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Planning Your Study: Ethical Considerations Forest Arnold, DO, MSc Assistant Professor, Division of Infectious Diseases, University of Louisville Hospital.

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Presentation on theme: "Planning Your Study: Ethical Considerations Forest Arnold, DO, MSc Assistant Professor, Division of Infectious Diseases, University of Louisville Hospital."— Presentation transcript:

1 Planning Your Study: Ethical Considerations Forest Arnold, DO, MSc Assistant Professor, Division of Infectious Diseases, University of Louisville Hospital Epidemiologist, University of Louisville Hospital August 10 th, 2012

2 2 ObjectivesObjectives 1)To review the need for medical ethics 2)To apply medical ethics to clinical scenarios

3 3 OutlineOutline Introduction The history of ethics in research Ethical Principles Responsibilities of investigators Other ethical issues Introduction The history of ethics in research Ethical Principles Responsibilities of investigators Other ethical issues

4 4 OutlineOutline Introduction The history of ethics in research Ethical Principles Responsibilities of investigators Other ethical issues Introduction The history of ethics in research Ethical Principles Responsibilities of investigators Other ethical issues

5 5 Tuskegee Syphilis Trial

6 6 Tuskegee Key Ethical Issues Informed Consent and Deception Not only were the subjects not informed, they were intentionally deceived. [At the time informed consent was not generally accepted for medical research. The US Public Health Service didn’t start requiring in until 1966.] Informed Consent and Deception Not only were the subjects not informed, they were intentionally deceived. [At the time informed consent was not generally accepted for medical research. The US Public Health Service didn’t start requiring in until 1966.]

7 7 Tuskegee Key Ethical Issues Beneficence Because no treatments were given to the subjects, the risk/benefit ratio was unbalanced here. The risk outweighed the benefit. Beneficence Because no treatments were given to the subjects, the risk/benefit ratio was unbalanced here. The risk outweighed the benefit.

8 8 Tuskegee Key Ethical Issues Racism – Justice There was discrimination in the selection of research subjects There was also discrimination in judgments regarding the degree of risks to which the men could be subjected. Racism – Justice There was discrimination in the selection of research subjects There was also discrimination in judgments regarding the degree of risks to which the men could be subjected.

9 9 History of Ethics in Research 1721 – Variola vaccine in Newgate prisoners 1776 – Edward Jenner 1803 – Thomas Percival 1721 – Variola vaccine in Newgate prisoners 1776 – Edward Jenner 1803 – Thomas Percival Prisoners were pardoned if they agreed to undergo vaccination Began series of cowpox vaccinations First ethical guidelines Prisoners were pardoned if they agreed to undergo vaccination Began series of cowpox vaccinations First ethical guidelines

10 10 History of Ethics in Research 1721 – Variola vaccine in Newgate prisoners 1776 – Edward Jenner 1803 – Thomas Percival ~1850 – William Beaumont 1931 – Reichgesundheitsrat Circular 1721 – Variola vaccine in Newgate prisoners 1776 – Edward Jenner 1803 – Thomas Percival ~1850 – William Beaumont 1931 – Reichgesundheitsrat Circular Prisoners were pardoned if they agreed to undergo vaccination Began series of cowpox vaccinations First ethical guidelines Concept of informed consent Guidelines with informed consent Prisoners were pardoned if they agreed to undergo vaccination Began series of cowpox vaccinations First ethical guidelines Concept of informed consent Guidelines with informed consent

11 11 History of Ethics in Research 1721 – Variola vaccine in Newgate prisoners 1776 – Edward Jenner 1803 – Thomas Percival ~1850 – William Beaumont 1931 – Reichgesundheitsrat Circular ~1950 – Nuremburg Code sdfgsdgsdfg 1721 – Variola vaccine in Newgate prisoners 1776 – Edward Jenner 1803 – Thomas Percival ~1850 – William Beaumont 1931 – Reichgesundheitsrat Circular ~1950 – Nuremburg Code sdfgsdgsdfg Prisoners were pardoned if they agreed to undergo vaccination Began series of cowpox vaccinations First ethical guidelines Concept of informed consent Guidelines with informed consent “The voluntary consent of the human subject is absolutely essential” Prisoners were pardoned if they agreed to undergo vaccination Began series of cowpox vaccinations First ethical guidelines Concept of informed consent Guidelines with informed consent “The voluntary consent of the human subject is absolutely essential”

