An effective and ethical informed consent process must go beyond obtaining a patient’s signature and must ensure that the patient fully understands what the trial involves and feels confident in their decision to participate. In this blog, we provide key tips for crafting an effective informed consent form and communicating the right level of study information to participants.
What is Informed Consent and How Does it Influence Patient Retention?
Informed consent has conventionally been obtained by asking potential study participants to read paperwork, which is often lengthy and not always in plain language. Yet, according to the European Patients Forum, informed consent should be seen as a process, a kind of “decision aid” that enables a patient to make an enlightened decision.
There are other ways of providing study information that are more engaging, such as providing it as video content. This approach allows patients to go through the materials at their own pace and provides the information that allows them to accurately assess the journey that lies ahead.
Misunderstanding expectations about a trial is a key cause of patient dropout. In a comparison of patients who completed or dropped out of a study, 35% who dropped out said it was difficult to understand the informed consent form, compared with 16% who completed the study. Among those who dropped out, 64% said that their questions were satisfactorily answered during the consent process, compared with 89% of people who completed the trial.
An effective informed consent process not only means that patients have more knowledge, but also helps to engage them in the study and improves patient retention.
What are the Regulatory Requirements for Informed Consent?
The European regulation on informed consent is defined in Directive 2001/20/EC as the “decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks.”
In the United States, informed consent is governed by the 1991 Federal Policy for the Protection of Human Subjects, otherwise known as the “Common Rule.”
Both the European and US regulations for informed consent stipulate that potential participants must receive the following information:
All this information must be given in plain language and delivered by a physician or another individual with appropriate scientific training.
Updated Requirements for Informed Consent
Following patients’ complaints that consent forms are too complicated, the US ‘Common Rule’ was updated in 2017 to reflect the fact that research involving patients has grown in scale and become more diverse in terms of types of trials, analytical methods, and digitization of data.
The intent of the updated requirements is to provide substantially shorter “core” sections of consent forms, so that prospective participants receive the most important information in the body of these relatively short forms, instead of having that key information buried in long and overly complex documents.
Regulators also emphasize that informed consent is a continuing process – especially in long-term trials – and that researchers should engage with patients in an ongoing dialogue to keep them updated about any changes to the trial.
Tailoring an Informed Consent Form
Informed consent forms should be tailored to the participant and the research study. In practice, this means ensuring that all materials are written in plain, non-scientific language aimed at a 12- to 13-year-old reading level. The writing style must be simple and transparent, be relevant to the medical condition being studied, and use a factual and not promotional tone of voice. The consent form must also be tailored to the specific patient population. This means taking into account different languages and cultures.
- The informed consent process is more than just a checkbox exercise and a signature on a piece of paper
- It should provide the appropriate amount of tailored information about the study and what it will involve for participants, written at an appropriate level for their understanding
- It is not a one-off event, but an ongoing dialogue between study investigators and patients that continues throughout the trial
- A carefully crafted consent form and informed consent process is a critical component of your study, contributing to patient retention