Informed Consent Form

The document that provides written proof of consent, obtained after providing the volunteer with detailed and comprehensible information regarding the research, is referred to as the "Informed Consent Form." 

Prior to the commencement of the research, any individual wishing to participate as a volunteer, or their legal representative, shall be informed in a sufficient and understandable manner by the principal investigator or an investigator who is a physician or a dentist possessing full command of the research subject. This briefing shall comprehensively cover the purpose and methodology of the research, expected benefits, foreseeable risks, potential challenges, and aspects that may be unsuitable regarding the individual's health and personal characteristics, as well as the conditions under which the research will be conducted and maintained, and the explicit right of the individual to withdraw from the research at any time. 

Furthermore, the fact that an Informed Consent Form has been obtained from a volunteer participating in the research does not waive the volunteer's right to seek compensation for any damages sustained as a result of the study.

When obtaining informed consent from a volunteer participating in research, the following requirements must be observed:

• During the process of obtaining and documenting informed consent, adherence to Good Clinical Practices (GCP), the relevant legislation, and the ethical principles derived from the current Declaration of Helsinki is mandatory.
• The written Informed Consent Form to be provided to participants must receive approval from the Ethics Committee and authorization from the Turkish Medicines and Medical Devices Agency (TITCK) prior to the commencement of the research.
• The written Informed Consent Form must be revised in light of any new information that may be relevant to the volunteer's ongoing consent. Any such revised form must obtain Ethics Committee approval and TITCK authorization before being implemented. Furthermore, the volunteer or their legal representative must be promptly notified of any new information that might influence the volunteer's willingness to continue their participation in the research. Such disclosures of information must be strictly documented.
• Neither the principal investigator nor any individual involved in the research shall coerce or exert undue influence upon a volunteer to participate in or continue with the research.
• None of the oral information or written documents pertaining to the research, including the written Informed Consent Form, shall contain any provision or language that waives the legal rights of the volunteer or their legal representative. Furthermore, such documents shall not include any statements that release the principal investigator, any individual involved in the research, the institution, the sponsor, or their representatives from liability for their own negligence.
• The volunteer or their legal representative shall be fully informed regarding all relevant aspects of the research.  
• The language used in oral and written information and documentation regarding the research, including the Informed Consent Form, must be as free from technical jargon as possible, ensuring it is easily understandable by the volunteer, their legal representative, or an impartial witness.
• During the informed consent process, the volunteer or their legal representative must be granted ample and sufficient time to inquire about the details of the study and to decide whether or not to participate. All questions regarding the research must be answered by the individual conducting the briefing to the full satisfaction of the volunteer or their legal representative.
• Prior to participation in the research, the written Informed Consent Form must be signed and dated. This document must include the names and surnames of the volunteer, the investigator (a competent physician or dentist from the research team who conducted the consent interview), and, where applicable, the legal representative and the impartial witness—all of which must be written in their own handwriting. Additionally, each page of the written Informed Consent Form must be initiated by the volunteer or, where necessary, by the legal representative and the impartial witness.
• If a volunteer or their legal representative is illiterate, or if the volunteer is visually impaired, the entire informed consent interview must be conducted in the presence of an impartial witness who is not a member of the research team. In such instances, after the written Informed Consent Form and all other written information have been read and explained to the volunteer or their legal representative, and once the volunteer or their legal representative has provided oral consent to participate and, where possible, has signed and dated the form, the impartial witness shall then sign and date the document. By signing the consent form, the witness attests and certifies that the information provided in the form and all other written materials were accurately explained to and understood by the volunteer or their legal representative, and that informed consent was granted of their own free will.
• The informed consent interview, the written Informed Consent Form provided to volunteers, and all other written information must, at a minimum, include explanations regarding the following subjects:
  • That the study is a research project,
  • The purpose of the research,
  • The treatments to be administered in the research and the probability of random assignment of volunteers to research groups for different treatments,
  • All methods to be followed or applied to the volunteer, including invasive methods to be applied during the research,
  • The responsibilities of the volunteer,
  • The experimental parts of the research,
  • The foreseeable risks or discomforts to which the volunteer (or the embryo, fetus, or nursing infant, if the research is to be conducted on pregnant or postpartum women) will be exposed,
  • Information provided to the volunteer in cases where there is no intended clinical benefit to the volunteer regarding the reasonably expected benefits of the research,
  • Alternative methods or treatment regimens applicable to the volunteer and their potential benefits and risks,
  • Compensation to be paid or treatments to be provided to the volunteer in the event of a research-related injury,
  • Information regarding expenses such as transportation and meals to be provided to the volunteers,
  • That the volunteer's participation in the research is voluntary and that the volunteer may refuse to participate or withdraw from the research at any time, without being subject to any penalty or sanction and without losing any rights,
  • That monitors, auditors, the ethics committee, the Turkish Medicines and Medical Devices Agency, and other relevant health authorities may have direct access to the volunteer's original medical records, but this information will be kept confidential, and by signing the written informed consent form, the volunteer or their legal representative will have authorized such access,
  • That, in accordance with the relevant legislation, records identifying the volunteer will be kept confidential and will not be made available to the public, and that the volunteer's identity will remain confidential if the results of the research are published,
  • That the volunteer or their legal representative will be informed in a timely manner when new information related to the research topic is obtained that may affect the volunteer's willingness to continue participating in the research,
  • The persons whom the volunteer may contact to obtain further information about the research, their rights, or any adverse events related to the research, along with the telephone numbers through which these persons can be reached 24 (twenty-four) hours a day,
  • Situations or reasons that would require the termination of the volunteer's participation in the research,
  • The anticipated duration of the volunteer's participation in the research,
  • The estimated number of volunteers expected to participate in the research.
• Prior to participation in the research, the volunteer or the volunteer's legal representative must be provided with a copy of the signed and dated written informed consent form and other written information provided to the volunteer. During the volunteer's participation in the research, the volunteer or the volunteer's legal representative must be provided with a copy of the signed and dated consent form updates and a copy of any amendments made to the written information provided to the volunteers. One copy of these informed consent forms must be kept by the principal investigator, and the other copy must be kept by the volunteer.
• When a clinical trial is a study where the volunteer can only be enrolled with the consent of their legal representative, the volunteer must also be informed about the research to the extent of their own capacity to perceive, and if possible, the written informed consent form must be approved, signed, and dated by the volunteer themselves.
• Except for the cases specified in the article below, non-therapeutic research (research in which there is no expected direct clinical benefit to be gained by the volunteer) must be carried out on volunteers who can personally give consent and who can sign and date the written informed consent form.
• Non-therapeutic research may also be carried out on volunteers for whom the volunteer's legal representative gives consent, provided that the following conditions are met:
  • The objectives of the research cannot be met through research involving volunteers who can personally give informed consent,
  • The foreseeable risks to which the volunteers will be exposed are low,
  • That the negative effects that may occur on the volunteer's health are minimized and low,
  • That the research is not prohibited by law,
  • That approval is obtained from the ethics committee regarding the participation of such volunteers and that the written favourable opinion covers this matter.

