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When clinical trials are carried out, it is necessary to enrol participants. Before anyone can be enrolled, they must first voluntarily confirm their willingness to participate in the trial by reading, filling, dating, and signing an informed consent form (ICF). This essential document is the only way to assess if potential participants have understood what the trial involves and their willingness to participate in it. ICFs are not only used for clinical trials, but also, for example, when a new medicine is made available to patients through a Compassionate Use Programme (CUP) or a Medical Need Programme (MNP), or when new vaccines are urgently rolled out in an area (COVID-19 vaccines being a recent example). The process of obtaining consent is ongoing throughout a clinical trial or treatment, where ICFs must be updated with new information when it arises, and patients have the right to withdraw their consent at any moment.
ICFs are shorter than trial protocols or reports, and might seem less crucial, or at least that less attention is needed to write them. Unfortunately, that is not the case. To be able to give a valid consent, participants must have received all the necessary information that is relevant for them to be able to decide to take part in the trial. It is not enough to give them the information, it must be given in a way that can be understood by laypeople, as they are not necessarily familiar with clinical and medical terms.
In the past, informed consent was not systematically sought from trial participants; now the necessity to include ICFs when carrying out clinical trials is included in the International Council for Harmonisation (ICH) guidelines for Good Clinical Practice (GCP). These guidelines are followed by the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions. Since the ICH-GCP is followed in these regions, it is certain that ICFs are being given to patients and trial participants. However, what if the ICFs are not understood by them due to the level of technical language used? What would that imply for the consent given? Would it truly be an informed consent? This possibility is quite real, as clinical trials and medical procedures become more sophisticated, there is also the risk that the level of technical language used in ICFs becomes too complex for a layperson.
As it turns out, these issues do happen on occasions. In 2012, a study carried out in Italy involving 7 ICFs in English and Italian for cardiology procedures found that these ICFs were complex, incomplete, and unreadable for a layperson due to the amount of jargon used. More recently, a similar issue was found in 4 ICFs from 4 COVID-19 vaccine trials carried out between October 2020 and January 2021. In both cases, ICFs were too long and difficult to read and understand, while shorter and more readable ICFs were possible.
Ensuring that trial participants have been given the necessary information in an understandable way is crucial to ensure that their consent, if given, was truly informed. Furthermore, by having an informed consent, the participant’s rights are protected, and helps them to comply with the procedures.
Here at Modis Life Sciences, we have the expertise to prepare fitting ICFs, for example for clinical trials, CUPs, and MNPs, and can support pharmaceutical and medical organisation in completing these documents for their projects.
– Michel-Olivier Laurent, Scientific Writer