Kuliah Prof Delfi

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

Documents

Kuliah Prof Delfi