Ethical issues in research 2

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  • Medical ethics are the moral guidelines and ethical laws that help to prioritize a medical professional's work responsibilities. The code of medical ethics outlines the proper conduct between medical professionals and their patients, communities, and colleagues. Each country has a different code of medical ethics, though most contain the same basic principles, and all share the same history of evolution, according to the World Medical Association.
  • Hippocratic Oath The first basic guideline for medical ethics was introduced during the life of Hippocrates, a classical Greek physician who lived between 460 and 377 BC. Hippocrates' three-word phrase created the first ethical law in the field of medicine. The phrase, now known as the Hippocratic Oath, began as the simple phrase, "Do no harm," and evolved into the 181-word vow recited at modern medical school graduation ceremonies. Read more: The History of Medical Ethics | eHow.com http://www.ehow.com/about_5572014_history-medical-ethics.html#ixzz3jRL53UdC Euthanasia - refers to the practice of intentionally ending a life in order to relieve pain and suffering.
  • Nazi human experimentation was medical experimentation on large numbers of people by the German Nazi regime in its concentration camps during World War II. These experiments were supposedly designed to help German military personnel in combat situations, and to aid in the recovery of military personnel that had been injured,
  • A chemical agent that attacks the skin and eyes, mustard gas is one of the best known and most potent chemical weapons. It causes severe blisters
  • Declaration of Helsinki -is a set of 12 principles adopted by the World Medical Association in 1964 to guide physicians.
  • enhancements of health or knowledge must be derived from the research;
  • the research must be methodologically rigorous
  • unaffiliated individuals must review the research and approve, amend, or terminate it
  • Informed consent is the process whereby human participants in a research project are provided with all the information needed so that they can decide whether to participate. The elements that must be provided are:
  • subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored.

Transcript

  • 1. Research ethics & ethicalResearch ethics & ethicalclearanceclearanceKantha LankatilakeKantha LankatilakeSenior LecturerSenior LecturerDept. of Community MedicineDept. of Community MedicineFaculty of Medicine, ColomboFaculty of Medicine, Colombo
  • 2. EthicsEthics a set of principles that determine thea set of principles that determine theright and acceptable conductright and acceptable conductHippocratic OathHippocratic Oath
  • 3. Main principles of the Hippocratic Oath areMain principles of the Hippocratic Oath aresummarised as,summarised as, do no harmdo no harm not to assist suicide or administernot to assist suicide or administereuthanasiaeuthanasia not to cause abortionnot to cause abortion to refer patients for specialized treatmentto refer patients for specialized treatment not to abuse professional relationships,not to abuse professional relationships,especially for sexual motivesespecially for sexual motives to maintain patient’s confidenceto maintain patient’s confidence
  • 4. Research ethicsResearch ethicsThe application of moral rules and professionalThe application of moral rules and professionalcodes of conduct to the collection, analysis,codes of conduct to the collection, analysis,reporting, and publication of information aboutreporting, and publication of information aboutresearch subjects, in particular active acceptanceresearch subjects, in particular active acceptanceof subjects right to privacy, confidentiality, andof subjects right to privacy, confidentiality, andinformed consent.informed consent.
  • 5. How did research ethics evolve?How did research ethics evolve?
  • 6. Tuskegee Study ( Alabama)Tuskegee Study ( Alabama)1932 -19721932 -1972 399 poor and mostly illiterate Negro males suffering from399 poor and mostly illiterate Negro males suffering fromSyphilis were studied to observe the natural progression ofSyphilis were studied to observe the natural progression ofthe disease.the disease. The subjects were not told they had syphilis andThe subjects were not told they had syphilis andconsequently they went into infecting many of their wives,consequently they went into infecting many of their wives,which resulted in 19 of their children being born withwhich resulted in 19 of their children being born withcongenital syphilis.congenital syphilis. by 1947 penicillin had become the standard treatment forby 1947 penicillin had become the standard treatment forsyphilis. However, the treatment was withheld.syphilis. However, the treatment was withheld. Plenty of papers were published from this study. EventuallyPlenty of papers were published from this study. Eventuallythe study was leaked to the press and the programme wasthe study was leaked to the press and the programme wasterminated.terminated.
