chap - principles- principles3- principles of H.E for HEW.pptx

chap 3- principles of H.E for HEW.pptx

1. Chapter three: Principles of Health Ethics for health Extension Workers The following principles are intended to aid Health Extension Worker individually and collectively in maintaining a high level of ethical conduct. They are not laws, but stands by which Health Extension worker may determine the propriety of his/her conduct in his relationship with:-

2. Cont ….. client/community members/community organizations Other members of health professions Government authorities and other sectors

3. Cont ….. Section 1: HEW must protect the confidentiality of information that can bring harm to an individual or community. Section 2: HEW should achieve community health in a way that respects the rights of individuals in the community at large. Section 3: Health Extension Worker should carry out the best interest of the clients.

4. Cont ……. Section 4: HEW worker should see that health policies, guidelines and programmes should be developed and evaluated through processes that ensure an opportunity for input from community members, Section 5: Health Extension Worker should recognize health and illness in the broader context of social, environmental, political and economic factors as related to Health Service Extension programmes Section 6: Health Extension Worker practice concerns in prevention of illness and diseases and ensuring the well being of the rural mass.

5. Cont …. Section 7: The Impaired Health Extension worker: A physically, mentally, or emotionally impaired Health Extension Worker should withdraw from those aspects of practice affected by the impairment. If the Health Extension worker does not withdraw, it is the duty of others who know of the impairment to take action to attempt to prevent him from harming himself or others.

6. Cont …….. Section 8: Advertisement and Publicity The Health Extension worker in her practice shall avoid direct or indirect self-advertisement. Section 9: Health Extension worker should participate and must have interest in all activities of the community which have the purpose of improving both the health and well-being of individuals and the community.

7. Cont ……. Section 10: The Health Extension Worker is expected to be friendly in carrying out her responsibilities. Section 11: The Health Extension Worker is expected to be present on time for every commitment she makes in duties and responsibilities. Section 12: The Health Extension Worker is expected to respect the confidential aspects of her assignment, and the dignity and privacy of the clients with whom she works.

8. Cont …. Section 13: The Health Extension Worker must be involved, in a warm and natural manner with the clients she serves without becoming over involved. Section 14: The Health Extension Worker should show empathy with the clients, not sympathy. Section 15: The Health Extension Worker should be optimistic about life in general and clients outlook in particular without encouraging any unrealistic goals or attitudes. Section 16: The Health Extension Worker should be honest and genuine at all times.

9. Chapter four: Research ethics Research ethics is the codification of scientific morality in practice Basic principles of research ethics: There are four are principles of biomedical ethics: 1-autonomy 2-beneficence 3-non-maleficence 4-justice

10. Other health ethics Decision making capacity truth-telling Patient safety Conflict of interest Equity of resources Ethics of privatization

11. 1-Autonomy (respect for the person - a notion of human dignity). The principle of autonomy requires us to treat subjects as autonomous individuals whose welfare and rights need to be respected. It refers to the respect of the autonomy and self -determined of all human beings, acknowledging their dignity and freedom. Respect for persons recognize the capacity and right of all individual to make their own choices and decisions.

12. Cont …… An important component of this principles is the need to provide special protection to vulnerable persons/groups . Respect for persons is embodied in the informed consent process, Informed consent is designed to empower the individual to make a voluntary informed decision regarding participation in the research Respect for persons incorporates at least two fundamental ethical considerations namely.

13. Cont …….. 1-Respect for autonomy, which requires that those who are capable of deliberation about their personal choices should be treated with respect for their capacity for self -determination. 2-Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or vulnerable be afforded security against harm or abuse.

14. 2. Beneficence, kindness (benefit to the research participant). BENEFICENCE refers to the ethical obligation to maximize benefits and to minimize harms. Beneficence Makes the researcher responsible for the participant's physical, mental and social well-being as related to the study. beneficence =non malfeasance =DO NOT HARM. The protection of the well-being of the participant's is the primary responsibility of the researcher.

15. Cont …….. Protection the participant is more important than: The pursuit of the new knowledge. The benefit to science that will result from the research personal or professional research interest Risk of research be reasonable in the light of the expected benefits Research design be sound and that the investigators be competent both to conduct the research and to safe guard welfare of the research subjects.

