Simulated Informed Consent Training Can Lead to Real-World Improvements

Kevin Gardner, Jr., MS, BSN, RN, CCRC, Director of the Clinical Trials Office, Penn State College of Medicine

Clinical research trainers will tell you that not every trainee will flourish under the same kind of instruction—some excel in face-to-face classroom settings, some blossom with online courses, and guided reading or some combination of these with other learning methods will hit the spot in other cases. However, when it comes to learning how to effectively conduct the sensitive and mandatory process of informed consent with clinical trial volunteers, simulated consenting holds many advantages for trainees who are new to the concept—and even for seasoned site staff whose consenting practices could use some fine tuning.

Tackling the many considerations involved in designing and executing a simulated informed consent experience at ACRP 2024 will be ACRP member and certificant Kevin Gardner, Jr., MS, BSN, RN, CCRC, Director of the Clinical Trials Office for the Penn State College of Medicine in Hershey, Pa., where “mock consenting” is in the early days of being included during onboarding of all brand new and new-to-Penn State clinical research professionals. Gardner graciously provided some background on what he’ll bring to the table about this topic at the Anaheim, Calif. conference in May.

Q: What are some of the mistakes people are most likely to make in informed consent (IC) if they are not properly grounded in why it’s important and how to effectively conduct the process?

A: There are several areas that can be improved upon in the whole consenting process that we cover in simulated consenting. First, we look at issues surrounding the use of medical terminology and speaking way over potential participants’ heads. In general, patients may not question their healthcare provider even when the patient does not understand what is being said or find it sensible in any way. In simulated consent, having an experienced coordinator serve as the “participant” allows trainees to take control of the conversation and ensure the learning opportunity is not missed. The way that we have set up the simulated consenting, the trainee is paired with an experienced clinical research professional who is neither a supervisor or a peer to the trainee, nor is familiar with the study protocol to which the trainee will be consenting the mock participant.

Second, participants may make statements that would cause seasoned clinical research professionals to question whether the participant truly understands what is being said to them. I myself have had potential participants say, “Doctor Smith has saved my life, so I know he/she would never do anything to put me at harm’s way” or “Whatever Doctor Jones says I should do, I will do.” Even scarier is when a potential participant says “I don’t need to read the consent form. You are a (fill in the blank). I trust you. Just tell me where to sign.”

For a novice clinical research professional, it is easy to come up with the perfect answer when they are sitting in a classroom of how they would respond; however, in the simulated consent environment they have to respond instantly. This creates a great learning opportunity that they really have not been explicitly prepared to address. Still, before we bring trainees to the simulation center, we do classroom training with them.

The first two parts of simulated consent involves didactic training from our Human Research Protection Program educator and Research Quality Assurance director for human research. This education is homegrown content that discusses the institutional review board and its role in research and consenting, respectively. This is the Who, What, When, Where, and Why of consent. The third part is also didactic training that is conducted by a member of my team, whereby we discuss the process of obtaining consent. This is the How of consent. In total, we spend about four hours in didactic training before we even go to the simulation center.

The fourth part of simulated consent is in the simulation center, and we do two rounds of consenting. Each round is with a different mock participant, so the student trainee gets an opportunity to try a fresh approach each time, based on the observations of the monitor (a person observing what is happening in the simulation room but not actually participating in the consent discussion) and the feedback from the mock participant. Depending on the results, we may recommend additional rounds of stimulated consent—and the trainees are free to request another go at it on their own initiative.

Q: Is the simulation better suited for those who are brand new to the idea or can it be/has it ever been modified to help reeducate those who need help in performing IC more effectively?

A: This was specifically designed for new clinical research professionals. However, it can be adapted to help re-train or reinforce skills. It may not be a popular statement to make, but to a degree, recruiting a potential participant for a clinical trial is like selling a used car. There may be a negative connotation around the idea of joining a trial; however, it may be the right option for the right person. To that end, as professionals recruiting participants and obtaining consent, we are selling the “clinical trial lifestyle.”

If an experienced clinical research professional is having difficulties recruiting participants and/or having the consenting discussion, mock consenting is a good opportunity to help hone those skills. Our intention of mock consenting is not to have it be a punitive measure or a remedial step as part of a corrective action plan, but it could be adapted for that should the need arise.

Using Simulation to Train the Next Generation to Provide Informed Consent

Join Kevin at ACRP 2024 [May 3 – 6; Anaheim, Calif.], as they explore how one institution implemented an informed consent training program through both didactic training and simulated consenting scenarios. View Complete Schedule.

Q: In an earlier blog, it was noted that your Clinical Trial Office had decided to incorporate this activity into the onboarding of all new clinical research professionals at the College of Medicine and Penn State Health—so how has that been going?

A: We just changed the format of the onboarding program (Clinical Research Skills Workshop), and we are at the point where the first two didactic sessions of the simulated consenting program have been completed as part of it. We have 30 attendees in this cycle of the workshop, including both novice and experienced clinical researchers, and we have had many of the workshop attendees request a slot in the simulated consenting program. I hope to be able to report more on this at ACRP 2024 when I also present a session on “Designing Internships as Clinical Research Career Preparation Tools” with Andrea Stevens, MS, PhD, Assistant Professor of Biology and Director of the Undergraduate Clinical Research Program at the Penn State Greater Allegheny campus in McKeesport, Pa.

Q: What kind of resources are needed for trial site leaders to take the lessons learned from this session and apply them to setting up their own IC simulations?

A: There are quite a few resources that are needed, and I will go into the details on those in my solo presentation at ACRP 2024. I will explore what site leaders need for implementing simulated consent—whether they have the large resources of an academic medical center or medical college or have limited resource of a small clinical research operation. The most important resources are personnel and a champion to make it all happen.

Edited by Gary Cramer