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Reserch Ethics - part 1
1.
2. How to write a
research proposal
Dr. Manori Gamage
3. How to write a research proposal correctly.
A research to be sound ethically it is essential to fulfil some requirements.
They are,
The Research should have
▪ Proper Social/ scientific value
▪ Acceptable Scientific validity
▪ Favourable - risk benefit ratio
▪ Valid informed consent from subjects
▪ Respect for human subjects
▪ Selected subjects with out bias (fair subject selection)
4. Scientific Validity
• It is clearly documented that,
Researches which are scientifically not valid, where subjects are
exposed to risks with out a known benefit are unethical.
Final result of the research depends on the methodology. So it is
not valid if cannot obtain Valid findings
5. • How to plan a scientifically valid research.
Choose an important area
▪ Choose a feasible and correct methodology.
▪ Identify clear scientifically valid objectives.
▪ Conduct the research by a competent investigator to achieve
objectives you identified.
6. • How to prove it is a valid study.
▪ Submit a justification for your research.
1. Do literature review.
2. Identify what is already known.
3. Highlight what you are going to add by doing this
research.
7. Next step
Identify, • Clear
• Scientifically valid
• Feasible
objectives to conduct your research.
They should be given as,
▪ General objectives - General overview of the study.
▪ Specific objectives - How to achieve the general objectives.
8. Need to select,
A study design.
Study design should be an appropirate one to achieve the objectives
you have identified.
Decide - • Are you going to see events already happened
→ Retrospective study
• Start at a patient and follow up till results
→ Prospective study
9. Study design - .....cont.
• Are you going to compare two groups
→ Case - control
• Are you going to assess data before and after intervention
→ Interventional
• Are you going to check new experience and compare with the
exsisting one
→ Trial study
10. Next select,
Study setting
Try to identify a setting where you can get the,
• Best sample
• With minimal exposure to any associated risk
to achieve your desired objectives.
11. Identify and decide on,
Study duration
Duration should be sufficient to meet the identified objectives.
Next decide on,
Study population
• With minimal exposure to risk.
• Suitable to achieve objectives.
• With minimal disturbance from other co founding factors.
12. Plan and describe the recruitment process of the subjects you identified.
• Voluntary participation should be respected.
• Following informed consent which is should be valid.
So need to identify,
where/When/by whom the recruitment is going to happened.
13. Next step is one of the most important step which plays a major role on
validity of the research results.
That’s → study sample size.
So depending of the,
• Design of the study
• Sampling technique
Most appropirate sample size calculation method should be selected.
14. For the next step,
Clearly describe the methodology of your study.
→ From recruitment process till the final outcome you
are trying to achieve.
15. Describe clearly.
• What you expect participants to do.
• How you collect data
Study tools
Ex. ☆ Questionnaire type
☆ Interviewer type
☆ Focus group discussion
16. Next clearly describe how you,
• Analyze • Manage
• Discard • Maintain confidentiality
• Store
of data you have collected.
This data could be,
1. Questionnaires
2. Biological samples