National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

: Evaluation The effect of Photobiomodulation Therapy and Platelet Rich Plasma on viability and proliferation of Human Gingival Fibroblast (in vitro study).

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

Role/Tasks in the Research Project

The researcher emphasized the aim of the project rather than clearly stating her role as the Principal Investigator (PI) of a PhD project.

 

Funding Source

The project is partially funded by the National Research Centre (NRC).

 

Sample Size and Study Groups

The number of cells is not clearly stated in this section, although “5000 cells” is mentioned under the origin of biospecimens.
10 ml of blood is drawn from each patient.
The reference or justification for the sample size calculation is missing and must be provided.
A bony cavity is used to receive the PRP gel; however, the source of the bone is unclear and should be clearly identified.
 

Origin of Biological Samples

Cells: Obtained from the ICTAR lab. However, the code for gingival cells is missing and should be included.
Blood sample (10 mm) is collected from patient.
 

Source of Coded Biospecimens: should be corrected

Cells: ICTAR is the correct source.
Blood Samples: The site/protocol for blood sample collection is not mentioned and should be added.
Bone Samples: The source is not identified and needs to be clarified.
The current attribution to “research center/institute/department” is inaccurate and should be corrected with the specific entity responsible.
 

 

Waiver or Alteration of Consent

A waiver of informed consent is requested; however, the study includes blood sample collection, which typically requires a signed consent form.
The purpose of the waiver request is not described and should be explicitly stated.
 

 

 

Comment to the Committee

Role/Tasks in the Research Project

The researcher emphasized the aim of the project rather than clearly stating her role as the Principal Investigator (PI) of a PhD project.

 

Funding Source

The project is partially funded by the National Research Centre (NRC).

 

Sample Size and Study Groups

The number of cells is not clearly stated in this section, although “5000 cells” is mentioned under the origin of biospecimens.
10 ml of blood is drawn from each patient.
The reference or justification for the sample size calculation is missing and must be provided.
A bony cavity is used to receive the PRP gel; however, the source of the bone is unclear and should be clearly identified.
 

Origin of Biological Samples

Cells: Obtained from the ICTAR lab. However, the code for gingival cells is missing and should be included.
Blood sample (10 mm) is collected from patient.
 

Source of Coded Biospecimens: should be corrected

Cells: ICTAR is the correct source.
Blood Samples: The site/protocol for blood sample collection is not mentioned and should be added.
Bone Samples: The source is not identified and needs to be clarified.
The current attribution to “research center/institute/department” is inaccurate and should be corrected with the specific entity responsible.
 

 

Waiver or Alteration of Consent

A waiver of informed consent is requested; however, the study includes blood sample collection, which typically requires a signed consent form.
The purpose of the waiver request is not described and should be explicitly stated.
 

 

 

Informed consent form:

Accepted

Login

Email Address *
Enter your username or email address
password *
Enter your password

Reset Password

Enter Your Email
Please insert your email and check your email for rest password link

Still not a member? Register