Principles of Research Ethics: consent, risk and justice Lisa Schwartz, PhD Arnold Johnson Chair in Health Care Ethics McM...
Outline <ul><li>History </li></ul><ul><li>Principles </li></ul><ul><li>A challenging balance </li></ul><ul><li>Practical c...
A history for concern <ul><li>Nuremberg & Japan </li></ul><ul><li>Tuskegee </li></ul><ul><li>US prison experiments </li></...
Christine Borland  Cet etre-la, c’est a toi de le creer! Vous devez la creer!   1997
Ongoing concerns <ul><li>Disturbing stories about paediatric post-mortem collection of organs  </li></ul><ul><li>The routi...
The response <ul><li>Nuremberg code  http://www.med.nus.edu.sg/phar/sgcpp/nuremburg.htm   </li></ul><ul><li>Declaration of...
Problems <ul><li>They need to be interpreted  </li></ul><ul><li>Variability of application </li></ul>
Principles Respect for human dignity Beneficence / Non-Maleficence Utility Justice
Respect for human dignity <ul><li>Respect for autonomy </li></ul><ul><li>Informed Consent </li></ul><ul><li>Honesty </li><...
Tallon D, Chard J, Dieppe P. Consumer involvement in research is essential.  BMJ  2000; 320 :380-380   <ul><li>“… consumer...
Ends, means, subjects and objects <ul><li>There is a danger of reducing research subjects  </li></ul><ul><li>to research o...
Edward Weston  Nude  1936   © Center for Creative Photography, Arizona Board of Regents Scan courtesy of  Masters of Photo...
Edward Weston  Shells  1927  © Center for Creative Photography, Arizona Board of Regents Scan courtesy of  Masters of Phot...
Ends, means, subjects and objects <ul><li>Be aware of the humanity in each person </li></ul><ul><li>Treat persons as ends ...
Beneficence / Non-Maleficence <ul><li>Intentions </li></ul><ul><li>Outcomes </li></ul><ul><li>Balance the good of many wit...
M.H. Pappworth in 1967 <ul><li>“ No physician is justified in placing science or the public welfare first and his obligati...
Utility <ul><li>Make best use of scarce resources </li></ul><ul><li>Research participants are a valuable resource not to b...
Justice <ul><li>Fairness as equity </li></ul><ul><li>Equal access to benefits </li></ul><ul><li>Equal share of burdens </l...
A challenging balance Justice, risk and consent
Risk  Edwards SJ et al Research Ethics Committees and paternalism,  Jrl of Medical Ethics  2004;30:88-91   <ul><li>Researc...
US  Hearings on Human Experimentation,  1973 <ul><li>“ Those who have borne the brunt of research – whether it is drugs or...
Acceptable levels of  risk? <ul><li>Baltimore Lead in Children study </li></ul><ul><li>Relative to context and interpretat...
A modest proposal by M Spriggs <ul><li>‘ My proposal is that researchers and reviewers should be expected to contemplate a...
Justice, Risk and REBs <ul><li>Safe mechanisms </li></ul><ul><ul><li>e.g. REBs, Monitoring, Audit </li></ul></ul><ul><li>E...
Practical considerations Justice and the measurement of benefit and burden in research
Considerations that might affect the appropriateness of involvement of some communities in research   (Beyrer & Kass 2002)...
Research findings that could increase risk of violations <ul><li>In some instances, the findings rather than the procedure...
4 theoretical considerations <ul><li>Information sharing for consent </li></ul><ul><li>Voluntariness </li></ul><ul><li>Tru...
Justice  from Beyrer C, Kass NE Human rights, politics, & reviews of research ethics.  Lancet  2002 Jul 20;360(9328):246-5...
Vulnerable populations  (Beyrer & Kass 2002)   <ul><li>Typically, the justification for including a vulnerable group in re...
Share in benefits  (Beyrer & Kass 2002)  <ul><li>If a community is to bear the risk of research, it must also reap future ...
After the trial is over  (Beyrer & Kass 2002)  <ul><li>What responsibilities are owed to the research community? </li></ul...
