What is Ethical Committee?

These are independent committees approved by the Authority (Turkish Medicines and Medical Devices Agency - TITCK), established to provide scientific and ethical opinions on the methods and documents used to inform volunteers, the consent to be obtained from them, and other research-related matters, for the purpose of protecting the rights, safety, and well-being of volunteers.

Ethical committees conduct evaluations by prioritizing the protection of the rights and health of volunteers during the execution of studies.

An ethical committee must possess the following characteristics:

• The ethical committee must be qualified to evaluate the scientific, medical, and ethical aspects of the proposed research.
• The ethical committee shall be established in accordance with the relevant legislation, consisting of a minimum of seven and a maximum of fifteen members. The composition must include at least one non-healthcare professional and one legal expert, with the majority of members being healthcare professionals holding a PhD or a medical specialty degree.
• Ethical committee members who are healthcare professionals must have received and documented basic training in current legislation-compliant Good Clinical Practices (GCP) and clinical trials prior to their participation in the committee.
• In the formation of the ethical committee, it is expected that the distribution of members should, where possible, maintain a balanced gender ratio.
• The ethical committee must safeguard the health, rights, and safety of the volunteers participating in the research, and exercise special diligence in studies involving vulnerable subjects.
• The ethical committee shall ensure that the information and documents required for clinical trial applications are complete and in full compliance with the relevant legislation.
• The ethical committee must review clinical trial applications within the timeframes specified in the relevant legislation and notify the applicant of its decision.
• In notifying its decision, the Ethical Committee shall adhere to the following requirements, ensure compliance with the decision format published on the Turkish Medicines and Medical Devices Agency (TITCK) website, and document these in writing:
  • Full title of the research,
  • A list of reviewed documents, including date and version numbers where available,
  • A list of committee members, specifying their respective fields of expertise,
  • In the event of a favourable opinion, the decision and the date of issuance,
  • In the event of an unfavourable opinion, the decision, the underlying justification, and the date,
  • The justification and date for the termination or temporary suspension of any previously issued favourable opinion.  
• The Ethical Committee shall evaluate the qualifications of the principal investigator and, where necessary, other investigators, the coordinator, and the administrative supervisor by reviewing their curriculum vitae or any other requested documentation.
• If the Ethical Committee determines that it would significantly contribute to the protection of the rights, safety, and well-being of the volunteers, it may request information beyond what is provided in the standard Informed Consent Form.
• If a non-therapeutic research project is to be conducted with the consent of the volunteer’s legal representative, the Ethical Committee must exercise additional diligence to ensure the proposed research protocol or other documentation sufficiently addresses ethical considerations and complies with the relevant legislation.
• In cases where prior consent cannot be obtained—such as scenarios defined in the research protocol where the subject's condition requires urgent intervention, the subject is unconscious, and neither a next of kin nor a legal representative is present—the Ethical Committee must determine whether the proposed research protocol or other documentation sufficiently addresses the ethical considerations and complies with the relevant legislation.
• The Ethical Committee shall review the amount and method of payment to ensure that reimbursements for expenses (such as transportation and meals) incurred by volunteers due to their participation do not exert undue influence or result in any coercive effect. Payments to volunteers must not be made solely contingent upon the volunteer’s completion of the entire research study.
• The Ethical Committee may, if necessary, request detailed information regarding the method and schedule for the distribution of payments among volunteers.
• The Ethical Committee shall ensure that information regarding the reimbursement of expenses, such as transportation and meals, is explicitly stated in the written Informed Consent Form and any other written documentation provided to the volunteers.
• The Ethical Committee shall review and evaluate ongoing clinical trials at regular intervals—at least once a year—based on the risk levels posed to volunteers. This evaluation shall be conducted through annual notification forms and relevant documentation.
• The Ethical Committee is responsible for both the initial and continuous review of clinical trial applications.
• Members of the Ethical Committee are strictly obligated to adhere to the principle of confidentiality regarding any information disclosed to them.
• Ethical Committee members are prohibited from disclosing any documents or information obtained in relation to clinical trials. Such documents and information may only be submitted to legally authorized individuals or authorities upon official request.
• Ethical Committee members shall assume their duties only after signing the "Confidentiality Agreement and Commitment Form" prepared and published on the official website of the Turkish Medicines and Medical Devices Agency (TİTCK). These documents must be renewed annually or whenever a change in the declared status occurs, and subsequently submitted to the Turkish Medicines and Medical Devices Agency.
• To ensure the standardized operation of ethical committees, their operating methods are determined by the Turkish Medicines and Medical Devices Agency (TITCK) and published on the Agency's official website. Ethical committees shall conduct their activities strictly within the framework of these established standards.
• The Ethical Committee must operate in accordance with relevant legislation, Good Clinical Practices (GCP), and Standard Operating Procedures (SOPs), and must maintain written records of all activities performed.
• When necessary, the Ethical Committee may seek the opinions of specialists from relevant fields and invite them to meetings as consultants. These individuals are required to sign a confidentiality agreement and commitment form, prepared by the Turkish Medicines and Medical Devices Agency (TITCK) and available on the Agency’s official website.
• Only the Ethical Committee members who have participated in the review and deliberations of a specific application shall be entitled to vote, issue a decision, or provide recommendations.
• Ethical Committee members may only vote or provide opinions on research matters if they are independent of the clinical trial team or the sponsor. Any member who has a relationship with the study under review or holds a role within the research team shall not participate in the deliberations or voting process for that specific study, nor shall they sign the Ethical Committee’s decision.
• The coordinator, administrative supervisor, principal investigator, sub-investigators, sponsor, or the sponsor’s legal representative may be invited to the Ethical Committee meeting for the sole purpose of providing information regarding any aspect of the research. However, these individuals are strictly prohibited from participating in the voting or the issuance of the committee’s final decision.
• A current list containing the names and qualifications of the Ethical Committee members must be maintained at all times.
• The names and qualifications of the Ethical Committee members may be disclosed to relevant parties when necessary.
• The Ethical Committee shall convene with a two-thirds majority of its total membership and shall reach decisions by an absolute majority of its total membership.
• The term of office for Ethical Committee members is two years; members whose terms have expired may be reappointed.
• The membership of any individual who fails to attend three consecutive meetings or five meetings in total without a valid excuse shall be automatically terminated. A new member, preferably possessing the same qualifications, shall be appointed to replace any member whose term has expired or whose membership has been terminated.

Link: 

https://titck.gov.tr/storage/Archive/2020/legislation/KADKLVZ01IKU13.11.2015Rev08_13ac0133-274b-44dc-98cd-33998758cc72.pdf