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8/6/2019 Kuliah Prof Delfi
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WHO Spesial Programme Reseach Development and
Research Training in Human Reproduction
Preparing a Research
Project Proposal
Guidelines and FormsWorld Health Organization
Geneva.
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Rationale and Objectives
Rationale- justify the proposal
- hypotheses to be testes- endpoints
- justify use of human subjects
Objectives- main
- subsidiary
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Background
Previous Similar Studies
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Design and Methodology
General Outline
Criteria for subject selection
Subject allocation
Description of drugs and/or devices to be
studied
Admission procedure
Follow-up procedure
Criteria for discontinuation
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Design and Methodology cont
Laboratory and other investigations
Data management
Data analysis
Sample size
D
uration of project
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Subject Allocation
Type
Method
Where allocation will take place
Access to hospital/clinic records
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Description ofDrug/Device
Commercially available
New drugs/devices/vehicles
- toxicology
- pharmacology
- bioavailability
- human studies
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Criteria for subject Selection
Describe and justify the population
chosen for the study
Inclusion criteria
Exclusion criteria
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Criteria for Subject Selection cont
Selection of comparison groups andmatching criteria
Sampling procedures and type of sample
How will potential subjects beapproached and recruited?
Access to hospital/clinic records
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Admission Procedure
Timing of subject interview
Allocation to study groups
Data to be recorded upon admission
Information on subjects declining to
participate
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Follow-up Procedure
Frequency and timing of follow-up
Investigations to be conducted
Data to be collected
Subject tracing
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Discontinuation Criteria
Subject discontinuation
Treatment discontinuation
Study discontinuation
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Sample Size and Statistical Power
Estimate incidence and prevalence rates
Differences this study is expected to detect
Power required to demonstrate these difference
Method of computation of sample size
Variablities to be expected
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Data Management and Analysis
Data coding, monitoring and verification
Administrative/computer procedures to beused
Staff available
Statistical methods to be used to testhypothesis
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Data Management and Analysis
contt Loss to follow-up, subject discontinuation
Subgroup analyses/comparisons
Special statistical techniques
Qualitive approaches
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Laboratory/Other Investigations
Diagnostic and investigative procedures
Essential tests and new tests
Routine tests
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Duration of Project
Time needed to recruit subjects
Collection of samples/specimens
Follow-up
Laboratory tests
Data analysis
Report/manuscript writing
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Ethical Considerations
Declaration of Helsinki
International Principles forBiomedicalResearch involving animals (CIOMS)
Local institutional ethics committee
National ethics committee
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Informed Consent (A)
Detailed descriptin of the research
In language subject can understand
Details of any benefits or compensation and
when it will be given
Details of discomfort, side effects, risks
anticipated
Comparison with available standard drugs or
treatments
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Informed Consent (B)
All information given by the subject and all
laboratory data are confidential
State to whom the subjects data will be
disclosed
Subject free to withdraw from the research
without prejudice to current or future
treatment
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Informed Consent (C)
SPECIAL CASES
Illiterate cases
Commercial sexworkers Children/adolescents
Institutionalized (prisoners, armed services)
Emotionally disturbed Mentally handicapped
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Ethical Review
SHOULDBE BASED UPON:
Helsinki declaration
International ethical guidelines for biomedicalresearch involving human subjects
International guidelines for ethical review of
epidemiological studies International guiding principles for biomedical
research involving animals
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Ethical Considerations
Declaration of helsinki
Interanational principles for biomedicalresearch involving animals (CIOMS)
Local institutional ethics committee
National ethics committe
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Sample Bar Chart
ACTIVIYT Year 1 Year 2 Year 3
Recruitment ------------------------------------
Sample collection-------------------Follow-up -------------------------------
Laboratory tests--------------------
Data Analys interim finalManuscript --------
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Project Summary
Justification for the project
Summary of proposed research
New features
Techniques and skills required
Problems anticipated
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PROJECT CLEARANCE PATHWAYPROJECT CLEARANCE PATHWAY
Institues reviewcommittee(s)
Task Force Steering
Committee, WHO
Scientific and Eyhical
Review Group, WHO
Secreatariat Committee on
Research Involving Human
Subjects (SCRIHS)
Toxicology
Panel
Investigator
WHO Secretariat
National/
government
clearance
Funding