Informed Consent in a Clinical Study

Informed consent is the most important document in the medical history of each patient in a clinical study.

It is a document that provides information in a straightforward and accessible form on:

the study, its objectives, schedule of visits and the course of individual visits, potential risks, and adverse events, study drug, methods of treatment, requirements for basic treatment, length and course of the study, and procedures performed during the study. It includes detailed contact information with the center where the study is being conducted and the contact details of the treating physician (called the investigator in a clinical study).

The study team has no right to perform ANY procedure in the study without proper and signed consent.

If new drug safety information becomes available during the course of the study, or the schedule of visits or any of the study procedures changes in any way, the Sponsor is obliged to enter the relevant information into the existing Informed Consent Form. In practice, this means the need to create a new version of the consent and sign it with the patient participating in the study during the next visit to the facility.

The patient has the right to withdraw informed consent at any time during the study without giving any reason - in practice, this means discontinuing active treatment and moving to the observational part of the study or, if the patient so wishes, withdrawing from the study altogether and switching to standard medical care without assessment of the safety of the current treatment.

Necessary conditions for obtaining an informed consent

The patient has the competences
The patient has been appropriately informed
The patient understands the situation
The patient has the freedom of decision
The consent is obtained solely in written form

In practice, this means that informed consent can only be obtained from a patient who is informed and aware, has been provided with all available information about the study in an understandable way, understands what the study is abou... (zobacz więcej)t and what its rules are, and made the decision independently and is completely sure of it. In clinical trials, only the written form of consent is valid, so it must be obtained in this form. (zobacz mniej)

Informed consent - obtaining process

Each Clinical Study Center has its own customs regarding the process of obtaining informed consent from the patient. However, there are certain rules enabling to carry out this stage in an optimal way:

A potential participant in a clinical trial receives information about the trial with an informed consent form for detailed reading. The document is provided to the patient in paper form or electronically.
The patient reads the document at home, in a quiet environment, without haste, jotting down all the questions that arise while reading the document.
The time to read the document in detail is at least 2 days.
After reading the information about the study, the patient is invited for a visit, during which the issues of participation in the study, rights, and obligations resulting from signing the consent and the course of treatment are discussed in detail.
The patient asks questions prepared earlier and those that have arisen during the visit. Then the patient receives exhaustive answers to all questions asked. The researcher provides the answers in a form that is understandable to the patient.
No coercion or pressure is used when making decisions. The patient must be 100% convinced of their willingness to participate in the study, and the decision must be made by the patient himself (and not, for example, by a family member).
The patient and the physician hand-sign and date the informed consent form.
The patient receives a copy of the signed informed consent form. The second copy is retained in the study documentation.

No examination procedure may precede the signing and date of the informed consent form by the patient or their legal guardian.

For example, the signing of the informed consent document by the patient must precede the first blood collection as part of a clinical trial, as well as the discontinuation of drugs previously taken by the participant, but prohibited in the study.