1. Taking informed consent and withdrawal
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2. Who should take consent for the ANODE trial?
Any health care professional (site specific) who:
Has a good knowledge of the ANODE trial and its aims
Has been trained by the ANODE Local Research Midwives (LRMs) on the study, randomisation process, drug administration and taking of consent
Has full GCP training
Has signed the Delegation Log- and has been signed off by the PI prior to carrying out any ANODE related tasks
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3. What is informed consent?
Giving informed consent is the process by which an individual voluntarily confirms their willingness to participate/allow their inclusion in something that is asked of them
It should only be obtained if the individual has been informed of the benefits and risks of taking part in any study or procedure that they consent to
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4. Taking informed consent
Important notes when asking for consent
Use language that is easy to understand and free from jargon
Use open and approachable body language
Actively listen to any concerns she may have
Answer all questions asked
The woman should understand that by not giving consent it will not affect the standard of care that she receives
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5. Taking informed consent
Because of the difficult timing of taking consent to the trial there are two ways that women may be consented:
Where there is no time constraint (e.g. in cases of OVD for delayed second stage), the healthcare professional will discuss the trial with the woman and provide her with the Participant Information Leaflet ‘A’. If she is happy to join the trial informed written consent will be obtained using the Written Consent Form
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6. Taking informed consent
Where there is a time or other constraint (e.g. cases of OVD for suspected fetal compromise or delivery already taken place), women will be approached to give verbal consent recorded on the Verbal Consent Form
It is important to also capture emergency cases as they are likely to have received a lower standard of asepsis
Please note there is an ANODE Verbal Consent Crib Sheet available to assist with obtaining Verbal Consent
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7. Verbal Consent
Women who provide Verbal Consent must be approached prior to discharge to provide full Written Consent for the inclusion of their data in the trial and participation in the planned follow-up as soon as is possible and prior to discharge
Please present the with Participant Information Leaflet ‘B’ prior to obtaining written consent
This post verbal written consent should be recorded on the lower section of the Verbal Consent form
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8. 3 point checklist for taking verbal consent1
Have you explained and has the woman understood the aim of the ANODE trial and what it will involve? 2
Have you explained the possible risks and benefits of the trial and that she is free to withdraw at any time without it affecting her care? 3
Have you explained that she will be required to complete written consent?
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9. Verbal consent forms
Ensure that the study number is entered on the consent form once a woman has been randomised
Ensure that the clinician taking verbal consent prints, signs, times and dates the Verbal Consent Form (this must be witnessed)
Ensure that the witness prints, signs and dates the Verbal Consent Form (the witness should be a non-clinical person if possible for e.g. birth partner but can be another health professional if no alternative is available) – dates should not be pre-populated
PLEASE NOTE: Written consent MUST be sought and recorded on the lower part of the Verbal Consent Form prior to discharge (ideally prior to leaving theatres or delivery suite!)
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10. 6 point checklist for taking written consent1
Have you given the woman an opportunity to read the Participant Information Leaflet? 2
Have you explained and has the woman understood the aim of the ANODE Trial and what it will involve? 3
Have you explained what a randomised controlled trial is?
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11. 6 point checklist for taking written consent4
Have you explained the possible risks, possible side effects and benefits of the Trial? 5
Have you explained that the woman is free to withdraw at any time without having to give a reason and without her medical care being affected? 6
Have you explained the purpose of the 6 week follow-up phone call and questionnaire and answered all of her questions?
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12. Written Consent forms
Ensure that the study number is entered onto the consent form following randomisation
Ensure all 8 statements are initialed not ticked by the woman
The woman and the person taking consent should print, sign and date the form – dates should not be pre-populated for the woman
(These points also apply for the written consent section of the Verbal Consent Form)
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13. What to do if a woman withdraws from the trial?
The woman has the right to withdraw from the trial follow-up at any time.
Women DO NOT need to give a reason for withdrawing though it may be helpful to discuss the decision with them but this should only be done if they are willing to talk about their decision.
It is important that you clarify with the woman and record on the form whether they would agree to retention and use of the data already collected and for data collection to continue.
Unless we obtain consent to continue to use data at withdrawal, they will be excluded from future analysis. Depending on the wishes of the woman further data collection and form completion may be required.
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14. What to do if a woman withdraws from the trial?
After consulting the woman complete Form 7: Withdrawal recording their wishes regarding the withdrawal.
Please make two photocopies of the completed Form 7 and file one in the woman’s clinical notes and the other 2 copies in the ANODE tray.
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