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

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

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

4. Research Methodology Research Materials& Methods Research Objectives
Question(s)
Research Objectives
Materials& Methods

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
Objectives

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

7. Materials Methods 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

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. Scientific Principles
Research Methodology
& Ethical consideration
Scientific Principles
Rationale
Literature review
Background
Research Title
Research objectives

11. & 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.

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. the inherent risks & burdens to the subject…..
# 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. & Ethical consideration
Research Methodology
& Ethical consideration
Research subjects
Well being
Risks &
Burdens
Health & Right
Benefits
Inclusion (potential benefit)
Exclusion (possible risk)
Withdrawal (Right, Well being)

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

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

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

21. Comparison effectiveness of a new method
Research design
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

22. Smoking is a protective factor of PONV ???
Research design
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

23. & Ethical consideration
Research Methodology
& Ethical consideration
Q 3: What make the RCT design in
smoking study unethical?
This design is inappropriate and
will result with invalid result.
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. A: Observational study B: Experimental study What is research design?
Smokers have low risk of PONV than nonsmokers
A: Observational study
B: Experimental study
What is research design?

25. 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 Experiment
to the eight remaining survivors, May 16,1997.
africanpress.wordpress.com

26. Sample Size

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

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

29. & Ethical consideration
Research Methodology
& Ethical consideration
Q 4: Why too large/small samples is inappropriate
in terms of research methodology and ethics?
Possibly let the subjects expose to unnecessary risks/burdens.
Inappropriate utilization of resources.
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

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

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

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

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

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

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

37. A Heavy Price in the Name of Bad Science

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

39. Comments?

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in the learning,
but in it’s application to
the benefit of the mankind ”
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