12 12 History of Ethics in Research 1721 – Variola vaccine in Newgate prisoners 1776 – Edward Jenner 1803 – Thomas Percival ~1850 – William Beaumont 1931 – Reichgesundheitsrat Circular ~1950 – Nuremburg Code sdfgsdfgsdfg 1964 – Declaration of Helsinki 1978 – Belmont Report 1981 – Common Rule 1721 – Variola vaccine in Newgate prisoners 1776 – Edward Jenner 1803 – Thomas Percival ~1850 – William Beaumont 1931 – Reichgesundheitsrat Circular ~1950 – Nuremburg Code sdfgsdfgsdfg 1964 – Declaration of Helsinki 1978 – Belmont Report 1981 – Common Rule Prisoners were pardoned if they agreed to undergo vaccination Began series of cowpox vaccinations First ethical guidelines Concept of informed consent Guidelines with informed consent “The voluntary consent of the human subject is absolutely essential” World Medical Association National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Prisoners were pardoned if they agreed to undergo vaccination Began series of cowpox vaccinations First ethical guidelines Concept of informed consent Guidelines with informed consent “The voluntary consent of the human subject is absolutely essential” World Medical Association National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

13 13 History of Ethics in Research 1721 – Variola vaccine in Newgate prisoners 1776 – Edward Jenner 1803 – Thomas Percival ~1850 – William Beaumont 1931 – Reichgesundheitsrat Circular ~1950 – Nuremburg Code sdfgsdfgsdfg 1964 – Declaration of Helsinki 1978 – Belmont Report 1981 – Common Rule 1721 – Variola vaccine in Newgate prisoners 1776 – Edward Jenner 1803 – Thomas Percival ~1850 – William Beaumont 1931 – Reichgesundheitsrat Circular ~1950 – Nuremburg Code sdfgsdfgsdfg 1964 – Declaration of Helsinki 1978 – Belmont Report 1981 – Common Rule Prisoners were pardoned if they agreed to undergo vaccination Began series of cowpox vaccinations First ethical guidelines Concept of informed consent Guidelines with informed consent “The voluntary consent of the human subject is absolutely essential” World Medical Association National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Prisoners were pardoned if they agreed to undergo vaccination Began series of cowpox vaccinations First ethical guidelines Concept of informed consent Guidelines with informed consent “The voluntary consent of the human subject is absolutely essential” World Medical Association National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1964 – Declaration of Helsinki 1978 – Belmont Report 1964 – Declaration of Helsinki 1978 – Belmont Report

14 14 OutlineOutline Introduction The history of ethics in research Ethical Principles Responsibilities of investigators Other ethical issues Introduction The history of ethics in research Ethical Principles Responsibilities of investigators Other ethical issues

15 15 Ethical Principles Respect Beneficence Justice

16 16 Ethical Principles 1)Respect for persons requires investigators to: obtain informed consent Assent age 7 Consent age 15 Protect participants with impaired decision-making capacity maintain confidentiality Ulysses Contract – once a contract signed then continue study even if patient changes their mind Consent for use of genetic tissue in research If want to use tissue later for a different study question, then do you need to obtain consent again? 1)Respect for persons requires investigators to: obtain informed consent Assent age 7 Consent age 15 Protect participants with impaired decision-making capacity maintain confidentiality Ulysses Contract – once a contract signed then continue study even if patient changes their mind Consent for use of genetic tissue in research If want to use tissue later for a different study question, then do you need to obtain consent again?

17 17 Ethical Principles 2)Beneficence requires that: the research design be scientifically sound the risks of the research be acceptable in relation to the likely benefits -physical, breaches of confidentiality, stigma, descrimination 3)Justice requires that the benefits and burdens of research be distributed fairly Children, women and ethnic minorities must have adequate representation 2)Beneficence requires that: the research design be scientifically sound the risks of the research be acceptable in relation to the likely benefits -physical, breaches of confidentiality, stigma, descrimination 3)Justice requires that the benefits and burdens of research be distributed fairly Children, women and ethnic minorities must have adequate representation

18 18 Ethical Principles Case handout

19 19 Ethical Principles Case handout

20 20 OutlineOutline Introduction The history of ethics in research Ethical Principles Responsibilities of investigators Other ethical issues Introduction The history of ethics in research Ethical Principles Responsibilities of investigators Other ethical issues

