Protocol
- All protocol sections must be completed.
- Primary and secondary outcome parameters should be measurable and not overstated.
- Clearly mention eligibility criteria including gender and age range
- Clearly mention source of patients or samples.
- Sampling technique and sample size calculation are necessary.
- Statistical analysis plan must be correctly stated and relevant to research objectives.
- Describe how privacy and confidentiality of data will be maintained.
- In the time plan section, you couldn’t mention a suggestion date to start before obtaining Research Ethics committee approval.
- If there is no funding agency for the research work, the source of funds should be Cairo University.
- References must be correctly prepared and in a consistent reference style.
- All protocols should be revised electronically for typos and grammar check before submission to REC.
المدرس و الاستاذ المساعد لا يلقب “استاذ دكتور”
Consent form
- Guiding template is available.
- Arabic title of the protocol must be stated in the consent form.
- Eight essential items mentioned in the consent guide must be clearly written to study participants in full detail, especially the procedure, risks, and anticipated benefits.
- Not allowed to ignore or delete any part of the consent form.
- Any human subject research that involves intervention or interaction with a human subject or prospective collection of data related to humans requires a consent form.
- Oral consent means no signature is needed “so the signature section is to be removed”. This is applicable in case the signature will bear the only identifier for data that will be collected anonymously. Example is a study involves data collection through a self-administered questionnaire.
- For research participants under 18 years: parental consent is needed, so consent documents should be directed to parents and a field for parent or legally authorized representative signature will be required.
- For research participants (6-18 years): An assent is also required in addition to parental consent. This is a document directed to the child himself/herself and written in a simpler illustrative way.
- In the case of a patient lacking decision making capacity (e.g. disturbed conscious level, or mental disability), Surrogate consent applies. That is a consent signed by a patient surrogate or legally authorized representative.
- A waiver of consent could only be granted if the study entails retrospective data collection from patients’ records review or studies of existing pathology specimens or investigations (stored biological samples) that will be collected anonymously.
Data collection sheet
- Questionnaire or -patient sheet or Case report form
- This depends on the study design, objectives, and outcome parameters.
- A unique identification number should be put instead of patient name.
- All variables to be collected should be clearly presented with units of measurements/ clear categories mentioned if applicable.
Application from
- Should be filled completely.
- For non-applicable questions to your study: you could check or mention “Not applicable”
Conflict of Interest
- Must be signed from all investigators
Department approval
- Is mandatory to obtain the scientific committee approval and department approval of the principal investigator department and/or research site department.
- A hard copy should be delivered to the Vice Dean for Research and Postgraduate studies office.
Electronic Copy
- All documents must be signed by the principal investigator or supervisor (application, protocol, protocol summary, data sheet, consent, cover letter, conflict of interest)
- Email should be sent to kasralainyrec@kasralainy.edu.eg
- The title of the email is the PI-Name and Title of study.
Replies to reviewers’ inquiries
- Replies to reviewers’ inquiries should be submitted as a soft copy to kasralainyrec@kasralainy.edu.eg including:
- A cover letter with the responses to every comment raised by the reviewers and signed by the principal investigator.
- A copy of the conditional approval or deferral letters.
- The relevant modified documents with changes highlighted.
- Replies to REC concerns must be submitted within 1 month for conditional approval decision and 2 months for deferral decision.
Responses submitted after the indicated periods should include the reason/s for delay, otherwise it will be considered as a new application.