Informed consent procedure

Do you want to request permission from a patient or volunteer to participate in a clinical trial? And does that research fall under the Medical Research Involving Human Subjects Act (WMO)? Then you must first inform them about the purpose, nature, duration of the research and about the risks and objections to participation. This is the so-called informed consent and it is of great importance. The research protocol must describe how this consent procedure works.

In practice, the patient or volunteer will often be informed in a personal interview and asked if he might want to participate. In any case, he must receive an information letter explaining the research and the possible risks and objections. This letter must also offer the possibility of an oral explanation insofar as it does not take place nevertheless. In this way, the patient or volunteer is given ample time to carefully reconsider the options. The patient or volunteer then decides whether he would like to participate in the trial. If he decides to participate, he gives written consent by signing the informed consent form included with the information letter.

Handling questions during the consent procedure

If a patient or volunteer has questions during the consent procedure, these questions must be answered adequately by the person who provides the information. That does not necessarily have to be the (principal) investigator of the trial. It can also be another person from the trial team. Are the questions from the patient or volunteer medical or otherwise specific in nature? Then, of course, they must be answered by an expert in this field.

The Health and Youth Care Inspectorate (HYCI) advises recording or otherwise documenting the questions and answers. We also take this advice into account with regard to the obligation as a care provider to keep a medical record. For trials with medicinal products for human use, a physician or dentist working in healthcare is responsible for the medical care and medical decisions for the subject. This appears in Article 13d under c of the WMO.

Recording questions and answers

In addition to the patient or the volunteer, the person who implements the consent process also should sign the consent form. Is the person who also signs someone other than the doctor or expert in the field of the trial? Then in the opinion of the Inspectorate it is even more important that:

• additional medical or otherwise specific questions from a patient or volunteer are recorded;
•  the person who has answered these questions is recorded.

Does the patient or volunteer have no specific questions? Even then it is advisable to record this. To do so, put in the procedure that a patient or volunteer has had the opportunity to ask questions to a doctor or expert. These are medical or otherwise specific questions. This applies to all research covered by the WMO.

Research with medicinal products is often performed worldwide. The Inspectorate notes that outside the Netherlands it is often a doctor who signs the consent form. This has been laid down in other countries, for example, in national legislation. Therefore, for international clinical trials, following this process is strongly recommended.