Article 1. The purpose of these guidelines is to determine procedures and principles pertaining to rules to apply, research permits and approval application, consideration and evaluation of the applications and decisions thereabout to protect the rights of patients and subjects used in the researches

BASIS:
Article 3. The basis of these guidelines is comprised of the following international and national declarations, statutes, regulations and guidelines:

PART TWO

DEFINITIONS, TYPES AND CHARACTERISTICS OF MEDICAL RESEARCH

Article 4. Unless the contrary is specified, the following terms used in these guidelines shall mean as follows;

 TYPES AND CHARACTERISTICS OF A MEDICAL RESEARCH:

Article 5. Medical researches are divided into 3 groups according to their relation to Professional care.

Article 6. Medical researches at the faculty are divided into the following groups according to the reasons of their conduct.

Article 7. Medical researches are divided into 4 main categories according to the anticipated risks.

 PART THREE
BASIC RULES AND CONDITIONS FOR VOLUNTEERING

BASIC RULES:

Article 8. Medical researches to be conducted by the teaching staff of the Faculty of Medicine, Uludağ University in the University or externally are to be done by strictly abiding by current legislation, statutes, regulations, the Declaration of Helsinki, Circular and provisions of these guidelines protecting and setting out health and personal rights of human subjects.

Article 9. Medical research to be done at the Faculty should be conducted abiding by commonly accepted scientific principles.

Article 10. The expected benefit and public interest from the research to be done at the Faculty cannot be held superior to the life and maintenance of body integrity of the volunteer who has declared consent to be subject to the research.

Article11. All measures should be carefully taken to prevent damage to the health and violation of personal rights of a volunteer to a medical research conducted at the Faculty. If the probable damage of the research to the volunteer are unpredictable that person may not be subjected to the research, albeit by his/her consent.

Article 12. Medical research at the Faculty may only be conducted by persons with sufficient scientific education within the borders of clinical area under supervision of sufficient medical staff.

Article 13. Experiment protocol, experimental operations to be carried out and methods in medical researches conducted at the Faculty should be openly noted down in writing.

Article 14. For a research to be conducted at the Faculty prior permit and approval should be obtained. No research can be done without such a permit and approval. Medical researches are to be conducted according to the permitted and approved protocol. Protocol amendments should be reported and permit as well as approval should be obtained once again for the said amendments.

Article 15. Volunteering and consent of volunteers (patients, subjects) made subject to a research at the Faculty should be certified in the written form.

Article 16. During the medical researches to be conducted at the Faculty the patient’s privacy should be respected. All kinds of medical researches and interference shall be carried out respecting the patient’s privacy.

Article 17. Even for purposes of research and publishing, the information obtained during provision of healthcare services and/or conducting the research cannot be disclosed in the way exposing the patient’s identity information and no identity information of the patient may be disclosed.

Article18. Expenses incurred during the research done at the Faculty cannot be assigned to be born by the patients/subjects or by the subjects’ insurance institutions (Pension Fund, SSK, Occupational Pension Fund, Private Insurance Companies, etc.).

ARticle19. Subjects participating in medical researches may be rewarded materially and morally. Kind and material value of this reward, conditions and time of payment is made clear in full to all the subjects when obtaining consent of the subject candidates. However the reward cannot be used as means to negotiate consent.

CONDITIONS FOR VOLUNTEERING AND CONSENT FORM SIGNED BY THE INFORMED SUBJECT:

Article 20. Patients and healthy subjects that participate in medical researches conducted at the Faculty are required to volunteer for cooperation based on their free will.

The volunteer is informed in writing and orally about the purpose of the research, its method, probable benefits and damage, his/her right to change his/her mind about participating in the research and his/her right to withdraw the consent given at the beginning of the research.

After providing sufficient information about the medical research the consent of the informed volunteer should especially be obtained completely based in his/her free will without any material or mental pressure whatsoever.

All subjects participating in medical research are required to sign a “Consent Form Signed By The Informed Subject”. If physical or mental disability prevents informing or obtaining of consent or if the subject is a child the “consent form signed by the informed subject” is obtained from a parent or a legal guardian. The child’s consent must be taken along with that of the guardian.

The consent form signed by the informed subject mainly contains necessary information about the study (such a purpose of the medical research to be conducted, methods and operations to be applied, benefit expected from the study, possible dangers, possible complaints) and assurances as to the rights of the volunteer whose consent is requested (such as the right to change his/her mind about participating in the study and the right to withdraw the consent to participate in the experiment at any moment, assurance that he/she will receive the best known diagnosis and treatment methods independent of his/her volunteering for the study).

Volunteer subjects and subject candidates should be sufficiently informed about the purpose of the medical research to be conducted, methods and operations to be applied, expected benefit from the study, possible dangers and complaints. It should be made clear to the subject that he/she is free to change his/her mind about participating in the study and that he/she may withdraw the participation consent at any moment.

Special attention must be paid to the researcher’s relationship with the subject during obtaining the consent and whether or not the subject is under pressure.

