Announcements

The application deadline for the May Ethics Committee meeting ended on 08 May 2020. However, the Ministry of Health for applications related to Covidien-19 Turkey Pharmaceuticals and Medical Devices has written confirmation must be obtained from the Authority. There were delays in reaching the project executives as this certificate of approval intervened at the weekend. In order to prevent this victimization, our Ethics Committee will only accept an application file between 11.05.2020-12.05.2020 for applications related to COVID-19. It is necessary to pay attention to the directions on our web page in the applications.

Prof. Dr. Haydar BAĞIŞ

Non-Interventional Clinical Research Ethics Committee Chairman

COUNCIL OF ETHICS;

Our Ethics Committee has started to accept the project. All application documents have been renewed and these forms should be used in applications. Applications made with old forms will not be accepted due to incorrect document presentation. Applications will be accepted in the first 5 working days of each month in the Academic Calendar. Due to the COVID-19 pandemic, applications will be received via e-mail until this process ends. Documents that must be signed will be scanned and sent by e-mail. The physical form of the documents will be delivered by hand after the pandemic. Documents to be submitted physically should not exceed the application deadline of the month in which the application is made. The requested documents will be compressed in Zip format and named with the applicant's name. If 2 applications are made, it must be specified separately. Ministry of Health, Turkey Pharmaceuticals and Medical Devices Applications for the decisions taken by the Authority primarily due to the Covidien-19 will be the commission formed by the Ministry of Health. After the decision of the commission, an application can be made to the Ethics Committee.

*In the approval to be obtained from the head physician, it should be clearly stated that the study is Retrospective or Prospective,

It should be clearly stated from where the budget for the study will be met,

It should be clearly stated whether the procedure to be performed provides an additional cost to the patient or SSI

• Applications will be accepted by the Ethics Committee secretariat within the first 5 (five) business days of each month. Files brought after the application date will not be received.
• Files will be received "within the first 5 (five) working days of each month" in order to prevent accumulation of files, therefore, files brought for the next month will not be received by us.
  
  
• Applications to the Ethics Committee are made directly with a petition to the Ethics Committee Secretariat.
• In order for the application files to be included in the meeting agenda, 1 copy for each research and additionally 1 CD containing all documents must be submitted to the secretariat at least seven working days before the meeting date.
• In order for the application to be registered, all documents must be completed completely.
• The application process cannot be started until the documents that are found to be incomplete by the Ethics Committee Secretariat are completed
• The application is automatically deemed invalid if the necessary corrections are made by the investigator and not submitted to the Ethics Committee within 3 months from the date on which the regulations and corrections requested by the Ethics Committee are notified to the investigator.
• When the Ethics Committee deems necessary within the framework of the evaluation of the applications, it may invite the responsible researchers of the projects to participate in the board meeting to provide additional information and answer questions, limited to the period of discussion of their applications.
• As a project manager, at most 2 projects per month can be submitted to the ethics committee.
• Apart from the academic calendar, the Ethics Committee will meet once a month at the latest.
• The meetings will generally be held on the 3rd week of each month during working hours.
• The results of the projects evaluated by the Ethics Committee will be notified to the concerned parties by e-mail within one month at the latest (preparation period of the documents), and the project executives will receive the result documents from the Secretariat of the Ethics Committee in person.
• Certainly, the relevant people will not be informed by phone about the results of the file.

INFORMED CONSENT FORM:

• In the informed consent form, information about the treatment method to be applied in the study, the drug to be used and all possible side effects of the medical device should be given in a way that the patients can understand.

• An informed consent form specific to each study should be prepared.

• Generally prepared informed consent form will not be accepted.

THE ETHICS COMMITTEE TAKES INTO CONSIDERATION FIRST OF THE FOLLOWING IN THE EVALUATION OF THE RESEARCH APPLICATION

•  Whether the research project has been duly prepared

• Appropriateness of written information given about the research

• The rationale and purpose of the study

• Analysis of the benefits and risks expected from the research,

• The suitability of the responsible researcher and his assistants to the subject,

• The suitability of the research unit for research,

• Whether the research subject is supported by sufficient literature knowledge,

• Protection of volunteers' rights, safety, dignity and health,

• The adequacy and suitability of the content of the Informed Consent Form in terms of the designed research,

• The adequacy of the justification for research to be carried out on restricted persons and children,

• Whether the social security institutions and revolving funds that provide health insurance are used as financial sources

• If any financial resource is required in the study, questioning its source and compliance with ethical rules,

• Scientific efficiency, benefits and possible harms of the study and their precautions, examines the aspects.

• You can submit your complaints about our Board and your suggestions, if any, to the Secretariat of our Ethics Committee.

• An appointment must be obtained from the Ethics Committee Secretariat to meet with the Ethics Committee Chairman.