recurring basis with clients participating in HIV research studies, with investigators calling for guidance on the legal implications of particular aspects of their proposed studies, and with research institutions and health care facilities struggling to make sense of legal maneuvers aimed at obtaining the records of their HIV-infected patients.
It is impossible to thank each of these persons individually for their provocative questions and their insights. The discussion of ethical and legal issues relating to the design of clinical trials reflects questions raised during discussions with Donald J. Slymen, Ph. Sometimes, however, a physician must determine whether his duty to society requires him to employ knowledge, obtained through confidence as a physician, to protect a healthy person against a communicable disease to which he is about to be exposed.
In such instance, the physician should act as he would wish another to act toward one of his own family in like circumstances.
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The only exception to this general principle is when the doctor judges that the failure to disclose would put the health of any member of the health care team at serious risk. A similar principle applies to the sharing of confidential information between specialists or with other health care professionals such as nurses, laboratory technicians and dentists.
This view has been accepted by Supreme Court of India in Mr.
X v Hospital Z. It is imperative that the doctor must discuss with the patient the question of informing a spouse or other sexual partner when a patient is found to be HIV positive or is diagnosed with AIDS. If the patient refuses to give consent for such disclosure, the doctor may consider informing the partner in order to safeguard such persons from infection. Kirpal, 6 the petitioner was employed as a senior officer in the health service of a North Eastern State. While in service, he was asked by his government to accompany a patient to Apollo Hospital, Chennai.
As the patient required blood, the petitioner volunteered to donate blood but it was found that he was HIV positive. Besides informing the petitioner, the hospital revealed the information to the patient. As a result, the petitioner was put to mental trauma and stress. The petitioner moved the National Consumer Disputes Redressal Commission and claimed damages from Apollo Hospitals for breach of privacy. His contention was that the hospital had every right to reject his blood but it should not have revealed to the patient the identity of a possible donor who was HIV positive.
The Commission dismissed his case and he moved the Apex court. The Division Bench dismissed his appeal, holding that the right of privacy — an essential component of the right to life under Article 21 of the Constitution — is not treated as absolute and is subject to such action as may be lawfully taken for the prevention of crime or disorder or protection of health or morals or protection of rights and freedom of others. Finally, a doctor may wish to disclose a diagnosis to a third party other than a health-care professional. The question that remains unresolved in this case is whether it is ethical of hospitals to reveal identities of blood donors who are HIV positive to third parties and in the present case the patient.
This impulse, being the notorious human failing if not disciplined, can afflict and overtake anyone how high so ever or for that matter, how low he may be in the social strata. When patients have undergone tests for HIV, their doctors must maintain separate records to prevent test results from being inadvertently disclosed with other records. They can be guided by existing regulations for medical termination of pregnancy concerning the custody of consent forms and maintenance of admission registers. Justice Cardozo offered what has become perhaps the best-known statement on the principle of informed consent in the New York case of Schloendorff v New York Hospital.
Consent may be express or implied. Express consent is an oral or written authority by the patient to render the proposed treatment. In HIV testing, written consent should be obtained. Both criminal and civil law, in particular laws relating to battery and negligence, are relevant to the legality of testing. The testing should only be performed on clinical grounds.
Pre-test counselling is essential prior to HIV antibody testing. These steps are essential because of the serious social and financial consequences the patient may face for the mere fact of having been tested for HIV. Post-test counselling should be done when the test results become available.
Ethics and Research - Pacific AIDS Network
When the test result is positive, the person should be informed of the physical complications caused by HIV, possible treatments, and measures to avoid transmitting the infection to others. Adequate psychiatric counselling and other supportive measures should also be provided. People who are HIV negative should be educated on high-risk behaviour and on preventive measures. A particular difficulty arises when a child must be tested for HIV infection.
Consent of a parent or guardian is normally sought.
In such a situation, the doctor should see if the child is competent to give consent, and if so, obtain consent from the child. Otherwise, the doctor should decide whether the interest of the child should override the wishes of the parent. It is not unethical if a doctor performs such a test without parental consent provided always that the doctor is able to justify that the action was in the best interests of the patient.
