Module 2 - Consent in Perinatal Research

Question 1

For a very common (1/1 - 1/10) risk, when should information about research projects be given to women?

Answer 1

Antenatally.

To all women.

Should be given full information. (there is a risk of overburdening women).

Question 2

For common (1/10 - 1/100) risks, when should information about research projects be given to women?

Answer 2

Antenatally.

To all women.

Should be given summary information and full information if the research project becomes applicable to them. (there is a risk of overburdening women).

Question 3

For uncommon (<1/100) risks, when should information about research projects be given to women?

Answer 3

Antenatally.
Summary information should be made available to all women (e.g. posters or leaflets). But full details if women become eligible.

Question 4

In acute situations, how can consent be gained?

Answer 4

Full information may not be able to be given, therefore oral consent may be taken and full details and written consent may be gained at a later point.