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Biomedical r esearch: Methodology & Ethical Considerations

Biomedical r esearch: Methodology & Ethical Considerations. Salaya March 25, 2014. Siriporn Pitimana-aree , MD Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital. …….Biomedical research.

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Biomedical r esearch: Methodology & Ethical Considerations

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  1. Biomedical research:Methodology & Ethical Considerations Salaya March 25, 2014 SiripornPitimana-aree, MD Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital

  2. …….Biomedical research Outline of my talk:Introduction Research methodology & Ethical considerationsScientific validityConclusion …………………………………………………………… Biomedical Research July 29,2013 Biomedical Research March 25,2014

  3. …….Biomedical research …………………………………………………………… Introduction What is biomedical research? Biomedical Research March 25,2014 Biological specimens: Blood, cells, tissues etc. Clinical information & / or Subjects’ confidential data Any types of study involving human subjects & related to medicine

  4. Research Methodology Biomedical Research , March 25,2014

  5. Good Start Research Question ???? Understandable (answerable) Feasibility Creativity & Clinically useful Good Question

  6. Research Methodology Biomedical Research , March 25,2014

  7. Research Methodology Research Questions Research Objectives Biomedical Research , March 25,2014

  8. Research Methodology

  9. Research Methodology

  10. Research Methodology TargetPopulation & Sample size Biomedical Research , March 25,2014

  11. Research Methodology Biomedical Research , March 25,2014

  12. Observational study (No intervention) • Descriptive study • Case control study • Cohort study Biomedical Research , March 25,2014

  13. Experimental study (Intervention) • Randomized control study (RCT) • Non-randomized control study • Cross - over study • Before - after study Biomedical Research , March 25,2014

  14. Comparison effectiveness of a new method against those of the best current methods. Q:2 What is the best research design? A. Randomized control study (RCT) B. Non-randomized control study C. Historical control D. Observational study Biomedical Research , March 25,2014

  15. Smokers have low risk of PONV than nonsmokers Smoking is a protective factor of PONV ??? Then, you choose RCT in your study A: No B: Yes Biomedical Research , March 25,2014

  16. What is research design? A: Observational study B: Experimental study Smokers have low risk of PONV than nonsmokers Biomedical Research , March 25,2014

  17. Question & Objective Descriptive Study Experimental Study Biomedical Research , March 25,2014

  18. …….Biomedical research …………………………………………………………… Outcomes • Appropriate with research question • Appropriate measurement tool • All possible outcomes measured Biomedical Research , March 25,2014

  19. Sample Size

  20. Too small Too large …….Biomedical research …………………………………………………………… How large of the sample? N O T • Unnecessary • potential risks & burdens • budget & resources • Unable to • prove hypothesis or make conclusion Biomedical Research , March 25,2014

  21. Computer program SAM Epi-info PS-power N -Query Sample size determination D. I. Y. Consult Statistician or

  22. Statistical analysis Statistical tests (appropriate for any measurement variables)

  23. …….Scientific validity Biomedical Research July 29,2013 Biomedical Research March 25,2014 Research result = Truth + Error

  24. Random error (การคลาดเคลื่อนแบบสุ่ม ) Systematic error (Bias) (การคลาดเคลื่อนเชิงระบบ) …….Biomedical research …………………………………………………………… Error

  25. Chance Chance Direction Direction Random error Systematic error Adjusted by Statistical method Adjusted by Research method Design Statistical analysis Randomization Sample size calculation Blinding

  26. Good research design and Good construction framework …….Biomedical research …………………………………………………………… Bias : cannot be eliminated entirely simply because of human nature, But it should be recognized and controlledas much as possible Biomedical Research March 25,2014

  27. ? FAQ: Frequent Ask Question ? Research methodology & Ethical considerations Why IRBs / ECs need to do a review on research methodology ? Biomedical Research , March 25,2014

  28. Research methodology & Ethical considerations IRB review: Biomedical Research , March 25,2014

  29. Biomedical Research , March 25,2014

  30. A Statement of Ethical Principles for Medical Research involving Human Subjects 3 Parts (A,B, C) 35 criteria Biomedical Research , March 25,2014

  31. ( 35 criteria) Rational & Background # 12 : Medical research involving human subjects must conform togenerally accepted“ scientific principles” • be based on a thorough knowledge of • the scientific literature, • relevant sources of information , • adequate laboratoryand where • appropriate, animal experimentation Biomedical Research , March 25,2014

  32. Research Methodology & Ethical consideration Biomedical Research , March 25,2014

  33. Methodology # 32: The benefits, risks, burdens & effectiveness of a new method should be tested against those of the best current methods. “ This does not exclude the use of placebo, or no treatment, in studies where no provenmethod exists.” Biomedical Research , March 25,2014

  34. ( 35 criteria) Human Participant Protection: # 9: Respectfor all human beings, Protect their health& rights Special attention……“ vulnerable subjects” # 18: Research study must be preceded by careful assessment of predictable risks / burden …. in comparison with foreseeable benefits …. Risk Benefit Biomedical Research , March 25,2014

  35. ( 35 criteria) Human Participant Protection: # 21: Research study should only be conductedif the potential of benefit of the objectiveoutweighs the inherent risks & burdensto the subject….. # 6: Considerations related to the well-being of the individual subject should take precedence over all other interests in the study Risk Benefit Biomedical Research , March 25,2014

  36. Research Methodology & Ethical consideration Biomedical Research , March 25,2014

  37. Research Methodology & Ethical consideration

  38. Research Methodology & Ethical consideration Q1: What is the same consideration between research ethics and methodology? • Both are concern of research budget. • Both are concern of burden of the subjects. • Both are based on scientific principles. • Both are based on subject coercion • & inducement.

  39. …….Biomedical research …………………………………………………………… Conclusion: To make our study/ research result ethics, valid and usefulness…… We should sacrifice our effort to consider both ethics and methodology as much as possible. Biomedical Research March 25,2014

  40. Ethics in Research & Biomedical Research July 29,2013 Biomedical Research March 25,2014

  41. “ True success is not in the learning, But in it’s application to the benefit of the mankind ” “ความสำเร็จที่แท้จริง มิได้อยู่ที่การเรียนรู้ แต่อยู่ที่การนำมาใช้ เป็นประโยชน์แก่มนุษยชาติ ” Thank you

  42. …….Biomedical research …………………………………………………………… ทำไมต้องทำวิจัย Biomedical Research July 29,2013 “ค้นพบองค์ความรู้ใหม่” ผลพลอยได้ : การมีผลงานตีพิมพ์ การเลื่อนตำแหน่งทางวิชาการ การเพิ่มรายได้ ความภูมิใจ

  43. The Tuskegee Syphilis Experiment (1932-1972) The Tuskegee Experiment : An Apology at Last “ The United States government did something that was wrong …….deeply, profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all our citizens . . . . .. clearly racist.” President Clinton's apology for the Tuskegee Syphilis Experimentto the eight remaining survivors, May 16,1997. africanpress.wordpress.com

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