National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Developing celecoxib-loaded aptamer-functionalized extracellular vesicles for targeted cancer therapy

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

The protocol needs modifications:

Comment to the Committee

The protocol needs modifications:

1- The project is funded by the Academy of Scientific Research and one of the members is a foreigner (Hungarian national), so does it require security approval?

2- Some data of the research team participating in the project is missing (department and institute)

3- The project objectives were written as protocol work steps (this is incorrect)

4- The country from which the vesicles will be purchased (BioHeal Company) was not mentioned.

5- Sample size and groups: not explained and no reference was mentioned.

6-Age group of participants: It is written 20 to 30, but it did not mention a week or a year.

7- Although the principal investigator stated that the vesicles would be purchased from BioHeal, he also stated that the umbilical cords would be collected to obtain the vesicles from the stem cells from Al Jazeera Hospital (women aged 20 to 30 years).

8- Although the principal investigator stated that the umbilical cord would be collected after informed consent was obtained, the protocol did not include informed consent.

Informed consent form:

Needs Modification

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