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Ethical Committee Instructions

T.C.

SELÇUK UNIVERSITY

FACULTY OF NURSING

NON-INTERVENTIONAL CLINICAL RESEARCH ETHICS COMMITTEE DIRECTIVE

PURPOSE

Item 1. The purpose of this directive is to determine the procedures and principles regarding the design, execution, record keeping, decision-making, ensuring national and international ethical and scientific standards in order to protect the rights of volunteers, and monitoring the approved studies, provided that they are non-interventional clinical researches, and the thesis and research projects in which the academic staff working in the Departments affiliated to S.Ü. Faculty of Nursing are the executors / research participants.

WORKING PRINCIPLES AND BASIS

Item 2. Within the framework of European Union Standards and Good Clinical Practices, the Regulation on Clinical Trials published in the Official Gazette dated 19/08/2011 and numbered 28030, the Regulation Amending the Regulation on Clinical Trials published in the Official Gazette dated 13/04/2013 and numbered 28617, and the Regulation on Medical Device Clinical Trials published in the Official Gazette dated 06/09/2014 and numbered 29111 constitute the basis for the working principles of the ethics committee.

SCOPE

Item 3. This directive covers the research projects defined as "non-interventional clinical trials" in the Regulation on Clinical Trials in line with the above-mentioned purposes, which will be carried out without the direct intervention of a physician and will be carried out by the researchers specified in Article 1.

DEFINITIONS

Item 4. This directive states,

Faculty Selçuk University Faculty of Nursing,

Dean: Dean of Selçuk University Faculty of Nursing,

Clinical research: Any non-interventional scientific research conducted on human volunteers or materials obtained from them,

Non-interventional clinical research: All observational studies, survey studies, retrospective archive scans such as file and image records, non-interventional research to be conducted with biochemistry, microbiology, pathology and radiology collection materials such as blood, urine, tissue, radiological images or materials obtained during routine examination, examination, analysis and treatment procedures, research to be conducted within the limits of nursing activities, Researches related to body physiology such as exercise, studies based on anthropometric measurements, researches measuring the results of health education, researches on nutrition, researches on the evaluation of living habits, qualitative studies, all researches that do not require the direct intervention of a physician,

Informed consent form: A written document, signed and dated by the parties, showing that the volunteer has decided to participate in the research with his/her free will, after the volunteer who will participate in the research or, where necessary, his/her legal representative has been informed about all kinds of information about the research, the application and the importance of the risk for human health, or if the volunteer or his/her legal representative is illiterate or if the volunteer is visually impaired, a written document showing the consent of the volunteer in the presence of at least one witness independent of the research and by obtaining the signature of the witness,

Ethics committee: It refers to the committee to be established and approved by the Faculty Board in order to give scientific and ethical opinions on the research protocol, the suitability of the researchers, the adequacy of the places where the research will be conducted, the methods and documents to be used in informing the volunteers, the methods and documents to be used in informing the volunteers, the consent to be taken from these people and other issues related to the research in order to ensure that the research is carried out and monitored in accordance with the directive.

PRINCIPLES OF ESTABLISHMENT OF THE ETHICS COMMITTEE AND MEMBERS

Item 5. The Ethics Committee consists of a minimum of 7 and a maximum of 15 members, preferably at least one faculty member from each department of the Faculty or a faculty member who has completed his/her doctorate education and a civilian member.

The civilian member must be a citizen of the Republic of Turkey who has no interest in the institution or organisation other than the faculty members.

The faculty members of the Ethics Committee are elected by the Faculty Board to serve for two years. A member who fails to attend three consecutive meetings in a calendar year without permission or excuse shall lose his/her membership and a new member shall be elected in the same way. Ethics committee member cannot take part as a member of the committee in the meeting where his/her own work is evaluated. Withdrawal from the board membership and loss of membership become effective with the approval of the Faculty Dean's Office. A new member is elected by the same method to complete the remaining term instead of the member who has left his/her duty. An ethics committee member whose term of office has expired can be reappointed. However, a member cannot serve on the board for more than two consecutive terms. A member with the same qualifications is elected to replace the member(s) whose term of office has expired or whose membership has fallen. At the first meeting, a chairman and a rapporteur are elected among the members.

Item 6. Members shall sign a confidentiality agreement after their appointment. The Board shall hold the first meeting within 15 days following the appointment of the members and shall make the necessary announcements by determining the methods and documents to be used in the preparation of the application file and the appropriate format for the notification of the result. Meeting dates are announced to the board members and researchers in advance by the secretariat.

Item 7. The secretariat of the Board is carried out by at least one officer appointed by the Dean. Receiving applications, informing researchers, archiving documents, making correspondence, arranging application forms, organizing meetings and similar tasks are carried out by the secretariat.

Item 8. Studies implemented before the application to the Ethics Committee are not evaluated and no Ethics Committee permission is given retroactively.

Item 9. If the opinion of a different branch of science is needed in the evaluation of the research project, the Ethics Committee may invite one of the faculty members of the relevant unit to the ethics committee as an expert. If necessary, it can send research proposals to these experts in advance for scientific evaluation.

EVALUATION AND DECISION

Item 10. In order for the application file to be included in the meeting agenda, it must be submitted to the Faculty record at least seven (7) business days before the meeting date. The Board meets every month of the year, on the last Tuesday of each month. The frequency of meetings may also be determined by the ethics committee. Urgent research files can be submitted to the board with the proposal of the board president and the approval of the Dean. Meeting days and the deadline for submission of the application file are announced on the faculty website at the beginning of each academic year.

