1-      Funding amount not mentioned

2-      The primary objective is in fact the aim of the study, as it is general and not SMART. The second point in the secondary objective could be in fact the primary objective.

3-      Hypothesis is missing

4-      Rationale is not clear

5-      The scientific gap is not clear, as well as how will this study fill this gap. (At the end of the “Background” section)

6-      Who is the study population, cases and controls? How will the controls be recruited and from where?

7-      How much blood will be collected from the patients and controls?

8-      DNS testing, will be done to cases and controls? What will be tested? What other data can be retrieved from the DNA testing?

9-      Will the controls undergo all the tests like the cases? Will they be followed up for one year as well?

10-  The protocol involves a vulnerable group, children 6 months to 10 years.

11-  What are the inclusion criteria for the controls?

12-  What are the benefits to the controls?

13-  What are the benefits to the cases that they will not get if they do not enroll in the study?

14-  Risks:

a.      Other risks include infection at the site of blood drawing.

b.      To minimize risks, sample collections must be done by experts and using sterile techniques.

15-  The information will be disclosed to the parents. Will information be added to the patients’ files?

Informed Consent

1-      A separate consent must be presented for the controls

2-      Children 8-10 years must sign an assent in addition to their parents’ consent.

3-      The informed consent in this case must mention the age of the participant and the name of their legal guardian/parent

4-      The English abbreviations and terms must be removed and replaced by Arabic easy terms.

5-      The amount of blood that will be drawn must be mentioned.

6-      Risks must be mentioned specifically for this study, and how they will be prevented and minimized.

7-      Genetic results and their confidentiality must be mentioned explicitly.

8-      The informed consent template is general, so the information that does not apply should be removed, e.g. any mention of drugs for example.