Dear All

Having recently sat on a ethics committee for 2 years representing nursing and midwifery and teaching research governance and ethics at Masters level, there are a number of approaches that you could take which I am sure would be acceptable to the ethics committee and be pragmatic. These could include:

1) Using a preliminary study information sheet and circulate at antenatal clinics and/or via community services etc explaining the study and stating they may be approached during labour, where you could get verbal consent, followed by written consent post birth or verbal consent from mother and written from partner as a witness. This approach would also work and be acceptable if you listed all the ongoing studies you have running in your department.

2) If a low risk study, you could approach during early stage of labour (you would need to define this) and this would be acceptable to most ethics committee.

3) If moderate - high risk study then you would need to undertake antenatal recruitment & consent.

4) Rarely - an ethics committee would agree to intrapartum (verbal and/or written) consent to a moderate-high risk study if benefits outweighed risk.

I am happy to discuss on or off line any particular projects.



kind regards

Debbie


Debbie Carrick-Sen
Trust Lead for Nursing and Midwifery Research/Senior Lecturer, Newcastle University
Room 77, Education Link Corridor
Level 1,
Freeman Hospital
Freeman Rd
Newcastle upon Tyne
NE7 7DN

Office: 0191 213 8235
DECT: (0191 21) 39493
Mobile: 07843441631


>-----Original Message-----
>From: A forum for discussion on midwifery and reproductive health
>research. [mailto:[log in to unmask]] On Behalf Of BARTON
>Andy, RDS
>Sent: 07 January 2011 10:29
>To: [log in to unmask]
>Subject: Re: seeking advice on ethical issue regarding recruitment
>
>(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
>
>
>
>************************************************************
>Please consider the environment. Do you really need to print this
>email?
>
>
>
>
>>>> 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
>The Sunday Times Scottish University of the Year 2009/2010
>The University of Stirling is a charity registered in Scotland, number
>SC 011159.
>
>
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>--
>Lucia Rocca-Ihenacho
>Senior Midwife and Research Fellow
>Barts and the London NHS Trust
>
>07989 230313
>
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