The rights of a person participating in research

Medical research on human patients may not be conducted without the subject’s informed written consent.

The research subjects must be provided with a sufficient account of their rights, the objective and nature of the research, and the methods applied. The subjects must also be sufficiently informed of the potential risks and harms. This information must be provided to ensure subjects are fully aware of all issues related to the research that may have a bearing on their decision-making to allow them to make an informed decision about their consent.

The research subjects may at any time withdraw their consent prior to the completion of the research project. Subjects must be duly informed of this right before the start of the research project.  Withdrawal of consent and the resulting withdrawal from the research must not involve any negative consequences for the research subject.