16. 3. Non-maleficence (absence of harm to the research participant). Non-maleficence holds a central position in the tradition of medical ethics and guards against avoidable harm to subjects. Non-maleficence (do not harm) requires investigators to minimize the harm and enhance benefits to the study population. لاضرر ولا ضرار

17. Cont …. 4. Justice (notably distributive justice - equal distribution of risks and benefits between communities) Example: {Poor vs rich, old age vs adolescent, citizen vs non-citizen, comorbidities vs only affected, state of illness of the patient}. Justice literally means moral or absolute rightness; justice may be defined as a form of fairness; justice is giving to each that which is his.

18. Cont …. Justice refers to the ethical obligation to treat each person in accordance with what is morally right and proper to give each person what is due to him or her. in the ethics of research involving human subject the principle refers primarily to distributive justice, which requires the equitable distribution of both the burdens and the benefits of participation in research

19. Justification for Ethical Guidelines Historical Reasons Ethical Reasons Ethical justification History of unethical clinical research and trials dates back to ancient times. Many of the early advances in medicines have been developed at the expense of many marginal groups such as asylum inmates and prisoners . These test subjects were involved in these clinical trials without being informed or even asked.

20. Cont ….. The most horrifying example of unethical clinical trials and research was that done by the Nazi doctors in Germany. They conducted clinical research trials with prisoners of concentration camp against their consent and most of the prisoners died due to such trials. Not only in Germany, has unethical clinical trials also been performed in United State and Britain. Ethical requirements for clinical research are meant to minimize the possibility of exploitation.

21. Ethical justification guidelines source Year and revision Nuremberg code Nuremberg military tribunal decision 1947 Declarations of Helsinki World medical association 1964, 1975, 1983, 1989, 1996, 2000 Belmont report National commission for protection of human subjects of biomedical and behavioral research 1979

22. Cont …….. guidelines source Year and revision International ethical guidelines for biomedical and research involving human subjects Council of international organization of medical science ( cioms ) Proposed in 1982 revised in 1993, 2002 Guidelines for good clinical practice for trials on pharmaceutical products World health organization 1995 Operational guidelines for ethics committees that review biomedical research World health organization 2000

23. Nuremberg Code: is the 1 st international document on research ethics was promulgated in 1947 as a consequence of trial of German physician who had conducted cruel experiments on prisoners and detainees during 2 nd world war. The Nazi doctors were trialed at Nuremberg court and this trial gives birth to the world’s first guideline for ethical medical research, the Nuremberg code in 1948.

24. Declaration of Helsinki Declaration of Helsinki was adopted by world medical association in 1964 at its 18 th assembly. This was the statement of ethical principles to provide guidance to physician and other participants in medical research involving human subject. The declaration of Helsinki underscored 12 basic principles for the conduct of human biomedical research. The guidelines underwent many revisions.

25. Cont ….. Revision was made in 29 th assembly in Tokyo in 1975 termed as Helsinki two, subsequent review was done in venice , Italy in October 1983, Hong Kong in September 1989, south Africa in October 1996, Edinburgh Scotland in October 2000.

26. The 8 ethical requirements: Collaborative partnership social or scientific value scientific validity fair subject selection favorable risk-benefit ratio independent review informed consent respect for potential and enrolled subjects

27. 1-Collaborative partnership To be ethical clinical research must involve the community in which it occurs. This requires: –community participation in planning, conducting and overseeing research, and integrating research results into the health system. –avoidance of supplanting existing health care services and the sharing rewards with the community.

28. Cont ….. Mechanisms to achieve collaborative partnership can be achieved by: Community advisory boards Patient advocates on scientific advisory boards Advocates for funding of research

29. 2-Social or scientific value To be ethical clinical research must lead to improvements in health or advancement in generalizable knowledge. Must consider how the research will improve health of: Participants in the research Community in which research is conducted World

30. 3-Scientific validity Research must be conducted in a methodologically rigorous manner that is practically feasible. To be ethical the research must produce reliable and valid data that can be interpreted. Invalid research includes underpowered studies, studies with biased endpoints, instruments, or statistical tests, and studies that cannot enroll sufficient subjects.

