1. SCOPE
Research types specified in Article 8, Paragraph 1 of the Republic of Türkiye Giresun University Medical Research Ethics Committee Directive fall within the scope of our Ethics Committee.
2. PLACE OF APPLICATION AND SUBMISSION METHOD
Applications must be delivered in person to the Giresun University Rectorate Private Secretary (Filiz Mert or Kübra Apaydın) during working hours on weekdays. Submission consists of two stages: physical file (Petition) and digital record (CD). You can access the Ethics Committee Application page, containing current forms and documents required for project applications to the Giresun University Medical Research Ethics Committee, via the link.
A) CD Content and Format
The following documents must be included in the submitted CD in a single merged PDF format:
Application Petition: With the wet signature of the principal investigator,
Application Form: With all required fields completed and wet-signed,
Other Documents: With necessary arrangements made and relevant fields signed.
B) Submission via E-Mail
The principal investigator must also submit the application petition and the CD content (Merged PDF) via e-mail.
Address: tibbiarastirmalarek@giresun.edu.tr
Subject Line: Ethics Committee Application File
Attachment: In addition to the PDF file, the Word version of the application form must be included in the e-mail.
3. POINTS TO CONSIDER IN APPLICATION FILE CONTENT
Your file must contain the following documents completely:
GRU Medical Research Ethics Committee Application Petition: To be completed and wet-signed by the principal investigator who is an employee of GRU. The sample petition can be accessed on the university’s website.
Declaration Petition Stating That No Application Has Been Submitted to Any Other Ethics Committee.
GRU-MREC Application Form: All sections must be completed in full. The commitment section must be signed by all researchers.
GRU-MREC Informed Consent Form: Must be prepared in accordance with the format provided on the university website and adapted to the specific research. For studies involving children, a Child Assent Form and a Parent/Guardian Consent Form must also be prepared (See Item 8).
Data Form: A sample of the questionnaire must be included for survey studies. For other types of studies, a template showing the data to be collected must be added, signed by the principal investigator.
Studies Using a Scale: A source document demonstrating the validity and reliability of the scale must be included in the file.
Biological Material Transfer Form: Must be completed and added when applicable.
Multicenter Studies:
Each page of the Multicenter Study Protocol Form must be signed by the principal investigator.
The approval section of the protocol must be prepared separately for each researcher/research center and included in the file.
To apply to this Ethics Committee, the study coordinator must be an employee of Giresun University.
Pediatric Population Guidelines: The pediatric population includes individuals from birth to 18 years of age. For clinical research conducted in this population:
• Parents or legal guardians must be informed about which procedures constitute standard treatment and which are part of the research.
• The consent form prepared for the parent/legal guardian must include a statement such as: “Your child aged 6–18 will be informed about this research in a manner appropriate to their level of understanding, and their assent will be obtained.”
• For children from birth to 6 years, understanding of the research is not expected, and assent is not required. In such cases, consent is obtained solely from the parent.
• For literate children (6 years and older), a Child Assent Form and a Parent Consent Form must be prepared.
• Adolescent volunteers who are under 18 at the start of the study but turn 18 during the study must provide a new Informed Consent Form upon turning 18.
4. FILES REQUIRING REVISION (CORRECTION)
When a correction is requested by the Committee, the application must be repeated as follows:
Revision Petition: Must be prepared and the "Revision Form" available on the webpage must be attached.
Revised Form: The corrected version of the application form must be submitted.
Missing Documents: Must be completed if any.
Submission: The revision application must be submitted via both CD and E-Mail (Subject: Ethics Committee Revision Application), adhering to the rules of the initial application.
