Dear Lucia

My PhD Study was an ethnographic study that involved observing the practice of health professionals obtaining informed consent to intrapartum procedures with 100 low risk women.

Recruitment was undertaken by placing a poster advertising the study in all antenatal clinic areas, followed by written information (Participant Information Sheet) about the study given out to low risk women and who spoke English by the midwives in the clinic towards the end of pregnancy and prior to the onset of labour.

As in Mary's study, these women were then approached by the attending midwife upon admission to the labour ward for their written consent, providing the woman was able to give her consent, was not distressed or in advanced labour. In a minority of cases this also involved teenagers participating in the study, providing they were able to demonstrate understanding of what the study was about (i.e. were Gillick competent if under 16). In all cases they were accompanied by an adult (usually their own mother).

Approval was gained from the Local Research Ethics Committee to this process of gaining consent from the participants.

I hope that this information also is useful in contributing towards the decision made about the recruitment of participants to your own study.

Good Luck

Jayne

Dr Jayne E Marshall
Midwife Lecturer: Course Director for BSc (Hons) in Midwifery Studies and PGD / MSc in Midwifery

University of Nottingham
School of Nursing, Midwifery and Physiotherapy
Academic Division of Midwifery
Post Graduate Education Centre
Nottingham University Hospitals NHS Trust (CITY HOSPITAL Campus)
Hucknall Road
Nottingham
NG5 1PB

e-mail : [log in to unmask]

Tel: 0115 82 31925 (direct)
Fax: 0115 82 31930

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From: A forum for discussion on midwifery and reproductive health research. [[log in to unmask]] On Behalf Of Mary Ross-Davie [[log in to unmask]]
Sent: 05 January 2011 21:12

To: [log in to unmask]
Subject: Re: seeking advise on ethical issue regarding recruitment

Dear Lucia

I am in my final year of my PhD and am in the process of undertaking direct observations of midwifery support in labour rooms in four maternity units in Scotland. All women were given written information about the study at the 36 week appointment and they are then approached by a senior member of midwifery staff when they are admitted in early labour or for induction to labour ward, midwifery unit birthing suite or triage unit. I received ethical approval to obtain written consent from women and their birth partners in early labour if the woman is over 16, able to provide consent, not distressed and is not in advanced labour.

One of my supervisors, Dr Helen Cheyne, who undertook an early labour multi-centre cluster trial also obtained written consent from women in early labour with ethical approval.

Hope this helps

kind regards

Mary Ross-Davie

NMAHP Research Unit, University of Stirling

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From: A forum for discussion on midwifery and reproductive health research. [[log in to unmask]] On Behalf Of Marianne Mead [[log in to unmask]]
Sent: Wednesday, January 05, 2011 8:12 PM
To: [log in to unmask]
Subject: Re: seeking advise on ethical issue regarding recruitment

Dear Lucia,

Good luck for your research project.

Re gaining approval - I don't think that asking the women to sign a form at the time of their arrival at the labour ward is a good idea. I doubt that any ethics committee would approve of this because the stress that some women would be under at that time would be high and not conducive to receiving and digesting up to date information about what they may have forgotten in the last 20 weeks, not to provide calm informed consent.

I wonder if you not consider providing the information at 20 weeks and simultaneously setting up an information website where women could seek complementary information and have information about how to contact you. Most people would be on the Internet and it may be useful to get email addresses at 20 weeks and resend the information at about four week interval until 36 weeks when you could ask women to return a consent form by post. It may also be possible to advertise the study in the clinics and provide the url of the information page. That page could then contain information about the research office where interested women could phone to get more information and potentially to register their interest.

I would still reconfirm consent on admission, but if consent has not been provided around 36 weeks, I would consider that these cannot be included in the study.

You are a bit stuck really because 20 weeks is very early in pregnancy and labour is too late. So I would explore electronic contact if possible because this may increase awareness and ease of contact.

I am sure there will be many other suggestions and wish you well

Marianne

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From: LUCIA ROCCA <[log in to unmask]>
To: [log in to unmask]
Sent: Wednesday, 5 January, 2011 18:49:50
Subject: seeking advise on ethical issue regarding recruitment

Dear All,

We are a group of researchers applying for funding for an educational pilot RCT involving labouring women and have a burning issue with timing for seeking written consent from research participants.

We will approach women, who are planning a hospital birth, at the 20 week scan. For convenience this is the best time to get as many pregnant women as possible in the same venue. At this point we will put a sticker at the front of the notes of the women who have been given the info and were keen ( but have not signed the consent form yet). At this point we will give the women time to think about whether they want to take part or not.

We will not see the women anymore at the hospital until they arrive in labour, recontacting the women in local clinics is too expensive and time consuming.

When is for you the best time to gain written consent?

Would, asking the women to sign the form on arrival in labour be seen as non ethical? Could they sign the form, which we could attach securely to the notes, at home and give it to the midwife on arrival?

Any suggestion would be more than welcomed.

Thanks

Lucia

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Lucia Rocca-Ihenacho

Senior Midwife and Research Fellow

Barts and the London NHS Trust

07989 230313

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