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Ethical issues in biomedical research

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The Presentation will take the reader through various ethical issues in biomedical research. It covers topics like The Nuremberg Code, Declaration of Helsinki, Declaration of Geneva, selected code and regulations that guide research with human subjects, etc.

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Ethical issues in biomedical research

  1. 1. ETHICAL ISSUES INETHICAL ISSUES IN BIOMEDICAL RESEARCHBIOMEDICAL RESEARCH Dr. SUMAN BAISHNABDr. SUMAN BAISHNAB
  2. 2. INTRODUCTIONINTRODUCTION  The Word Ethics derives from the Greek word – Ethikos  Meaning - Moral principles governing human character & conduct Medical Ethics include:  Moral values and judgments applied to medicine  Ethical guidelines governing the health care system – both medical practice and research
  3. 3. EVOLUTION OF THE CONCEPTEVOLUTION OF THE CONCEPT  The concept of ethics in western clinical practice was introduced as early in 400 BC-by the father of modern medicine “Hippocrates”  In Indian Medicine  Siddha follow Theraiyars  Ayurvedha follow Charaka  Muslim physicians – ‘conduct of a physician’ by Ishaq bin Ali Rahawi
  4. 4. TO QUOTE FROM HIPPOCRATESTO QUOTE FROM HIPPOCRATES -Written 400 B.C.-Written 400 B.C. I SWEAR by Apollo the physician, and Aesculapius, and Health, and All-heal, and all the gods and goddesses, that, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous I will give no deadly medicine to any one if asked, nor suggest any such counsel……….
  5. 5.  This term was introduced by a British Doctor Thomas Percival (1705 – 1804)  In 1847, the American Medical Association adopted its first code of ethics – based mainly on Thomas Percival’s work  In 1960 – 1970 – “Medical Ethics” (internal concerns of the professions) has gone through dramatic shift into “Bio ethics”(matters of public, political debate). EVOLUTION OF THE CONCEPT…EVOLUTION OF THE CONCEPT…
  6. 6. MEDICO ETHICAL DECLINE – A HISTORYMEDICO ETHICAL DECLINE – A HISTORY  During World War II, the Nazi regime in Germany-- human medical experimentation on large numbers of people in its concentration camps  In particular, Josef Mengele’s experiments on prisoners at Auschwitz earned him the nicknames “the Angel of Death” and “Dr. Death”  Between 1937 and 1945, Japanese medical personnel participated in the torture killings of as many as 10,000 Chinese and Korean prisoners during the II Sino – Japanese War
  7. 7. MEDICO ETHICAL DECLINE – AMEDICO ETHICAL DECLINE – A HISTORY…HISTORY…  During world War II, the Japanese tried out various biological weapons on Chinese subjects  Japanese surgeons also performed vivisection and other medical experiments to torture American prisoners of war in several islands of the Pacific
  8. 8. The following are some of the unethicalThe following are some of the unethical and cruel experiments conducted byand cruel experiments conducted by Nazis which led to theNazis which led to the ““ Nuremberg CodeNuremberg Code ”” 1. Experiments on twins 2. Freezing experiments 3. Malarial experiments 4. Mustard gas experiments 5. Sulfonamide experiments 6. Sea water experiments 7. Sterilization experiments 8. Typhus experiments 9. Experiments with poison 10. Incendiary bomb experiments 11. High altitude experiments
  9. 9. Evidences for Some of the Experiments
  10. 10. Evidences for Some of the Experiments…
  11. 11. Evidences for Some of the Experiments…
  12. 12. AFTERMATHAFTERMATH  Many diedMany died  Murdered to study the post mortem effectsMurdered to study the post mortem effects  survivors left mutilated, suffering permanentsurvivors left mutilated, suffering permanent disability, weakened bodies, and mentaldisability, weakened bodies, and mental distressdistress  On August 19,1947, the doctors captured byOn August 19,1947, the doctors captured by allied forces were put on trial in USA,allied forces were put on trial in USA, commonly known as the Doctors’ Trialcommonly known as the Doctors’ Trial
  13. 13. THE NUREMBERG CODETHE NUREMBERG CODE  Verdict delivered AugustVerdict delivered August 19, 194919, 1949  Subsequently, Dr. LeoSubsequently, Dr. Leo Alexander and AndrewAlexander and Andrew Canway Ivy drafted aCanway Ivy drafted a ten point memorandum,ten point memorandum, Permissible MedicalPermissible Medical Experiments –Experiments – ““The NurembergThe Nuremberg Code”Code”