Whether volunteering for the research or not, the subject should be confident of receiving the best diagnosis and treatment known. The subject should be assured that even in case of his/her refusal to participate in a study or withdrawal of the consent the quality of medical treatment he/she receives will not change.

If a material and moral reward is to be given to the subject participating in medical researches, kind and material value of such reward as well as conditions and time of its payment should be made clear to all the subjects while obtaining their consent.

PART FOUR

MEDICAL RESEARCH PERMIT AND APPROVAL APPLICATION EVALUATION OF APPLICATİONS AND DECISIONS

INITIAL APPLICATION:

Article 21. Approval and permit application for a medical research is filed with the dean’s Office by the research officer. The research officer is required to be part of the teaching staff at the Faculty. Research officer for thesis studies is a member of the teaching staff officially assigned as a “thesis consultant”. If there is no thesis consultant officially assigned from among the teaching staff the research officer is the head of the related main scientific branch. In medical studies involving medicine research, research officers should bear characteristics required by İAHY, İKUK and İLUK.

Research officers will fill in a form from among standard permit and approval application forms available with the Dean’s Office for medical research, prepare the enclosures provided in the form and send 2 (two) copies of each to the Dean’s Office as ordinary correspondence. The following Standard forms are used for medical research approval and permit application:

EVALUATIONS OF APPLICATIONS AND DECISIONS:

Article 22. Medical research permit and approval applications are evaluated by the board whose establishment is specified in articles 28 and 29 and whose authority and responsibilities are specified in article 30. Applications are carried to the agenda during a meeting following submittal of necessary documents to the Dean’s Office and decisions are made within 1 month at latest.

Article 23. The said board studies and evaluates the form and contents of Permit and Approval Applications.

During the form evaluation the board checks if the application documents have been fully filled and whether or not the enclosures are all in place.

During the evaluation of contents the application file is primarily studied and evaluated on the following aspects:

Article 24. Examining the form is finalized at the first meeting. If faults are detected in terms of the form in the application file during the session a decision to “complete the file” is taken. Faults are listed done by one in the decision and the research officer is requested to complete them within 15 days. The research officer may request additional time to complete the file on valid grounds. If the application file is not completed within 15 days (or the period given upon additional time request) the application file cannot receive permit or approval. The application file is then rejected due to incompleteness.

If the faults detected during the form examination are such that do not prevent the examination of the application file in terms of its contents the content examination may start immediately after the decision to “complete the file”.

Article 25. An application file complete in terms of form (or a completed file, or a file with such faults that do not prevent content examination) is examined in terms of content.

Permit and approval decisions on medical researches, whose application is made using FORM-1 or FORM-2 and that qualify as “Medical Research Involving No Extra Risk” or “Medical Research Involving Minimum Risk” according to the classification of article 7 of these guidelines, are generally made during the first meeting. Decisions on medical researches, whose application is made using FORM-1, FORM-2 or FORM-3 and that qualify as “Medical Research Involving Predictable Risk” and “Medical research Involving Uncertain Risk” according to the classification of article 7 of these guidelines, can finalize (“approve and permit” or “reject”)after examination of content at the first meeting or be proceeded as follows; 1) examination of the application by the members and discussion during the meetings to follow, 2) examination of the application by a member assigned from among the board members and discussion of the application in light of the written report prepared by that member, 3) examination of the application by a specialist assigned exteriorly of the board and discussion of the application in light of the written report prepared by that specialist, or 4) discussion of the application after a member of the board and a specialist Express their opinions.

The assigned member of the board and the specialist whose judgment is asked examine the application file in accordance with the principles specified in article 23 and present their opinions to the board in the written form within 15 days at latest. Examination process by the members is completed within 15 days at latest, too. The board, taking the file and the reports into account, makes a decision on the application file during the first two meetings.

Decisions of the board regarding the application are communicated to the applicant in the written form through the Dean’s Office. In case of permit and confirmation denial reason explanation is attached to the decision. A copy of the permit and approval certificate is stored at the Dean’s Office along with the application document.

OBJECTION AND RE-APPLICATION:

Article 26. Research officer whose Approval and Permit application was denied can appeal to the decision at latest within 1 (one) month fter the decision was notified to him/her or re-apply after correcting the faults set forth as grounds for the rejection.

Appeal and re-application are discussed by the board and decision is made during the first meeting. Research officer whose appeal or re-application was rejected may appeal to this decision and apply to legal means to pursue his/her rights. Appeal made upon the second rejection decision of the board is settled at the Faculty Board by the dean’s Office.

AMENDMENT APPLICATION:

Article 27. During conduction of studies along a permitted and approved medical research if there is a necessity to make an amendment this amendment shall require permit and approval. “MEDICAL RESEARCH AMENDMENT APPLICATION FORM –FORM 4” (ENCLOSURE-4) is used for amendment applications.

