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Introduction to research ethics

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Introduction to research ethics

  1. 1. Why Ethics In Medical Research? Tamer Hifnawy. MD. Dr (PH) Associate Professor of Public health Faculty of Medicine, Beni Suef University, Egypt College of Dentistry, Taibah University, KSA Vice Dean for Quality and Development Certified Trainer in International Research Ethics
  2. 2. Points Covered Today  Define ethics  Define Research  Identify Human Subjects in research  Overview of history of research ethics  Identify evolution of codes of ethics  Identify three fundamental principals of research ethics
  3. 3. WHAT IS ETHICS ?
  4. 4. WHAT IS: ETHICS ? The word is derived form the Greek word “ethos” meaning; “the set of moral principles”
  5. 5. What do we mean by ethics?  Morality or ethics represents a code of conduct that governs how people treat each other.  In essence, it is concerned with the way people act or behave.  The term ‘ethics’ usually refers to the moral principles, guiding conduct, which are held by a group or even a profession” (Wellington, 2000: 54)
  6. 6. WHAT IS: ETHICS ?  Ethics are ways of understanding and examining the moral life, or of right and wrong human conduct.  Bioethics is a way of understanding and examining the moral aspects of biomedical research and practice
  7. 7. WHY WORRY ABOUT RESEARCH ETHICS ?  The science itself  Other scientists  The research participant  The public  The future  Ourselves
  8. 8. WHY WORRY ABOUT ETHICS ?  The science itself  Other scientists  The research participant  The public  The future  Ourselves
  9. 9. WHO IS THE RESEARCH PARTICIPANT ?
  10. 10. WHO IS A HUMAN SUBJECT? “a living individual about whom an investigator (professional or student) conducting research obtains; 1. Data or 2. Identifiable private information Through intervention or interaction with the individual.” 45 CFR 46.102(f)
  11. 11. WHAT IS RESEARCH ?
  12. 12. It is important at this point to draw the line between “research” and “practice”.
  13. 13. WHAT IS RESEARCH ? Research is defined as; “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to GENERALIZABLE knowledge.” 45 CFR 46.102(d)
  14. 14. HUMAN SUBJECT RESEARCH A research Involving living individuals about whom the researcher obtains: Data through intervention or interaction Identifiable Human Material +/Private Information AND OR
  15. 15. BALANCING TWO GOALS Advancement of Science Protection of Subject Welfare/Rights
  16. 16. HISTORICAL BACKGROUND
  17. 17. During The Islamic Era  Islamic Rules included all the basic ethical principles known in modern history which include:  Respect for persons  Non-maleficence  Beneficence  Justice
  18. 18. History of Research Ethics Codes, guidelines & regulations developed to guide research involving human participants. Guidelines were created in response to: 1. An ethical lapses in research. 2. Provide answers to new problems and challenges in research.
  19. 19.  By 1833 William Beaumont records what some consider to be the oldest American document dealing with research ethics. Which identified key issues which may be summarized as follows:  Experimentation is needed;  Investigator must be conscientious and responsible;
  20. 20.  Investigations must have good methodological approach and there should be no random studies;  Voluntary consent is necessary;  Discontinuation of experiment when it causes distress to the subject or the subject objects or becomes dissatisfied
  21. 21. HISTORY OF RESEARCH ETHICS  Before 20th century  Small scale, involving few individuals  Edward Jenner -- Small pox vaccine  Beginning of 20th century  Larger scale clinical trials  Collect Systematic data  Groups of individuals  Vulnerable groups Prisoners Orphans Mentally ill No Formal Codes of Research Ethics
  22. 22. RESEARCH HISTORY TRAGEDIES  Albert Neisser, discoverer of the gonococcus  In order to find a method of syphilis prevention he injected cell free serum from patients with syphilis into patients who were admitted for other medical conditions.  Most of these patients were commercial sex workers, who were neither informed about the experiment nor asked for their consent.
  23. 23. Neisser Case Cont.  When some of them contracted syphilis Neisser concluded that the “vaccination did not work”.  However, he argued that the women did not contract syphilis as a result of his serum injections but contracted the disease because they were commercial sex workers.
  24. 24. Neisser Case Cont.  Most academic physicians at the time supported Neisser.  In 1898 the public prosecutor investigated the case.
  25. 25.  The court ruled that, though Neisser as a well known medical authority may have been convinced that the trials were harmless, he should have sought the patients' consent.  Not questionable science but lack of patients' consent was the main principle for the legal judgment.
  26. 26. World War II
  27. 27. Nazi Experiments Hypothermia Experiments The goal of this type of experiments was to determine how long German pilots would survive after parachuting into the cold north sea. A prisoner is submerged in a tank filled with cold water.
  28. 28. High Altitude Experiments • High altitude experiments were performed to test how long pilots would survive after being ejected from their planes. Prisoners were put into low-pressure tanks with little oxygen. • Many of those who did not die immediately were put under water until they died.
  29. 29. Tuskegee Syphilis Study (1932 - 1972)  Tuskegee, Alabama High prevalence of syphilis Although treatment existed, blacks in the rural southern town were not receiving treatment Lack of funds/Lack of doctors  Study natural course of syphilis Enrolled 400 black males infected with syphilis Not an experiment but rather a “study in nature”
  30. 30. Tuskegee Syphilis Study (1932 - 1972) Ethical Issues  Inadequate disclosure of information  Subjects believed they were getting free treatment  Told that spinal taps was therapy  US Gov’t actively prevented men from receiving penicillin  1972 press reports caused the U.S. Gov’t to stop the study
  31. 31. Ethical issues in Tuskegee study:  Inadequate disclosure of information  Subjects believed they were getting free treatment  Told that spinal taps was therapy  US Gov’t actively prevented men from receiving penicillin  1972 press reports caused the U.S. Gov’t to stop the study