Ethics Review  (Beyrer & Kass 2002)  <ul><li>The review board must assess whether studies have an adequate balance of bene...
Research Ethics Boards <ul><li>The REB is your friend </li></ul><ul><li>Element of peer review </li></ul><ul><li>Protects ...
References <ul><li>Beauchamp T L, Childress J F, 1994 The principles of biomedical ethics, 4th edn. Oxford University Pres...
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    1. 1. Principles of Research Ethics: consent, risk and justice Lisa Schwartz, PhD Arnold Johnson Chair in Health Care Ethics McMaster University
    2. 2. Outline <ul><li>History </li></ul><ul><li>Principles </li></ul><ul><li>A challenging balance </li></ul><ul><li>Practical considerations </li></ul>
    3. 3. A history for concern <ul><li>Nuremberg & Japan </li></ul><ul><li>Tuskegee </li></ul><ul><li>US prison experiments </li></ul><ul><li>HeLa cell line </li></ul>
    4. 4. Christine Borland Cet etre-la, c’est a toi de le creer! Vous devez la creer! 1997
    5. 5. Ongoing concerns <ul><li>Disturbing stories about paediatric post-mortem collection of organs </li></ul><ul><li>The routine use in research without consent of </li></ul><ul><ul><li>Patient records </li></ul></ul><ul><ul><li>Guthrie Cards </li></ul></ul><ul><ul><li>Prenatal screening samples </li></ul></ul><ul><ul><li>Tissue collected for treatment </li></ul></ul>
    6. 6. The response <ul><li>Nuremberg code http://www.med.nus.edu.sg/phar/sgcpp/nuremburg.htm </li></ul><ul><li>Declaration of Helsinki www.wma.net </li></ul><ul><li>CIOMS Statement http://www.cioms.ch/ </li></ul><ul><li>Tri-Council Policy Statement (Canada) </li></ul><ul><li>National Committee on Ethics in Human Research (Canada) http://ncehr-cnerh.org/ </li></ul><ul><li>Belmont Report (US) </li></ul><ul><li>Office of Human Research Protection (US) http://ohrp.osophs.dhhs.gov/index.html </li></ul><ul><li>MRC guidelines ( http://www.mrc.ac.uk/ethics UK) </li></ul><ul><li>British Sociological Society (UK) </li></ul><ul><li>Nuffield Reports (UK) http://www.nuffieldbioethics.org/home/index.asp </li></ul><ul><li>Research Ethics Boards </li></ul>
    7. 7. Problems <ul><li>They need to be interpreted </li></ul><ul><li>Variability of application </li></ul>
    8. 8. Principles Respect for human dignity Beneficence / Non-Maleficence Utility Justice
    9. 9. Respect for human dignity <ul><li>Respect for autonomy </li></ul><ul><li>Informed Consent </li></ul><ul><li>Honesty </li></ul><ul><li>Respect for privacy </li></ul><ul><li>Fair recruitment procedures </li></ul><ul><li>Follow up </li></ul><ul><li>Collaborative research </li></ul>
    10. 10. Tallon D, Chard J, Dieppe P. Consumer involvement in research is essential. BMJ 2000; 320 :380-380 <ul><li>“… consumer involvement will greatly enhance the overall relevance of clinical research. It will ensure that the most fruitful research questions are addressed and the most appropriate outcome measures used, thus maximising the potential for the results to be relevant and beneficial to research consumers. Furthermore, it should lead to a more efficient use of research resources.” </li></ul>
    11. 11. Ends, means, subjects and objects <ul><li>There is a danger of reducing research subjects </li></ul><ul><li>to research objects </li></ul>
    12. 12. Edward Weston Nude 1936 © Center for Creative Photography, Arizona Board of Regents Scan courtesy of Masters of Photography
    13. 13. Edward Weston Shells 1927 © Center for Creative Photography, Arizona Board of Regents Scan courtesy of Masters of Photography
    14. 14. Ends, means, subjects and objects <ul><li>Be aware of the humanity in each person </li></ul><ul><li>Treat persons as ends in themselves and never solely as means to ends </li></ul><ul><li>Includes honesty, consent </li></ul>
    15. 15. Beneficence / Non-Maleficence <ul><li>Intentions </li></ul><ul><li>Outcomes </li></ul><ul><li>Balance the good of many with the good of few </li></ul>
