In November 2011, several Belgian Ethics Committees took the initiative to develop a template for informed consent. Several reasons lead to the start of this project:
- the excessive increase of the number of pages of informed consent documents,
- different templates between companies,
- lack of structure,
- repetitions and irrelevant information, etc.
As a result, the informed consent document often is a very complicated document, impossible to be understood unassisted by lay people. Hence, it is doubtful trial subjects and even members of the study staff will review the document in its entirety.
The Declaration of Helsinki, the Guideline for Good Clinical Practice and the Belgian law on experiments focus on the obligation of informed consent and the level of information to provide to the person who will accept to participate in an experiment and accept processing of his/her personal data and/or samples of human body material for research purposes.
The creation of a proper template for informed consent should lead to the following advantages :
• a simplification of editorial work,
• a simplification of evaluation work by the Ethics Committee,
• harmonisation of the requirements towards the sponsors,
• a simplification in the process of informing the patient
• and better information to the patient.
The template was developed with specific attention to the following aspects :
• Structured information, clear guiding principle ;
• Understandable language: correct sentence structure, short sentences, absence of technical language, use of the identical terminology throughout the entire document, avoid use of too much abbreviations, free of spelling errors ;
• Sufficient font size policy (Arial 10) ;
• Sufficient interspaces throughout text.
The need for structured information is practically carried out in the division into 3 parts, all 3 receiving page numbering.
1. Information vital to the decision to take part
Essential information for understanding of the research.
2. Informed consent
The consent itself.
3. Supplementary information
Information which is not immediately part of the decision process.
The sequence of these parts can be adapted.
The first part should always be the vital information.
The following two parts can be switched.
Apart of the optional front page, the informed consent document, which should be as short as possible, cannot be more than 15 pages long.
In total, 4 different templates have been developed :
1. for interventional clinical trials on adults
2. a specific introduction in case of a legal representative
3. a specific introduction for participation in an emergency situation
4. for non-interventional studies on adults
These templates are written in 3 different colours :
• red : instructions, alternatives or comment to the document editor, which are to be removed from the final informed consent document ;
• blue : indicating what should be added, mentioned or adapted,
• black : wording to be kept in the final informed consent document.
These templates have been agreed and approved during the Clinical Trial Taskforce meeting of June 26, 2013. The famhp strongly supports the use of these templates. All 4 templates can be downloaded by clicking on the links above. With some adjustments they can be used for clinical studies on medical devices as well.
The use and adoption of these templates will be re-evaluated after an evaluation period. Comments or suggestions can be sent to firstname.lastname@example.org with the subject « informed consent templates ».