Table 5 Representative quotations - Acceptable levels of risk in general

Continuum of acceptable risks in general

REG00, focus group LAREB: But with regard to the foetus you want to accept nothing, risks have to be zero and you cannot guarantee that [..].

PW07, participating in APOSTEL VI: There is never an acceptable risk for the foetus, never.

REC05, gynaecologist: A pregnant woman is very much protected in our society. After all, a pregnant woman is a little sacred. I can understand that.

HCP09, gynaecologist: You should at least demonstrate that you have no reason to assume that it [research] is unsafe.

HCP12, gynaecologist-in-training: If you run the risk that if you stop with that medication the mother dies, that’s a different story than when you want an alternative for a very safe medication simply because the pills taste bad or they are big or whatever.

PW08, not participating in APOSTEL VI: If you face a huge growth retardation and it will not change during the course of your pregnancy and you can participate in a study that potentially offers a remedy, then I think that I would also be more willing to go further […].

PW11, participating in APOSTEL VI: The most important thing is whether there are risks for the baby. The baby needs to be able to grow optimally and survive the pregnancy. And as a mother I would accept quite a lot for that myself. Unless the risks are really dangerous [e.g. resulting in serious illness or death].

Desirability of clinical research in pregnant women in general

REC01, legal expert: When a researcher has already decided that he doesn’t want to expose a certain category of research subjects to the intervention or the medication or the risks of a study, well, then who am I as a REC member to tell him that maybe he should do that?

REC03, gynaecologist: If it’s unnecessary than of course it’s always more sensible… Because that is something you notice, pregnancy always raises extra questions that make you think longer about whether it is acceptable or not. So for me I would say, let’s just keep them out if it is not strictly necessary to include them.

REG02, MEB member: And it’s a question whether it always needs to be proven, because gathering the evidence requires a lot of pregnant women, with all the risks that entails.

HCP06, gynaecologist-in-training: There is often so much happening when someone comes in and then you think, “oh yes, the trial. That is really the last priority.

HCP10, research midwife: I said that I wouldn’t counsel for this study […]. You shouldn’t go beyond your own limits. I’m really not going to do something that I cannot support.

PW12, not participating in APOSTEL VI: Why would you take a risk if you don’t have to, or if there is nothing to gain? I would not take such a risk for science.

Interest in an upper limit of acceptable risk

HCP05, gynaecologist: There should be a maximum risk for the foetus, but where do you draw the line?

HCP10, research midwife: It worries me because if you as a caregiver offer this, and that woman is desperate enough and she thinks my child is going to die this is my last resort, then maybe she doesn’t look beyond delivering a child that is alive.

PW05, participating in APOSTEL VI: They won’t allow you to take the big risks anyway. There are laws and regulations for that. […] It is offered for a reason and if they offer it, well than I guess that the risks won’t be so high.

PW11, participating in APOSTEl VI: I trust that most studies are to some extend safe, they won’t allow you to take a lot of risk here [in the Netherlands]. That is a consideration that initially makes me say yes quite fast. Because if there is too much risk than it wouldn’t be conducted here.