National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Evaluation of surface defects and deformation of three rotary NiTi systems after root canal preparation. An in Vivo Study

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

in the inclusion criteria:

clarify the gender of volunteers are they males or females or both genders.

clarify if it is an open label or blinded design. 

clarify method of allocation of volunteers in each group.

Informed consent:

this is clinical research thus requiring formulation of an informed consent of research not for clinical practice. your justification of waiver of informed consent is not accepted.  please fill the form and send it. 

for the risks of the research: although this is a clinical intervention, there are risks related to the clinical intervention that may be pain after treatment and other clinical signs and symptoms related to post operative endodontic treatment. please mention them and how will the researcher treat them if they happened. 

 

Comment to the Committee

the PI is requesting waiver of consent which is not acceptable because this is a clinical research. 

Informed consent form:

N/A

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