Health Sciences Ethics Comittee

Submission Deadline: 17 December 2021
Date of Meeting: 23 December 2021

Health Sciences Ethics Comittee

Submission Deadline: 17 December 2021/span>
Date of Meeting: 23 December 2021

Formation of the Institutional Review Board and Its Working Principles
Formation of the Institutional Review Board
Institutional Review Board (IRB) consists of 9 members nominated by University Senate and appointed by the rector for three years. A member whose incumbency comes to an end can be assigned again. The members select the President of IRB and a reporter among themselves.

Institutional Review Board Working Principles
Institutional Review Board meets once a month upon the invitation of the IRB President. Decisions are taken by majority voting and in case of equality of votes; the President’s vote is considered as two votes. Either personal or institutional research proposals that requested to be evaluated by the Institutional Review Board are forwarded to the IRB by means of the respective faculty deaneries, institutions and graduate school directorates of the university. Applicants from other organizations, institutions and facilities that not affiliated with Near East University should relay their applications by means of the highest authority of the respective unit. All research proposals that submitted to IRB are evaluated respectively at the first meeting. When IRB considers it necessary, researchers who proposed the research study or experts in the relevant field can be invited to the meetings to receive their opinions or the Board can send research proposals to these experts for evaluation in advance. IRB prepares forms and guides related to the application requirements and procedures. IRB review and evaluates each research proposal and informs the respective researcher about IRB’s advisory opinion as “Appropriate” or “Inappropriate”. While reviewing and evaluating research proposals that belong to member(s) of IRB, the relevant member(s) cannot participate in the meeting and cannot vote. After evaluating a research proposal, IRB may request clarifications/additions/changes in the submitted projects before giving an approval. The applicant will be informed so that (s)he may make these amendments. The Board re-evaluates such proposals at the first meeting provided that the relevant researcher(s) make the required clarifications, additions, changes, corrections or completions.

IRB’s archive services, staff employment, office and stationary supplies are provided by Rectorate.

Institutional Review Board carries out all its correspondences through the Rectorate.

IRB’s decisions are confidential; apart from the proponents no one is informed about the proposals.

Even if a research proposal receives the approval of the Ethics Committee; all legal, criminal and financial responsibility of the research belongs to the person, institution or organization, sponsor-researcher that conducted the research.

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:

  1. 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.
  2. 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)

Hayriye KOCACAN
Near East University, Faculty of Medicine
Ethics Committee Secretariat
Tel: 0392 675 1000 / 3044
E-mail: baek@neu.edu.tr