21 21 Scientific Misconduct FabricationFalsification Plagiarism

22 22 Scientific Misconduct Association exists No Association exists Association exists No Association exists AssociationNo Association Exists Exists True False Positive Positive False True Negative Negative True False Positive Positive False True Negative Negative Stated Conclusion Stated Conclusion True Positive True Negative Actual Truth in the Universe Actual Truth in the Universe..... :.. :.. :... :.. A B C D

23 23 Scientific Misconduct Association exists No Association exists Association exists No Association exists AssociationNo Association Exists Exists True False Positive Positive False True Negative Negative True False Positive Positive False True Negative Negative Stated Conclusion Stated Conclusion True Positive True Negative Actual Truth in the Universe Actual Truth in the Universe..... :.. :.. :... :.. β Type II  Type I A B C D

24 24 Falsification and Fabrication Example 1 Falsification and Fabrication Example 1 Page 1

25 25 Falsification and Fabrication Example 1 Falsification and Fabrication Example 1 Page 2

26 26 Falsification Example 2 Falsification Page 2

27 27 Failure to Follow Protocol Example 3 Failure to Follow Protocol Example 3 Page 2

28 28 Failure to Follow Protocol Example 3 Failure to Follow Protocol Example 3 Page 4

29 29 Punishment for Scientific Misconduct Suspension of a grant Debarment from future grants Administrative procedures Criminal procedures Suspension of a grant Debarment from future grants Administrative procedures Criminal procedures

30 30 Punishment for Scientific Misconduct Suspension of a grant Debarment from future grants Administrative procedures Criminal procedures Formal humiliation of your reputation Suspension of a grant Debarment from future grants Administrative procedures Criminal procedures Formal humiliation of your reputation

31 31Sade. Ann Thorac Surg 2003;75:

32 32 Xiao et al. Ann Thorac Surg 2003;75:

33 33 Xiao et al. Ann Thorac Surg 2003;75:

34 34Sade. Ann Thorac Surg 2003;75: Page 325

35 35

36 36 Alemtuzumab Induction therapy Alemtuzumab Induction therapy Tacrolimus Conventional Triple Drug Therapy Conventional Triple Drug Therapy Renal Transplant Renal Transplant

37 37 Alemtuzumab Induction therapy Alemtuzumab Induction therapy Tacrolimus Triple Drug Triple Drug Renal Transplant Renal Transplant

38 days 2,101 days Mean follow-up

39 days 2,101 days Mean follow-up

40 40 Author

41 41 Author AJTr 2006;6: Editor AJTr 2006;6:2228-9

42 Dual roles for the 42 ResponseResponse Conflicts of Interest Interest Responsibilities of Investigators Conflicts of Interest Clinician-Investigator Responses Investigators are blinded

43 Dual roles for the 43 ResponseResponse Conflicts of Interest Interest Responsibilities of Investigators Conflicts of Interest Clinician-Investigator Responses Investigators are blinded Independent data and safety monitoring board may review interim data

44 Dual roles for the 44 ResponseResponse Conflicts of Interest Interest Responsibilities of Investigators Conflicts of Interest Clinician-Investigator Responses Investigators are blinded Independent data and safety monitoring board may review interim data Peer review process for grants, abstracts and manuscripts

45 Financial 45 ResponseResponse Conflicts of Interest Interest Responsibilities of Investigators Conflicts of Interest Responses Ban holding related stock or stock options Review contracts with pharmaceutical companies carefully

46 Financial 46 ResponseResponse Conflicts of Interest Interest Responsibilities of Investigators Conflicts of Interest Responses Ban holding related stock or stock options Review contracts with pharmaceutical companies carefully Ensure that the contract gives the investigator: 1)Unrestricted access to the primary data and statistical analysis 2)Freedom to publish findings whether or not the drug is found to be effective Ensure that the contract gives the investigator: 1)Unrestricted access to the primary data and statistical analysis 2)Freedom to publish findings whether or not the drug is found to be effective

47 47 AuthorshipAuthorship Problems –Honorary authorship –Ghost authorship Problems –Honorary authorship –Ghost authorship Criteria does not include: –Mere acquisition of funding –Data collection –Supervision of a research group Criteria does not include: –Mere acquisition of funding –Data collection –Supervision of a research group

