SAMSUN EDUCATION AND RESEARCH HOSPITAL

Clinical Research Ethics Committee Application Principles;

1- The principal investigator (academic, doctor, nurse, etc.) working in the institution applies with the forms determined in the Ethics Committee in order to obtain the necessary permission from the head of the department of the relevant branch.

- The head of the department has to give a positive or negative written opinion to the principal researcher within 15 (fifteen) days after examining the study.

- If the head of the department gives a positive opinion, the principal investigator can carry out his work.

- If the head of the department gives a negative opinion, the principal researcher can apply to the EHK for re-evaluation of the study with a written justification. If the EHK gives a negative opinion, it will not be possible to carry out the study.

2- (a) If single-center studies are to be carried out in our Institution, the approval of our Institution's Ethics Committee must be obtained.

    (b) If single-center studies will be conducted outside our institution, the ethics committee should be applied after the administrative approval obtained from the institution where the study will be conducted.

3- (a) In multicenter studies, Ethics Committee approval should be obtained preferably from the institution where the study will be conducted, following the approval of the institution's supervisors.

       -However, the approval of the ethics committee to be obtained from any of the centers where the study will be conducted will be sufficient.

4- In studies for which budget support is provided by our hospital, the interim evaluation report should be submitted to the Ethics Committee Unit every 6 months until the study is completed.

5- Each rapporteur will evaluate more than 2 files at the Ethics Committee meetings.

6- A maximum of 2 files belonging to the same researcher will be evaluated in 1 ethics committee meeting.

Araştırmacıların, Etik Kurul onayı alındıktan sonra (Çok Merkezli Bilimsel Araştırmalar ve Covıd-19 pozitif numune talepleri hariç olmak üzere) Samsun İl Sağlık Müdürlüğünden de onay alması gerekmektedir. Müdürlüğümüz Bilimsel Araştırma Değerlendirme Komisyonu Onayı için https://samsunism.saglik.gov.tr/TR-187142/ar-ge-bilimsel-arastirma-calismalari-basvuru-formlari.html adresinde bulunan evraklar doldurularak, Etik Kurul onayı ile birlikte Samsun İl Sağlık Müdürlüğü Bilimsel Araştırmalar Değerlendirme Komisyonu'na teslim edilecektir.

 Başvuru sahipleri başvuru belgelerini mavi telli dosya içinde dosyalayarak , çalışmanın kopyalandığı bir adet CD ile birlikte Samsun Üniversitesi Klinik Araştırmalar Etik Kurul sekretaryalığına teslim eder.

Ethics Committee Secretary: