The rationale provides the scientific justification and public health importance for the study. Include current references to support scientific statements. Animal model and pilot study data should be referenced, if appropriate. Indicate the extent and levels of prior relevant investigations and identify the gaps in information motivating new studies. Specify the target population likely to benefit from the intervention.
Bibliography is required for support of hypotheses and choice of variables.
State how testing the specific study hypothesis will address the existing information gap identified in the study rationale. Study Hypothesis and Objectives Objectives should be specific and stated as specific hypotheses to be tested. All objectives must be clearly addressed in the Rationale and Study Design sections of the concept outline. Planned Intervention Include planned intervention, proposed intervention or justication why concept does not include intervention. Study Design Clearly outline research methods to be employed.