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L10 public health_ethics

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  • 1. 1 Public Health Ethics Prof. Yigzaw Kebede

2. 2 Objectives of the course At the end of the course students will be able to: Understand the definition of ethics Understand the principles of ethics Appreciate ethical controversies in health care, public health, and research design consent forms 3. 3 Definition Ethics is the branch of philosophy that deals with distinctions between right and wrong-with the moral consequences of human actions. Morality: refers to norms about right and wrong human conduct that are so widely shared that they form a stable social consensus 4. Definition cont.. There is a clear relationship between ethics and law. Ethics is a branch of philosophy that deals with moral principles law is the whole system of rules that every citizen of the country must obey. Ethics requires legal backing, and law plays an important role in enforcing the implementation of ethics. A breach of ethics is considered a legal offence. 4 5. 5 Historical Perspectives Nazi War Crimes and the Nuremberg Code Prior to and during the World War II (1940s), Nazi physicians and scientists conducted experiments on concentration camp prisoners without their consent Many of these experiments involved exposing subjects to extreme suffering for observational purposes such as: To determine the time to death for individuals submerged in freezing water To determine the ability of subjects to withstand high altitude conditions by forcing them into low-pressure chambers 6. 6 Historical Perspectives cont Other experiments Deliberately inflicting wounds or burns; Infecting subjects; Poisoning them; in order to test various treatments or to perform autopsies afterwards. 7. 7 Historical Perspectives cont During the Nuremberg Military Tribunals at the end of World War II, the scientists who conducted these experiments were held accountable for their actions, and many issues in research ethics received public scrutiny. 8. 8 Historical Perspectives cont The Nuremberg Code (1947) The 10 principles outlined in Nuremberg Code were among the 1st rules for experimentation involving human subjects The first and most famous principle from this historic code states the voluntary consent of the human subject is absolutely essential 9. 9 Historical Perspectives cont The Tuskegee Syphilis Study In 1932 the U.S Public Health Service (PHS) began a study of the natural course of untreated syphilis among rural black males in Macon Country, Alabama About 400 men with syphilis and 200 uninfected controls were enrolled in the study Informed consent was not obtained from study participants 10. 10 Historical Perspectives cont They were not told about the studys objective Study procedures such as spinal taps were represented as free treatment Burial stipends motivated family members to allow autopsies on participants who reached the studys endpoint 11. 11 Historical Perspectives cont When penicillin became widely available by 1947 as a standard cure for syphilis, treatment was denied to these subjects The PHS actively sought to prevent study subjects from obtaining treatment and information from other sources 12. 12 Historical Perspectives cont This study was halted in 1972 when national press reports prompted public outrage This was the longest non-therapeutic experiment on human beings in medical history By the time the study was stopped dozens of the participants had died of syphilis Many of their wives had been infected Many of their children had been born with congenital syphilis 13. 13 Historical Perspectives cont The study has come to symbolize racism in medicine and science, ethical misconduct in research, and governmental exploitation of the vulnerable The history of this study in the U.S has contributed to persistent mistrust of public health authorities today, particularly among racial and ethnic minority groups President Clinton formally apologized for the studys injustices on behalf of the U.S government in 1997. 14. Historical Perspectives cont The Belmont Report In 1972, the public became aware of the Tuskegee study As a result, in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established. In 1978, the commission submitted its report titled, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 14 15. Historical Perspectives cont The report sets forth the fundamental ethical principles underlying the acceptable conduct of research involving human participants. These principles are: respect for persons beneficence and justice 15 16. 16 Historical Perspectives cont The declaration of Helsinki (1964) was adopted by the World Medical Association in 1964 to guide application of the ethical principles for clinical research 17. 17 Historical Perspectives cont Other international guidelines A) International Guidelines for Biomedical Research Involving Human Subjects Published in 1982 by WHO/CIOMS (Council for International Organizations of Medical Sciences) Addressed issues of: informed consent; standards for ethical review; and protections for vulnerable persons such as pregnant women, children, people with mental illness, and communities in resource limited countries Guideline revised in 1993 and 2002 18. 18 Historical Perspectives cont B) International Conference on Harmonization (ICH) In 1990, representatives of the regulatory agencies and industry associations of the United States, Japan and Europe met and formed the International Conference on Harmonization (ICH) The goal of ICH was to standardize the process by which new drugs are developed, tested and brought to market. 19. Historical Perspectives cont In 1996 the ICH finalized the Guideline for Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects. Many pharmaceutical companies have adopted the GCP as the standard for conducting clinical trials. The ICH guidelines require review by an ethics committee and informed consent of participants. The guideline also details the responsibilities of both the sponsor of the research and the researcher who conducts it. 19 20. Historical Perspectives cont C) International Guidelines for the Ethical Review of Epidemiologic Studies. Published in 1991 by WHO/CIOMS Outlined unique ethical considerations for epidemiological research, Emphasis given to groups of people as opposed to individual patients 20 21. 