National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Incremental hemodialysis approach based on residual kidney function measurement: A single-center study

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

1-   The definition of incremental hemodialysis the investigators wrote “adjust dialysis dose” what is meant by this? Do you mean frequency of dialysis, e.g. 3 versus 2?

2-   Sample size and the procedures are written in the past tense, is this a retrospective study?

3-   The methodology needs clarification of what exactly is the study point and how will this be done and at which RKF is incremental hemodialysis possible etc.

4-   How will these be measured: “better quality of life, and residual kidney function preservation”.

Consent

1-     Informed consent should be better formatted to be easier for the parents to read and comprehend, e.g. Instructions and extra sentences should be deleted, the document should be all in the same font, etc.

2-     Please mention the alternatives, not just write “ask the investigator”

3-     Please explain the procedures in the informed consent document, as well as the risks and when would the patient be excluded from the study and what will happen then.

Comment to the Committee

Informed consent form:

Needs Modification

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