Table 2 Healthcare professionals’ behaviour – Legal norms

For opt-out preferential option

[Sub-group M”]. “First of all we had to fight for the legal fundaments, because if you don’t have a legal fundament then in cantons some hospitals would simply refuse to deliver the data, which would then lower our response rate below the international acceptable limit. So, legal, a legal baseline is very important…There is a moral obligation to use data, to improve quality of life of patients, therefore to have good quality data and completeness. It means obligation to have an opt-out...There is a conflict of moral obligation with the data protection officer who wants first to protect individual privacy. That is why a law will help for [name of the clinical registry] registry.”

As a basis for confidentiality

[Sub-group M’]: “Confidentiality is very important to get that your patient information is given and that the patient is not disappointed. Depends on what you do, I mean, organ transplant recipients everybody knows they are transplanted so there is not that much to hide. With HIV that’s much different. You have more concern in the HIV cohort study.”

To better define research

[R] [translation] “There is a clear contradiction in the definition of a clinical trial in the law and in the ruling order. As a result, researchers want to take advantage of this…we have recurring discussions on this question, whether it is research or not. And researchers put a lot of energy and intellectual efforts to argue that in this particular concrete case, it is not research.”

With guidance for implementation

[Sub-group M”] “Well I mean, there is the legislation and so on, but maybe there is probably not enough guidance in practice, that is known by the people who are developing registries and using them.”

Applied with an idea of prudence

[Sub-group M’] “That’s an ongoing discussion. Because it’s a pain. … if you have a question that is beyond an individual patient’s treatment, basically it’s science. … So my interpretation is that we have to ask for every project for specific approval for the specific question, which is what I am doing...but not everybody in the cohort study is of my opinion and we have heated discussions because it makes a big difference if you have 40 projects running in this cohort study which are scientifically looking at the cohort study and all these 40 need ethical approval or don’t. … you can go through any kind of audit and I know if you don’t have ethical permits you are lost. You are dead before the game even starts; because for a lawyer, if you have no document, you’re dead.”