Table 4.

Selected quotes from respondents about ethical concerns.

Special vulnerability of patients as research subjects	• “It’s definitely the case that, in a sense, the patients are very nice and they’re very willing to work with you to help the research efforts. But I also understand that they’re in a position where they feel like maybe they should do this because they’re getting surgery, and so maybe it’s part of their obligation. And so, the question is, does that make them vulnerable or not?” (opportunity study)—co-investigator
	• “I think a lot of the patients that have this disorder, once they get to the DBS, they’re pretty severe, and they would come in the next day or the next week. I mean they would want to come in fast. I mean, those people that want to come are pretty desperate.” (experimental trial)—co-investigator
Unique risks	• “We’re adding an extra piece of hardware, so that’s extra time which is a fuzzy distinction. I mean it’s kind of a surgical risk, but they wouldn’t be encountering it if they weren’t in the study, and so we talk about that and just the idea that the longer you’re on the table, the more chance there is for things to go wrong, but the characterization of those risks is essentially what the surgical risks are.” (opportunity study)—research coordinator
Preserving voluntariness	• “And so we try to tell them and comfort them as many times as possible that, again, the decision to participate in the research has completely no bearing on their clinical care.”—co-investigator
	• “So the research nurses, by the way, who are obtaining the consent, they are actually not involved in the actual research itself. …I mean, they know generally what the infrastructure is involved, but they have no incentive to enroll or not enroll somebody in the studies.”—co-investigator
Therapeutic misconception	• “I think that the critical thing here is that there is no direct benefit to the patient and their disease. Their participation is really benefiting scientific understanding. So that needs to be fairly explained to the patient.” (opportunity study)—co-investigator
	• “And I think you have to be really clear- I think people can assume because you are doing intraoperative research that you are somehow doing an experimental operation and that is absolutely not the case.” (opportunity study)—co-investigator
	• “What we don’t know is who are patients who are not appropriate for this procedure. So when that comes up, in terms of what’s the likelihood of getting well, or a patients’ therapeutic misconception that they will get well, they have to temper that.” (experimental trial)—principal investigator
Inconsistent regulatory guidance	• “Well, they’ve told us different things on different IRB protocols. So to be perfectly honest with you, I can’t remember what it is on this one.”—co-investigator
	• “So at our institution, our IRB believes that since this is an invasive procedure, a surgical procedure that has inherent risk due to the invasiveness, that the informed consent must be performed by a surgeon who actually understands the risks and can explain the risks to the person enrolling in the study. We have recently have gotten an amendment to our protocol so that I, as the surgeon, can tell the patient about the study and the related risks and then the rest of the informed consent can be done by a research assistant who is trained in the risks and I’m immediately available in case additional questions come up regarding the risks of the study. I say it’s controversial because I know other sites insist that the consent cannot be done by the surgeon because there’s a conflict of interest there, so it’s kind of interesting.”—co-investigator
	• “They have in the past expressed the desire that only physicians be the ones to consent patients, and in studies with adaptive DBS or DBS and other indications, that has been the case in the past, but it is not for this study the case.”—research coordinator