    16. 16. M.H. Pappworth in 1967 <ul><li>“ No physician is justified in placing science or the public welfare first and his obligation to the individual, who is his patient or subject, second. No doctor, however great his capacity or original his ideas, has the right to choose martyrs for science or for the general good.” </li></ul><ul><ul><ul><ul><ul><li>Pappworth M.H. Human Guinea Pigs; Boston: Beacon Press, 1967; pg. 27 </li></ul></ul></ul></ul></ul>
    17. 17. Utility <ul><li>Make best use of scarce resources </li></ul><ul><li>Research participants are a valuable resource not to be exploited </li></ul><ul><li>Ensure value of the research question </li></ul><ul><li>Ensure quality of method </li></ul>
    18. 18. Justice <ul><li>Fairness as equity </li></ul><ul><li>Equal access to benefits </li></ul><ul><li>Equal share of burdens </li></ul><ul><li>Deprived populations </li></ul><ul><li>Global research </li></ul>
    19. 19. A challenging balance Justice, risk and consent
    20. 20. Risk Edwards SJ et al Research Ethics Committees and paternalism, Jrl of Medical Ethics 2004;30:88-91 <ul><li>Research entails risk </li></ul><ul><li>Should we permit high risk research? (e.g. Gelsinger, Roche) </li></ul><ul><li>Respect for persons + Beneficence </li></ul><ul><li>= </li></ul><ul><li>Paternalism or Disclosure of Risk </li></ul><ul><li>But the risks associated with research are mostly unknown and ... </li></ul>
    21. 21. US Hearings on Human Experimentation, 1973 <ul><li>“ Those who have borne the brunt of research – whether it is drugs or even experimental surgery – have been the more disadvantaged people within our society; have been the institutionalised, the poor, and minority members.” </li></ul><ul><ul><ul><ul><ul><li>Sen. T Kennedy, prt 3, 7.3.1973, p. 841 </li></ul></ul></ul></ul></ul>
    22. 22. Acceptable levels of risk? <ul><li>Baltimore Lead in Children study </li></ul><ul><li>Relative to context and interpretation </li></ul><ul><li>May imply that risky research is tolerable among populations who live with high levels of risk in their day to day existence </li></ul><ul><ul><ul><ul><ul><li>Spriggs M Canaries in the mines: children, risk, non-therapeutic research and justice, </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Jrl of Medical Ethics 2004;30:176-181. </li></ul></ul></ul></ul></ul>
    23. 23. A modest proposal by M Spriggs <ul><li>‘ My proposal is that researchers and reviewers should be expected to contemplate and sign a statement that says: ‘‘I would not hesitate to submit myself, or members of my own family, or anybody for whom I have any respect or affection, if in circumstances identical to those of the intended subjects’’’. </li></ul><ul><ul><ul><ul><ul><li>Based on Papworth quote </li></ul></ul></ul></ul></ul>
    24. 24. Justice, Risk and REBs <ul><li>Safe mechanisms </li></ul><ul><ul><li>e.g. REBs, Monitoring, Audit </li></ul></ul><ul><li>Equal distribution of risks, harms and benefits of research </li></ul>
    25. 25. Practical considerations Justice and the measurement of benefit and burden in research
    26. 26. Considerations that might affect the appropriateness of involvement of some communities in research (Beyrer & Kass 2002) <ul><li>Vulnerability </li></ul><ul><li>Poverty </li></ul><ul><li>Human rights violations </li></ul><ul><li>Discrimination </li></ul><ul><li>Poor access to resources </li></ul><ul><li>Education </li></ul><ul><li>Coercion </li></ul><ul><li>Lack of trust </li></ul>
    27. 27. Research findings that could increase risk of violations <ul><li>In some instances, the findings rather than the procedures of studies, could lead to harm </li></ul><ul><li>Findings could be used to stigmatise </li></ul><ul><li>e.g. the status of refugees can be compromised by research </li></ul>
    28. 28. 4 theoretical considerations <ul><li>Information sharing for consent </li></ul><ul><li>Voluntariness </li></ul><ul><li>Trust </li></ul><ul><li>Privacy </li></ul>
