Clinical Research Ethics Committee

Istanbul Atlas University Clinical Research Ethics Committee, within the scope of the Regulation on Clinical Research on Human Medicinal Products, which was published in the Official Gazette dated 27.05.2023 and numbered 32203,

• Clinical research and low-risk scientific studies,
• Post-market studies in Medical Device Clinical Research and medical device clinical research,
• Clinical research conducted with stem cells within the scope of Circular No. 5/4 published by the General Directorate of Health Services on 2018/2018/10,
• It was established to scientifically and ethically evaluate observational studies conducted on human medicinal products.

Besides;
In accordance with the Health Services Fundamental Law No. 3359 (Additional Article 10) (Amendment: 21/2/2024)
(Except for research on traditional and complementary medicine practices)

• Studies on treatment methods,
• It evaluates scientific studies on the use of health claims in foods and food supplements for special medical purposes, from a scientific and ethical perspective.
• Clinical studies on cosmetics and studies using traditional, complementary and functional medicine methods cannot be evaluated by our ethics committee.

*For all clinical studies except observational drug studies and non-interventional studies, approval from the Turkish Pharmaceuticals and Medical Devices Agency is required along with the ethics committee approval.

Applications must be prepared in accordance with the provisions specified in the Guide on Research Applications prepared by the Medicines and Medical Devices Agency of the Republic of Turkey Ministry of Health.

1. APPLICATION PROCESS:

Our Clinical Research Ethics Committee accepts applications with the documents used by the Turkish Medical Devices and Medical Drugs Agency. The application file is prepared by the Ministry of Health, Turkish Medicines and Medical Devices Agency (TİTCK). Good Clinical Practice Guidelines on Research Applications It should be prepared in accordance with the provisions of the . Therefore, before the application Guidelines for Clinical Research Applications to Ethics Committees examination is of great importance.

2. APPLICATION STEPS:

a. Applications are prepared in order in the checklist section of the Clinical Research Ethics Committee application forms and are sent in pdf format with the form names. online It is accepted. ka.etik@atlas.edu.tr You can send your applications to the address.

(It is important that you receive a confirmation email stating that the documents have reached us.)

• Your application must be sent to the e-mail address of the principal investigator and all assistant investigators in the application file must be added to the information section.
• KAEK Initial Application File must be written in the subject section of your application.
• Files not submitted in this manner will not be taken into consideration and will not be added to the meeting agenda.

b. Documents should be written in Times New Roman font, 12 point size and 1,5 line spacing.

c. The files discussed in the meeting agenda are finalized within 10 days. The relevant sections deemed appropriate for revision by the board members are sent to the researcher who applied to the ethics committee unit via e-mail. Revisions should be submitted to the ethics committee unit within 15 days after the relevant sections in the file are corrected and marked in yellow and a petition is prepared as a response to the referee. The decision letters of the approved studies are sent via e-mail in pdf format with signatures within 10 days.

d. In order for the Ethics Committee applications to be evaluated/approved, applicants must submit their applications in full by 14:00 on the last project submission date, taking into account the meeting dates specified on the website. ka.etik@atlas.edu.tr Applications with all complete documents will be included in the agenda of that meeting. Applications with missing documents will be included in the agenda of the next meeting after their deficiencies are completed.

e. It is recommended that the originals of all documents in the ethics committee application file be kept by the applicant to be submitted to the Ethics Committee upon request.

f. The decision letters of the files discussed in the ethics committee meetings must be followed up from the Ethics Committee office.

3. APPLICATION DOCUMENTS:

a. Cover Letter

It is signed by the applicant or authorized person(s) on behalf of the applicant and added to the application file.

b. Application Form

For initial research applications, the application form below is filled out and signed by the authorized person(s) and added to the application file.

c. Related Documents

In order to check the documents that need to be submitted in the first application. Document Checklist document must be used.

The required documents specified in the Application Checklist and Application Forms are added to the application file in the order they are listed. The draft/support documents specified in the Application Checklist are listed below.

***The decision form must be filled in by the applicant up to page 7. Become format, all other documents must be in e-signature or wet signature format. ka.etik@atlas.edu.tr must be sent to the address. 

4. CLINICAL RESEARCH ETHICS COMMITTEE APPLICATION FEES

Ethics Committee application fee for research to be conducted for academic purposes and/or as a specialist thesis not taken.

Application fee in cases where the sponsor is Istanbul Atlas University members and/or state funds (TÜBİTAK, DPT, University research fund, etc.) not taken.

Application for all types of clinical research applications (initial application, notification, protocol change, etc.) except for cases where the sponsor is Istanbul Atlas University members and/or government funds (TÜBİTAK, DPT, University research fund, etc.). no fee is charged.

You can access the application fees in the related files section.

IBAN NUMBER TO WHICH ETHICS COMMITTEE APPLICATION FEES WILL BE PAID: 

IMPORTANT: The Application Fee must be paid under the name of “Clinical Research Ethics Committee Evaluation Fee” (this statement must be written on the receipt). The Turkish ID number or tax number, address, telephone and e-mail address of the person making the payment must be reported to us.

 Istanbul Atlas Clinical Research Ethics Committee Full Member List / ISTANBUL

Istanbul Atlas Clinical Research Ethics Committee Reserve Member List / ISTANBUL

Secretary of the Ethics Committee

Fatma Irem KAYA
Internal:1950
Email: ka.etik@atlas.edu.tr