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- To be told that the study involves research.
- To be told the purpose of the clinical trial.
- To be told any reasonably foreseeable risks, side effects
or discomforts that might be expected.
- To be told of any benefits to the participant or to others
that can be reasonably expected.
- To be told what procedures will be administered and whether
any of them are experimental.
- To be told of appropriate alternative drugs, treatments,
or procedures that might be advantageous to the participant.
- To be allowed to ask any questions about the trial before
giving consent and at any time during the course of the study.
- To be told who they can contact with questions about the
study, their rights as a participant and who to contact in the
case of a research-related injury.
- To be allowed ample time, without pressure, to decide whether
to consent or not to consent to participate.
- To refuse to participate, for any reason, before and after
the trial has started.
- To be informed that if they refuse to participate or decide
to stop participating, they will not suffer any penalty or loss
of benefits.
- To receive a signed and dated copy of the informed consent
form.
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