    29. 29. Justice from Beyrer C, Kass NE Human rights, politics, & reviews of research ethics. Lancet 2002 Jul 20;360(9328):246-51. <ul><li>In research ethics, the principle of distributive justice forbids research risks and burdens being borne disproportionately by vulnerable groups within society ; similarly, the more privileged in society cannot disproportionately reap research benefits </li></ul><ul><li>Just research may be impossible to achieve in settings where equality, fairness, and the distribution of social good and harm are routinely abrogated </li></ul><ul><li>Where permission is granted by the very people who are oppressing the potential participants, researchers must be aware of potential misuse of findings. Conversely, there may be instances in which participation would be in the best interests of the minority group, but government officials deny access </li></ul>
    30. 30. Vulnerable populations (Beyrer & Kass 2002) <ul><li>Typically, the justification for including a vulnerable group in research is when a problem disproportionately affects that group </li></ul><ul><li>Conversely, forbidding research in regions with limited human rights could deny research benefits to those with the most pressing health or social needs. </li></ul><ul><li>Macrolevel concerns about justice become involved if global research consistently ignores the health problems of poor communities </li></ul>
    31. 31. Share in benefits (Beyrer & Kass 2002) <ul><li>If a community is to bear the risk of research, it must also reap future benefits </li></ul><ul><li>Institutional review boards should ask investigators about the implementation plan for their research, steps to ensure the chances that the intervention will be available to local groups, and how serious any discussions with governments, aid agencies, or both have been </li></ul>
    32. 32. After the trial is over (Beyrer & Kass 2002) <ul><li>What responsibilities are owed to the research community? </li></ul><ul><li>Encourage access to the benefits from findings </li></ul><ul><li>Train researchers and care providers in the community </li></ul><ul><li>Ensure privacy of participants and researchers </li></ul>
    33. 33. Ethics Review (Beyrer & Kass 2002) <ul><li>The review board must assess whether studies have an adequate balance of benefits to risks, whether consent procedures are adequate, and whether any groups of participants are improperly targeted or denied benefits as a result of the study. </li></ul><ul><li>Beneficence and Justice </li></ul>
    34. 34. Research Ethics Boards <ul><li>The REB is your friend </li></ul><ul><li>Element of peer review </li></ul><ul><li>Protects participants </li></ul><ul><li>Protects researchers </li></ul>
    35. 35. References <ul><li>Beauchamp T L, Childress J F, 1994 The principles of biomedical ethics, 4th edn. Oxford University Press </li></ul><ul><li>Beyrer C, Kass NE Human rights, politics, & reviews of research ethics. Lancet 2002 Jul 20;360(9328):246-51. </li></ul><ul><li>Centre for Disease Control and Prevention http://www.cdc.gov/nchstp/od/tuskegee/time.htm#top </li></ul><ul><li>CIOMS International Guidelines for Biomedical Research Involving Human Subjects http://www.cioms.ch/frame_guidelines_sept_2002.htm </li></ul><ul><li>Health Care Consent Act Ontario, 1996 </li></ul><ul><li>Hornblum, Allen M 1998 Acres of Skin. Routledge, NY </li></ul><ul><li>MRC guidelines for good clinical practice in clinical trials 1998. http://www.mrc.ac.uk/ethics </li></ul><ul><li>Pappworth M H 1990 &quot;Human Guinea Pigs&quot;- a history. British Medical Journal 301:1456-1460 </li></ul><ul><li>Pappworth M H 1967 Human Guinea Pigs. Beacon Press, Boston </li></ul><ul><li>Tri-Council Policy Statement http://www.nserc.ca/programs/ethics/english/index.htm </li></ul><ul><li>Uris L, 1992 QB VII Harper Collins London </li></ul>
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