Volunteer

A Volunteer in Clinical Trials refers to the patient or healthy individual who participates in a clinical trial by obtaining their own written consent or the written consent of their legal representative.  

The following conditions are sought in order to conduct research on volunteers:

a) It is mandatory that the research has been conducted primarily in a non-human experimental environment or on a sufficient number of experimental animals.
b) The scientific data obtained as a result of experiments conducted in a non-human experimental environment or on animals must necessitate that these also be conducted on humans in order to achieve the intended goal.
c) The scientific benefits expected from the research and the public interest cannot be held superior to the health of the volunteer participating in the research, or to potential risks that may arise in terms of their health and other personal rights.
ç) No research may be conducted aimed at altering the genetic structure of the volunteer's germ cells. 
d) Decisions regarding the medical follow-up and treatment of the volunteer participating in the research belong to a physician or dentist possessing the professional qualifications necessitated by these decisions.
e) During the research, it is prohibited to apply methods that would cause the volunteer pain to an extent incompatible with human dignity.
f) The research is designed in a manner to minimize pain, discomfort, fear, and any risk related to the patient's disease and stage of development to the lowest possible level. Both the risk threshold and the degree of discomfort must be specifically defined and continuously monitored.
g) The objective intended to be achieved by the research must outweigh the burden it imposes on the person and the danger to the person's health.
ğ) It is mandatory that the research does not leave a foreseeable harmful and permanent effect on human health.
h) In the event that the ethics committee is convinced that the benefits to be obtained are greater than the potential risks arising from the research, the research may be initiated after obtaining the approval of the ethics committee and the authorization of the Agency, provided that an informed consent form is obtained in accordance with the procedure, respecting personal rights. The research shall only be conducted as long as these conditions persist.
ı) Before the research begins, the individual wishing to volunteer to participate in the research or their legal representative shall be informed sufficiently and in an understandable manner regarding the purpose, methodology, expected benefits, foreseeable risks, and difficulties of the research, aspects that are inappropriate in terms of the individual's health and personal characteristics, and the conditions under which the research will be conducted and maintained, as well as their right to withdraw from the research at any time, by a principal investigator from the research team who has mastery of the research subject or (Additional phrase: OG-6/7/2022-31888) by an investigator who is a physician or dentist from the research team assigned by the principal investigator.
i) The consent of the volunteer, stating that they will be included in the research entirely of their own free will and not tied to the procurement of any interest, is obtained, and this situation is documented with the Informed Consent Form covering the matters regarding the information provided in subparagraph (ı).
j) At least one person from the research team is assigned so that the volunteer can obtain information about their own health and the progress of the research at any time and establish contact for this purpose.
k) The volunteer may withdraw from the research at any time of their own will, with or without justification, and therefore cannot be subjected to any loss of their existing rights during their subsequent medical follow-up and treatment.
l) (Amended: OG-25/6/2014-29041) In order to guarantee volunteers against damages that may arise from clinical research, it is mandatory to provide insurance in accordance with the relevant legislation for volunteers who will participate in clinical research, excluding Phase IV clinical trials and observational drug studies specified in subparagraph (ç) of the first paragraph of Article 10 of the “Regulation on Clinical Trials of Drugs and Biological Products dated 13.04.2013 and numbered 28617”.
m) Apart from insurance coverage, no persuasive incentives or financial offers may be made to the volunteer or their legal representative to ensure the volunteer's participation in or continuation of the research. However, the expenses arising from the volunteers' participation in the research and the decrease in income of healthy volunteers resulting from the loss of working days shall be specified in the research budget and covered from this budget.
n) In the event that the information obtained as a result of the research is published, the volunteer's identity information cannot be disclosed.
o) (Additional: OG-6/7/2022-31888) Clinical trials are designed, conducted, recorded, and reported in line with the most current version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects and the international standards in the relevant field.
ö) (Additional: OG-6/7/2022-31888) The rights of volunteers regarding physical and mental integrity, privacy, and the protection of their relevant data in accordance with the Personal Data Protection Law No. 6698 dated 24/3/2016 are guaranteed.

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