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Table 3 Ethical Considerations

From: A qualitative study exploring the acceptability of the McNulty-Zelen design for randomised controlled trials evaluating educational interventions

Z2, PRACTICE MANAGER: “where we’re not notified in advance actually is a really good idea it gives you a really true picture of the reality”

 

S6, ASSISTANT JOINT COMMISSIONING MANAGER: “I just think the perception of some individuals may be that it’s slightly underhand”

 

Awareness of trial influences behaviour:

 

Z15, NURSE: “I think it’s a very good thing if you do research without us knowing about it really because you’re getting a true life situation aren’t you? Actually rather us thinking oh yes we really need to do that, we’d better do that because we’re in a trial.” “Its natural reaction isn’t it to think well we’re doing this therefore we’ve got to perform better at this.”

 

Z10, GP: “you might feel obliged to increase your screening so I think blindness is useful”

 

Z9, NURSE: “as far as consent for this goes …if somebody is taking that out of our hands and doing it as a at a PCT level then that’s fine but I think sometimes it’s nice to know that that an annual thing or an on-going thing so we consenting that it’s going to happen but we don’t necessarily need to know when it’s going to happen.”

 

PCT GP Relationships:

 

S4, PUBLIC HEALTH COMMISSIONING MANAGER - SEXUAL HEALTH: “I worry quite a lot that we … are investing quite a lot of work in primary care to make them see that we’re working together and that we can all trust each other, and I just worry that they might get frustrated that were kept out of that decision.”

 

Z9, NURSE: “Some people might always look on the bleak side, and think you know are they trying to catch us out, you know what are they trying to gain from it?”

 

Ethical approval important because of design:

 

S8, PCRN RESEARCH OFFICER: “Because it’s so novel it’s such a novel design you do need something in place that will ensure GPs that the research was ok so for this type of design. I would actually probably be seeking the ethics for educational research.”

 

S1, PCRN SENIOR RESEARCH OFFICER: “Approval should still be sought because I think there still needs to be some checks and balances on the study design.”

 

S5, REC CHAIR: “I think it would be helpful if this sort of [Zelen] design was at least shown to a chair to confirm or make everybody feel comfortable that it really was the sort of Zelen design that could raise no issues.”