APPLICATIONS TO BE EVALUATED BY INSTITUTIONAL REVIEW BOARD AND APPLICATION REQUIREMENTS
Studies that require the evaluation of the Institutional Review Board
The Institutional Review Board has undertaken an important role in ensuring the ethical standards and scientific merit of research involving human. Studies with human subjects on the following issues require the evaluation of the Institutional Review Board:
- Surveys, interviews, focus group studies, studies on adult and fetal cadaver, retrospective archive screening, research studies on blood, urine, tissue specimens, genetic materials and radiological images, or research on materials collected during routine examination for diagnostic and therapeutic purposes, studies on tissue culture, gene therapy studies that have no therapeutic aim, research studies involving nursing activities, diet studies on food additives, body physiology such as exercises, anthropometric measurements, life style habits and similar issues that not require physician’s direct intervention.
- Even if the license or permission is taken, pharmaceutical research on clinical trials with drug and its compounds, observational drug studies, observational studies on medical device-instruments and apparatus, clinical studies on herbal products with medical and biological products- medical devices and advanced therapeutic products, clinical studies with cosmetic raw materials and products and with all other raw materials and products that can be tested in humans, studies on stem cell transplantation, tissue and organ transplantation, surgical research, gene therapy research and similar studies that require physician’s direct intervention.
APPLICATION FOR THE INSTITUTIONAL REVIEW BOARD APPROVAL
An ‘Application File’ and a CD that comprises the file shall be submitted to the secretariat of the Institutional Review Board. The Application File is required to be prepared in the format of the ‘Sample Application File’ given on our website. Applicants are required to fill in all spaces preciously and sign the application file.
Application files are reviewed by IRB reporter and the eligible ones are submitted to the Institutional Review Board for evaluation and approval.
IRB has the authority to grant or deny ethical approval to such projects.
DOCUMENTS REQUIRED FOR APPLICATION
INFORMATION: All of the following documents are required and a sample for each is available in the Sample Application File on IRB’s website.
- Application letter
- Application form
- Current curriculum vitae of all the researchers involved in the study (in the sample format)
- Study description (/institute, materials, methods and references should be included in detail)
- Approval of the department/institute chairperson
- Informed consent form (If participants under the age of 18 are volunteer subjects for the study, child consent form and parent/guardian consent form should be prepared as well. For survey studies, consent form is not required; a copy of survey should be included).
- Budget of the Study (budgetary resources for all expenditures should be specified)
- Declaration for Good Clinical Practice Guidelines (GCP)
- Declaration of Helsinki (all researchers that participated in the study are required to sign all of the pages of the declaration)
- 3 articles on the subject (in pdf format)