Steps for submitting a thesis proposal to the Post-Graduate office starting July 2023
- The candidate will download the needed formats and guidelines from the faculty website or have it as a soft copy from the post-graduate office on a flash memory. Downloaded formats are:
- Research protocol template,
- Consent form template OR Waiver from consent form template.
- The candidate will come to the post graduate office to verify his ID (potential candidate) and will receive the format for registration
- The candidate will fill in the application form, print it, and sign from supervisors.
- The candidate will fill in the following word files:
- The Research template.
- The consent form in Arabic (or waiver from consent if retrospective study)
- The data collection sheet according to his study type
and will sign them from the supervisors.
- The candidate will have the department approval, but it has to be signed from the head of the scientific committee in the department before the department head.
- The candidate will bring to the Post-Graduate office the following:
- The online application form after being signed from supervisors.
- The protocol of the study in the research template format signed from the supervisors
- The Department approval format signed by the head of the scientific committee in the department and the department head.
- The consent form in Arabic signed by the supervisors (Or waiver from consent if retrospective study)
- The data collection sheet signed by the supervisors.
- A soft copy of all word documents is to be also sent to the following email: pg@kasralainy.edu.eg
- After filling all the data of the candidate in the post-graduate database (by an employee of post-graduate office), the file (all documents) will be transferred to the Research Ethics Committee.
- The REC will evaluate the proposals and decide which will be:
- Approved unconditionally
- Conditional approval (minor changes needed)
- Deferral (major changes needed)
- Rejection
After final approval of the protocol from the REC, it will proceed to the post graduate committee of the faculty, the departments will be notified, and the candidate can proceed with his research.
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.
Replies to reviewers’ inquiries
- Replies to reviewers’ inquiries should be submitted as a soft copy including:
- A cover letter with the responses to every comment raised by the reviewers and signed by the principal investigator or supervisor.
- 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.