Medical Research Ethics In The Egyptian Regulation


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The physician shall comply with observing the implementation of all moral criteria and guidelines as well as the social and religious values laid down by the competent authority for conducting medical research on human beings

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Medical Research Ethics In The Egyptian Regulation

  1. 1. <ul><li>Medical </li></ul><ul><li>Research Ethics </li></ul><ul><li>in The Egyptian </li></ul><ul><li>Profession Ethics Regulations </li></ul><ul><li>Dr. Ahmed-Refat AG Refat </li></ul>
  2. 2. <ul><li>EGYPTIAN MEDICAL SYNDICATE </li></ul><ul><li>Profession Ethics </li></ul><ul><li>Regulations </li></ul><ul><li>Issued By the Resolution of the </li></ul><ul><li>Minister of Health & Population No. 238/2003 </li></ul>
  3. 4. Medical Profession Ethics Regulations <ul><li>  </li></ul><ul><li>Part Three </li></ul><ul><li>Medical Interventions of Special Nature </li></ul><ul><li>  </li></ul><ul><li>First : Gender Correction Procedure </li></ul>
  4. 5. <ul><li>Article 43 : </li></ul><ul><li>The physician shall be prohibited from carrying out gender change operations. As regards gender correction operations, it is conditional that the approval of the competent committee at the syndicate would be obtained. The correction operations shall be carried out after carrying out the hormonal analyses and inspecting the chromosomal map after spending the accompanying psychiatric and hormonal treatment for a period not less than two years. </li></ul>Medical Profession Ethics Regulations
  5. 6. Second : Assisted Reproductive Operations Article 44 <ul><li>The assisted reproductive operations for the wife’s ovum from the husband’s sperm inside or outside the wife’s body (laboratory reproductive techniques or intra cytoplasmic sperm injection) shall be subject to the moral guidelines which aim at preserving the human race and treating infertility, while observing the purity of lineages and the legal criteria issued by the competent quarters. </li></ul>
  6. 7. <ul><li>Article 45 : </li></ul><ul><li>It shall be unallowable to carry out the assisted reproductive operations inside or outside the body of the wife except by using her husband’s sperm if there is consummation of marriage between them. </li></ul><ul><li>It shall also be unallowable to transfer fertilized ova to transplant them in the uteruses of women other than the legitimate mother of these ova. </li></ul>Medical Profession Ethics Regulations
  7. 8. <ul><li>Article 46 : </li></ul><ul><li>  </li></ul><ul><li>It shall be unallowable to establish ovum, spermatozoon or embryo banks. </li></ul>Medical Profession Ethics Regulations
  8. 9. <ul><li>Article 47 : </li></ul><ul><li>  </li></ul><ul><li>It shall not be authorized to practice the assisted reproductive operations except in equipped centers licenced to practice such operations. </li></ul>Medical Profession Ethics Regulations
  9. 10. <ul><li>Article 48 : </li></ul><ul><li>  </li></ul><ul><li>The center must keep a detailed register for each case containing all the data separately for a period that is not less than ten years. The file must include contract and a declaration from both spouses. </li></ul>Medical Profession Ethics Regulations
  10. 11. Third : Human Organs & Tissues Removal and Transplant <ul><li>Article 49 : </li></ul><ul><li>  </li></ul><ul><li>The human organs and tissues transplant operations shall be subject to the moral criteria and guidelines stipulated in the legislation and regulations organizing the foregoing. </li></ul><ul><li>  </li></ul>
  11. 12. <ul><li>Article 50 : </li></ul><ul><li>  It shall be imperative upon the physician prior to carrying out an organ transplant operation, pursuant to the legislation organizing the foregoing, to notify the donor of the medical consequences and the risks to which he may be exposed as a result of the transplant operation and to take the necessary declarations which state his knowledge of all the consequences in this concern prior to carrying out the operation. </li></ul>Third : Human Organs & Tissues Removal and Transplant
  12. 13. <ul><li>Article 51 : </li></ul><ul><li>  </li></ul><ul><li>It shall be prohibited to trade in the human organs, tissues and cells, and human embryos. Under no circumstance shall the physician be allowed to take part in these operations, otherwise he shall be subject to disciplinary accountability. </li></ul>Third : Human Organs & Tissues Removal and Transplant
  13. 14. <ul><li>  </li></ul><ul><li>Part Four </li></ul><ul><li>Conducting Medical Research & Experiments On Human Beings </li></ul>
  14. 15. First : General Provisions <ul><li>Article 52 : </li></ul><ul><li>  </li></ul><ul><li>The physician shall comply with observing the implementation of all moral criteria and guidelines as well as the social and religious values laid down by the competent authority for conducting medical research on human beings. </li></ul>
  15. 16. First : General Provisions <ul><li>Article 53 : </li></ul><ul><li>  </li></ul><ul><li>The physician shall be prohibited from conducting any experiments for drugs and techniques on human beings prior to being endorsed by the competent quarters. </li></ul>
