• Home
• Responsibility
• Research practices
• Clinical research
• Informed consent

Corporate Responsibility Report 2008

Informed consent

Informed consent means that a potential clinical trial participant voluntarily confirms their willingness to participate after being informed of aspects of the trial that are relevant to their decision to participate. It is documented by means of a written, signed and dated informed consent form.

Informed consent for a clinical trial involves more than just reading and signing a consent form. There are two essential elements; a process to communicate the information and answer any questions, and signed documentation.

The informed consent information is written and communicated in a non-technical style so that a lay person can understand it. It includes a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation and provisions for data protection) and explains participants' rights (including voluntary participation and the right to end participation).

Researchers and health professionals know that a written document alone may not ensure that someone understands what participation means. Therefore, the research team discusses with the person the trial's purpose, procedures, risks and potential benefits, and the participants' rights. If the person decides to participate, the team will continue to update them on any new information that may affect their willingness to continue in the trial. Before, during and even after the trial, the person is given opportunities to ask questions and raise concerns. Thus, informed consent is an ongoing and interactive process.

There may be special cases where obtaining someone’s informed consent is not possible such as emergency research scenarios, or when children are below the age of legal consent. In these circumstances consent is sought from someone who is allowed to provide it under local laws and regulations. In situations when someone cannot read but is able to speak and understand the local language, an impartial witness is present during the informed consent process to confirm in writing that the information in the informed consent form was accurately explained and that the potential participant was able to ask questions and gave consent voluntarily.