The obligation of the State to ensure the creation and the sustaining of conditions congenial to good health is cast by the Constitutional directives contained in Articles 38, 39 e f , 42, 47 and 48 A in Part IV of the Constitution of India. The Preamble and Article 38 of the Constitution of India envision the duty of the state to ensure that life is meaningful and liveable with human dignity.
The State has to direct its policy towards securing that the health and strength of workers, men and women, and that the tender age of children are not abused; that citizens are not forced by economic necessity to enter avocations unsuited to their age or strength Article 39 e ; that children are given opportunities and facilities to develop in a healthy manner and in conditions of freedom and dignity, and that childhood and youth are protected against exploitation and against moral and material abandonment Article 39 f.
The State is required to make provisions for just and humane conditions of work and for maternity benefits. Article It is the primary duty of the State to endeavour the raising of the level of nutrition and standard of living of its people and improvement of public health, and to bring about prohibition of the consumption, except for medicinal purposes, of intoxicating drinks and of drugs, which are injurious to health.
Article 47 Protection and improvement of the environment is also made one of the cardinal duties of the State. Article 48 A 10 Abichandani at Article 25 1 of the Universal Declaration of Human Rights guarantees the right to a standard of living adequate for health and well-being. The Supreme Court of India in Mr. They have to have their avocation and government jobs or service cannot be denied to them.
Attending to public health in our opinion, therefore, is of high priority — perhaps the one at the top. In a welfare state, the primary duty of the Government is to secure the welfare of the people. Providing adequate medical facilities for the people is an essential part of the obligations undertaken by the Government in a welfare State.
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The Government discharges this obligation by running hospitals and health centres, which provide medical care to the person seeking to avail those facilities. Article 21 imposes an obligation on the State to safeguard the right to life of every person. Preservation of human life is thus of paramount importance. The Government hospitals run by the State and the Medical Officers employed therein are duty bound to extend medical assistance for preserving human life. Failure on the part of a government hospital to provide timely medical treatment to a person in need of such treatment results in violation of his right to life guaranteed under Article Considerable public anxiety has been aroused by suggestions that HIV positive health workers may endanger their patients.
The risk is very small; to date there is only one known case in the world of HIV having been transmitted by a health care worker to patients, in the course of dental treatment.
Federal regulations governing informed consent in research carry special requirements that must be followed for inclusion of these people in vaccine clinical trials. The UNAIDS ethics guidelines recommend that any HIV vaccine demonstrated to be safe and effective should be made available as soon as possible to all research trial participants, as well as other populations at high risk of HIV infection, and that plans at the initial stages of HIV vaccine development ensure the availability of benefits.
Finally, a practical challenge that relates to ethical issues in AIDS vaccine trials abroad is the limited research regulatory framework in some countries. At a recent conference in Cape Town, South Africa, participants from African countries discussed the difficulties they face in creating rigorous ethical review processes, including the lack of research regulation, unavoidable conflicts of interest among the small number of people with skills to be members of research ethics committees, and the lack of opportunities for formal academic training in research ethics.
Some have urged the establishment of strong regional and national regulatory bodies to respond to these challenges. Many of the legal concerns that apply to HIV vaccine trials, and that likely would apply to an approved vaccine, relate to stigma and discrimination against people who are presumed to be infected or are assumed to be at a higher risk for infection because of their participation in vaccine trials. Many countries, including the United States, have legislation that protects people who are HIV infected against discrimination.
Current ethical issues in HIV/AIDS research and HIV/AIDS care
But what of a person thought to be infected because of a positive test only due to the vaccine? Interpretations of a western blot test—the confirmatory test for HIV—can be read as positive for a person whose vaccine produces antibodies. Under U. However, conflict between agency interpretation of the ADA and the U.
Additional concerns relate to the fact that vaccine volunteers may be considered at higher risk for HIV infection merely because of their participation in a vaccine trial. Disability law does not extend to discrimination solely based on trial participation. Additional legal issues relate to the requirement to provide medical care and other benefits to volunteers in vaccine trials who have adverse reactions to the vaccine. Although the legal requirement is far from firm, these volunteers should be entitled to state of the art medical care for the reaction.