21 General Ethical Principles 1. Respect for autonomy - a norm of respecting the decision-making capacities of autonomous persons 2. Beneficence -a group of norms for providing benefits and balancing benefits against risks and costs 3. Nonmaleficence -a norm of avoiding the causation of harm 4) Justice - a group of norms for distributing benefits, risks, and costs fairly 22. 22 General Ethical Principles cont It is unlikely that all 4 principles can operate with equal weight in relation to every action to be considered The principle-based approach to ethical analysis allows to be transparent in the rational for actions 23. 23 Respect for persons recognizes the capacity and rights of all individuals to make their own choices and decisions. There is a need to provide special protection to vulnerable persons. Examples of vulnerable groups Children, prisoners, mentally ill people with limited education, living in poverty, limited access to health care services Women (in some cultures) 1. Respect for autonomy/ Respect for person 24. 24 Respect for autonomy cont Respect for persons is embodied in the informed consent process. Informed consent is designed to empower the individual to make a voluntary informed decision. Potential research participants must fully comprehend all elements of the informed consent process. 25. Respect for autonomy cont A person of diminished autonomy is in some respect controlled by others or incapable of deliberating or acting on the basis of his/her desires and plans E.g prisoners and mentally retarded individuals Mental incapacitation limits the autonomy of the retarded person Coercive institutionalization constrains the autonomy of prisoners 25 26. 26 Group work Compare ethical acceptability of isolating HIV and SARS patients Your comment should address the 4 ethical principles What is your final decision? 27. 27 Rights and needs in communicable disease control Notifying cases of infectious disease may lead to stigma Isolation & quarantine restrict freedom Notification, isolation, and quarantine can be applied to individuals, to families, even to the entire communities 28. 28 Rights and needs in communicable disease control cont Notification, isolation, and quarantine are widely accepted features for communicable disease control Stigmatizing by notifying & restricting freedom infringes individual autonomy These practices are generally held to be necessary restrictions whose purpose is to benefit society as a whole 29. 29 Rights and needs in communicable disease control cont For surveillance purpose, public health authorities need data on the prevalence of HIV infection WHO agree that unlinked HIV testing is the best way to generate prevalence data Blood taken for other purposes from large representative populations, are tested for HIV after all personal identifiers have been removed Suitable populations include pregnant women and newborn infants 30. 30 Rights and needs in communicable disease control cont In United Kingdom & Netherlands, it was held for a time that unlinked testing is unethical Identifying & counseling cases and their sexual partners was regarded as a higher moral responsibility than determining community-wide prevalence trends 31. 31 Informed consent Process of informed consent consists of: transfer of information understanding of its significance, followed by explicit consent of the person (or responsible proxies) to take part in the intervention Consent is usually active i.e agreement takes place Some times it is passive or tacit i.e people are regarded as taking part unless they explicitly refuse 32. 32 Informed consent cont Consent need not be written In some cultures, patients regard their personal physician as responsible for decisions about participation In other cultures, a village headman, tribal elder, or religious leader is considered to have responsibility for the group, in which individuals do not perceive themselves as autonomous Nevertheless, each individual in such a group should be asked to provide consent to whatever procedure is being conducted 33. 33 Elements (components) of informed consent 1. competence 2. disclosure 3. understanding 4. voluntariness 5. Consent In other words, One gives an informed consent to an intervention if (and perhaps only if) one: is competent to act, receives a thorough disclosure, comprehends the disclosure, acts voluntarily, and consents to the intervention 34. 34 Competence means the ability to make choices based on an understanding of the relevant consequences of that choice on oneself and others The ability to understand the relevant consequences is to be judged by common sense, rather than a technical or professional standard The competent patient must understand the consequences of her/his decision to accept or reject a particular treatment 35. 35 Classifying the incompetent In general, the assumption is that adults are competent unless there is clear evidence to the contrary Unconscious people are temporarily incompetent People under the influence of alcohol or drugs may be temporarily incompetent A few patients have so permanently lost contact with reality 36. 36 Disclosure Disclosure is a necessary, and some times the sole, condition of informed consent Without adequate way for professionals to deliver information, many patients and subjects will have an inadequate basis for decision making 37. 37 Disclosure cont The core set of information during disclosure include: 1. those facts or descriptions that patients or subjects usually consider material in deciding whether to refuse or consent to the proposed intervention or research 2. information the professional believes to be material 3. the professionals recommendation 4. the purpose of seeking consent 5. the nature and limits of consent as an act of authorization 38. 38 Consent by surrogates Surrogates or substitutes are people who are authorized by law or custom to make decisions when the patient is incompetent or doubtfully competent There is no handy list of surrogates that can be relied on with certitude 39. 39 Consent by surrogates cont Parents are considered surrogates for their minor children Spouses for one another Adult children for parents when parents are lacking Adult grand children for grand parents 40. 40 Contents of the consent form The consent form for research need to include the following (Sarantakos, 2005) Identification of the researcher Identification of the sponsoring institution Indication of how the participants were selected Identification of the purpose of the research 41. 