Hello, everyone. My name is Nikhil Sharma, and this is our presentation titled Ethical Issues in Intraoperative Neuroscience Studies, Assessing Subjects' Understanding of Study Purpose and Motivations for Participation. We have no financial disclosures, and we obtained an NIH grant as our funding source with our grant ID listed above. One interesting portion of this grant was that it added an embedded neuroethicist call supplement. Let's begin. Intraoperative neuroscience studies have very unique ethical considerations, not only because these disease states may trigger anxiety in patients, but also because there is a risk of forgetfulness. This is especially important during the consent process for procedures and research studies. Our study involved some features of a healthy volunteer study as it did not test a drug or treatment, but it did involve an intraoperative setting. For our study, we had four primary purposes shown here. However, for the purposes of this presentation, we will focus on the first two, patient's motivation to participate and patient's recall of risks and benefits and study purposes. So briefly, I'll describe the intraoperative study. Subjects were consented to two game tasks. The first was a game of probability where subjects were given two handheld buttons which were associated with two lights above them. Subjects were then instructed to pick the button or light that they thought was the correct or rewarded light. Each time they picked the correct light, they heard a ka-ching sound similar to a cash register, and every time they picked the incorrect light, they heard an error sound. The second game was just an ocular saccade tracking game where there were four lights above them, up, down, left, and right, and their job was to follow each light with their eyes as best they could. So this is the general setup. Essentially, our computer systems were right next to the patients. The patients were given these two handheld devices in the middle. The light system is right above them, as you can see with the gray box, and they would just follow the light system for the ocular saccade task, and they would use the buttons to pick the correct light for the button task. So for our methods, we approached any patient with a diagnosis of Parkinson's disease who elected to undergo unilateral or bilateral DBS placement in the subthalamic nucleus. Patients were first asked to participate in the game study. They were not paid for any participation. If the patient did consent, then they were asked to participate in the ethics portion of the study, in which they were paid $75 for each interview. If the patient declined to participate in either study, they were asked to answer five questions on why they declined, and they were offered $5 for those answers. Of course, patients had the opportunity to not participate in any studies. For the ethics study, the patients completed two phone interviews with our ethics team. One was pre-op, which occurred a few days after the consent process, and one was post-op. Each interview lasted for 30 minutes and included semi-structured interviews of approximately 30 minutes in length. All interviews were conducted by an embedded ethicist. The pre-op interviews occurred at a mean of 7.8 days following the informed consent and a mean of 5.2 days prior to surgery. The post-op interview was not included in this analysis as the results of interest revolved around motivation to participate and the recall of recent procedures. But just for reference, the post-op interviews were conducted at a mean of 35.4 days after surgery. Here's an example of the pre-op phone interview questions. They mainly revolved around the subject's motivation to participate and their ability to recall risk and purposes. So quickly, here's a summary of the demographics. We had a total of 22 patients, 5 were female. There's a mean age of 60.9. Overwhelming majority of patients, 19 out of 22, did not have a prior DBS implantation. Overwhelming majority of patients had at least an associate's degree. And majority of patients did not participate in research prior. In regards to the results, we'll first look at motivation to participate. Approximately 91% of all participants informed the research staff that their reasoning to participate were altruistic in nature. Some patients were even quoted saying, if it helps with PD for somebody, I'm happy to do it. Others said, we'll do it right now. We'll sign right now because it's going to help someone. Or for the advancement of science. Some patients even said, I'm going to do it because I want to help Dr. B, the lead PI in this, in any way I can and try to give back for what he's done for me. For recall of risk, majority of the patients, 77%, said that they don't know, remember, or thought risk weren't mentioned during the pre-op interviews. Only three subjects recalled the risk, while two subjects partially recalled the risk. Keep in mind, at our institution, all coordinators go through intense training to appropriately ensure that the informed consent process is completed fully and patients are completely in the know. Some of these quotes that patients offered included, well, I didn't quite see a whole lot of risk, so I wouldn't think that there were. Or, I don't remember. Or even just, I don't think that there are any risks besides being up to a half hour more than normal, in reference to the surgery time. Finally, in regards to the purposes of the study, our findings show that eight patients knew it was neuroscience-related. The rest of the patients either could not remember, remember the task but not the purpose, or thought it was PD-related, although it was made clear throughout the study consent process that this had no impact on Parkinson's disease. Some quotes from the interviews included, it's going to help them see the function of the brain and how it responds. Or, I thought it was something about my eyes. As we saw, even though there was training, both by the institution and the department, in regards to the informed consent process, subject recall for risk was poor. However, nearly all subjects did understand that the study would not confer a direct benefit for Parkinson's. So how does our study relate to other similar studies? Well, in our study, risk recall was markedly lower than previous studies assessing PD patients for recall. A variety of methods were used to assess risk, ranging from multiple choice questionnaires in the Ravina et al. study to closed-ended yes or no questions in the Valada study. Study methods and how risk recall is assessed may have contributed to the higher recall rates in those studies. When compared to previous studies that assess for recall of purpose in PD patients, our results were fairly mid-range. This wide variation in recall rates may be due to study methodologies, such as multiple choice versus open-ended, the time point at which patients were queried. For example, the Kim et al. study queried patients post-surgery at one month, two years, and four years after surgery. What was determined to be correct? This could include things like partially correct answers may have been included as correct count, and patients sometimes selected more than one answer. But overall, our results for assessing purpose was pretty mid-range. To conclude, the NIH is now funding an increasing number of interoperative studies. But we want to emphasize that informed consent studies should also be prioritized. We believe that there is a big difference between understanding and recall. Future work should focus on informed consent interventions to improve recall by potentially separating the informed consent process from the rest of the procedures for that day. For example, when our research coordinators approach studies, it would be right after an hour-long visit with the clinic team, so there could be some confusion between the clinic side and the research side. Also, it would be important to assess the relationship between the capacity to understand and actually recall study-related tasks. Thank you so much for your time, and have a great day.

Ethical Issues

Intraoperative Neuroscience Studies

Study Purpose

Motivations for Participation

Deep Brain Stimulation (DBS)