National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Fabrication of Carboxymethyl Cellulose/PVA-Sulfonamide Composite for the Amelioration of Benign Prostatic Hyperplasia in Rats via Modulating NRF2/NF-κB, PI3K/AKT, and NOX-2/NLRP3 Pathways

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

The protocol needs modifications:

 

Comment to the Committee

The protocol needs modifications:

العنوان العربى: يجب تغير كلمة الفئران بالجرذان .. ايضا يفضل تعريب الاختصارات المكتوبة بالانجليزية

2- It is known that azo dyes are toxic and cause DNA damage. How are they used in cancer treatment? This was not clearly explained in the background.

3- It is written that the protocol has not been reviewed despite the existence of Form 90

4-The methods written in the past tense

5- It is written in the protocol that prostate cancer cells (PC3 cells) were obtained from the American Tissue Culture Group (ATCC). How? Was it cooperation or purchase?

6- The protocol did not explain how rats with benign prostatic hyperplasia (BPH) were obtained.

7- Some abbreviations are unclear, such as SD... (The BPH+SD group will be injected with testosterone, then SD will be given orally???.. Also, the BPH+SO group will be injected with testosterone, then SO will be given orally.)

8- Calculating the sample size: You did not explain how to calculate the sample size, nor did you provide the reference used in this calculation.

9- In the protocol, the study period is written as 2 months, but in the Gantt Chart it written 7 months.

10- When asked whether human biological samples would be imported into Egypt, the answer was no, although she did say that prostate cancer cells (PC3) would be imported from the American group.

 

Informed consent form:

Needs Modification

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