41 Contents cont Identification of the benefits for participating Identification of the level and type of participant involvement Notation of risks to the participant Guarantee of confidentiality to the participant Assurance that the participant can withdraw at any time Provision of names of persons to contact if questions arise 42. 42 Minor Assent & Parental Permission Minor / Children- are persons who have not attained the legal age for consent (18 years of age in most countries), and thus cannot legally provide "consent" to treatments or procedures involved in research When children/minors are involved in research, the regulations require the assent of the child/minor and the permission of the parent Assent means a child's affirmative agreement to participate in research. 43. 43 Parental Permission & Assent Forms The Parental Permission Form must contain the same elements as a typical Consent Form. The child should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. 44. 44 Parental Permission & Assent Forms cont.. Children less than 5 years of age A simple oral explanation of the study should be offered to the child before study related procedures are conducted. A signed Parental Permission form is required as well. 45. 45 Parental Permission & Assent Forms cont.. Children between the ages of 5 and 12 years Informed voluntary assent should be obtained without pressure from parents or investigators. 46. 46 Parental Permission & Assent Forms cont.. Children between the ages of 12 and 16 years An assent form should cover: What the study is about Why he/she qualifies for the study The voluntary nature of the study The procedures that will be done Potential benefits & potential risks An assurance that he/she will be treated the same whether or not he/she agrees to join the study An invitation to ask questions Assurance that he/she may withdraw from the study after discussing it with his/her parents 47. 47 Consenting minors Minors may consent to participate in research without parental or guardian permission (i.e as if adults) if legally emancipated and in certain treatment circumstances 48. 48 Paternalism Paternalism involves acting without consent or even overriding a persons wishes, wants, or actions in order to benefit the patient or at least to prevent harm to the patient 49. 49 Paternalism cont.. There are 2 elements in this definition: 1. the absence of consent or even the overriding of consent 2. the beneficient motive (the welfare of the patient) 50. 50 Paternalism cont Paternalism exists when the health care worker intervenes to prevent patients from harming themselves in some serious way E.g they can intervene in the case of those who are attempting suicide 51. 51 Paternalism cont Strong Vs weak paternalism 1) strong (extended) paternalism Attempts to overrule the wishes of a competent person 2) weak (or limited and restricted) paternalism Consent is missing or the health care provider overrules the wishes of an incompetent or a doubtfully competent patient Weak paternalism is sometimes called cooperative paternalism when one of its purpose is to restore the persons competence so that the patient may give informed consent 52. 52 Paternalism cont From an ethical point of view, writers generally reject the right of health care providers to use strong paternalism The courts have sometimes allowed treatment without informed consent to relieve serious pain or suffering This treatment may remove doubts about competency of the person and allow informed consent Here the treatment is directly in the service of autonomy 53. 53 Confidentiality Confidentiality is necessary in diagnostic, therapeutic and research context Confidential information is both private and voluntarily communicated in confidence and trust 54. 54 Confidentiality in research During research, investigators should make arrangements for protecting the confidentiality of data by: omitting information that might lead to identification of individual subjects limiting access to the data, or by other means. When personal identifiers remain on records used for a study, investigators should explain why this is necessary and how confidentiality will be protected. 55. 55 Confidentiality in research cont Unlinked information Refers to information that can not be linked, associated or connected with the person to whom it refers. As this person is not known to the investigator, confidentiality is not at stake and the question of consent does not arise. 56. 56 Confidentiality in research cont Linked information may be: anonymous when the information can not be linked to the person to whom it refers except by a code or other means known only to that person, and the investigator can not know the identity of that person non-nominal when the information can be linked to the person by a code which is not a personal identifier and which is known to the person and the investigator nominal or nominative when the information is linked to the person by means of personal identification, usually the name 57. 57 2. Principles of beneficence/duty to do good No personal motive Benefiting the public Minimizing the risk and managing if any Outweighing the benefit over the risk Bringing new knowledge to the society 58. 58 3. Principle of Non-Maleficence/do no harm The protection of the well-being of the participant is the primary responsibility of the researcher. Protecting the participant is more important than: the pursuit of new knowledge the benefit to science that will result from the research personal or professional research interest 59. Principle of Non-Maleficence cont.. There should be no or minimal harm to the respondent; Harms: can include economical & social damages; There should be precautions to handle cases seen during the study 59 60. 4. Principle of Justice (equitable distribution) Researchers obligation - distribute equally the risks and benefits of participation in the research. Recruitment and selection of research participants should be done in an equitable manner. The principle of justice forbids placing one group of people at risk solely for the benefit of another. E.g justice would not permit using vulnerable groups as research participants for the exclusive benefit of more privileged groups. 60 61. Scientific Misconduct Scientific misconduct includes fabrication, falsification, plagiarism, or other practices that deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research. Scientific misconduct does not include honest error or honest differences in interpretations or judgments of data. 61 62. 