  • 7. Nazi human experimentationNazi human experimentationearly 1940’searly 1940’s Experiments carried out on large numbers ofExperiments carried out on large numbers ofprisoners in concentrated camps by the Germanprisoners in concentrated camps by the GermanNazi regime during World War IINazi regime during World War II They were forced into participatingThey were forced into participating Typically, the experiments resulted in death,Typically, the experiments resulted in death,disfigurement or permanent disability of thedisfigurement or permanent disability of thesubjectssubjects
  • 8. Nazi human experimentationNazi human experimentationFreezing/hypothermia experiment - 1941Freezing/hypothermia experiment - 1941 Victims troops; healthy Jews/RussiansVictims troops; healthy Jews/Russians They were usually stripped naked andThey were usually stripped naked andprepared for the experimentprepared for the experiment A insulated probe was inserted into theA insulated probe was inserted into therectum to measured the drop in therectum to measured the drop in thebody temperaturebody temperature The victimThe victim put into an air force uniform,was then placed in the tub of coldwas then placed in the tub of coldwater and started to freezewater and started to freeze Results: most victims lostResults: most victims lostconsciousness and died (about a 100)consciousness and died (about a 100)when the body temperature dropped towhen the body temperature dropped to77 °F (25 °C).Results of these experiments were published at the 1942 medical conference entitled,“medical problems arising from sea and winter”.
  • 9. Nazi human experimentationNazi human experimentation Malaria experiments (1942-1945) – conducted on over1200 prisoners to test for immunization and treatment of malaria.to test for immunization and treatment of malaria.Prisoners were infected by mosquitoes or by injections of extracts ofPrisoners were infected by mosquitoes or by injections of extracts ofthe mucous glands of female mosquitoes. About a half died of thethe mucous glands of female mosquitoes. About a half died of thedisease and subsequent complications.disease and subsequent complications. Mustard gas experiments (1939-1945) -Mustard gas experiments (1939-1945) - subjects weresubjects weredeliberately exposed to mustard gas which inflicted severe chemicaldeliberately exposed to mustard gas which inflicted severe chemicalburns . Then they were tested to find the most effective treatment forburns . Then they were tested to find the most effective treatment forthe mustard gas burns.the mustard gas burns. Sulfonamide experiments (1942-1943) - WoundsWoundsinflicted on the subjects were infected with bacteria, such asinflicted on the subjects were infected with bacteria, such asStreptococcus, gas gangrene and tetanus.Streptococcus, gas gangrene and tetanus. Blood circulation to theseBlood circulation to thesewounds was interrupted to create a condition similar to that of awounds was interrupted to create a condition similar to that of abattlefield wound. Infection was aggravated by forcing wood shavingsbattlefield wound. Infection was aggravated by forcing wood shavingsand ground glass into the wounds. The infection was treated withand ground glass into the wounds. The infection was treated withsulfonamide and other drugs to determine their effectiveness.sulfonamide and other drugs to determine their effectiveness.
  • 10. Aftermath of the experimentationAftermath of the experimentation Many of the subjects died, many others were murdered afterMany of the subjects died, many others were murdered afterthe tests were completed to carryout a post mortem. Thosethe tests were completed to carryout a post mortem. Thosewho survived were often left mutilated, suffering permanentwho survived were often left mutilated, suffering permanentdisability, weakened bodies, and mental duress.disability, weakened bodies, and mental duress. On August 19, 1947, the doctors captured by Allied forcesOn August 19, 1947, the doctors captured by Allied forceswere put on trial in USAwere put on trial in USA –– Doctor’s trialDoctor’s trial.. At the trial, severalAt the trial, severalof the doctors argued in their defense that there was noof the doctors argued in their defense that there was nointernational law regarding medical experimentation.international law regarding medical experimentation. This led to the development of theThis led to the development of the Nuremberg Code ofNuremberg Code ofmedical ethics.medical ethics.
