10 januari: Recruitment and informed consent

Question 1

Which code/ regulation initiated informed consent?

Answer 1

Code of Nuremberg

Question 2

What has to be included in informed consent, according to the code of Nuremberg? (3)

Answer 2

• voluntary consent
• legal capacity to give consent
• subjects have sufficient knowledge and comprehension to make an informed decision

Question 3

Name the two types of informed consent.

Answer 3

1) for clinical procedures; to protect physicians

2) for research procedures; to protect subjects

Question 4

Name four situations where special informed consent is required, and describe how to go about.

Answer 4

1) subjects do comprehend, but cannot read/write > impartial witness.
2) subject does not comprehend verbal info > legal representative
3) subject is unconscious > differs per country, legally ‘acceptable’ person signs ICF with an impartial witness.
4) subject is underage > assent, consent from legally acceptable representative & impartial witness