Modern clinical research standards are based on voluntary participation and the provision of comprehensive information to participants. Medical research's ethical principles are set out in the World Medical Assembly Declaration of Helsinki adopted in 1964, which has been regularly updated since.
According to the declaration, participants' consent must not only be entirely voluntary but might also be withdrawn at any time without disclosing the reason. In addition, everyone agreeing to participate in a trial should clearly understand what exactly is being investigated, as well as their own interest in participation and the risks of doing it.
Informed consent is a legal process in which a patient voluntarily confirms their consent to participate in a particular trial after being familiar with all its aspects. Informed consent is documented in a written, signed, and dated form.
Potential subjects must be informed about the objectives and methodology, the drug and course of treatment, the available alternative courses of treatment, the potential benefits and risks, as well as possible complications and inconveniences that may arise as a result of participation in the trial.
Based on the information received and understood, the potential subject gives their consent to participate in the trial. The patient's consent cannot be obtained under duress. The subject must be informed that they have the right to withdraw from the trial at any time without penalty as long as it won't affect their other medical care.
No study procedure can be performed before the patient signs the informed consent form. Informed consent also contains the research doctor's contact information, the ethics committee, and the contact number in case of health deterioration or medical emergencies. The patient has the right to receive an information sheet in order to carefully read it, ask the doctor all questions, discuss the information received with family and friends, and make an informed decision about participation or non-participation in a clinical trial. By signing the informed consent form, the patient confirms that they have read the information sheet and understood everything related to the trial, received answers to their questions, and that their consent to participate is voluntary and informed.