Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent

Table 1 Deferred consent criteria in Europe: existing laws and the EU Directive (adapted from Druml et al. [7] )

1.	The research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods
2.	The research has to relate directly to a life-threatening or debilitating clinical condition from which the incapacitated adult suffers
3.	The clinical trial has to be designed to minimise pain, discomfort, fear, and other foreseeable risks in relation to the disease and developmental stage
4.	The risk threshold and the degree of distress shall be specially defined and constantly monitored
5.	An ethics committee with expertise in the relevant disease and the patient population concerned or after taking advice in clinical, ethical, and psychosocial questions in the field of the relevant disease and patient population has endorsed the protocol
6.	The interests of the patient always prevail over those of science and society and the requirement that there are grounds for expecting that administering the medical product to be tested will produce a benefit to the patient that outweighs the risks or has no risk at all.
7.	Consider that scientifically unsound research is ipso facto unethical in that it may expose individuals to risks for no purpose at all.

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