Table 2.

Thematic Analysis of Focus Group Discussions

Domains of Concern (number of statements)	Meaning Abstraction (number of statements)	Demonstrative Quotes
Autonomy (29)	Choice without coercion (13)	“The way I think of autonomy is pretty straightforward, and that is, having the capacity of, or having the capability of making decisions, making choices, without coercion, which I define narrowly as the use of force, the threat of the use of force-without anycoercion limiting your choices.”
Vulnerabi	Participants have characteristics of vulnerability requiring relatively higher-level consideration of protection. (16)	“Well, I have 2 concerns. One is the use of the term vulnerability. You know, just, in general…in general, I object to the use of the term ‘vulnerability.’ I’m not sure what it means. Especially as the classification of vulnerability expands…I would like to have a very narrow definition of ‘vulnerable’ so that it doesn’t include everything and everybody under the sun.”
Domains of Concern	Meaning Abstraction	Demonstrative Quotes
Researcher Role Boundaries (26)	Perceptions can blur distinction between care provider and research roles	“One of my long-term concerns is about the relationship between the researcher and the subject when the researcher is also the care-giving physician for that patient before the patient becomes a subject because I’ve always thought that there was a substantial conflict between the roles of the scientist and physician, which most people don’t really recognize. And that is that the primary goals of medicine and of research are entirely different.” “The major goal of patient care is to do whatever is best for the patient. The goal of the investigator or scientific investigation is to advance the knowledge that underlies science and those two are quite different and sometimes are incompatible.”
Subdomains
PI Transparency can contribute to maintaining distinction between research and standard care boundaries (12)	Disclosure processes for potential conflicts of interest	“My concern is financial disclosure that occurs at the outset and then over a longitudinal study that goes on for 4 or 5 years, what are our duties to be informing them about financial interest, and financial development, and investment into different things. Is it a continuing obligation from the point of start to the end? Or is it just at the front end? These things concern me.”
Sharing Results with Participant (7)	Returning findings to study participants is not traditional part of research communication-risks confused perceptions about shared information	“But one of the issues that comes up there, and that’s another place I see therapeutic misconception being a problem, do participants understand they are getting back research data, as opposed to a clinical treatment finding, and the potential confusion of therapeutic misconception to that individual.”
Future Direction to raise Investigator awareness (3)	Reflections on how to promote	“The question of training and educating people to do this well…that has not been taken seriously.”
	best practices	“Senior people themselves weren’t trained, so they’re not sure how to train the junior people. So I think it’s a really important area.”
Domains of Concern	Meaning Abstraction	Demonstrative Quotes
Research Participant Understanding of study purpose and goals (23)	Expressing implications of poorly informed consent	“You can use all of these intensive recruitment and retention techniques, but are you going to end up with a bunch of patients who didn’t really want to be on the study or they didn’t really understand that study; are they going to drop out? How good’s your data? So there’s a scientific reason to really care about this.”
Subdomains
Justice (8)	Equitable distribution of the opportunity to be part of research	“You want to find patients that are going to understand the consent process and enroll them for them to meet your goals, so people who could benefit from the research are being left out, and they don’t get a chance to actually participate, I think that would be a concern.”
Subdomains
Health literacy (8)	Understanding medical language as a	“So the challenges that we have is how do you take the long consent process and redesign it so that it can be lower literacy but still have all of the information.”
	factor in providing informed consent	“The whole idea of health literacy, which to me is more than just reading level, it’s all of these phrases that the IRB makes huge.”
Domains of Concern	Meaning Abstraction	Demonstrative Quotes
Theoretical constructs of informed consent instruments (12)	Workshop focus group participants expressing thoughts regarding multiple dimensions to measure	“… 2 kinds of therapeutic misconception, whether or not you’re confused about your benefit, and whether or not you’re confused about whether it’s treatment or research.”
Subdomains
Hope (3)	Optimism about what can be accomplished by research	“As far as the people that don’t really buy into the therapeutic misconception, and it should not exist at all, and that one example is hope, not squashing hope because that is enormously helpful in the healing process but that sometimes can be a slippery slope.” “Hope with realistic expectations”
Domains of Concern	Meaning Abstraction	Demonstrative Quotes
Informed Consent Process (23)	Implementing protection has implications for steps in the research process	“I think that IRBs have gone way overboard and in many different areas, the biggest one I think is in the area of informed consent forms…you know when you get up to 30 or 40 pages, who is going to read those?”
Subdomains
Benefit vs. Risk (4)	Risks different than standard care	“The benefits statements in those consent forms had to be very vague, and so it’s not surprising that people should overestimate benefits because nobody actually ever told them that the chance that they would benefit was 5%.”
Contextual Influences on voluntariness (13)	Workshop participants recognize that the approach process can have implications	“I think if depends on the context and how it’s done…same with the use of intensive retention methods…it’s again not necessarily manipulative, but there’s a sense of…‘we’re going to keep asking you no matter what’, it’s almost like harassment I think.
Altruism (4)	Research personnel bring their own motivations and goals	“A patient was laying down…I just kind of asked him, ‘why are you doing this?’ and he clearly said to me ‘I’m doing this so my grand kids don’t have to suffer.”
Text Language in informed consent documents (8)	Workshop focus group sharing	What if we called them ‘experiments’ instead of ‘trials’…whole different thing is we want you to participate in an experiment.
	thoughts about the consent forms	“Very rarely the drug is described as an ‘experimental agent’ it’s typically called ‘the therapy’…it’s potentially a little misleading.”
Trust (7)	Focus group expressions of perceived status of trustworthiness	“Somebody who is perfectly bright, college graduate, etc. who just is bound and determined that he loves his doctor so much that there’s no way that this doctor would ever do anything that would expose him…that wasn’t for his benefit…. doesn’t really care about all of the other stuff and isn’t really listening, and he’s under a therapeutic misconception. He thinks that what the doctor is recommending is for his benefit, just because of his trust in the doctor.”
Patient Advocate Role (9)	Ideas about development of potential roles and responsibilities of the investigative team	“The role of recruiter should fall to someone who is not involved in the study, something like a patient advocate….advises the patient about what’s going on, if the patient looks puzzled at some point, takes the patient aside and straightens them out.”
Domains of Concern	Meaning Abstraction	Demonstrative Quotes
Instruments and Screening Tools (25)	Focus group’s perceptions of screening potential research subjects’ voluntariness and decisional capacity	“What I’d like to see is an investigation of the use of these instruments to identify thresholds for excluding subjects from research projects… subjects considered so far from understand what’s going on that they shouldn’t be allowed to participate.” “It’s kind a burdensome, especially for…the caregivers I work with are just super stressed out people and…to interject another screen at that point (informed consent) to determine if they really did have…voluntariness and knowledge of the subject…decisional capacity, I would be worried about that.”
Subdomains
Decisional Capacity (9)	ideas about screening research subjects’ ability to make informed decision about research participation	“I think it would be really worthwhile to have a good, sure decisional-capacity screen for me because a lot of times, I have a spouse signing consent…but I wanna be sure that this person is also cognitively able to understand.”
Voluntariness (7)	perceptions regarding voluntariness	“People haven’t looked at voluntariness, though, as an outcome, to my knowledge, because there haven’t been good measures until now.”