Ch5- ethical guidelines.pp.pptxguidelines

Ch5- ethical guidelines.pptx

1. Chapter 5: Introduction to Nuremberg code (1947) The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to which physicians must conform when carrying out experiments on human subjects in a new code that is now accepted worldwide. This judgment established a new standard of ethical medical behavior for the post-World War II human rights era. Amongst other requirements, this document enunciates the requirement of voluntary informed consent of the human subject. The principle of voluntary informed consent protects the right of the individual to control his own body.

2. Cont…. This code also recognizes that the risk must be weighed against the expected benefit, and that unnecessary pain and suffering must be avoided. This code recognizes that doctors should avoid actions that injure human patients. The principles established by this code for medical practice now have been extended into general codes of medical ethics.

3. Cont ….. 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force , fraud , deceit , duress , or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

4. Cont ……. 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results justify the performance of the experiment. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. Cont …… 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

6. Cont …. 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

7. Cont …….. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

8. Cont ….. 10.During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

9. Chapter six: declaration of Helsinki World Medical Association - Adopted by the 18 th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 29 th WMA General Assembly, Tokyo, Japan, October 1975, 35 th WMA General Assembly, Venice, Italy, October 1983, 41 st WMA General Assembly, Hong Kong, September 1989, 48 th WMA General Assembly, Somerset West, Republic of South Africa, October 1996, 52 nd WMA General Assembly, Edinburgh, Scotland, October 2000 ,53 rd WMA General Assembly, Washington, DC, USA, October 2002 (Note of Clarification added), 55 th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added), 59 th WMA General Assembly, Seoul, Republic of Korea, October 2008, 64 th WMA General Assembly, Fortaleza, Brazil, October 2013

10. Preamble 1-The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

11. Cont ….. 2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

12. General Principles 3 . The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “ A physician shall act in the patient's best interest when providing medical care. ” 4 . It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty.

13. Cont ……. 5 . Medical progress is based on research that ultimately must include studies involving human subjects. 6 . The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatment) best proven interventions must be evaluated continually through research for their safety , effectiveness , efficiency , accessibility and quality .

14. Cont ….. 8 . While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects. 9 . It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

15. Cont…. 10 . Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration. 11 . Medical research should be conducted in a manner that minimizes possible harm to the environment.

16. Cont … 12 . Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

17. Cont ….. 15 . Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

18. Cont…. Risks, Burdens and Benefits 16 . In medical practice and in medical research, most interventions involve risks and burdens. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

19. Cont … 17 . All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimize the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.

20. Cont … 18 . Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

21. Cont …. Vulnerable Groups and Individuals 19 . Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.

22. Cont ….. 20 . Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

23. Cont … Scientific Requirements and Research Protocols 21 . 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 adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.

24. Cont … 22 . The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed.

25. Cont … Privacy and Confidentiality 24 . Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

26. Cont …. Informed Consent 25 . Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

27. Definition of terms Equity (see also Distributive Justice) Equity focuses on equal outcomes and this may require an unequal distribution of some good to bring about the equal outcome. Health equity requires responding to “differences in health which are not only unnecessary and avoidable but, in addition, are considered unfair and unjust” . Ethics Branch of knowledge concerned with questions about right versus wrong conduct and what constitutes a good or bad life, as well as the justificatory basis for such questions.

28. Cont ….. Human rights Fundamental freedoms and rights enshrined in a set of universal legal statements. Some of the most important characteristics of human rights are that: they are acknowledged in international declarations; states and state actors are obliged to respect them; they cannot be waived or taken away (although the enjoyment of particular human rights may be limited in exceptional circumstances); they are interdependent and inter-related; and they are universal.

29. Cont ……. Informed consent Agreement to a certain course of action, such as treatment or participation in research, on the basis of complete and relevant information by a competent individual without coercion. Justice A highly contested concept that can, roughly, be thought of as giving people what they deserve.

30. Cont …… Privacy Privacy seeks to protect a person from scrutiny by others. Respect for privacy implies that a person should not be expected to share personal information unless they so choose. Any violation of privacy requires ethical justification although it might be outweighed by other considerations in some cases (i.e. for the protection of the common good ).

31. Cont …. Proportionality The balancing of the positive features and benefits of a particular intervention, policy, or research study against its negative features and effects, when deciding whether or not to implement it.

32. Cont … Autonomy Most often taken to refer to the ability of an individual to be his or her own person, to make his/her own choices on the basis of his/her own motivations, without manipulation by external forces. However, others in a more Kantian tradition see autonomy as being firmly related to accepting and acting on the basis of one’s obligations, i.e. acting morally, the precise opposite of doing what one wants.

33. Cont ….. Beneficence Principle requiring that governments, health care providers, and researchers do good for, provide benefit to, or make a positive contribution to the welfare of populations, patients and study participants. Bioethics The field of enquiry that examines ethical issues arising from the “creation and maintenance of the health of living things”. Bioethics is much broader than medical ethics, and includes all ethical issues in medicine, the life sciences and biomedical research.

34. Cont ….. Confidentiality The obligation to keep information secret unless its disclosure has been appropriately authorized by the person concerned or, in extraordinary circumstances, by the appropriate authorities . Dignity A term used to suggest the idea of human worth or value. It is often used to link to the idea of persons as being of value. “The notion of dignity is used to mark a threshold, a kind of respect and care beneath which the treatment of any human being should never fall” .

35. Cont ……. Solidarity A social relation in which a group, community, or nation stands together. It is often appealed to in discussions about justifications for the welfare state or shared risks through insurance pooling, and in thinking about how states might defend the interests of vulnerable groups within their population.

36. questions 1-very sick pregnant women is admitted to your hospital, the treatment is complex and the best choice to save the life of the mother is to induce abortion “nevertheless both the mother and fetus will die), what should you do?

37. Cont ….. 2 -if patient complaining with specific signs and symptoms comes to you, after diagnosis the patient becomes HIV +VE, if the patient was male with family containing (mother and two children) and his wife with him during the diagnosis, suppose you are the doctor what do you do?

38. Cont ….. 3-What ethical challenges arise from the use of electronic health records and telemedicine? 4-What measures should be taken to safeguard individuals who may be at higher risk of exploitation? 5-How should researchers balance scientific advancement with potential risks to participants?

39. thanks