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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”