Ethics of Medical Researches

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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.

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Ethics of Medical Researches

  1. 1. Ethics <ul><li>In Medical Researchs </li></ul><ul><li>Dr. Ahmed-Refat Refat </li></ul><ul><li>FOM-ZU-Egypt </li></ul>
  2. 2. Physician <ul><li>A profession </li></ul><ul><li>Who is performing the practice of medicine </li></ul><ul><li>His client will be referred to as patient </li></ul>
  3. 3. Practice <ul><li>Intervention that are designed to enhance the well being of an individual patient </li></ul><ul><li>and that have a reasonable expectoration of success </li></ul>
  4. 4. Investigator <ul><li>An individual who performing a research </li></ul><ul><li>The individual upon whom the investigator perform research will be called : </li></ul><ul><ul><ul><li>Subjects </li></ul></ul></ul><ul><ul><ul><li>Volunteers </li></ul></ul></ul><ul><ul><ul><li>Participants </li></ul></ul></ul>
  5. 5. Research <ul><li>Activity designed to test an hypothesis permit conclusion to drawn and thereby to develop knowledge. </li></ul>
  6. 6. PHYSICIAN-INVESTIGATOR <ul><li>Med. Practice </li></ul><ul><li>Hospital </li></ul><ul><li>Physician </li></ul><ul><li>Practice </li></ul><ul><li>Medicine </li></ul><ul><li>Patients </li></ul><ul><li>To care </li></ul><ul><li>Med. Research </li></ul><ul><li>Laboratory/ hospital. </li></ul><ul><li>Researcher </li></ul><ul><li>Conduct a trial </li></ul><ul><li>Hypothesis Testing </li></ul><ul><li>Subjects </li></ul><ul><li>To Know </li></ul>
  7. 7. Randomized Double-Blind Placebo-Controlled Trial <ul><li>Trial </li></ul><ul><li>Experiment </li></ul>
  8. 8. Blind Trial <ul><li>Single Blind Trial </li></ul><ul><li>To minimize the possibility of bias at least one person is unaware of treatment assignment. </li></ul><ul><li>Double Blind Trial </li></ul><ul><li>Both subjects and investigators are unaware of treatment assignment </li></ul>
  9. 9. PLACEBO ( L. I will please ) <ul><li>Placebo </li></ul><ul><li>a preparation devoid of pharmacological effect, given for psychological effect, or as a control in evaluating a drug. </li></ul>
  10. 10. Declaration of Helsinki,2000 #4 <ul><li>Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. </li></ul>
  11. 11. <ul><li>The primary purpose of medical research is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. Even the best proven methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality. </li></ul><ul><li>Declaration of Helsinki,2000 #6 </li></ul>
  12. 12. <ul><li>In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks and burdens . </li></ul><ul><li>Declaration of Helsinki,2000 #7 </li></ul>
  13. 13. Ethics <ul><li>Is that branch of philosophy that seeks to determine how human action may be judged right </li></ul><ul><li>or wrong. </li></ul>
  14. 14. Role of MEDICAL ETHICS in daily clinical practice <ul><li>For those situations in which we already know what is right and what is wrong </li></ul><ul><li> it should help us explain why the one choice is right and the other wrong </li></ul><ul><li>For those situations in which it is not obvious what is right and what is wrong </li></ul><ul><li> it should guide us to discover what is the right thing to do </li></ul>
  15. 15. <ul><li>Ethics </li></ul><ul><li>Principles </li></ul>
  16. 16. Main Ethical Principles <ul><li>   Non- maleficence – دفع الضرر </li></ul><ul><li>T he obligation to </li></ul><ul><li>avoid the causation of harm </li></ul>
  17. 17. Main Ethical Principles <ul><li>   Beneficence - النفع </li></ul><ul><li>The obligation to provide benefits and to balance benefits against risks </li></ul>
  18. 18. The differerence of two principles <ul><li>Nonmaleficence </li></ul><ul><li> One ought not to inflict evil or harm </li></ul><ul><li>Beneficence </li></ul><ul><li>One ought to prevent evil or harm </li></ul><ul><li>One ought to remove evil or harm </li></ul><ul><li>One ought to do or promote good </li></ul>
