Table 7 Overview of risk continuum
From: A qualitative study on acceptable levels of risk for pregnant women in clinical research
Stakeholder | What level of research risk? (for the foetus) | What type of research is acceptable? | When is research acceptable? |
|---|---|---|---|
Regulators (LAREB) | Zero Zero Close to zero | None Observational Phase IV | Never Registries Post-authorisation studies with off-label medications already used by pregnant women |
Regulators (MEB) | Zero Low but with exceptions | Observational Phase III and/or Phase IV | Registries Research that has potential individual benefit with high potential direct benefit for severely ill pregnant woman |
RECs | Extremely low (below 1%) | Observational Intervention | Research that is not too demanding Research that has potential individual benefit with high potential direct benefit for severely ill pregnant woman |
Pregnant women | Zero Minimal More than minimal | Observational Intervention | Not too demanding/useful for other women Research that has potential individual benefit with high potential direct benefit for the child |
Healthcare professionals | Low, at least not higher in comparison to not participating | Observational Intervention Phase II Phase III | Research that has no potential individual benefit and research that has potential individual benefit Benefit for individual or group ”no harm in trying principle” |