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(Sorry to have entered this late)
I think Andrew and Mary (below) have just about nailed it and, I agree, it's a really tricky issue.
In our perineal suturing study (which I admit is ancient history now) we gained in principle consent at clinic '...in the very unlikely event that you should become suitable for the study.', or some such. Consenting women sustaining a suitable second degree tear during labour were then asked if they were still ok for the study and randomised. Obviously it's quite unethical (and impractical) to try to spring a study on women during labour.
I too have no hesitation in contacting the ethics chair (or any other member) for discussion about recruitment tactics. There is a lot of experience there and they will also know what thje committee will find acceptable, or not.
Good luck Lucia.
bw
a
________________________________
From: A forum for discussion on midwifery and reproductive health research. on behalf of Mary Steen
Sent: Thu 06/01/2011 11:06
To: [log in to unmask]
Subject: Re: seeking advice on ethical issue regarding recruitment
This is very valuable advise, I sought advise from an ethics committee
chair when undertaking an RCT to investigate localised treatments to
alleviate perineal trauma and the first treatment needed to be applied
immediately following suturing.
The ethics committee were very concerned and discussed in great length
ethical issues and safeguards re: gaining consent from women in labour
(especially women who first language was not English) and recommended
that women where to receive information about the study (on several
occassions) at the 18-20 scan apt, at 36 weeks, at antenatal eductaion
sessions and that I gain verbal consent on admission from potential
participants, and then following birth if they fit the inclusion
criteria ask for wrritten consent.
I changed my methodology to meet these recommendations and gained
ethical approval, so it is worthwhile approaching a chair of an ethics
committee.
Good luck with your research
Mary
Dr Mary Steen
Professor of Midwifery
Faculty of Health & Social Care
Rm. 416, Riverside Building
Castle Drive
CHESTER
CH1 1SL
Tel: 01244 512284
Fax: 01244 382144
>>> Andrew Symon <[log in to unmask]> 01/06/11 9:06 AM >>>
As several have noted, this tricky situation is not impossible. Consent
can be obtained in advance, but must be verified at the time. When there
are language / literacy issues, this gets complicated.
One avenue that's not been suggested so far is the ethics committee
administrator, who is supposed to offer advice and support. Anecdotally,
I know this doesn't happen everywhere, but in my experience it's always
worthwhile taking your well-reasoned suggestions to the administrator or
committee chair, and running the ideas past him/her.
Firstly, this prepares the way. They have some advance notice so that a
potentially tricky application doesn't land 'cold' on the desk.
Secondly, they may offer some practical advice on the best way of
preparing or phrasing the proposal. They know the committee members
best, after all, and these are the people you have to convince.
Good luck - and let us know how you manage it.
Andrew Symon
Dr. Andrew Symon
Senior Lecturer
School of Nursing & Midwifery
University of Dundee
01382 388553
http://dundee.academia.edu/AndrewSymon/
http://uk.linkedin.com/in/andrewsymon
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>>> LUCIA ROCCA <[log in to unmask]> 05/01/2011 22:28 >>>
Dear Jayne,
Thanks a lot, that is very reassuring!
Our situation presents issues because of language barriers..so posters
are not very helpful and written info needs to be discussed one-to-one
and translated in person ( many women cannot read and Sylheti is a
non-written dialect anyway....)
Tower Hamlets is one of the most deprived boroughs in the uk. In our
previous survey 89% of women had English as a second language, many of
them cannot access internet. We will also have to communicate with half
of the women in Sylheti and Bengali....
But the fact that we could gain consent at the arrival is great! How
about asking the woman to sign the consent at home and give it out on
arrival?
thanks again
Kind regards
Lucia
2011/1/5 Jayne Marshall <[log in to unmask]>
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 wasin 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
From: A forum for discussion on midwifery and reproductive he
alth
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
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 pregnancpossible because this may increase awareness and ease of contact.
I am sure there will be many other suggestions and wish you well
Marianne
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 t
hey 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
--
Lucia Rocca-Ihenacho
Senior Midwife and Research Fellow
Barts and the London NHS Trust
07989 230313
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