  19. 19. Main Ethical Principles <ul><li>Autonomy – حرية الاختيار </li></ul><ul><li>The obligation to respect the patient’s right to refuse or choose their treatment   </li></ul>
  20. 20. Main Ethical Principles <ul><li>   Justice – العدالة </li></ul><ul><li>The obligations of fairness in the distribution of benefits and risks </li></ul>
  21. 21. Principles of distributive justice <ul><li>To each person an equal share </li></ul><ul><li>To each person according to need </li></ul><ul><li>To each person according to effort </li></ul><ul><li>To each person according to contribution </li></ul><ul><li>To each person according to merit </li></ul><ul><li>To each person according to free-market exchanges </li></ul>
  22. 22. Main Ethical Principles <ul><li>   Dignity - الكرامه </li></ul><ul><li>The patient (and the person treating the patient) have the right to dignity. </li></ul>
  23. 23. Main Ethical Principles <ul><li>  Truthfulness – الصدق </li></ul><ul><li>The patient deserves to know the whole truth about their illness and treatment. </li></ul>
  24. 24. Main Ethical Principles <ul><li>Beneficence </li></ul><ul><li>Non-maleficence </li></ul><ul><li>Dignity </li></ul><ul><li>Autonomy </li></ul><ul><li>Trustfulness </li></ul><ul><li>Justice </li></ul>
  25. 25. Ethical Codes , Principles and Guidelines <ul><li>For </li></ul><ul><li>Medical Research </li></ul><ul><li>Involving Human Subjects </li></ul>
  26. 26. Nuremberg Code, 1947 <ul><li>In response to unethical Human Experiments conducting during World Ware II </li></ul>
  27. 27. Declaration of Helsinki.1964….2000 <ul><li>The World Medical Association WMA Adopted a formal code of ethics for physicians engaged in clinical researches </li></ul>
  28. 28. WHO & The Council for International Organizations of Medical Sciences CIOMS, 1982 <ul><li>WHO& CIOMS issued in 1982 the International Guidelines For Biomedical Research Involving Human Subjects </li></ul>
  29. 29. The USA 1950s <ul><li>Many Physicians thought that the American Medical Association “AMA” Principles Were Sufficient to meet The Nuremberg Code </li></ul>
  30. 30. Declaration of Helsinki, 2000 -Cont. <ul><li>2- It is the duty of the physician to promote and safeguard the health of the people. </li></ul><ul><li>The physician's knowledge and conscience are dedicated to the fulfillment of this duty. </li></ul>
  31. 31. Declaration of Helsinki, 2000 -Cont. <ul><li>3- The Declaration binds the physician with the words, &quot; The health of my patient will be my first consideration ,&quot; and the International Code of Medical Ethics declares that, &quot; A physician shall act only in the patient's interest when providing medical care . </li></ul>
  32. 32. Declaration of Helsinki, 2000 -Cont. <ul><li>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. </li></ul>
  33. 33. Declaration of Helsinki, 2000 -Cont. <ul><li>8. Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. </li></ul>
  34. 34. Declaration of Helsinki, 2000 -Cont. <ul><li>10. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject. </li></ul>
  35. 35. Declaration of Helsinki, 2000 -Cont. <ul><li>11. Medical research involving human subjects must conform to generally accepted scientific principles , be based on a thorough knowledge of the scientific literature, and on adequate laboratory and, where appropriate, animal experimentation. </li></ul>
  36. 36. Declaration of Helsinki, 2000 -Cont. <ul><li>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. </li></ul>
  37. 37. Declaration of Helsinki, 2000 -Cont. <ul><li>13 . The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol </li></ul>
  38. 38. Declaration of Helsinki, 2000 -Cont. <ul><li>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. </li></ul>
  39. 39. Declaration of Helsinki, 2000 -Cont. <ul><li>15. Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. </li></ul>
  40. 40. Declaration of Helsinki, 2000 -Cont. <ul><li>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. </li></ul>