  • 11. Nuremberg Code - 1949Nuremberg Code - 1949The code calls for standards such as,The code calls for standards such as, voluntary consent of human subjectsvoluntary consent of human subjects to recognize that the risks must out weigh theto recognize that the risks must out weigh theexpected benefit, and that unnecessary pain andexpected benefit, and that unnecessary pain andsuffering must be avoided.suffering must be avoided. doctors should avoid actions that injuredoctors should avoid actions that injurehuman patients.human patients.Nuremberg code was updated by WHO as theNuremberg code was updated by WHO as theDeclaration of Helsinki (1964)Declaration of Helsinki (1964)
  • 12. In 1972 with the termination of theIn 1972 with the termination of the Tuskegee Study The,The, National Commission for the Protection of HumanNational Commission for the Protection of HumanSubjects of Biomedical and Behavioral ResearchSubjects of Biomedical and Behavioral Research and theand theNational Research ActNational Research Act were established.were established.The act required the establishment ofThe act required the establishment of Institutional ReviewInstitutional ReviewBoards (IRBs)Boards (IRBs) Special consideration was given to ethnic minorities andSpecial consideration was given to ethnic minorities andvulnerable groups in the design of clinical studies.vulnerable groups in the design of clinical studies.
  • 13. Codes and GuidelinesCodes and Guidelines Nuremberg CodeNuremberg Code (1949)(1949) Declaration Of HelsinkiDeclaration Of Helsinki (1964- 2000)(1964- 2000) The Belmont ReportThe Belmont Report (1979)(1979) CIOMS/WHO International GuidelinesCIOMS/WHO International Guidelines (1993, 2002)(1993, 2002) ICH/GCP-International Conference onICH/GCP-International Conference onHarmonization- Good Clinical PracticeHarmonization- Good Clinical Practice (1996)(1996)
  • 14. Values that commonly apply to medical ethicsValues that commonly apply to medical ethics Autonomy - right to refuse or choose their treatmentAutonomy - right to refuse or choose their treatment Beneficence – the practitioner should act in the bestBeneficence – the practitioner should act in the bestinterest of the patientinterest of the patient Non-maleficence - do no harmNon-maleficence - do no harm Justice - concerns the distribution of scarce healthJustice - concerns the distribution of scarce healthresources, and the decision of who gets whatresources, and the decision of who gets whattreatment (fairness and equality).treatment (fairness and equality). Dignity - the patient (and the person treating theDignity - the patient (and the person treating thepatient) have the right to dignity.patient) have the right to dignity. Truthfulness and honesty - the concept of informedTruthfulness and honesty - the concept of informedconsentconsent
  • 15. The 7 principlesThe 7 principlesthat makes clinical research ethicalthat makes clinical research ethical
  • 16. 1. Social value1. Social valueIs this research of any value??Is this research of any value?? why do this research?why do this research? if not done would the information be missed?if not done would the information be missed? can the results be generalized?can the results be generalized?Research has no value when,Research has no value when, results unlikely to be disseminatedresults unlikely to be disseminated interventions could never be practically implementedinterventions could never be practically implemented
  • 17. 2. Is this research scientifically valid?2. Is this research scientifically valid?
  • 18. for research to be scientifically valid,for research to be scientifically valid, clear scientific objectivesclear scientific objectives design in relation to objectivesdesign in relation to objectives methodology reliable – produce valid datamethodology reliable – produce valid data practically feasiblepractically feasible principal investigators and the otherprincipal investigators and the otherresearch personnel should be competent.research personnel should be competent.A socially, clinically, or scientifically useful research question that willgenerate useful new knowledge about human healthResearch must be conducted in a methodologically rigorous manner.
