Bioethics issues in human studies

Informed consent

Scientists' inquiry

Opinion of the scientists

• Consent should be obtained through the physician involved in the study.
• It should be given by the parents or legal representatives.
• The subjects who are legally responsible (such as pregnant women), should sign the informed consent on their own.
• Guardians or parents should be involved in the process of informed consent, possibly supported by the application of pictures, models etc. Perhaps two witnesses should be present during the process. "Doctors frequently do not understand the difference between consent for clinical purpose and consent for research".
• It is necessary to explain that consent can be withdrawn without any penalties.
• Dutch and UK scientists pointed out that their new legislation makes adequate provision for this kind of research.