Before enrolling in a clinical trial, human subjects must sign a consent form that details the nature of the study and the types of risks involved. One survey conducted by CenterWatch determined that 30% of participants did not understand that their study could pose additional risks, and 70% did not know what questions to ask at the beginning of the informed consent process. Companies can protect themselves in clinical trials through careful preparation of the consent form and extensive investigator training on the consent process.
The consent document needs to be easy for the participant to read and understand. The industry standard for consent forms is that they are written at or below an eighth grade reading level. It is very important that the potential subject is able to understand the information in the form. It can be challenging to write consent documents, which often need to explain complex medical issues, at such low grade levels. However, the sponsor and the investigator should treat the task as important. It should not be left up to the institutional review board to make adjustments. Rather, sponsors should review any changes that institutional review boards make to ensure that no critical information has been deleted and that the readability and comprehension levels have not been corrupted.
Researchers should never just hand the consent form to participants to read and sign. Instead, they need to have face-to-face discussions with them and answer any questions they may have. After reviewing the consent document with the participant, some investigators test potential subjects to see how much information they actually understood. If a subject does not appear to grasp the critical points, the researchers need to discuss those issues with them again until they fully understand. This will help to ensure that true informed consent is obtained from all trial participants.
Wadlund, Jill. Heading Off a Clinical Trial Liability Lawsuit. APPLIED CLINICAL TRIALS. vol. 12, no. 4.
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