Item 11. Ethics committee members meet with a two-thirds majority of the total number of members and make decisions with the absolute majority of the total number of members attending the meeting. In case of equality, the vote of the chairman of the board is decisive.

Item 12. The sponsor of the research and the ethics committee member(s) who are related to or have a role in the research under review cannot participate in the discussions and voting of this research in the ethics committee and cannot sign the board decision.

Item 13. While the Ethics Committee examines applications:

  • Suitability of the responsible investigator and assistants who will conduct the research,
  • Suitability of the unit where the research will be carried out for the research,
  • Analysis of benefits, harms and risks expected from the research,
  • Whether the research topic is supported by sufficient literature information,
  • Justification and purpose of the study, proper planning, formation of the working group,
  • Whether the research is based on scientific data and a new hypothesis,
  • Protection of the rights, safety, dignity and health of volunteers,
  • The written information given regarding the research, the method followed to obtain voluntary consent, the adequacy of the justification for the research to be conducted on people with disabilities who cannot give consent, children, pregnant women, postpartum women and breastfeeding women,
  • The liability of the researcher or his/her assistants in case of injury or death, including permanent health problems that may arise due to the research, and the scope of the insurance certificate or policy issued for both them and the volunteers,
  • If there is any agreement between the sponsor and the place where the research will be conducted regarding the compensation arrangements appropriate for the researcher and the volunteer, it evaluates whether the agreement is ethical or not. In studies carried out using the survey or interview method, the survey or interview forms are requested to be added to the projects. In studies requiring permission from any institution or organization, care is taken to obtain permissions, add them to the project, and ensure that the processes followed regarding the permission are clearly stated in the method section of the project. In addition, evaluations include the protection of the rights, safety, dignity and health of volunteers, the adequacy and suitability of the content of the "Informed Consent Form" in terms of the designed research (see the minimum content form of the informed consent form), the presence of a declaration of no conflict of interest signed by the researchers and the health assurance provider. It also includes evaluations of whether social security institutions and revolving funds are used as financial resources.

Item 14. The Ethics Committee determines whether the research/thesis projects applied for approval comply with ethical standards; It evaluates the purpose and justification of the study, its method, benefits and harms of the study, possible dangers, and budget, and, if appropriate, gives approval indicating the feasibility of the study. Ethics committee decisions are made by consensus or majority vote. The decision text contains the wet signatures of the members. The justification for dissenting votes is written in the decision text. The decision text is given in Turkish and English.

Item 15. The ethics committee is obliged to finalize the applications that do not require correction and notify the decision in writing within 10 days after the meeting date at the latest. The ethics committee notifies the researcher in writing about any issues it finds deficient and/or incorrect regarding the research. The decision is notified to the researcher in writing within the calendar month after the requested correction or information is submitted to the ethics committee. The decision regarding research rejected by the ethics committee is notified in writing along with the justification.

Ethics Committee Secretariat

Item 16. Ethics Committee Secretariat is carried out by the secretariat appointed by the Deanship. Receiving applications to the ethics committee, informing researchers, archiving documents, making necessary correspondence, arranging application forms, organizing meetings and similar tasks are carried out by the ethics committee secretariat. The Chairman of the Ethics Committee coordinates the work of the Secretariat. Personnel working in the ethics committee secretariat must comply with the confidentiality principle for all information they receive.

BINDING AND OBLIGATIONS

Item 17. Financial and legal responsibility for the positive or negative decision of the Ethics Committee belongs to the researchers who conducted the research. Ethics Committee Decisions are advisory. It never has any legally binding force. The ethics committee and its members are not subject to criminal or legal liability for the decisions they make.

Item 18. If the ethics committee deems it necessary, it may inspect the research site for ongoing studies, request oral or written information about the research, request the application or research to be stopped by stating the reason, and withdraw its approval. If a stopped study is to be restarted, the ethics committee can re-evaluate and decide whether the reasons requiring the study to be stopped have been eliminated. When deemed necessary, the ethics committee may invite researchers to its meetings to listen and obtain information, or may seek the opinions of experts other than its members regarding the research. Exchange of views, discussions and objections made during ethics committee meetings are confidential. Ethics committee members must comply with the confidentiality policy for all information they receive.

Item 19. If changes occur in some stages of the research process of the project that has previously applied to the ethics committee (such as not granting institutional permission(s), changes in institutional permission, waiver or addition of researchers, obtaining data from different study populations with similar characteristics due to not reaching the targeted number); The Ethics Committee must be informed with a petition containing the changes in the project. It may be deemed appropriate by the decision of the ethics committee.

Item 20. If researchers do not comply with the principles and rules of publication ethics and the promises they made on the project, the unethical behavior of the researcher is reported to the relevant Faculty Dean's Office.

Item 21. The ethical, legal and administrative responsibility of research conducted without the approval of the Ethics Committee or for which a negative opinion is given belongs to the responsible researcher who conducted the research.

Item 22. This directive comes into force after being approved by the Selçuk University Senate.

Item 23. The provisions of the directive shall be enforced by the Dean of the Faculty of Nursing on behalf of the Rector of Selçuk University.


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