WHO Spesial Programme Reseach Development and

Research Training in Human Reproduction

Preparing a Research
Project Proposal

Guidelines and Forms

World Health Organization
Geneva.
 Rationale and Objectives

• Rationale
- justify the proposal
- hypotheses to be testes
- endpoints
- justify use of human subjects

• Objectives
- main
- subsidiary
 Background

Previous Similar Studies

 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
 Design and Methodology con’t

• Laboratory and other investigations

• Data management

• Data analysis

• Sample size

• Duration of project
 Subject Allocation

• Type

• Method

• Where allocation will take place

• Access to hospital/clinic records

 Description of Drug/Device
• Commercially available

• New drugs/devices/vehicles
- toxicology
- pharmacology
- bioavailability
- human studies
 Criteria for subject Selection

• Describe and justify the population

chosen for the study

• Inclusion criteria

• Exclusion criteria
Criteria for Subject Selection con’t

• Selection of comparison groups and

matching criteria

• Sampling procedures and type of sample

• How will potential subjects be

approached and recruited?

• Access to hospital/clinic records

 Admission Procedure
• Timing of subject interview

• Allocation to study groups

• Data to be recorded upon admission

• Information on subjects declining to

participate
 Follow-up Procedure

• Frequency and timing of follow-up

• Investigations to be conducted

• Data to be collected

• Subject tracing
 Discontinuation Criteria
• Subject discontinuation

• Treatment discontinuation

• Study discontinuation
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
Data Management and Analysis
• Data coding, monitoring and verification

• Administrative/computer procedures to be
used

• Staff available

• Statistical methods to be used to test

hypothesis
 Data Management and Analysis
cont’t
• Loss to follow-up, subject discontinuation

• Subgroup analyses/comparisons

• Special statistical techniques

• Qualitive approaches
Laboratory/Other Investigations
• Diagnostic and investigative procedures

• Essential tests and new tests

• Routine tests
 Duration of Project
• Time needed to recruit subjects

• Collection of samples/specimens

• Follow-up

• Laboratory tests

• Data analysis

• Report/manuscript writing
 Ethical Considerations
• Declaration of Helsinki

• International Principles for Biomedical

Research involving animals (CIOMS)

• Local institutional ethics committee

• National ethics committee

 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
 Informed Consent (B)
• All information given by the subject and all
laboratory data are confidential

• State to whom the subject’s data will be

disclosed

• Subject free to withdraw from the research

without prejudice to current or future
treatment
 Informed Consent (C)
SPECIAL CASES
• Illiterate cases
• Commercial sexworkers
• Children/adolescents
• Institutionalized (prisoners, armed services)
• Emotionally disturbed
• Mentally handicapped
 Ethical Review
SHOULD BE BASED UPON:
• Helsinki declaration
• International ethical guidelines for biomedical
research involving human subjects
• International guidelines for ethical review of
epidemiological studies
• International guiding principles for biomedical
research involving animals
 Ethical Considerations
• Declaration of helsinki

• Interanational principles for biomedical

research involving animals (CIOMS)

• Local institutional ethics committee

• National ethics committe

 Sample Bar Chart
ACTIVIYT Year 1 Year 2 Year 3
Recruitment ------------------------------------
Sample collection-------------------
Follow-up -------------------------------
Laboratory tests--------------------
Data Analys interim final
Manuscript --------
 Project Summary
• Justification for the project

• Summary of proposed research

• New features

• Techniques and skills required

• Problems anticipated
 PROJECT CLEARANCE PATHWAY

Institue’s review
Investigator
committee(s)

Task Force Steering

Committee, WHO
Toxicology
WHO Secretariat
Panel
Scientific and Eyhical
Review Group, WHO
National/
government
clearance
Secreatariat Committee on
Research Involving Human
Subjects (SCRIHS) Funding