  41. 41. Declaration of Helsinki, 2000 -Cont. <ul><li>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 </li></ul>
  42. 42. Declaration of Helsinki, 2000 -Cont. <ul><li>22. In any research, 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. </li></ul>
  43. 43. Declaration of Helsinki, 2000 -Cont. <ul><li>22.cont.. 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 subject's freely-given informed consent , preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed. </li></ul>
  44. 44. Declaration of Helsinki, 2000 -Cont. <ul><li>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. </li></ul>
  45. 45. Declaration of Helsinki, 2000 -Cont. <ul><li>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. </li></ul>
  46. 50. الميثاق العربي لحقوق الإنسان <ul><li>اعتمد من قبل القمة العربية السادسة عشرة التي استضافتها تونس 23 مايو / أيار 2004 مادة 9 </li></ul><ul><li>لا يجوز إجراء تجارب طبية أو علمية على أي شخص أو استغلال أعضائه من دون رضائه الحر وإدراكه الكامل للمضاعفات التي قد تنجم عنها، مع مراعاة الضوابط والقواعد الأخلاقية والإنسانية والمهنية والتقيد بالإجراءات الطبية الكفيلة بضمان سلامته الشخصية وفقا للتشريعات النافذة في كل دولة طرف . </li></ul><ul><li>ولا يجوز بأي حال من الأحوال الاتجار بالأعضاء البشرية . </li></ul>
  47. 51. Application of Ethics rules <ul><li>Beneficence </li></ul><ul><li>Non-maleficence </li></ul><ul><li>Dignity </li></ul><ul><li>Autonomy Consent IRB-EC </li></ul><ul><li>Trustfulness </li></ul><ul><li>Justice </li></ul>
  48. 52. Models of Medicine Relationship between physician and patient <ul><li>Five Models </li></ul>  The engineering model,              The priestly model,              The collegial model,             The contractual model and           The covenant model.
  49. 53. 1- The Priestly Model <ul><li>  </li></ul><ul><li>The model assumes that since the physician is an expert in medicine he or she is also an expert about life in general. The physician assumes a moral dominance over the patient. The priestly physician treats the patient as a child .   </li></ul>
  50. 54. 2- The Engineering Model <ul><li>  Makes the physician an applied scientist if not a technician . Like the technician , the physician in this model tends to be interested in the facts not in values . In this model the health care professional is likely to speak of treating a disease rather than taking care of a patient. </li></ul>
  51. 55. 3- The Contractual Model <ul><li>Sees the relationship between the health care provider and the patient as a business relationship governed by a contract or a free agreement entered into for consideration that is for specified goods that are to be exchanged. </li></ul>
  52. 56. 4- The Covenant Model <ul><li>The health care relationship goes beyond mere contract. This becomes clear in emergencies when the health care provider must help even in the absence of a contract . The covenant also supposes a permanent relationship or at least an open-ended one in its duration. </li></ul>
  53. 57. <ul><li>The covenant relationship is also supposes a permanent relationship ( an open-ended one ) in its duration. The covenant relationship is also seen in the tradition that the physician has to provide at least some care on the basis of patient need independent of merit or ability to pay. </li></ul>
  54. 58. 5- The Collegial Model <ul><li>  </li></ul><ul><li>Sees the physician and the patient as colleagues cooperating in pursuing the common goal { curing of illness}. Such a model demands confidence and trust from both parties in the relationship and calls for long continued conversation between the two so that they will be sure of the goal and in agreement about the means. </li></ul>
  55. 59. <ul><li>Consent </li></ul>
  56. 60. Consent “ Voluntary” <ul><li>The voluntary consent of the human subject is absolutely essential. </li></ul><ul><li># 1: The Nuremberg Code, 1947 </li></ul><ul><li>  </li></ul>
