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Siriporn Pitimana-aree, M.D.,Dept. of Anesthesiology,Faculty of Medicine Siriraj Hospital
Research methodology & Ethical considerations
Research methodology & Ethical considerations
? FAQ: Frequent Ask Question ?
Why IRBs / ECs need to do a review on
research methodology ?
Scientific merit
Ethical Issues
Quality
IRB review:
Research methodology & Ethical considerations
Research Methodology
Research
Question(s)Research Objectives
Materials& Methods
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?
ResearchQuestions
ResearchObjectives
Research Question / Title
Research Question
P: Population
I: Intervention
C:
Comparison
Clinical sig.
O: Outcomes
Materials & Methods
• Target populations (Inclusion /Exclusion Withdrawal criteria)
• Sample sizeMaterials
• Research design (Prospective/Retrospective; Observational/ Experimental)
• Research intervention(s)• Outcome (s) measurement• Statistical analysis
Methods
# 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
Research Methodology & Ethical consideration
Research Title
Research objectives Scientific
Principles
Rationale
Literature review
Background
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.
# 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”
# 18 : Every medical research study involving human subjects must be preceded by careful assessment of predictable risks / burden …. in comparison with foreseeable benefits ….
RiskBenefit
# 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…..
RiskBenefit
# 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.
# 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.”
Research Methodology & Ethical consideration
Research subjects
Well being
Risks &
Burdens Health &
Right
Benefits
Inclusion (potential benefit)
Exclusion (possible
risk)
Withdrawal (Right, Well
being)
Risks & Benefits
Subjects
Intervention Outcomes
Design
Research Methodology & Ethical consideration
Observational study (No intervention)
• Descriptive study• Case control study• Cohort study
Research design
• Randomized control study (RCT)• Non-randomized control study • Cross - over study• Before - after study
Experimental study (Intervention)
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
Research design
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
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.
Smokers have low risk of PONV than nonsmokers
A: Observational study B: Experimental study
What is research design?
Research design
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)
Sample Size
Sample size determination
D. I. Y. Consult Statistician
Computer program
SAMEpi-info
PS-powerN -Query
or
How large of the sample?
NOT
Too largeToo small
Unnecessary potential risks & burdens budget & resources
Unable to prove hypothesis or make conclusion
Sample size
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.
Sample size determination: Not just formula Not just number
Rationale for that formula, number Appropriateness with research design Appropriateness with outcomes
Sample size
Statistical analysis
Statistical tests should be appropriated with measurement variables design
Systematic error
Adjusted by Statistical method
Adjusted by Research method
Statistical analysis
Sample size calculation
Design
Randomization
Blinding
Chance Chance
DirectionDirection
Random error
Scientific validity
Literature review
Research Question (PICO)
Design & Sample size
Statistical tests
Ethical Principles
Research Methodology & Ethical consideration
In Summary
Research methodology & Ethical considerations
What make medical research ethical?
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
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.
RiskBenefit
A Heavy Price in the Name of Bad Science
Research methodology & Ethical considerations
? FAQ: Frequent Ask Question ?
Why IRBs / ECs need to do a review on
research methodology ?
Comments?
“ True success is notin the learning,
but in it’s application to the benefit of the mankind ”
“ ความสำ�าเร็จที่ �แที่�จร็�ง ม�ได้�อยู่��ที่ �การ็เร็ ยู่นร็�� แต่�อยู่��ที่ �การ็น�ามาใช้� เป็�น ป็ร็ะโยู่ช้น"แก�มน#ษยู่ช้าต่� ”