National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

A split-face comparative assessment of the effects of poly-l-lactic acid and calcium hydroxylapatite injections

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

Non

Comment to the Committee

Primary and secondary objectives are identical ????

The protocol is missing blinding and randomization, which is a critical point for the scientific prevention of bias

Recommend randomization & blinding with photo assessments or third-party evaluators.

Risks & Risk Management:
• Asymmetry: Psychological impacts
• Adverse Events:  Severe reactions (e.g., vascular occlusion) , Need to include staff training and emergency measures.

The site of research implementation is not clear

Qualification of the PI ???

الموافقة المستنرة

تفتقد لأسم الباحث مؤهله
معلومات التواصل مع الباحث و لجنة الاخلاقيات
لا معلومات كافيه عن تبعات بخث تقسم الوجه و احتمالية حدوث اختلاف يترتب عليه عدم رضاء المشارك نحتاج الى التعامل مع الموقف هذا بعد انتهاء الدراسة بالاستشارة و الاصلاح فى حال عدم الرضاء

Informed consent form:

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