Accepted Manuscript Original article Pregnant women’s views on informed consent for research in labour R.T. George, M. Butcher, S.M. Yentis PII: DOI: Reference:
S0959-289X(14)00036-3 http://dx.doi.org/10.1016/j.ijoa.2014.03.004 YIJOA 2273
To appear in:
International Journal of Obstetric Anesthesia
Accepted Date:
5 March 2014
Please cite this article as: George, R.T., Butcher, M., Yentis, S.M., Pregnant women’s views on informed consent for research in labour, International Journal of Obstetric Anesthesia (2014), doi: http://dx.doi.org/10.1016/j.ijoa. 2014.03.004
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
1
IJOA 13-00191
2
ORIGINAL ARTICLE
3
Pregnant women’s views on informed consent for research in labour
4
R.T. George, M. Butcher, S.M. Yentis
5
Magill Department of Anaesthesia, Chelsea and Westminster Hospital, London, UK
6 7
Short title: Women’s views on consent for research
8 9
Correspondence to: RT George, Department of Anaesthesia, St. George’s Hospital,
10
Blackshaw Road, London, SW17 0QT
11
Email: [email protected]
12
1
13
ABSTRACT
14
Background: Studies of the optimal treatment of accidental dural puncture occurring during
15
epidural insertion in labour are difficult for practical reasons and because of the ethical issues
16
around seeking consent. In a recent study of accidental dural puncture, participants were
17
assigned to one of two treatment groups and only informed about the study and consent
18
sought, after treatment. We sought the views of parturients on the timing of consent for such a
19
study.
20
Methods: After ethical approval and written consent, 100 nulliparous women in the third
21
trimester of pregnancy completed a structured, facilitated questionnaire, rating the
22
acceptability of the consent process occurring: (i) in antenatal clinic; (ii) after the epidural was
23
requested in labour; (iii) after the accidental dural puncture had occurred but before treatment;
24
(iv) after the allocated treatment; or (v) without consent (waived consent). Results were
25
analysed with the Friedman and Wilcoxon signed-rank tests.
26
Results: Antenatal consent was considered the most acceptable option, whilst consent on
27
request for epidural analgesia and after accidental dural puncture were least acceptable.
28
Consent after treatment and waived consent were rated in-between these extremes. There was
29
a statistically significant difference between these three groups (P < 0.0001). There was a
30
wide range of opinions on each option presented.
31
Conclusions: Antenatal consent was the preferred option but if this is not possible and the
32
need for the research is strong, consent for the use of women’s data after intervention, or
33
waived consent, is acceptable to many women. It is important to seek the views of the
34
participants themselves before planning research with difficult ethical aspects.
35 36
Key words: Consent, Research, Labour
37 38
Introduction
39
There are strong moral and legal arguments for obtaining informed consent before recruiting
40
participants to a clinical trial.1 On occasion, this may be difficult or impossible and Doyal has
41
defined three situations in which informed consent for research is not necessary: i) when the
42
proposed participant does not have capacity; ii) when the proposed research involves
43
epidemiological examination of medical records; and iii) when the proposed research involves
44
examination of tissue from anonymous donors.2
45 46
During labour, concerns over the capacity of parturients and the practical difficulties in ensuring a full consenting process at a time of rapidly changing circumstances can make
2
47
consent for research particularly challenging.3 This has implications for anaesthetic research,
48
since anaesthetists’ first encounter with their obstetric patients is often during labour.
49
A recent publication by Russell described a study conducted at several centres,
50
comparing two methods of management of an accidental dural puncture (ADP) during labour
51
epidural insertion.4 Immediate management of ADP involves either placing the epidural
52
catheter intrathecally through the needle or removing the needle and resiting the epidural at a
53
different lumbar interspace. It is not known which of these two methods of management is
54
preferable in terms of risks and/or benefits, hence Russell conducted a prospective study.
55
Russell had argued successfully to the Research Ethics Committee (REC) that
56
obtaining informed consent for the study before insertion of the epidural was
57
impractical/impossible as it would mean seeking consent from a very large number of
58
women, of whom only a small minority would request epidural analgesia, sustain an ADP and
59
be eligible for recruitment. Further, seeking consent at the time of the ADP was also
60
impractical and unreasonable as it would be difficult to explain the subtleties of the treatment
61
arms whilst the woman was still in pain/distress and awaiting effective analgesia. Also, once
62
an ADP was diagnosed, the imperative was to finish the procedure, and leaving the epidural
63
needle in the woman’s back during potentially prolonged subsequent discussion (and further
64
painful contractions) may risk further harm. Similarly, initiating a randomisation process at
65
that time would also be difficult and potentially delay treatment.