62 Scientific Misconduct cont.. Plagiarism - is the use or close imitation of the language and thoughts of another author and the representation of them as one's own original work Within academia, plagiarism by students, professors, or researchers is considered academic dishonesty or academic fraud 63. Scientific Misconduct cont Self-plagiarism -is the reuse of significant, identical, or nearly identical portions of ones own work without acknowledging that one is doing so or without citing the original work. Articles of this nature are often referred to as multiple publications. 63 64. 64 The World Medical Association Declaration of Helenski Adopted in 1964, amended in 1975, 1983, 1989, 1996, 2000, 2002 Has 32 articles under three Chapters A. INTRODUCTION B. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE 65. 65 A. INTRODUCTION 1. The World Medical Association has developed the Declaration of Helsinki as statement of ethical principle to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data. 2. It is the duty of the physician to promote and safeguard the health of the people. The physicians knowledge and conscience are dedicated to the fulfilment of this duty. 66. 66 INTRODUCTION cont 3. The Declaration of Geneva of the World Medical Association binds the physician with the worlds, The health of my patient will be my first consideration, and the International Code of Medical Ethics declares that, A physician shall act only in the patients interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient. 4. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. 67. 67 INTRODUCTION cont 5. In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society. 6. The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality. 68. 68 INTRODUCTION cont 7. In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks and burdens. 8. Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care. 69. 69 INTRODUCTION cont 9. Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this declaration. 70. 70 B. BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH 10. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject. 11. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation. 71. 71 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 12. Appropriate caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected. 72. 72 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 13. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects. 73. 73 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 14. The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration. 15. Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent. 74. 74 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 16. Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. This does not preclude the participation of healthy volunteers in medical research. The design of all studies should be publicly available. 75. 75 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 17. Physicians should abstain from engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results. 76. 76 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 18. Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers. 19. Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research. 77. 77 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 20. The subjects must be volunteers and informed participants in the research project. 21. The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patients information and to minimize the impact of the study on the subjects physical and mental integrity and on the personality of the subject. 78. 78 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 22. In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subjects freely-given informed consent, preferably in writing. If the consent can not be obtained in writing, the non-written consent must be formally documented and witnessed. 79. 79 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 23. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship with the physician or may consent under duress. In that case the informed consent should be obtained by a well-informed physician who is not engaged in the investigation and who is completely independent of this relationship. 80. 80 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 24. For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons. 81. 81 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 25. When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. 82. 82 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 26. Research on individuals from who it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee. The protocol should state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate. 83. 83 BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH cont 27. Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. 84. 84 C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE 28. The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects. 85. 85 ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE cont 29. The 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 method exists. (See footnote*) 86. 86 ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE cont 30. At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study. 31. The physician should fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study must never interfere with the patient- physician relationship. 87. 87 C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE cont32. In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physicians judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed. 88. 88 ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE cont*FOOTNOTE: Note of Clarification on Paragraph 29 of the WMA Declaration of Helsinki The WMA hereby reaffirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances: 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; or Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor conditions and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review. 89. 89 References 1. http:://www.apha.org. Ethical guideline 2. Robert B. Wallace, Nearl Kohatsu, Brownson, Schetcer, Scutchfield, Zaza. Public health and preventive Medicine 3. Tom L. Beauchamp, James F. Childress. Principles of biomedical Ethcs, 5th Edition, Oxford University Press, 2001 4. Thomas M. Garrett, Harold W. Baillie, Rosellen M. Garrett. Health Care Ethics. Principles and Problems (4th edition). Upper Saddle River, New Jersey, 2001

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