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Siriporn Pitimana-aree, M.D., Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital Research methodology & Ethical considerations.

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Presentation on theme: "Siriporn Pitimana-aree, M.D., Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital Research methodology & Ethical considerations."— Presentation transcript:

1 Siriporn Pitimana-aree, M.D., Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital Research methodology & Ethical considerations

2 ? FAQ: Frequent Ask Question ? Why IRBs / ECs need to do a review on research methodology ?

3 Scientific merit Ethical Issues Quality IRB review: Research methodology & Ethical considerations

4 Research Methodology

5 Question & Objective What is the incidence of perioperative stroke? What are the risk / protective factors ? What are the short and long term outcomes? Does preoperative statin decrease incidence of stroke? Research Questions Research Questions Research Objectives Research Objectives

6 Research Question / Title Research Question P: Population I: Intervention C: Comparison Clinical sig. O: Outcomes

7 Materials & Methods Target populations (Inclusion /Exclusion Withdrawal criteria) Sample size Materials Research design (Prospective/Retrospective; Observational/ Experimental) Research intervention(s) Outcome (s) measurement Statistical analysis Methods

8

9 # 12 : Medical research involving human subjects must conform to generally accepted “ scientific principles ” be based on a thorough knowledge of  the scientific literature,  relevant sources of information,  adequate laboratory and where appropriate, animal experimentation

10 Research Methodology & Ethical consideration

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

12 # 9: Medical research is subject to ethical standards that promote respect for all human beings protect their health & rights Special attention is also required for those who cannot give or refuse consent for themselves “ vulnerable subjects”

13 # 18 : Every medical research study involving human subjects must be preceded by careful assessment of predictable risks / burden …. in comparison with foreseeable benefits …. Risk Benefit

14 # 21: Medical research involving human subjects should only be conducted if the importance or the potential of benefit of the objective “ outweighs” the inherent risks & burdens to the subject….. Risk Benefit

15 # 6: In medical research on human subjects, considerations related to “ the well-being” of the human individual subject should take precedence over all other interests.

16 # 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 proven method exists.”

17 Research Methodology & Ethical consideration Research subjects Well being Risks & Burdens Health & Right Benefits Inclusion (potential benefit) Exclusion (possible risk) Withdrawal ( Right, Well being)

18 Risks & Benefits Subjects Intervention Outcomes Design Research Methodology & Ethical consideration

19 Observational study (No intervention) Descriptive study Case control study Cohort study Research design

20 Randomized control study (RCT) Non-randomized control study Cross - over study Before - after study Experimental study (Intervention) Research design

21 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 Research design

22 Smoking is a protective factor of PONV ??? Smokers have low risk of PONV than nonsmokers Then, you choose RCT in your study A: No B: Yes Research design

23 Research Methodology & Ethical consideration Q 3: What make the RCT design in smoking study unethical? A.This design is inappropriate and will result with invalid result. B.Risk and well being of the subjects are the major factors. C. The RCT will result with too large sample size. D. It is not based on scientific principle.

24 Smokers have low risk of PONV than nonsmokers A: Observational study B: Experimental study What is research design? Research design

25 africanpress.wordpress.com 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 Experiment to the eight remaining survivors, May 16,1997. The Tuskegee Syphilis Experiment (1932-1972)

26 Sample Size

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

28 How large of the sample? NOTNOT Too large Too small Unnecessary  potential risks & burdens  budget & resources Unable to  prove hypothesis or make conclusion Sample size

29 Research Methodology & Ethical consideration Q 4: Why too large/small samples is inappropriate in terms of research methodology and ethics? A.Possibly let the subjects expose to unnecessary risks/burdens. B.Inappropriate utilization of resources. C.Probably / always end up with invalid / inconclusive result. D. All of the above.

30 Sample size determination:  Not just formula  Not just number Rationale for that formula, number Appropriateness with research design Appropriateness with outcomes Sample size

31 Statistical analysis Statistical tests should be appropriated with  measurement variables  design

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

33 Scientific validity Literature review Research Question (PICO) Design & Sample size Statistical tests Ethical Principles Research Methodology & Ethical consideration

34 In Summary Research methodology & Ethical considerations What make medical research ethical?

35 What make clinical research ethical? Emmanuel EJ, Wender D, Grady C. What make Clinical Research Ethical? JAMA 2000;283: 2701-11. 1. Social & Scientific value (prophylaxis, diagnostic, therapeutic) 7 considerations: 2. Scientific sounds / principles (Methodology valid) 3. Expected research risks < Potential benefits 4. Approved by IRBs or ECs

36 What make clinical research ethical? Emmanuel EJ, Wender D, Grady C. JAMA 2000;283: 2701-11. 5. Respect all research subject participants & Protect their health and rights (clear inclusion/exclusion criteria) 6. Informed consent (Comprehensive, Understandable, Voluntary) 7 considerations (cont.): 7. The refusal of a patient to participate in a study must never interfere with the patient-physician relationship. Risk Benefit

37 A Heavy Price in the Name of Bad Science

38 Research methodology & Ethical considerations ? FAQ: Frequent Ask Question ? Why IRBs / ECs need to do a review on research methodology ?

39 Comments?

40 “ True success is not in the learning, but in it’s application to the benefit of the mankind ” “ ความสำเร็จที่ แท้จริง มิได้อยู่ที่การ เรียนรู้ แต่อยู่ที่การ นำมาใช้ เป็น ประโยชน์แก่ มนุษยชาติ ”


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