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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 research:Methodology & Ethical Considerations Salaya March 25, 2014 SiripornPitimana-aree, MD Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital
…….Biomedical research Outline of my talk:Introduction Research methodology & Ethical considerationsScientific validityConclusion …………………………………………………………… Biomedical Research July 29,2013 Biomedical Research March 25,2014
…….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
Research Methodology Biomedical Research , March 25,2014
Good Start Research Question ???? Understandable (answerable) Feasibility Creativity & Clinically useful Good Question
Research Methodology Biomedical Research , March 25,2014
Research Methodology Research Questions Research Objectives Biomedical Research , March 25,2014
Research Methodology TargetPopulation & Sample size Biomedical Research , March 25,2014
Research Methodology Biomedical Research , March 25,2014
Observational study (No intervention) • Descriptive study • Case control study • Cohort study Biomedical Research , March 25,2014
Experimental study (Intervention) • Randomized control study (RCT) • Non-randomized control study • Cross - over study • Before - after study Biomedical Research , March 25,2014
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
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
What is research design? A: Observational study B: Experimental study Smokers have low risk of PONV than nonsmokers Biomedical Research , March 25,2014
Question & Objective Descriptive Study Experimental Study Biomedical Research , March 25,2014
…….Biomedical research …………………………………………………………… Outcomes • Appropriate with research question • Appropriate measurement tool • All possible outcomes measured Biomedical Research , March 25,2014
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
Computer program SAM Epi-info PS-power N -Query Sample size determination D. I. Y. Consult Statistician or
Statistical analysis Statistical tests (appropriate for any measurement variables)
…….Scientific validity Biomedical Research July 29,2013 Biomedical Research March 25,2014 Research result = Truth + Error
Random error (การคลาดเคลื่อนแบบสุ่ม ) Systematic error (Bias) (การคลาดเคลื่อนเชิงระบบ) …….Biomedical research …………………………………………………………… Error
Chance Chance Direction Direction Random error Systematic error Adjusted by Statistical method Adjusted by Research method Design Statistical analysis Randomization Sample size calculation Blinding
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
? FAQ: Frequent Ask Question ? Research methodology & Ethical considerations Why IRBs / ECs need to do a review on research methodology ? Biomedical Research , March 25,2014
Research methodology & Ethical considerations IRB review: Biomedical Research , March 25,2014
A Statement of Ethical Principles for Medical Research involving Human Subjects 3 Parts (A,B, C) 35 criteria Biomedical Research , March 25,2014
( 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
Research Methodology & Ethical consideration Biomedical Research , March 25,2014
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
( 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 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
Research Methodology & Ethical consideration Biomedical Research , March 25,2014
Research Methodology & Ethical consideration
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.
…….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
Ethics in Research & Biomedical Research July 29,2013 Biomedical Research March 25,2014
“ True success is not in the learning, But in it’s application to the benefit of the mankind ” “ความสำเร็จที่แท้จริง มิได้อยู่ที่การเรียนรู้ แต่อยู่ที่การนำมาใช้ เป็นประโยชน์แก่มนุษยชาติ ” Thank you
…….Biomedical research …………………………………………………………… ทำไมต้องทำวิจัย Biomedical Research July 29,2013 “ค้นพบองค์ความรู้ใหม่” ผลพลอยได้ : การมีผลงานตีพิมพ์ การเลื่อนตำแหน่งทางวิชาการ การเพิ่มรายได้ ความภูมิใจ
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