irec.or.ke

–  TITLE
–  INVESTIGATORS & INSTITUTIONAL AFFILIATION
–  ABSTRACT
–  BACKGROUND/LITERATURE REVIEW
–  JUSTIFICATION/RATIONALE
–  HYPOTHESIS
–  OBJECTIVES
         General
Specific
MATERIAL AND METHODS
         Design
Study Site
Study population     – Inclusion Criteria
–  Exclusion Criteria
–  Animal use
        Sampling
        Procedures
Data collection methods
Data management and analysis
–  TIME FRAME (TIMELINE)
        Pilot Study
        Definitive Study
        Report Preparation
–  ETHICS CONSIDERATIONS
        Risks
        Benefits to the subjects
Informed consent
Confidentiality
–  STUDY IMPLICATIONS
–  REFERENCES
–  ESTIMATED BUDGET
–  SIGNATURES OF INVESTIGATORS
–  APPENDICES
         Role of each investigator
Memorandum of understanding/contractual agreement between collaborating Institutions/Organizations
Questionnaires
Consent forms
Other relevant documents