National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Prevalence and impact of hyperacusis in a sample of Egyptian children with autism

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

1.   Please, explain why the sample size was decreased from 332 children (calculated sample size) to 100 children only in methods section. And in the informed consent you stated the sample size will be 500 patients.

كم عدد األشخاص المشتركين في هذه الدراسة؟ سوف تتم الدراسة علي نحو 500 مريض لديهم نفس الحالة الطبية.

2.       files are not uploaded in the correct place

3.       PI must rewrite the informed consent form. The language of the form should be directed to the patient which will read it. He must delete helping instructions, irrelevant questions, unused paragraphs and any unrelated choices in the template of informed consent form. This will help also to shorten and focus the consent form.

Comment to the Committee

Informed consent form:

N/A

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