  16. 17. <ul><li>Second : </li></ul><ul><li>Procedures that Must be Taken Prior to Conducting any Research on Human Beings </li></ul>
  17. 18. Article 54 : <ul><li>Taking into consideration the provisions of the two previous articles, the researcher physician shall comply prior to conducting any medical research on human beings with acquiring a detailed study of the risks and burdens to which the individual or the group will be exposed and comparing them with the benefits expected to be obtained from the research. </li></ul>
  18. 19. Article 54 : <ul><li>. Conducting such research shall be confined to the specialists scientifically qualified to conduct them under the supervision of a highly efficient and specialized physician. </li></ul>
  19. 20. Article 54 : <ul><li>The responsibility of the health protection of the volunteers for conducting the research shall be attached to the physician supervising him. </li></ul>
  20. 21. <ul><li>Article 55 : </li></ul><ul><li>  </li></ul><ul><li>The researcher shall comply with fully informing the volunteers in a clear way of the targets of the research, the research approaches which will be used in it, the benefits expected therefrom, the probable risks and the extent of their effect on the volunteers. The volunteers must also be informed of the sources of financing the research, the identity of the researcher in charge and his institutional belonging. </li></ul>
  21. 22. <ul><li>The right of the volunteer to cease his voluntariness to conduct the experiments and research or the full withdrawal from the research without sustaining any negative consequences as a result of his cessation or withdrawal must be emphasized. </li></ul>
  22. 23. <ul><li>Article 56 : </li></ul><ul><li>  </li></ul><ul><li>The researcher physician shall comply with obtaining a written consent (built on knowledge) from the volunteer to conduct the research on him officially in the presence of a prosecution witness. If the volunteer is a minor, a retarded or incapacitated person the approval of the official guardian or curator must be obtained, in which case it is conditional that the research would pertain to his sick condition. </li></ul>
  23. 24. <ul><li>Article 57 : </li></ul><ul><li>  </li></ul><ul><li>The researcher shall comply with preparing a detailed and clear report on the targets of the research and the justifications for conducting it on human beings. This report shall be submitted to the quarter legally competent with approving to conduct the research in order to obtain such approval. </li></ul>
  24. 25. <ul><li>Third : Procedures that Must be Taken During & After Conducting the Research on Human Beings </li></ul><ul><li>  </li></ul>
  25. 26. <ul><li>Article 58 : </li></ul><ul><li>  </li></ul><ul><li>The researcher shall comply with immediately ceasing to complete any experiments on human beings if it was established that the accompanying risks exceed the benefits expected of the research. </li></ul><ul><li>  </li></ul>
  26. 27. <ul><li>Article 58 : </li></ul><ul><li>  </li></ul><ul><li>It is necessary to guarantee the privacy of the individuals, the secrecy of the results and keeping them as well as minimizing the negative effects on the physical, mental and psychological safety of the volunteers </li></ul>
  27. 28. <ul><li>Article 59 : </li></ul><ul><li>  </li></ul><ul><li>The researcher shall comply with ensuring the availability of all preventative, diagnostic and therapeutic methods for each patient for conducting the study. </li></ul><ul><li>  </li></ul>
  28. 29. <ul><li>Article 60 : </li></ul><ul><li>  </li></ul><ul><li>The researcher shall be prohibited from conducting researches and practices that involve the suspicion of mixing lineages, or participating in them in any way. He shall also be prohibited from carrying out or participating in medical research which aim at cloning the human being. </li></ul>
  29. 30. <ul><li>Article 61 : </li></ul><ul><li>  </li></ul><ul><li>The physician shall comply with taking the required undertaking from the quarter financing the research to the effect of supplying the drug - which is being experimented on patients and which has been proven to be effective - till the end of the treatment program, free of charge. </li></ul>
  30. 31. <ul><li>Medical Research Ethics Committee </li></ul><ul><li>How & Why ? </li></ul>
  31. 32. Medical Ethics Committee, How & Why <ul><li>A proposed guideline for establishing </li></ul><ul><li>of </li></ul><ul><li>Medical Research Committee </li></ul><ul><li>in an Egyptian Newspaper (Al-Ahram) </li></ul><ul><li>at 15 Aug 1995 and 17 July 1997 </li></ul>
  32. 35. 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>
  33. 36. <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).
  34. 37. 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>
  35. 38. 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>
  36. 39. 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>
  37. 40. 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>
  38. 41. 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>
  39. 42. 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>
  40. 43. <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>
  41. 44. Thank You شكرا د . أحمــد رفعت الكشمـــيـــرى 2004