  32. 32. Problems with research include;  Lack of informed consent  Use of vulnerable population  Exploitation of vulnerable population  Withholding information and / or treatment  Putting subjects at risk  Risks outweigh benefits  Deception and violation of rights
  33. 33. The Willowbrook Study (1963-1966)  Research done at a state school of mentally handicapped children  Deliberate infection with live Hepatitis virus  Institution could only take in those accepting to participate in the study  Poor public had no other institutional choice  Parents were not completely told what study involved
  34. 34. The Willowbrook Study cont.  Researchers defended the deliberate injection of these children by pointing out that the vast majority of them would acquire the infection anyway while at Willowbrook, given the crowded and unsanitary conditions, and  Only children whose parents had given consent were included
  35. 35. Nuremburg Nazi Doctors’ Trial (1947) Nazi doctors & scientists put on trial for the murder of concentration camp inmates who were used as research subjects 15 of 23 guilty, 7 hanged, 5 life sentences
  36. 36. How Could This Happen? German physicians had sworn to “DO NO HARM” by the Hippocratic Oath Science corrupted by politics?
  37. 37. Relevance of Hippocratic Ethics to Human Experimentation  Medical Practice  Ethics: guided by Hippocratic Oath  Doctor’s primary obligation is patient’s welfare  Doctor acts in the patients’ best interest  Research  Lies outside of the context of the physician-patient relationship  Two Interests  Test a hypothesis  Subject welfare Two different types of practices
  38. 38. Ends, means, subjects and objects There is a danger of reducing research subjects to research objects
  39. 39. Balancing Two Goals Without an Adequate Framework of Research Ethics Advancement of Science Protection of Subject Welfare/Rights >>>
  40. 40. In the context of research Could not protect human welfare Could not respect human rights Hippocratic Oath Expand on Hippocratic Ethics to Protect Research Subjects
  41. 41. + Concept of Human Rights Nuremberg Code
  42. 42. Nuremberg Code (1947) First Codification of Research Guidelines Human Rights + Welfare of Subjects The first and longest principle Article (9) Subjects have the right to withdraw at any time “The voluntary consent of the human subject is absolutely essential.”
  43. 43. The Declaration of Helsinki Developed by the World Medical Association in Finland in 1964. Provide guidance for physicians and participants in medical research. Many updates were introduced in 1975, 1983, 1989, 1996, 2000 and in 2008.
  44. 44. The Declaration of Helsinki It indicates: o The well-being of the subject should take precedence over the interests of science and society. o Physician should obtain the subject’s freely given informed consent in writing. o Ethical review committee approval is a must.
  45. 45. The Belmont Report • In 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established. • In 1978, it submitted The Belmont Report that sets the fundamental ethical principles 1. Respect for persons 2. Beneficence 3. Justice
  46. 46. The first step in the evolution of ethics is a sense of solidarity with other human beings. Albert Schweitzer
  47. 47. VULNERABLE POPULATIONS  Pregnant women / fetuses  Children  Elderly  Mentally disabled  Sick persons  Unconscious persons  Prisoners  Persons with little/ no education  Poor persons
  48. 48. CIOMS 2002  Council for International Organizations of Medical Sciences: International Ethical Guidelines for Biomedical Research Involving Human Subjects  Dealt with issues involving international clinical trials
  49. 49. CIOMS Guideline 10: Research in populations and communities with limited resources  “…the sponsor and the investigator must make every effort to ensure that: The research is responsive to the health needs and priorities of the population or community; and Any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community.
  50. 50. CONCLUSIONS  All ethical codes and principals advocate three fundamental principals; Respect for persons Beneficence Justice  Research is a privilege, not a right  The well-being of participant is a priority
  51. 51. CASE STUDIES
  52. 52. First Questions to Ask: Is the project considered research?
  53. 53. Second Questions to Ask: Does the study involve Human Subjects?
  54. 54. Case 1: Research with autopsy specimens  An application describes the following proposed activities:  An investigator receives autopsy specimens from a pathologist at the same institution.  The investigator will receive and record identifiable private information about the individuals from medical records
  55. 55. Case 1: Is the investigator conducting human subjects research?  No:  Research involving only specimens and data from dead individuals is not human subjects research  Investigator is neither interacting nor intervening with living individuals for research Definition of “human subject” is not met
  56. 56. Case 2: Discarded Tumor Specimens  An application describes the following proposed activities:  Investigators will obtain human specimens for basic research from a pathologist who has previously collected tumor specimens from cancer patients.  The pathologist will de-identify the data so that he/she and the investigators will not know the identities of the samples.
  57. 57. Case 2: Are the recipient investigators conducting human subjects research?  The recipient investigators are not conducting human subjects research, because  They have received existing de- identified data  There is no way they can ever access the identities of the samples  Data has been anonymized
  58. 58. What is meant by existing data? Data has already been collected at the time the proposal was conceived Existing data had been collected for purposes other than the proposed research Applies to retrospective studies involving already collected data where data must be “on the shelf” when the protocol is initiated.
  59. 59. THANK YOU Tamer Hifnawy MD. Dr PH. Associate Professor of Public Health & Community Medicine Faculty of Medicine, Beni Suef University, Egypt College of Dentistry, Taibah University, KSA Vice Dean for Quality and Development Certified Trainer in International Research Ethics Email: tamer.hifnawy@bsu.edu.eg thifnawy@yahoo.com Mobile: +201114130107 Egypt +966564356123 KSA

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