National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Non-Surgical Solutions for Female Genital Mutilation/Cutting: Platelet-Rich Plasma

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

1- How many times is the patient required to come for follow up and for how long? 

2- Because 100 ml of blood will be collected, what is the minimum weight of the participants that are allowed in the study? 

3- Who will do the procedures of blood drawing and PRP injection?

4- The counseling is not clearly mentioned in the protocol: by whom, when, frequency, etc.

5- Informed consent (IC):

- is too long and information is repeated more than once in different sections. Please simplify the IC

- Obviously all the participants would be females, so the IC should address females (مؤنث)and not males(مذكر).

- The patient number is written in the consent: how come it is known and what number is the consent referring to?

 

Comment to the Committee

Is research allowed in a private hospital per the Egyptian law?

What other approvals are required from higher authorities, if any?

 

Informed consent form:

Needs Modification

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