Non-Interventional Studies Ethics Committee Directive

BAHÇEŞEHİR UNIVERSITY

NON-INTERVENTIONAL STUDIES

ETHICS COMMITTEE DIRECTIVE

PART ONE

Introductory Provisions

 

Purpose

ARTICLE 1 - (1) The purpose of this Directive is to evaluate non-interventional clinical research to be conducted within Bahçeşehir University from scientific and ethical perspectives, to determine the working procedures and principles, and to protect the rights and freedoms of volunteers.

Scope

ARTICLE 2 - (1) This Directive covers the establishment and the working procedures and principles of the Bahçeşehir University Non-Interventional Clinical Research Ethics Committee.

Basis

ARTICLE 3 - (1) This Directive has been prepared on the basis of the provisions of the Regulation on Clinical Trials of Medicinal Products for Human Use .

Definitions

ARTICLE 4 - (1) In this Directive;

a) Ethics Committee: refers to the Bahçeşehir University Non-Interventional Clinical Research Ethics Committee,

b) Non-interventional clinical research: includes a range of methodologies other than observational drug studies. These methods include survey studies, retrospective archive reviews such as file and image records, studies conducted with biochemistry, microbiology, pathology and radiology collection materials, research conducted with materials obtained during routine examination, testing, analysis and treatment procedures, and cell or tissue culture studies. It also includes studies that do not require human intervention, such as descriptive research conducted with genetic material other than gene therapy clinical trials, research conducted within the limits of nursing activities, diet studies conducted with food additives, research related to body physiology, studies based on anthropometric measurements, and research evaluating lifestyle habits.

c) President: refers to the President of Bahçeşehir University,

ç) Principal Investigator: refers to the person who is responsible for conducting the research and has completed specialty or doctoral training.

 

PART TWO

Establishment, Working Procedures and Principles of the Ethics Committee

 

Establishment of the Ethics Committee

ARTICLE 5 - (1) The Ethics Committee consists of at least seven and at most twelve members who have completed their doctorate or specialty training, nominated by the University Senate and appointed by the President.

Working Procedures and Principles of the Ethics Committee

ARTICLE 6 - (1) The term of office of Ethics Committee members is four years. A member whose term has expired may be reappointed. When the President's term of office ends, the terms of the Ethics Committee members also end.

(2) At the first meeting of the Ethics Committee, the members elect a chair from among themselves. The chair appoints one of the members as rapporteur. In the absence of the chair, the most senior member acts as vice chair on behalf of the chair. If the chair leaves the chairmanship for any reason, the Ethics Committee members elect a chair from among themselves at their first meeting.

(3) The membership of a member who fails to attend five consecutive meetings within a calendar year without an excuse terminates automatically, and a new member is appointed in their place for four years in accordance with paragraph 1 of this article.

(4) The Ethics Committee meets as needed, upon the invitation of the chair, with at least five members. Decisions are taken by a majority of the members present; in the event of a tie, the chair's vote counts as two votes.

(5) A maximum of 8 files may be discussed on the meeting agenda. Once this number is reached, incoming applications are carried over to the next meeting.

(6) Ethics committee meetings are scheduled twice a month, on the 1st and 3rd Wednesdays of each month. At the discretion of the Chair, meetings may be held face-to-face or online. In this regard, at each meeting the Chair separately decides how the next meeting will be held.

 

ARTICLE 7 - (1) Applications from within the institution are submitted directly to the Ethics Committee by the principal investigator.

(2) Applications submitted to the Ethics Committee are placed on the agenda of the first meeting.

(3) When it deems necessary, the Ethics Committee may request written or oral information from the applicant(s) or expert(s) on the subject, and may invite these persons to the meeting.

(4) After evaluating the application, the Ethics Committee gives its opinion as either "ethically appropriate" or "not ethically appropriate". The opinion of the Ethics Committee is communicated to the applicant in writing within one week after the meeting. For applications found not ethically appropriate, the reasons must be stated.

(5) The Ethics Committee does not place on its agenda studies that started or were completed before the application date. If such studies are noticed on the meeting agenda, they are rejected without discussion.

(6) When research applications belonging to an Ethics Committee member/members are discussed, the relevant member/members may not participate in these discussions or vote; however, the Ethics Committee may consult this member/these members when necessary.

(7) The Ethics Committee may identify deficiencies and/or request corrections for the applications it evaluates. The response letter sent by the applicant regarding major corrections and/or deficiencies is discussed at the first meeting held by the Ethics Committee. If no response regarding the corrections and/or deficiencies is submitted to the Ethics Committee within ninety calendar days, the application is deemed withdrawn.

(8) When making its decisions, the Ethics Committee takes into account all relevant legal regulations and ethical principles.

(9) Research files submitted to the Ethics Committee and the decisions of the Ethics Committee are confidential, and no information is given to anyone other than the competent authorities and the applicants.

(10) If it is determined that a research study approved by the Ethics Committee is not being conducted in accordance with ethical principles, the Ethics Committee and the head of the institution to which the researchers are affiliated are informed, and the research is stopped if it is still ongoing. The Ethics Committee places the matter on the agenda of its first meeting and may revoke its decision.

ARTICLE 8 - (1) A committee secretary to carry out the correspondence and archiving of the Ethics Committee, a meeting room and archive space, as well as the office and stationery supplies and correspondence expenses needed by the Ethics Committee, are provided by the Office of the President.

ARTICLE 9 - (1) Documents related to applications submitted to the ethics committee are kept in the archive for three years. At the end of three years, these documents are destroyed with an official report.

PART THREE

Miscellaneous and Final Provisions

 

Entry into Force

ARTICLE 10 - (1) This Directive enters into force on the date it is adopted by the University Senate.

Enforcement

ARTICLE 11 - (1) The provisions of this Directive are enforced by the President.