66
In Russell’s study,4 the above dilemmas were addressed as follows: first, units were
67
randomly assigned to one treatment or other for successive periods of six months for a total of
68
two years, to avoid the need for randomisation at the time of ADP. Second, the requirement
69
for informed consent before ADP and its treatment was waived by the REC and consent for
70
the use of the woman’s data was sought at “a convenient time” after she was comfortable or
71
had delivered her baby. Whilst this latter measure may have reduced the harm from breach of
72
autonomy, in that the women were given a chance to remove their data from analysis, it does
73
not negate the fact that they had been recruited for inclusion in a clinical trial without their
74
knowledge. Further, their inclusion potentially exposed them to increased risk if, for example,
75
the epidural had been extremely difficult to site. In such circumstances, the anaesthetist(s)
76
might ordinarily choose intrathecal placement of the epidural catheter rather than try to resite
77
it according to the study protocol. This possibility is supported by the protocol violations that
78
occurred, nearly always in the resite epidural group, indicating difficulties with equipoise.4
79 80
Russell’s study was accompanied by an editorial in which the ethical issues raised by the study were discussed;5 in particular, whether the requirement for informed consent should
3
81
have been waived by the REC and whether full transparency and disclosure, and proper
82
randomisation, should have been guaranteed. Overall, the editorial was critical of the ethical
83
aspects of the study design, but supportive of the journal’s decision to publish the paper.
84
Questions remain over the appropriate management of ADP during labour, but studies
85
such as Russell’s highlight the ethical dilemma about how to conduct such research. The one
86
voice not yet heard, however, is that of the mothers themselves. The aim of this study was to
87
obtain the views of parturients on the appropriateness, need and timing for consent for such
88
intrapartum research, so that their views could inform the debate.
89 90
Methods
91
Following Research Ethics Committee approval and with written informed consent; 100
92
nulliparous women in the third trimester attending routine antenatal clinic appointments at our
93
hospital, and with English as their first language, were recruited to the study. They were
94
interviewed in the antenatal clinic after their routine midwife or obstetrician appointment.
95
Baseline information including age, gestation and level of education was collected. The
96
interview was facilitated by an investigator (RG or MB) and consisted of a questionnaire,
97
following a written, standardised, structured outline explanation of: (i) epidurals, ADP,
98
postdural puncture headache and the treatment options; and (ii) ethical aspects of research
99
into ADP during labour, including informed consent and randomisation. This initial
100
explanation took approximately10 min and participants were asked to confirm understanding
101
of each subsection before moving on to the next. It was also stressed that the purpose of the
102
interview was to explore their views about the process of conducting studies into ADP, not
103
about ADP or epidurals themselves Women were then asked to rate the acceptability of
104
various options for the consent process for a study into ADP during labour (Table 1), using a
105
score from 1 (unacceptable) to 10 (ideal). Data were analysed with the Friedman test and
106
Wilcoxon signed-rank tests, with P < 0.05 indicating statistical significance.
107 108
Results
109
Complete datasets were obtained from all 100 women recruited. Mean ± SD age was 34 ±4
110
years and median (IQR [range]) gestation was 34 (32-37 [27-41]) weeks. For the highest level
111
of education achieved, 39% of women had obtained a postgraduate degree or equivalent, 51%
112
an undergraduate degree, 9% General Certificate of Education Advanced level (A levels,
113
standard UK exams sat at age 17-18 years) and 1% General Certificate of Secondary
114
Education examinations (GCSEs, standard UK exams sat at age 14-16).
4
115
Scores for the acceptability of the various consent options are shown in Figure 1.
116
Antenatal consent was scored the most acceptable, with consent on request for epidural
117
analgesia and consent after ADP (but before treatment) the least acceptable. Each option was
118
scored by some women as the least acceptable and by others as the most acceptable.
