Pro Tips for Creating a Successful Informed Consent Form (ICF)
The informed consent form (ICF) is one of the most crucial documents sponsors draft for clinical trials. For many potential enrollees, the ICF is their first introduction to clinical research and a roadmap for what to expect moving forward.
Unfortunately, if an ICF is poorly written or drafted without participants in mind, it can turn people off rather than get them excited. In turn, this can significantly impact enrollment and leave your study stalled at the starting line.
Despite the ICF’s essential role, many sponsors fail to include patients in the draft process. This is unfortunate. Since understanding a patient’s perceptions, fears, and motivations is crucial for long-term engagement, moving forward without considering the patient’s experience makes little sense.
Rather than maintaining the status quo, why not include patients, patient advocates, and care partners in the ICF draft process? Although this might seem challenging, it’s easier than you think. Here are 3 Pro Tips for getting started:
Pro Tip #1: Start ICF reviews right away
Many sponsors and CROs view the ICF as an unchangeable monolith, but this mindset doesn’t serve anyone. The ICF is a living document. It can be edited at any time to improve clarity and ensure a positive patient experience. However, to achieve these goals, you need to have varying viewpoints. Get potential patients, care advocates, and partners involved in the review process. There’s no right or wrong way to do this, but it’s a good idea to include the following individuals on your ICF review team:
- One reviewer who is trial naive
- One reviewer who is trial savvy
- At least 3 other reviewers with unique backgrounds and geographic locations (especially if it’s a global study)
By starting the ICF review early and referring to it throughout the trial design process, you can avoid common pitfalls and create an ICF document that serves the audiences you’re trying to reach.
Pro Tip #2: Make it easy for reviewers to access the ICF and share feedback
Once you establish an ICF review team, you need to gather their feedback and insights. This can be challenging if your reviewers are located around the globe, but various digital platforms allow for secure data collection and sharing. Once you identify a platform, ensure all reviewers have access to the ICF and can read it at their own pace. Likewise, you should establish a point of contact so that if reviewers have questions or encounter technological issues, they can reach out.
Pro Tip #3: Give your review team plenty of time
A thorough ICF review takes time and energy. Most ICFs have 10-30 pages of dense text, so you don’t want to rush the process. Give each reviewer at least 7 business days to read the document and provide feedback. Similarly, consider providing an honorarium for your reviewers’ time and expertise. A small stipend provides even more incentive for your review team to give open and honest feedback.
A clear, concise ICF makes all the difference
As a sponsor, you know how much time and effort is dedicated to patient safety, but study participants don’t always have the same level of understanding. Deciding to enroll in a clinical trial and entrusting your body to a team of researchers can be scary. Try to view the ICF development process from this lens. By including ICF reviews as part of your trial design from day one, you can better inform patients, prevent common headaches, and meet your enrollment goals.
This article was inspired by a recent guest column in Clinical Leader: Considering the Patient Experience is Critical to Creating a Successful ICF By: Debra Densmore, MPA