PART FIVE
FACULTY MEDICAL RESEARCH ETHICS BOARD
ESTABLISHMENT, OBLIGATIONS AND AUTHORITY

ESTABLISHMENT:

Article 28. Faculty Medical Research Ethics Board is established under the patronage of the Faculty to assure patient and subject right protection, examine, evaluate, permit and approve research applications. After the Board establishment Dean’s Office submits names, academic titles and curricula vitae of the members to the Office of the President to be further submitted to the Ministry.

Article 29. Faculty Medical Research Ethics Board consists of members of following characteristics:

Members specified in paragraphs a-g are elected for the term of 2 years by the Faculty Board. Serving at the board for multiple terms is possible. Member specified in paragraph is assigned by the President while member specified in paragraph I is determined by the ethics board. At least 8 years of experience in their respective specialization fields is required for elected board members.

Faculty Medical Research Ethics Board elects a chair, a deputy chair and a reporter from among its members. The board meetings are held at least 2 times a month periodically at previously announced dates. The chair can call the board for an urgent meeting when necessary.

Member not attending three consecutive meetings in a calendar year without permission and a valid reason shall be automatically expelled from the board. Members assigned to work at a location away from the Faculty (in the country or abroad) for a long period (more than 3 months) shall be automatically expelled from the board. A new member of same characteristics is elected to complete the term of a previous one who has resigned or has been expelled.

DUTIES AND AUTHORITY:

Article 30. Faculty Medical Research Ethics Board is obliged to:

RESPONSIBILITIES AND OBLIGATIONS:

Article 31. Encourage the Faculty teaching staff to make researches, increase the number of researches, increase the level of their quality as well as provide full and complete respect to the subjects’ rights during researches, take measures assuring the public on this subject and increasing the respect to the institution.

Before a medical research can start the Dean’s Office takes measures that provide obtainment of permit and approval. In this scope:

The Dean’s Office takes measures to assure that medical research permit and approval applications are examined and finalized by the said board in a fast, unbiased and fair manner. The Dean’s Office shall take measures that prevent the board evaluating medical research permit and approval applications from blocking or delaying the researches on grounds not provided in these Guidelines. The Dean’s Office may request resignation of a board member/ board members when considered necessary.

Article 32. Practicing their legal rights and obligations to do research, members of the teaching staff are obliged to behave and act in the way that protects the Faculty’s institutional respect, rights and fair treatment of patients and subjects, following the basic principles and fundamentals provided in these guidelines and other regulations.

Researchers are obliged to give clear and correct answers on subjects in the application file when preparing medical research permit and approval applications. They cannot hide or leave hidden information possible to affect application evaluation or decisions. The researches are obliged to conduct their studies following the permitted and approved protocol. During the study process they are obliged to immediately inform the board of new information and data obtained that is possibly important in the aspect of patient and subject rights.

Article 33. Assigned to examine, evaluate and decide on permit and approval of medical research protocols the board is obliged to carry out these duties given to it by these guidelines in a fast, unbiased and fair way. Applicants should believe that their applications shall be examined and evaluated in an absolutely unbiased manner, with no prejudices and on fair basis and trust the board completely on this matter. The board is obliged to operate in a way to encourage this trust and belief.

Immediately after their assignment to the board, the board members sign a “confidentiality” (DECLARATION) agreement.

The board meets periodically with a previously announced frequency and on previously announced dates. During sessions when the board chair is absent, the deputy chair presides over the board.

Placement of permit and approval applications in the board agenda is done according to the application sequence.

Discussion minutes are recorded during the meetings. Opinions presented by the members on a file are fully and clearly recorded.

Decisions are made on absolute majority of votes. Vote of each member is expressed (as for or against) during the decision making process. Absence of missing members is recorded and is specified in the decisions. In case of a different vote in the majority decision the members specify the reason in the decisions in the written form. In decision to reject a provision of these Guidelines should be quoted as grounds for the decision. No decisions to reject can be made without specifying the grounds.

The board members act as follows pertaining to the work related with applications.

TEMPORARY ARTICLES:

Temporary Article 1. The board provided under article 29 of these guidelines shall be established at latest within 15 days after these guidelines take effect.

Temporary Article 2. Current researches and thesis studies that have commenced prior to the effective date of these guidelines are not covered by the provisions of these guidelines, disregarding their dependence on the permit of the ethics board.

PART SIX
OPERATION AND ENFORCEMENT

Article 34. Upon taking effect, these guidelines replace “Basic Ethical Principles To Be Applied During Medical research at the Faculty of Medicine, Uludağ University; Establishment and Operation Guidelines of the Local Ethics Board” valid since 13 January 2000.

Article 35. These guidelines take effect starting from 15 July 2003, the date of their approval by the Senate of Uludağ University.

Article 36. The provisions of these guidelines are enforced by the President of Uludağ University.

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Adress :
Uludağ Üniversitesi Tıp Fakültesi Dekanlığı Etik Kurul Sekreterliği
Görükle / Bursa / Turkey
Tel : (+90 224) 442 80 17 - Fax :(+90 224) 442 80 47 - (+90 224) 442 80 18
tipdek@uludag.edu.tr