Purpose, Scope, Basis, and Definitions

Purpose

ARTICLE 1 - (1) The purpose of this directive is to establish the principles and procedures for the Kayseri University Ethics Committee, which is set up to review and provide opinions on research activities conducted at our university or by our university members, excluding the responsibilities of the Ethics Board established at our university according to relevant laws and administrative regulations. These research activities include "surveys/scales, scale development, non-medical observations, and file or data source reviews for system/model development."

Scope

ARTICLE 2 - (1) The scope of this directive includes observational and descriptive research, surveys, scale studies, file reviews, data source reviews, system-model development studies, and ethical issues for which the university management seeks consulting that are conducted at our university or by our university members.

2) The following types of research are not within the purview of this Committee:

a) All medical observational studies,

b) Survey studies on patient samples,

c) Experimental studies on patient samples,

ç) Retrospective archive reviews such as medical records and imaging,

d) Research involving biochemical, microbiological, pathological, and radiological collection materials such as blood, urine, tissue, radiological images, or materials obtained during routine examinations, tests, analyses, and treatments, as well as cell or tissue culture studies,

e) Research involving genetic material for purposes other than gene therapy clinical research.

Basis

ARTICLE 3 - (1) This directive has been prepared based on Article 14 of the Higher Education Law No. 2547.

Definitions

ARTICLE 4 - (1) In this directive, the following terms are defined as:

Definitions

ARTICLE 4 - (1) In this directive, the following terms are defined as:

a) Survey: A data collection tool used to gather opinions from individuals about a specific topic, person, product, etc.

b) Survey/Scale Study: Research that uses data collection tools referred to as "survey/scale" with specific scientific measurement characteristics or aimed at examining these characteristics. These tools are used for capturing participants' opinions, attitudes, conditions, evaluations of their own behavior, etc., and are designed to facilitate statistical analysis of the obtained data.

c) Experiment: Any observation and measurement conducted in controlled environments to test a hypothesis, solve a problem, investigate an event, or determine the effectiveness or safety of an application.

ç) Observational Study: Research where an event is observed and recorded without intervening in its natural course. This type of study does not involve any protocols related to the group assignments of participating volunteers or the use of additional monitoring, tests, treatments, or follow-up methods that could alter routine practices or the natural course of the event.

d) Committee: The Kayseri University Ethics Committee. e) Scale: A measurement tool with formal attributes that includes symbols or numbers representing different degrees of a characteristic, graded with specific units, and answered or rated by individuals.

Formation of the Committee

ARTICLE 5 - (1) The Committee consists of 7 members appointed by the Rector. The term of office for the members is 3 years. A member whose term has expired may be reappointed. The members elect a chairperson and a rapporteur among themselves.

Meeting of the Committee ARTICLE 6 - (1) The Committee meets at least once a month upon the invitation of the Chairperson, with a quorum of the majority of the total number of members. Decisions are made by majority vote. In case of a tie, the Chairperson’s vote counts as two (2) votes. A member who fails to attend three (3) consecutive meetings without a valid excuse will automatically lose their membership, and a new member will be appointed in the same manner.

Application and Evaluation

ARTICLE 7 - (1) Research proposals, whether institutional or individual, that require examination by the Committee must be submitted with a completed Committee Application Form and any requested attachments. These should be sent through the relevant deans' offices, institutes, schools, and vocational schools of our university to the Committee via the Rectorate. Applications from outside the university should be submitted to the Rectorate by the highest authority of the institution where the applicant is employed.

(2) Research proposals received by the Committee are evaluated in the order of their submission at the first meeting. The Committee may invite researchers or subject matter experts to meetings to obtain their opinions if deemed necessary. The Committee may also send research proposals to these experts for review if required. The Committee prepares forms and guides related to application conditions and procedures.

(3) The Committee examines each research proposal in accordance with the "Regulation on Scientific Research and Publication Ethics of Higher Education Institutions" and provides a recommendation to the Rector indicating whether the proposal is "approved" or "not approved." Proposals for which data collection has already begun before the application will not be evaluated. When discussing research proposals from Committee members, the member who proposed the research cannot participate in the discussions or vote.

Correction Decision and Reapplication

ARTICLE 8 - (1) Research proposals that the Committee decides need corrections or completion of deficiencies must be revised by the researchers and re-submitted to the Rectorate. These proposals will be re-evaluated at the Committee’s next available meeting.

Staff and Material Needs

ARTICLE 9 - (1) The Committee’s archival services, required personnel, office, and stationery materials are provided by the Rectorate.

Correspondence

ARTICLE 10 - (1) The Committee conducts all correspondence through the Rectorate.

Confidentiality

ARTICLE 11 - (1) Committee decisions are confidential, and no information about the proposals is disclosed to anyone other than the proposers.

Responsibility

ARTICLE 12 - (1) Even if a research proposal has been approved by the Committee, all legal, criminal, and financial responsibilities of the research lie with the individual, institution, or organization conducting the research, as well as the supporting researcher.

THIRD SECTION Various and Final Provisions

ARTICLE 13 - (1) In situations not covered by this regulation, the provisions of relevant legislation and Senate decisions shall apply.

Enforcement

ARTICLE 14 - (1) This directive shall enter into force on the date it is approved by the University Senate.

Execution

ARTICLE 15 - (1) The provisions of this directive shall be enforced by the Rector of Kayseri University.