31. 4-Fair subject selection The scientific objectives of the study—not vulnerability or privilege—should guide inclusion criteria and targeted populations. •Lowering risk and enhancing generalizability can then be considered. •Convenient groups should not be selected. •Groups cannot be excluded without scientific reasons. •Higher risk is a reason to exclude certain groups. •Should not select rich, politically powerful or otherwise well-connected people for “promising research” studies.

32. 5-Favorable Risk-Benefit Ratio Clinical research must be conducted in a manner consistent with the standards of clinical practice. 1) Risks identified, assessed and minimized. Risks must include: Physical: death, disability, infection Psychological: depression and anxiety Social: discrimination, Economic—job loss

33. Cont ….. Evaluate the: Likelihood of harm Magnitude of harm Identify mechanisms to minimize risks: Additional diagnostic tests Hospitalizations

34. Cont ….. 2) Potential benefits to individual participants enhanced. Consider physical, psychological, social, and economic benefits to the individual 3) If potential benefits to the individual outweigh risks to the individual, then proceed. 4) If risks outweigh benefits to the individual, then evaluate risks against social benefit of knowledge gained.

35. 6-Independent Review •Because investigators have multiple legitimate interests, they have potential conflicts of interest. Independent review of the research minimizes these conflicts. •Independent review also assures society it will not benefit from abuse of subjects.

36. 7-Inform consent: The important ethical requirement in the research on human beings are obtained informed consent from the potential research subject, the need for the research subjects to derive health benefits from the research and keeping the risk of the subjects as minimum as possible. Informed consent ensures individuals decide whether they enroll in research and whether research fits with their own values, interests, and goals. For those who cannot consent—such as children and mentally impaired—must be sure research fits with their interests.

37. Cont …. Consent given by research participant to the investigator after understanding the reasons for research to become research participant. For all research involving human subject, the investigator must obtain the informed consent of subject.

38. Cont ….. Essential information to be included in the informed consent Aim and the method of research Duration of participation Expected benefits from the research Risk/discomfort involved during participation Confidentiality of records

39. Cont … Medical services to be provided by the investigator Provision of compensation in case of disability of death of subjects The individual is free to refuse to participate and will be free to withdraw from the research at any time without penalty or loss of benefits to which he or she would otherwise be entitled

40. 8-Respect for Human Subjects The ethical requirements of research do not end with a signed consent document. Also include: Protecting confidentiality Permitting withdrawal Providing new information Monitoring welfare Informing them of what was learned from the research

41. Cont …… All 8 requirements are necessary and essential to make clinical research ethical. Independent review and informed consent are procedural requirements to ensure certain values are achieved. In some circumstances, independent review and informed consent can be waived. All 8 ethical requirements are universal. They do not apply only to the US or Europe. They apply to clinical research everywhere.

42. Cont ….. Inducement: 1. They should be reimbursed for expenses incurred, in connection with their participation in research. 2. They may also receive free medical services however; the payment should not be so large or the medical services so extensive as to induce prospective subjects to consent to participative in the research against their better judgment (undue inducement). 3. All payment reimbursement and medical service to be provided to research subject should be mentioned in the research proposal and approved by an ethical review committee

43. Cont ….. Confidentiality in research: CONFIDENTIALITY the investigator must establish safe guards of the confidentiality of research data, subject should be told of limits to investigator ability to safe guard confidentiality and of the anticipated consequences of breaches of confidentiality

44. Examples of vulnerable groups: Women Children Elderly persons Prisoners Underprivileged people Rural population Population slums Minority groups Refugees prostitutes

45. Ethical questions 1-Why is ethics important? 2-What is the difference between morals and ethics? 3-What is the relationship between ethics and the law? 4 -Should individuals who donate their kidneys be allowed to choose who their organs should go to? 5 - what are the ethical principles that should guide the allocation of scarce healthcare resources? 6 - what should you do if your patient refused treatment for life threatening condition?

46. Cont ……. 1-Which of the following is an example of beneficence Giving a patient a helpful medication Distributing a scarce vaccine randomly among society Respecting s person Giving a person the ability to make their own decisions

47. Cont ….. 2- What ethical concept is central to the dilemma of allocating limited organ transplants and justifying who receives them? Autonomy Veracity Justice Fidelity justice

48. thanks