  14. 14. The Ten Points of the Nuremberg Code 1.The voluntary consent of the human subject is absolutely essential This means that the person involved should have legal capacity to give consent; exercise free power of choice, without the intervention of any element of force, fraud, dishonesty, pressure, over-reaching, or other hidden form of constraint or force; ……. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engage in the experiment
  15. 15. The Ten Points of the Nuremberg Code… 2.The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature 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 will justify the performance of the experiment
  16. 16. The Ten Points of the Nuremberg Code… 4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury 5.No experiment should be conducted where there is 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
  17. 17. The Ten Points of the Nuremberg Code… 7.7.Proper preparations should be made andProper preparations should be made and adequate facilities provided to protect theadequate facilities provided to protect the experimental subject against even remoteexperimental subject against even remote possibilities of injury, disability, or deathpossibilities of injury, disability, or death 8.8.The experiment should be conducted only byThe experiment should be conducted only by scientifically qualified persons. The highestscientifically qualified persons. The highest degree of skill and care should be requireddegree of skill and care should be required through all stages of the experiment of those whothrough all stages of the experiment of those who conduct or engage in the experimentconduct or engage in the experiment
  18. 18. 9.9.During the course of the experiment the humanDuring the course of the experiment the human subject should be at liberty to bring thesubject should be at liberty to bring the experiment to an end if he has reached theexperiment to an end if he has reached the physical or mental state where continuation ofphysical or mental state where continuation of the experiment seems to him to be impossiblethe experiment seems to him to be impossible 10.10.During the course of the experiment theDuring the course of the experiment the scientist in charge must be prepared toscientist in charge must be prepared to terminate the experiment at any stage, if he hasterminate the experiment at any stage, if he has probable cause to believe, in the exercise ofprobable cause to believe, in the exercise of the good faith, superior skill and carefulthe good faith, superior skill and careful judgment required of him that a continuation ofjudgment required of him that a continuation of the experiment is likely to result in injury,the experiment is likely to result in injury, disability, or death to the experimental subjectdisability, or death to the experimental subject The Ten Points of the Nuremberg Code…
  19. 19. DECLARATION OF GENEVA  TheThe Declaration of GenevaDeclaration of Geneva was adopted bywas adopted by the General Assembly of thethe General Assembly of the World MedicalWorld Medical Association at GenevaAssociation at Geneva in 1948 and amended inin 1948 and amended in 1968, 1984, 1994, 2005 and 20061968, 1984, 1994, 2005 and 2006  It is a declaration of physicians' dedication toIt is a declaration of physicians' dedication to the humanitarian goals of medicine, athe humanitarian goals of medicine, a declaration that was especially important indeclaration that was especially important in view of the medical crimes which had just beenview of the medical crimes which had just been committed in Nazi Germanycommitted in Nazi Germany  The Declaration of Geneva was intended as aThe Declaration of Geneva was intended as a revision of the Oath of Hippocrates to arevision of the Oath of Hippocrates to a formulation of that oath's moral truthsformulation of that oath's moral truths
  20. 20. THE DECLARATION OF GENEVA AMENDED – 2006, READS… At the time of being admitted as a member of theAt the time of being admitted as a member of the medical profession:medical profession:  I solemnly pledge to dedicate my life to theI solemnly pledge to dedicate my life to the service of humanityservice of humanity  I will give to my teachers the respect andI will give to my teachers the respect and gratitude that is their duegratitude that is their due  I will practise my profession with morality andI will practise my profession with morality and dignitydignity
  21. 21. THE DECLARATION OF GENEVA…  The health of my patient will be my firstThe health of my patient will be my first considerationconsideration I will respect the secrets that are confided in me,I will respect the secrets that are confided in me, even after the patient has diedeven after the patient has died I will maintain by all the means in my power, theI will maintain by all the means in my power, the honour and the noble traditions of the medicalhonour and the noble traditions of the medical professionprofession  My colleagues will be my sisters and brothersMy colleagues will be my sisters and brothers