Unless there is a justified exceptional case, such research should be carried out on patients who have a disease or condition targeted by the investigational product. Volunteers participating in such research should be closely monitored and should be withdrawn from the study if they are exposed to any discomfort.

• In emergency situations where it is not possible to obtain the volunteer's prior consent, the written consent of the volunteer's legal representative, if available, must be sought in order to protect the rights, safety, and health of the volunteer and to ensure compliance with the relevant legislation. In cases where the volunteer's legal representative is not present, the conditions specified in the research protocol, which has been previously approved by the ethics committee and authorized by the Turkish Medicines and Medical Devices Agency regarding the volunteer's participation in the research, must be followed. Thereafter, the volunteer or the volunteer's legal representative must be informed about the research as soon as possible, and the written consent of the volunteer or the legal representative must be obtained regarding the continuation of the volunteer's participation in the research or their voluntary withdrawal from the research.
• In clinical trials to be conducted on children, if the child has the capacity to express consent, their written informed consent is obtained following the informing of their parents, or their guardian if under tutelage, in accordance with the relevant legislation, in addition to the child's own consent.
• In clinical trials to be conducted on individuals in intensive care or those who are unconscious, written consent is obtained after informing their legal representative, if any, or otherwise their relatives, in accordance with the relevant legislation. If none of these individuals can be reached, the person may be included in the research under the responsibility of the principal investigator or an investigator who is a physician or a dentist. 
• Ethical committee approval and authorization from the Turkish Medicines and Medical Devices Agency are also required for other information and documents besides the informed consent form to be provided to the volunteers.
• Changes can be made to patient cards and patient diaries used in authorized and ongoing studies, provided that the Turkish Medicines and Medical Devices Agency and the ethical committee are informed. However, the Turkish Medicines and Medical Devices Agency or the ethical committee may request corrections regarding these changes along with their justification.

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

https://www.resmigazete.gov.tr/eskiler/2023/05/20230527-5.htm