48 48 AuthorshipAuthorship Criteria for authorship = (1) + (2) 1)Conception and design OR Data analysis and interpretation 2)Drafting or revising of the article with final approval Criteria for authorship = (1) + (2) 1)Conception and design OR Data analysis and interpretation 2)Drafting or revising of the article with final approval

49 49 OutlineOutline Introduction The history of ethics in research Ethical Principles Responsibilities of investigators Other ethical issues Introduction The history of ethics in research Ethical Principles Responsibilities of investigators Other ethical issues

50 50 Other Ethical Issues Randomized clinical trials –Equipoise Randomized clinical trials –Equipoise

51 51 Other Ethical Issues Randomized clinical trials –Equipoise Vancomycin vs. Linezolid for Hospital-Acquired Pneumonia Randomized clinical trials –Equipoise Vancomycin vs. Linezolid for Hospital-Acquired Pneumonia

52 52 Other Ethical Issues Randomized clinical trials –Equipoise Randomized clinical trials –Equipoise Linezolid = Vancomycin

53 53 Other Ethical Issues Randomized clinical trials –Equipoise Randomized clinical trials –Equipoise Linezolid > Vancomycin

54 54 Other Ethical Issues Randomized clinical trials –Equipoise Randomized clinical trials –Equipoise PHILADELPHIA– Pfizer Inc. ignored a 2005 FDA Warning Letter to stop promoting its antibiotic Zyvox® as clinically superior to the significantly less expensive, generic vancomycin when its own FDA-approved label indicated otherwise.

55 55 Other Ethical Issues Randomized clinical trials –Equipoise Randomized clinical trials –Equipoise PHILADELPHIA– Pfizer Inc. ignored a 2005 FDA Warning Letter to stop promoting its antibiotic Zyvox® as clinically superior to the significantly less expensive, generic vancomycin when its own FDA-approved label indicated otherwise.

56 56 Other Ethical Issues Randomized clinical trials –Equipoise –Principle of nonmaleficence Randomized clinical trials –Equipoise –Principle of nonmaleficence

57 57 Other Ethical Issues Randomized clinical trials –Equipoise –Principle of nonmaleficence –Mechanism for stopping the trial Research on previously collected specimens and data Genetic research Payment to research participants Randomized clinical trials –Equipoise –Principle of nonmaleficence –Mechanism for stopping the trial Research on previously collected specimens and data Genetic research Payment to research participants

58 58 ResourcesResources Designing Clinical Research, 2 nd Edition –Stephen B. Hulley et al Lippincott Williams and Wilkins, Philadelphia, PA 2001 Designing Clinical Research, 2 nd Edition –Stephen B. Hulley et al Lippincott Williams and Wilkins, Philadelphia, PA 2001

59 59 AcknowledgementsAcknowledgements John Burke, MA, R.Ph, Director of Human Subjects Protection Program, UofL Cathy Whalen, PharmD, Manager of Drug Policy & Research, UofL Hospital & James Graham Brown Cancer Center Julio Ramirez, MD, FCCP, Chief of Division of Infectious Diseases, UofL & VAMC Louisville Osborne Wiggins, Ph.D., Instructor, School of Public Health and Informational Sciences, UofL John Burke, MA, R.Ph, Director of Human Subjects Protection Program, UofL Cathy Whalen, PharmD, Manager of Drug Policy & Research, UofL Hospital & James Graham Brown Cancer Center Julio Ramirez, MD, FCCP, Chief of Division of Infectious Diseases, UofL & VAMC Louisville Osborne Wiggins, Ph.D., Instructor, School of Public Health and Informational Sciences, UofL

60 60 Informed Consent Nature of the research project –Explicit statement that the project involves research, Identification of investigators, Purposes of the research, Procedure for selection of subjects Procedures of the study –Time required, Assignment of treatments, Explanation of randomization and blinding, Procedures that are experimental rather than standard care Benefits and harms of procedures –Probability and magnitude of benefits and harms, Procedures to maximize benefits and minimize harms, Alternative procedures or treatments available outside the study, Potential costs, Information about results that will or will not be disclosed to subjects Appendix A

61 61 Procedures to maintain confidentiality Assurances and contact information –Assurances that participation in research is voluntary, Assurance that subject may decline to participate or withdraw at any time without penalty, Explicit offer to answer questions or provide further information, Directions on whom to contact with questions about the study and the rights of research subjects, or about injuries resulting from the research Informed Consent Appendix A


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