All research protocols carried out at local, national or regional level which are subject to revision of the Institutional Ethics Committee of INCAP have to meet the following criteria to be approved:
Prepare research plan based on the information below. Remove this box and numbered sections that do not apply to the study.
Title of Study:
- Objectives / research questions / hypotheses: Describe the primary and secondary objectives of the study, research questions or hypotheses.
- Background and Rationale: Write a brief summary of what is known about the subject, previous relevant research and where there are information gaps. If necessary, describe pre-clinical and clinical data, actual experience with the procedures, instruments, medications or devices. References are not required, but may be included if they are directly related.
Sections 1-2 should not exceed two pages.
- Describe the study participants (sex, age, education, socioeconomic status and ethnicity) and the population from which they will be selected.
- Describe any screening procedure and the criteria for inclusion and exclusion.
- Provide the size of the sample and a clear justification as to how the sample size was projected.
- Describe whether to collect identifiers.
Note: You cannot collect data from more people than those described in this section without an amendment. Identifiers include name, address, identity card number, etc, and other indirect identifiers (e.g., date of birth) which, when combined with other variables, can lead to the identification of the person. Include the destination that identifiers will have during and at the end of the study.