Episode 03: The Informed Consent Process
The informed consent process is generally the first impression that subjects make with your research site. As a result, the importance of how the process is manged is of the utmost importance. Here are some quick tips for how to simplify the informed consent process.
In addition, I would encourage all sites to consider the informed consent process a first impression for potential clinical trial participants. Put yourself in the subjects shoes: would you participate in a trial that your site was offering?
+ Full Episode Transcript
Brad: Hey guys, this is Brad Hightower. Thank you so much for tuning into episode three of the Note to File podcast, a collection of interviews, best practices and ramblings clinical research sites. Today, we're going to talk a little bit about the importance of clinical research coordinator. It's very likely that your first interaction with the patient is during the informed consent process, how this process is managed. Will it play a significant role in whether or not they decide to participate? Here's some tips that might help your process go a little more smoothly first, if at all possible have your PI be as involved as they can in the informed consent process, depending on the structure of your research site, it's likely that a majority of the patients you screen are those, the PI or the practice they've likely built a preexisting relationship and have built some level of trust over time. As a result, patients might be more receptive to receiving information from the PI. This can make a big difference as to whether or not they've decided to participate. Secondly, use the checklist. I think at this point, it's pretty much industry-wide standard to use some sort of checklist or template to document your informed consent process. This helps ensure you've covered all required elements of informed consent. Given the patient as much time and information they need to decide if they want to participate using a checklist can also help keep your conversation coherent and organized. So for any reason, you're not using a checklist, feel free to reach out to me and I'll send you a generic template. Consider the informed consent process, a first impression for your potential research subjects. If you're able to include your PI, use a checklist and go beyond the consent form, there'll be a lot more likely to enroll potential patients and retain them further down the line. Let me know what you think. Thanks so much for listening to Note to File podcast. Please make sure to rate, review and subscribe and check us out at notetofilepodcast.com.