  22. 22. THE DECLARATION OF GENEVA… I will not permit considerations of age, diseaseI will not permit considerations of age, disease or disability, creed, ethnic origin, gender,or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexualnationality, political affiliation, race, sexual orientation, social standing or any other factor toorientation, social standing or any other factor to intervene between my duty and my patientintervene between my duty and my patient  I will maintain the utmost respect for human lifeI will maintain the utmost respect for human life  I will not use my medical knowledge to violateI will not use my medical knowledge to violate human rights and civil liberties, even underhuman rights and civil liberties, even under threatthreat  I make these promises solemnly, freely andI make these promises solemnly, freely and upon my honorupon my honor
  23. 23. THE DECLARATION OF HELSINKI- 1964  The “Declaration of Helsinki”, first published by World Medical Association in 1964  Addresses international standards primarily for physicians involved inphysicians involved in biomedical research  But, WMA encouragesBut, WMA encourages otherother participants in medical researchparticipants in medical research involving human subjects to adoptinvolving human subjects to adopt these principlesthese principles  Cited as a reference in most national or international guidelines
  24. 24. THE DECLARATION OF HELSINKI- 1964… The heart of the declaration is the statement that “The well-being of the human subject should take precedence over the interests of science and society" It also gives special attention to the importance of written informed consent  The Helsinki declaration has beenThe Helsinki declaration has been amendedamended sixsix times since,times since, most recently in October 2008most recently in October 2008  The current (2008) version is the only official one; all previous versions have been replaced and should not be used or cited except for historical purposes (http://www.wma.net/e/policy/pdf/17c.pdf)
  25. 25.  The Belmont Report (1979)The Belmont Report (1979)  CIOMS International Ethical Guidelines forCIOMS International Ethical Guidelines for Biomedical Research Involving HumanBiomedical Research Involving Human Subjects (2002)Subjects (2002)  International Conference on HarmonizationInternational Conference on Harmonization Guidelines for Good Clinical Practice (1996)Guidelines for Good Clinical Practice (1996)  Title 45 US CFR, Part 46–The Common RuleTitle 45 US CFR, Part 46–The Common Rule  Title 21 US CFR, Parts 50 and 56Title 21 US CFR, Parts 50 and 56  ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)Research on Human Participants (2006) SELECTED CODES AND REGULATIONS GUIDING RESEARCH WITH HUMAN SUBJECTS
  26. 26. The Belmont Report (1979)The Belmont Report (1979) Published by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Describes three broad ethical principles that guide the conduct of bio medical research, viz. Respect for Persons – Informed Consent Beneficence – Risk-Benefit Evaluation Justice – Selection of Research Subjects
  27. 27. CIOMS International Ethical Guidelines forCIOMS International Ethical Guidelines for Biomedical Research Involving Human SubjectsBiomedical Research Involving Human Subjects The Council of International Organizations of Medical Sciences (CIOMS) in conjunction with the World Health Organization (WHO) issued this guideline (lastly amended in 2002) Adopts the three ethical principles of Belmont Report and maintains most of the tenets of Nuremberg and Helsinki But provides additional and valuable guidance and commentary on externally sponsored research and research with vulnerable populations
  28. 28. Title 45 of the U.S. Code of Federal Regulations,Title 45 of the U.S. Code of Federal Regulations, Part 46 (45 CFR 46)Part 46 (45 CFR 46) The Common Rule stipulates both the membership and the function of IRBs and specifies the criteria an IRB should employ when reviewing a research protocol and determining whether to approve it. The Common Rule also delineates the types of information that should be included in an informed consent document and how consent should be documented. Subparts B, C, and D of 45CFR46 describe additional protections for DHHS (United States Department of Health & Human Services) funded research with fetuses and pregnant women, prisoners, and children, respectively.
