National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

In silico study of SNPs miR-10a rs3809783, miR-27a rs895819 and miR-125a rs41275794 associated with Recurrent Pregnancy Loss in cohort of Egyptian women

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 Arabic translation of the title needs revision

2- This is a computational study (based on previously collected data), but blood samples will also be collected (clinical study). This should be clarified in the title!

3- The department and institute information is not included for the principal investigator

4- The background section is very small and does not contain any scientific references.

5- The specific analyses to be performed are not explained; only the TaqMan SNP Genotyping Assay is mentioned as a title, not as details.

6- The location for collecting samples from women with Recurrent Pregnancy Loss and those without is not specified.

7- The references section includes three references that are not found in the protocol text.
8- The Gantt chart indicates that blood samples will be collected, but the amount of blood drawn from each case is not specified in either the protocol or the informed consent form.

Informed consent form:

Needs Modification

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