  57. 61. Consent “ Informed” <ul><li>After ensuring that the subject has understood the information , the physician should then obtain the subject's freely-given informed consent, preferably in writing. </li></ul><ul><li>#22 : Declaration of Helsinki, 2000 . </li></ul>
  58. 62. Informed Consent -cont . <ul><li>Each subject must be adequately informed of: </li></ul><ul><li>The aims and detailed methods of the study, </li></ul><ul><li>Sources of funding, </li></ul><ul><li>Any possible conflicts of interest, </li></ul><ul><li>Institutional affiliations of the researcher, </li></ul><ul><li>The anticipated benefits and potential risks of the study and </li></ul><ul><li>The discomfort it may entail. </li></ul>
  59. 63. Informed Consent -cont. <ul><li>The subject should be informed of the right to abstain from participation in the study </li></ul><ul><li>or to withdraw consent to participate at any time . </li></ul>
  60. 64. Making The Information Understandable <ul><li>There is an obligation to present information in such a way that the patent does indeed understand the consequences . </li></ul><ul><li>If there is no understanding, there is no agreement, and so no authorization to proceed…. </li></ul>
  61. 65. Is informed consent,an informed consent? <ul><li>Patients are mostly illiterate and uneducated </li></ul><ul><li>Look upon doctors as “god” </li></ul><ul><li>Gender biases </li></ul><ul><li>Getting volunteers by offering financial incentives </li></ul>
  62. 66. <ul><li>The Informed </li></ul><ul><li>Consent </li></ul><ul><li>Process </li></ul>
  63. 68. Ethics Committees <ul><li>Institutional Review Board </li></ul><ul><li>( I.R.B). </li></ul><ul><li>Independent Ethics Committee (I.E.C). </li></ul>
  64. 69. <ul><li>A committee that meet to review protocols and other documentation used in clinical research; this independent body is responsible for verifying that the safety, integrity, and rights of human subjects are protected. </li></ul>Institutional Review Board ( I.R.B).
  65. 70. Independent Ethics Committee IEC <ul><li>An independent multidisciplinary group drown from the institution and the local community, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, and among other things, reviewing and approving/providing favorable opinion on the protocols and other documentation used in clinical research . </li></ul>
  66. 71. Functions of Ecs <ul><li>1- Education </li></ul><ul><li>The profession have a responsibility to educate the public as well as the institutional community about what is good and bad in health care </li></ul>
  67. 72. Functions of ECs - cont. <ul><li>2-Consultation Role </li></ul><ul><li>EC have a role to act as consultants in resolving conflicts and dilemmas about patient care </li></ul>
  68. 73. Functions of ECs - cont. <ul><li>3- Watching over the operation of the institution </li></ul><ul><li>Ecs should watch over the operation of institution regarding.. </li></ul><ul><ul><li>How the institution functions as a system </li></ul></ul><ul><ul><li>Its decision-making procedures, </li></ul></ul><ul><ul><li>The flow of institutional power </li></ul></ul><ul><ul><li>The effective use of resources </li></ul></ul>
  69. 74. Functions of ECs - cont. <ul><li>4- Writing Polices for their institution </li></ul><ul><li>Confidentiality policy </li></ul><ul><ul><ul><li>Treatment policy </li></ul></ul></ul><ul><ul><ul><li>Genetic Screening Policy </li></ul></ul></ul>
  70. 75. Misconduct in Science <ul><li>Misconduct means fabrication, falsification , plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.” </li></ul>
  71. 76. <ul><li>Fabrication is making up data or results and recording or reporting them. </li></ul><ul><li>Falsification is manipulating the research’s data in a such way that the research is not accurately represented in the actual findings. </li></ul><ul><li>Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. </li></ul>
  72. 77. Thank You شكرا د . أحمــد رفعت الكشمـــيـــرى 2004

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