  • 19. 3. Fair subject selection3. Fair subject selection JusticeJustice subject selectionsubject selection –– Selection of subjects for reasons ofSelection of subjects for reasons ofscience, related to the purpose of the study, not becausescience, related to the purpose of the study, not becausethey are readily available, vulnerable, or otherwise easilythey are readily available, vulnerable, or otherwise easilyexploited, or are favored.exploited, or are favored.-- select subjects to minimize risks and maximize benefitsselect subjects to minimize risks and maximize benefits-- have clear inclusion/exclusion criteriahave clear inclusion/exclusion criteria
  • 20. 4. Favorable Risk-Benefit Ratio4. Favorable Risk-Benefit Ratiofor research to be ethical, any risks mustfor research to be ethical, any risks mustbe balanced by the benefits to subjectsbe balanced by the benefits to subjects
  • 21. 5. Independent Review5. Independent ReviewMinimize conflict of interestMinimize conflict of interestPublic AccountabilityPublic Accountability Independent review of clinical researchIndependent review of clinical researchensures the public that investigator biasesensures the public that investigator biaseshave not distorted the approach, thathave not distorted the approach, thatethical requirements have been fulfilled,ethical requirements have been fulfilled,and that subjects will not be exploited.and that subjects will not be exploited.
  • 22. 6. Informed consent of subject6. Informed consent of subject
  • 23. What is informed consent ?What is informed consent ?Respect for PersonsRespect for Persons voluntary decision taken by an individual toparticipate in research based on understanding thebased on understanding theobjectives, risks, benefits, and alternatives of theobjectives, risks, benefits, and alternatives of theresearch.research. the principal investigator has responsibility to obtainthe principal investigator has responsibility to obtainvoluntary informed consent (eithervoluntary informed consent (either verbal orverbal orwrittenwritten) from all prospective participants or) from all prospective participants or in the case of individuals who are not capable ofin the case of individuals who are not capable ofgiving informed consent, the permission of theirgiving informed consent, the permission of theirlegally authorized guardians (proxy consent).legally authorized guardians (proxy consent).
  • 24. Components of informed consentComponents of informed consent information sheetinformation sheet seek consent only after the participant hasseek consent only after the participant hasreceived and adequately understood allreceived and adequately understood allnecessary information and the consequencesnecessary information and the consequencesof participation as given in the information sheetof participation as given in the information sheet if written, theif written, the consent formconsent form has to be in all threehas to be in all threelanguageslanguages if written, consent should be obtained byif written, consent should be obtained bysigning on a consent formsigning on a consent form
  • 25. Informed consent contin..Informed consent contin..Information sheet should contain Self introduction – from where & who you are;Self introduction – from where & who you are; purpose of the research;purpose of the research; description of benefits from participating;description of benefits from participating; description of risks from participating;description of risks from participating; details of time commitment required;details of time commitment required; details of any remuneration;details of any remuneration; plans to ensure the confidentiality of data;plans to ensure the confidentiality of data; details about the right to withdraw at any time for any reason;details about the right to withdraw at any time for any reason; information about how to communicate a decision to withdraw from theinformation about how to communicate a decision to withdraw from thestudy;study; name(s) of investigator(s) contact details.name(s) of investigator(s) contact details.The wording should suit the individual’s level of understanding
  • 26. 7. Respect for enrolled subjects7. Respect for enrolled subjectsBeneficence and Respect for PersonsBeneficence and Respect for Persons should be concerned about the wellbeing of the subjectsshould be concerned about the wellbeing of the subjectsas the study proceedsas the study proceeds assure confidentiality of informationassure confidentiality of information permitting them to change their mind – withdraw withoutpermitting them to change their mind – withdraw withoutpenaltypenalty informed of new information – new risks /treatmentinformed of new information – new risks /treatment share results of subjectsshare results of subjects ensure privacyensure privacy maintain anonymitymaintain anonymity minimise disruption to workminimise disruption to work
  • 27. As for research ethics, where do we standAs for research ethics, where do we standtoday?today? Faculty of Medicine, University of Colombo was the firstFaculty of Medicine, University of Colombo was the firstinstitution in Sri Lanka to establish an institutional Ethicsinstitution in Sri Lanka to establish an institutional EthicsReview Committee, in 1981.Review Committee, in 1981. In 1991, NARESA drew up a draft code for scientificIn 1991, NARESA drew up a draft code for scientificresearch, animal experimentation, biomedical researchresearch, animal experimentation, biomedical researchon humans and social sciences research.on humans and social sciences research. Since then several organisations such as, SLMA, SLAAS,Since then several organisations such as, SLMA, SLAAS,Min. of Health, NASTEC, NSF, SLMC have set up theirMin. of Health, NASTEC, NSF, SLMC have set up theirown institutional Ethics Review Committee.own institutional Ethics Review Committee. Ethical review is mandatory for the presentation andEthical review is mandatory for the presentation andpublication of research.publication of research.
