Obtaining Informed Consent

The Checklist 1 Explain the study clearly to the woman in non-medical language. 2 Explain that standard techniques will be used – no technique is known to be better than another. 3 The result of the study will not be known for several years. 4 The results may be useful for her or other women in the future. 5 Entry to the study is voluntary. If the woman declines to join the study, her care is unaffected. 6 There are no extra tests, examinations (or hospital visits).

The Checklist (cont.) 7 There will be no effect on the delivery of the baby – her baby will be born by caesarean section. 8 Re-assure the woman that if at the time of the operation an alternative method is considered more appropriate, this method will be performed. 9 Explain six week follow-up and long-term follow-up at 3 years. 10 Woman may withdraw from the Study at any time and her care will not be affected. However, if at all possible, all women randomised will be followed-up at 6 weeks and 3 years after delivery to see how they are doing.

The Consent Form Consent forms are in English and the local language. The consent form MUST be completed and signed (or marked) by the woman, after she has been informed about the study and BEFORE any data are collected. The person taking consent MUST also sign the consent form.

Copies of the Consent Form One copy must be stored at the participating site One copy must be sent to the Regional Trial Office One copy can be given to the woman or it can be stored in her hospital records