  29. 29. Title 21 of the U.S. Code of Federal Regulations,Title 21 of the U.S. Code of Federal Regulations, Part 50 & 56 (21 CFR 50 & 21 CFR 56 )Part 50 & 56 (21 CFR 50 & 21 CFR 56 ) Part 50 – “Protection of Human Subjects” Part 56 – “Institutional Review Boards” Contain regulations that are similar, but not identical, to those found in the “Common Rule” Compliance with FDA regulations is required for research that is testing a drug, biologic, or medical device for which FDA approval will ultimately be sought
  30. 30. ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)Research on Human Participants (2006) Any research using the human beings as participants shall follow the principles given below 1. Principle of Essentiality Necessary for the advancement of knowledge and for the benefit of all members of the human species and for the ecological and environmental well-being
  31. 31. ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)…Research on Human Participants (2006)… 2.Principles of voluntariness, informed consent  Research subjects are fully explained of the research, the impact and risk of such research on the research subject and others.  Research subjects retain the right to abstain from further participation in the research irrespective of any legal or other obligation.
  32. 32. ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)…Research on Human Participants (2006)… 3.Principles of non-exploitation Research subjects should be remuneratedResearch subjects should be remunerated 4.Principles of Privacy and Confidentiality The identity and records of the human subjectsThe identity and records of the human subjects of the research or experiment are as far asof the research or experiment are as far as possible kept confidentialpossible kept confidential
  33. 33. ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)…Research on Human Participants (2006)… 5.Principles of precaution and risk minimization  Due care and caution taken at all stages ofDue care and caution taken at all stages of research (research (from its inception as a research idea,from its inception as a research idea, its subsequent research design, the conduct ofits subsequent research design, the conduct of research or experiment and its applicative useresearch or experiment and its applicative use)) to ensure that research subjects are put toto ensure that research subjects are put to minimum risk, suffer from no irreversibleminimum risk, suffer from no irreversible adverse effects and, benefit from researchadverse effects and, benefit from research
  34. 34. ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)…Research on Human Participants (2006)… 6.Principle of professional competence The research is conducted at all times byThe research is conducted at all times by competent and qualified persons who act withcompetent and qualified persons who act with total integrity and impartiality and who have beentotal integrity and impartiality and who have been made aware of, and are mindful of, the ethicalmade aware of, and are mindful of, the ethical considerations to be borne in mind in respect ofconsiderations to be borne in mind in respect of such research or experimentsuch research or experiment
  35. 35. ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)…Research on Human Participants (2006)… 7.Principles accountability and transparency Research/ experiment will be conducted in aResearch/ experiment will be conducted in a fair, honest, impartial and transparent mannerfair, honest, impartial and transparent manner 8.Principles of maximization of public interest and of distributive justice Research should benefit all humans, inResearch should benefit all humans, in particular, the research subjectsparticular, the research subjects
  36. 36. ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)…Research on Human Participants (2006)… 9.Principles of institutional arrangements Take all appropriate steps to ensure thatTake all appropriate steps to ensure that research reports, materials and data connectedresearch reports, materials and data connected with the research are duly preserved andwith the research are duly preserved and archivedarchived 10.Principles of public domain Results are generally made known throughResults are generally made known through scientific and other publications subject to suchscientific and other publications subject to such rights as are available to the researcher andrights as are available to the researcher and those associatedthose associated
  37. 37. ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)…Research on Human Participants (2006)… 11.Principles of totality of responsibility The researchers Funding agency The institution(s) where research is conducted Persons, groups or undertakings who sponsor, use or derive benefit from research, market the product (if any) or prescribe its use
  38. 38. ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)…Research on Human Participants (2006)… 12.Principles of compliance Guidelines specifically laid down or prescribed for that research or experimentation, are meticulously observed and duly complied with
  39. 39. ICMR - Ethical Guidelines for BiomedicalICMR - Ethical Guidelines for Biomedical Research on Human Participants (2006)…Research on Human Participants (2006)… Out of these 12 principles the following areOut of these 12 principles the following are given the prioritygiven the priority  Autonomy of the individualAutonomy of the individual  BeneficenceBeneficence  Non-malficenceNon-malficence  JusticeJustice
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The Presentation will take the reader through various ethical issues in biomedical research. It covers topics like The Nuremberg Code, Declaration of Helsinki, Declaration of Geneva, selected code and regulations that guide research with human subjects, etc.

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