  • 28. Ethics Review Committee, Faculty of MedicineEthics Review Committee, Faculty of Medicinereceived renewal of SIDCER/FERCAP Recognitionreceived renewal of SIDCER/FERCAP RecognitionAward for 2012-2016 on 21Award for 2012-2016 on 21ststNovember 2012November 2012"The Strategic Initiative for Developing Capacity inEthical Review” (SIDCER) is a network of independentlyestablished regional fora for ethical review committees
  • 29. Process for ethical clearanceProcess for ethical clearanceEthics Review CommitteeEthics Review CommitteeFaculty of MedicineFaculty of MedicineUniversity of ColomboUniversity of Colombo
  • 30. Submission of application to the ERC/FM-ColomboSubmission of application to the ERC/FM-Colombo Standard Operating Procedures (SOP) Ethics Review Committee,Standard Operating Procedures (SOP) Ethics Review Committee,Faculty of Medicine, University of Colombo, version 3 June 2012Faculty of Medicine, University of Colombo, version 3 June 2012 Purpose: To describe the overall function and scope of responsibilities ofthe ERC OVERALL FUNCTION of the ERC, FM-ColomboOVERALL FUNCTION of the ERC, FM-Colombo1. is to protect the mental and physical welfare, rights, dignity and1. is to protect the mental and physical welfare, rights, dignity andsafety of human participants and animals used in research, to facilitatesafety of human participants and animals used in research, to facilitateethical research through efficient and effective review and monitoringethical research through efficient and effective review and monitoringprocesses, to promote ethical standards of human and animalprocesses, to promote ethical standards of human and animalresearch and to review research in accordance with theresearch and to review research in accordance with the Guidelines ofGuidelines ofthe Forum of Ethics Review Committees in Sri Lanka (FERCSLthe Forum of Ethics Review Committees in Sri Lanka (FERCSLGuidelines) and relevant national and international guidelines.Guidelines) and relevant national and international guidelines.
  • 31. SCOPE OF RESPONSIBILITIESSCOPE OF RESPONSIBILITIESi. To provide independent, competent and timely review and monitoring ofi. To provide independent, competent and timely review and monitoring ofhuman research projects in respect of their ethical acceptability.human research projects in respect of their ethical acceptability.ii. To provide ethical oversight, monitoring and advice for human andii. To provide ethical oversight, monitoring and advice for human andanimal research projects.animal research projects.iii. To prescribe the principles and procedures to govern human researchiii. To prescribe the principles and procedures to govern human researchprojects including those involving human tissue and/or personal records.projects including those involving human tissue and/or personal records.
  • 32. Applications received by ERCPreliminary reviewComments / Requests forRevisionAllocation of the proposalsRevised/ AmmendedproposalRegular reviewExempt from ReviewExpedited ReviewExecutive Committee Send to ReviewersDecisionRequest for RevisionsApproval Approval with conditionsRejectionEthical ClearanceResubmissionEthics Review ProcessEthics Review Committee, Faculty of Medicine, University of ColomboAgreement for theconditions
  • 33. ReferencesReferences bioethics.nih.gov/slides/10-29-03-Emmanuel.pdfbioethics.nih.gov/slides/10-29-03-Emmanuel.pdf http://www.pgis.lk/download/forms/uniform_guidelines.pdf http://www.pgis.lk/download/forms/uniform_guidelines.pdf  Emanuel E, Wendler D, Grady C. What makes clinical researchEmanuel E, Wendler D, Grady C. What makes clinical researchethical?ethical? Journal of the American Medical AssociationJournal of the American Medical Association 2000;2000;283(20):2701-11283(20):2701-11 http://fercsl.net/Colombo%20ERC%20SOP%20version%202.2.pdfhttp://fercsl.net/Colombo%20ERC%20SOP%20version%202.2.pdf