Informed consent is a critical component of any clinical trial. In order to ethically conduct a study, researchers must obtain informed consent from participants in order to ensure they understand the trial, and to confirm they are aware of the potential risks and benefits of participation. While the concept seems relatively straightforward, there are many nuances and challenges when it comes to communicating and obtaining informed consent from participants.
Here are some of the top informed consent challenges research institutions face:
In order for a consent form to be complete, the FDA requires certain information be included, such as what the trial is for and how it will run, the risks and potential benefits to the participant, the responsibilities of the participant and the staff, confidentiality for the participant, and the voluntary nature of participation. It can be difficult to ensure all necessary information is covered in an understandable way. Review the FDA’s full guidelines before submitting the consent form to your IRB.
Making consent forms readable largely depends on the intended audience. Knowing your subject population is key to ensuring your consent form is understandable for all participants. Consider the age of participants (talking to children is much different than teens, or adults), socioeconomic status, culture or education level for example. All of these different factors impact the way informed consent should be communicated and collected.
A principal investigator (PI) can’t be everywhere all the time, which is why proper delegation of authority in clinical trials is key. However, when it comes to delegating the task of collecting informed consent, there are extra considerations to take. While delegating parts of the informed consent responsibilities to non-principal investigators can save time for PIs, it also runs a risk of violating regulations requiring physicians, not their delegates, to obtain informed consent from participants. Make sure you know when and what to delegate when it comes to informed consent.
In clinical research, it is important to clearly and effectively communicate. When communicating informed consent to participants, consider these results of a 2013 study: Extended discussions and enhanced consent forms were associated with a significant increase in subject understanding, whereas multi-media approaches were associated with a non-significant increase. Don’t underestimate the value of having a meaningful consent conversation with your participants.
Another major informed consent challenge is knowing whether or not participants truly understand informed consent. It can be uncomfortable to quiz patients on informed consent materials, so instead try the “teach-back” method. Say something like, “I want to make sure I was clear in my explanation, can you tell me what you remember about X, Y and Z?” You can also provide a highlighter for the participant to mark areas of the consent form where they have questions, or where they would like more explanation. Beginning a dialogue is the first step to assessing, understanding and collecting informed consent.
6. Reducing informed consent declines
The final, and perhaps most frustrating, informed consent challenge is participant decline. After designing the informed consent form and communicating it to the participant, they may still decline to take part in the trial. While every patient has a right to decline participation, there are ways to reduce the decline rate, such as doing a root cause analysis. By finding out the reasons why participants declined informed consent, you can improve the process and reduce declines in the future.
Patient safety should be the top priority above all else in a clinical trial. When facing informed consent challenges, from the design process to obtaining consent, it can be helpful to take a step back and ask, “Is this in the best interest of the participant?” By ensuring informed consent is presented and collected in a clear and understandable manner, investigators can rest assured their studies are being conducted ethically.
Want to learn more about consent forms? Watch our webinar presented by Wendy Tate: “Making Your Consent Forms Readable: The Why and the How” and get tips for making making your consent form more understandable to your study population.