Clinical Research Ethics Committee

ACIBADEM MEHMET ALİ AYDINLAR UNIVERSITY CLINICAL RESEARCH ETHICS COMMITTEE

Establishment and Authority

The Acıbadem Mehmet Ali Aydınlar University Clinical Research Ethics Committee, approved by the Republic of Türkiye Ministry of Health, Turkish Medicines and Medical Devices Agency (TİTCK) on 11 July 2025 (TİTCK code: 2025-KAEK-51), operates in accordance with the Regulation on Clinical Research of Human Medicinal Products, which was published in the Official Gazette No. 32203 dated 27 May 2023 and entered into force.

In accordance with the Regulation on Clinical Research of Human Medicinal Products, the Committee evaluates the following studies from scientific and ethical perspectives:

• Clinical research and low-risk scientific studies,
• Post-market clinical follow-up studies and clinical investigations of medical devices,
• Clinical research involving stem cells within the scope of the Circular No. 2018/10 issued by the General Directorate of Health Services on 5 April 2018,
• Observational studies conducted with human medicinal products.

In addition, pursuant to Article 10 (Additional Article 10) of the Basic Law on Health Services No. 3359 (Amendment: 21 February 2024), the Committee evaluates the following studies from scientific and ethical perspectives (excluding research related to traditional and complementary medicine practices):

• Scientific studies related to treatment methods,
• Studies concerning the use of health claims for foods for special medical purposes and food supplements.

Note: Clinical studies related to cosmetic products and research based on traditional, complementary, and functional medicine methods are outside the scope of the Committee’s evaluation.

Applications for studies requiring permission from the Republic of Türkiye Ministry of Health, Turkish Medicines and Medical Devices Agency (TİTCK) must be prepared and submitted to TİTCK in accordance with the principles specified in the relevant guidelines published on the Agency’s website. Application documents can be accessed at www.titck.gov.tr.

Application Process

Our Clinical Research Ethics Committee accepts applications using the documents required by the Turkish Medicines and Medical Devices Agency (TİTCK). Application files must be prepared in accordance with the provisions of the “Guideline on Good Clinical Practices for Research Applications” published by the Republic of Türkiye Ministry of Health, Turkish Medicines and Medical Devices Agency (TİTCK). Therefore, applicants are required to review the “Guideline on Clinical Research Applications Submitted to Ethics Committees” before submitting an application. The relevant guideline can be accessed through the “Forms” section.

In order for applications to be evaluated and approved, applicants must ensure that all required documents are submitted to the Ethics Committee completely by the specified deadline, taking into consideration the meeting schedule announced on the website.

Initial applications are accepted after being prepared in accordance with the order specified in the checklist section of the Clinical Research Ethics Committee application forms and submitted as one printed copy and one PDF copy on a USB flash drive.

Notifications may be sent via email to kaek@acibadem.edu.tr.

Application documents must be prepared using Times New Roman font, 12-point size, with 1.5 line spacing.

Required Documents for the Application File

The application file must include the following documents:

• Cover Letter (signed by the applicant or an authorized person),
• Application Form (completed and signed by the relevant individuals),
• Document Checklist and other supporting documents.

The Decision Form must be completed by the applicant in Word format up to page 7; the remaining documents must be included in the application file with either an electronic signature or a wet signature.

Applications included on the meeting agenda are finalized within 15 days. The sections deemed appropriate for revision by the Committee members are communicated to the applicant researcher via email. The researcher must correct the relevant sections, highlight the changes in yellow, and resubmit the file to the Ethics Committee together with a letter responding to the reviewer’s comments.

Decision letters for approved studies are sent to the researcher via email in signed PDF format within 15 days.

The original decision letters for the files discussed during Ethics Committee meetings can be obtained from the Ethics Committee Office.

Application Fees

No Ethics Committee application fee is charged for studies conducted for academic purposes or within the scope of specialty theses.

No application fee is charged for studies where the sponsor is a member of Acıbadem Mehmet Ali Aydınlar University or where funding is provided by public institutions (such as TÜBİTAK, DPT, university research funds, etc.).

An application fee is charged for all other clinical research applications (initial applications, notifications, protocol amendments, etc.).

Current fee information can be accessed through the “Application Fees” form available in the “Forms” section.

IBAN NUMBER FOR PAYMENT OF ETHICS COMMITTEE APPLICATION FEES:

IMPORTANT: The application fee must be paid with the statement “Clinical Research Ethics Committee Evaluation Fee” included in the payment receipt. The payer’s Republic of Türkiye identification number or tax identification number, address, telephone number, and email address must be submitted to us.