According to CIOMS Guidelines, what is the acceptable risk when research is conducted with participants who are not competent to give informed consent?
a) Only minimal risks are permitted, even if the research is expected to directly benefit participants.
b) Risks should be minimal if the research is not expected to benefit participants directly. A minor increase above minimal risk may be considered acceptable if the research is expected to directly benefit the participants.
c) A minor increase above minimal risk may be considered acceptable by RECs if the research is not expected to benefit participants and it is possible to gather data in other populations.
d) A significant amount of risk may be acceptable if the expected benefits to society in terms of generalizable knowledge are sufficient.