What is Good Clinical Practices (GCP)?
Standard for designing, performing, implementing, monitoring, auditing, recording, analyzing and reporting clinical trials, reassuring that the results obtained and reported are reliable and accurate and that the rights, dignity and confidentiality of research volunteers are preserved.
What is Informed Consent?
The process in which the subject voluntarily approves his willingness to participate in the research, after being informed about all the elements related to the research associated with the volunteer’s decision to participate in a particular trial. Informed consent is documented through a written, signed and dated informed consent form.
What does a Volunteer / Subject mean?
The person to whom the investigational product(s) was applied, or who participated in the clinical trial as a control.
How is the Informed Consent of the Volunteers given?
-When obtaining and documenting informed consent, the investigator must comply with ethical principles based on valid regulatory conditions, Good Clinical Practices and the Helsinki Declaration. Before starting the research, the researcher must have received written approval / positive opinion from EC / MoH for the written informed consent form and other written information to be given to the volunteers.
-The written informed consent form and other written information to be given to the volunteers should be reviewed in the light of important new information about the approval of the volunteer. Any informed consent forms and written information that have been reviewed must have received written consent / positive opinion from EC / MoH before being used. The volunteer or the legal representative of the volunteer should be informed in a timely manner that new information is available that may affect the volunteer’s willingness to continue research. Sharing such information should be documented.
-Neither the investigator nor the research staff should force a subject to participate or continue improperly.
-Any language, including the written informed consent form, should not be used in any language that makes it seem as if the verbal and written information regarding the trial has waived or has waived the legal rights of the voluntary or volunteer’s legal representative or appears to have rescued or rescued the researcher, institution, sponsor or representatives from their negligence obligations.
-A person appointed by the researcher or investigator should inform the subject of the subject, or, if the volunteer is unable to provide informed consent, the legal representative of the volunteer about all relevant aspects of the research, including written information with which the EC / MoH gave approval / positive opinion.
-The language used in the oral and written information about the trial, including the informed consent form, should be a language of the volunteer or volunteer, or, if available, a daily language, as far as possible, in a way that the neutral witness can understand.
-In order to obtain informed consent, a person appointed by the investigator or investigator should allow the subject or legal representative of the subject a wide time to ask questions about the details of the trial and to decide whether to participate in the trial. All questions regarding the research should be answered at a level that satisfies the subject or the legal representative of the volunteer.p>
-Before participating in the voluntary study, the written informed consent form must be signed and dated by the volunteer or the legal representative of the volunteer and the person who made the informed consent interview.
-If the volunteer or the legal representative of the volunteer does not have a reading, a neutral witness must be present during the informed consent interview. After the written informed consent form and other written information to be given to the subject has been read or disclosed to the subject or the legal representative of the volunteer, and after the verbal consent of the volunteer or volunteer’s volunteer to participate in the research and, if possible, the approval form of the neutral witness, sign and date. By signing the approval form, the witness, the information in the approval form and other written information are correctly told to the subject or the legal representative of the volunteer.