Informed Consent Form

Informed consent can be defined as a volunteer process through which the person or subject provide his or her willingness to take part in clinical trial. Before giving the consent for participation, the participants have been informed with all aspects of the clinical trial that are necessary and relevant to the subject's voluntarily decision to participate. Informed consent is the process, which includes documentation of a written, signed and dated informed consent form.

In other words, informed consent, a process of learning, or understanding of key facts regarding the clinical trial and making a decision to take part or not. Also it is a process, which continues through out the trial period, providing necessary information. The process involves discussion regarding detailed aspect of clinical trial between the site personnel and subject or in presence subject’s legal representative. The discussion carried out in subject’s local and understandable language.

Also the Informed consent form provided in the understandable local language, which includes the study details such as a study purpose, total number of study participants, duration, study procedures, risks, potential benefits, financial implications and contact person name. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Informed consent is one of the most important elements of system ensuring the ethics of medical experiments and protection of the rights of the study subjects.

Informed consent is a process by which a subject voluntary confirms his/her willingness to participate in one or another clinical trial, after having been informed of all aspects of the study. Informed consent should be documented by means of a written, signed and dated Informed Consent Form (ICF).

Potential subjects should be informed of the objectives and methods of the study, the drug product and treatment regimen, the available alternative treatments, potential risks and benefits, and of possible complications and discomforts, which may arise from participation in the study.

Based on information that he/she had received and understood, the potential subject freely gives consent to participate in a study. The informed consent should not be obtained through inducement or coercion. The subject should be aware that he/she may withdraw from the study at any time, and this will not affect his/her future medical care in any way.

The main principles of Informed consent

The subject should be informed of the following:

• the purposes of the trial;
• the methods of the trial;
• the study drug(s) and treatment regimens;
• available alternative treatment(s);
• the potential risks and benefits, and possible discomforts.

The subject should understand:

that informed consent should be given freely; that consent should not be obtained through inducement or coercion; that he/she may withdraw from the study at any time; that withdrawal from the study will not affect his/her future medical care.