Table 3 Operationalizations
Coded as: | Defined as: | Number of PI respondents | Number of REB responses | Number of philosopher of science responses | Total responses | Relative frequency | Representative quote |
|---|---|---|---|---|---|---|---|
Literature review | Equipoise is established through a literature review, either informal or through systematic review and meta-analysis | 7 | 0 | 8 | 15 | 33.33% | We need a really good systematic of all the literature out there, we have to actually define the terms of who is the scientific community instead of just pointing to the scientific community and saying ‘they are uncertain’, so let’s actually define the parameters. – Phil 6 |
REB expert opinion | Equipoise is established through the opinion of physician experts, either on the REB on contracted externally to the REB | 0 | 5 | 3 | 8 | 17.78% | Well, I think it has to be sort of a common–sense clinical judgment, I mean, I think we ask the physicians who have a sense of the safety, a sense of the alternative treatments, a sense of what people need, whether a control arm or an alternative, well all these different arms, whether it should be clinically obvious or accepted that one rather is better or worse than the others. – REB 15 |
Investigator claim | Equipoise is established as a result of belief in the PI and his/her arguments | 0 | 6 | 0 | 6 | 13.33% | Yes, and it helps to have trust in the researcher. If it’s somebody that you know and that you work well with and that has come often to consult, it’s easier than for somebody you don’t know and you’re evaluating for a researcher that’s outside of the institution. That’s when I would need to be more sure of myself – REB 6 |
Asking colleagues | Equipoise is established through asking peers, either informally or through a formal process like surveys | 5 | 0 | 0 | 5 | 11.11% | [We] establish equipoise by surveying the key stakeholders in that particular area of research before even embarking on any sort of retrospective observational study or prospective observational study to get a sense of whether or not there is any equipoise in the frontline workers at all. – PI 6 |
REB vote | Equipoise is established through consensus of REB members | 0 | 2 | 2 | 4 | 8.89% | I’m happy that we really debate it and discuss it before we will accept it as a clinical trial. And we need to all feel very comfortable to eb able to say ‘if my patient were randomized to either arm, we would feel okay with that’. – REB 11 |
Making an argument | Equipoise is established through convincing the REB that it exists | 3 | 0 | 0 | 3 | 6.67% | Well, I think it’s like any scenario, you’re making an argument. Your thesis is there is equipoise and then you have to go and convince people that there is. – PI 5 |
Can’t be established | Equipoise cannot be established | 0 | 0 | 2 | 2 | 4.44% | Well, I really think would like to put that question to the proponents of equipoise, who I think have done an extremely poor job of defining it – Phil 5 |
Individual risk assessment | An individual member of the REB determining whether there is a balance of risk/benefits to patients participating in this study | 0 | 1 | 0 | 1 | 2.22% | That’s a tough question. Basically, we just look at it and see whether the risks involved with it appear to us to be worth it. I don’t know, I can’t do more than that. – REB 7 |
No answer | 0 | 1 | 0 | 1 | 2.22% | ||
Total responses: | 15 | 15 | 15 | 45 | 100.00% |