119 120
Discussion
121
The two main findings of our study are first, that the women considered antenatal consent to
122
be the most acceptable option, whilst consent on request for epidural analgesia and after ADP
123
were the least acceptable. Consent for the use of their data and waived consent were ranked
124
in-between. Second, there was considerable variation in women’s views as to the acceptability
125
of the various consent options presented to them. By definition, the nature of an ethical
126
dilemma is that there is no clear answer, and a balance of harms and benefits must be set in
127
context and weighed against each other in reaching a course of action. Whilst antenatal
128
explanation and consent were scored as most acceptable by the women in our study, they also
129
understood that requiring this option would essentially make such a study impossible. They
130
also were aware that without such a study, we would be unable to obtain the knowledge
131
required to offer the optimal treatment for ADP. We did not ask the women for their reasons
132
for assigning a particular score, but it is possible that those scoring this option low did so
133
because they recognised the impracticality of this option.
134
The women surveyed generally rejected the two options that would potentially delay
135
the provision of pain relief in labour: namely, consent on request for an epidural and consent
136
before treatment of a recognised ADP. We suggest that in practice, these options would be the
137
most difficult to achieve because of the issues around the level of capacity of women in
138
labour and the need to explain quite complex information relating to the study, above that
139
routinely required for epidural analgesia per se.6-8 We find it interesting that even for these
140
options, there were some women who assigned scores of 10/10 despite confirming their
141
understanding of the implications.
142
Consent for the use of their data, the approach taken in Russell’s study,4 and waived
143
consent, suggested as an option by Joynt in his editorial,5 were scored equally by the women
144
in our study, and more acceptable than consent before siting the epidural or treatment of ADP,
145
although less than antenatal consent. In some ways this would lend support to Russell’s
146
methodology, if one discounts antenatal consent as being impractical and if one accepts that
147
there is a need for such a study in the first place. Joynt argued that there are two possible
148
reasons why waived consent is morally preferable to consent for use of the women’s data.
5
149
Firstly, it permits proper randomization at participant level rather than the unit allocation
150
methodology used in Russell’s paper (thus increasing the benefits of the study considerably
151
by strengthening the evidence provided). Secondly, it allows full transparency and disclosure
152
(e.g. by advertising the study antenatally). If one accepts these arguments, then the similarity
153
between the scores given to the consent for the use of their data and waived consent options
154
would favour the latter.
155
There is little expert guidance or precedent for this option in the UK but both the USA
156
and Canada have published guidance about when research can take place with waived
157
consent, although this guidance relates primarily to pre-hospital care.9,10 A number of women
158
in our study stated that they were happy to be included in research without consent because
159
they trusted the research process and recognised the potential benefit to society. Joynt has also
160
pointed out that studies involving waived consent are required to demonstrate ‘additional
161
stringent safeguards’ in order to protect patients.7
162
The variability in the participants’ responses add to the dilemma in that for each
163
option, scores ranged from the least possible to the maximum possible. Similar broad ranges
164
in women’s views exist for the amount of information they would wish to receive before
165
consenting to regional or general analgesia/anaesthesia,11,12 and highlight the difficulty in
166
satisfying all parturients and potential participants. Such variability also reinforces the need to
167
involve consumers in the decision-making process for studies such as Russell’s. One could
168
argue that ideally, each participating unit should have sought the views of its local population
169
before taking part in the study. The involvement of patients in the research process is now an
170
established concept (http://www.ukcrc.org/patientsandpublic/ppi/) although anaesthetists
171
might initially consider such involvement less suitable for anaesthetic research than other
172
areas.
173
Our study has a number of limitations. The study was questionnaire-based and the
174
complex nature of the subject would mean that if the participants had not understood the
175
concepts being raised, their answers may not be valid. We attempted to minimise this risk in
176
several ways. First, we carefully structured the questionnaire and made it as simple as
177
possible, assessing and improving its readability using MS Word (see
178
http://office.microsoft.com/en-gb/word-help/test-your-document-s-readability-
179
HP010148506.aspx) before piloting and adapting it before starting the study. Second, we only
180
included women for whom English was their first language. Third, each interview was
181
conducted with an investigator facilitating the explanation and the questionnaire, checking
182
that the participant understood each concept before moving to the next. In different fields, it
6
183
has been shown that facilitation improves understanding of questionnaire studies.13 The
184
interviewers initially worked together for the interviews of a small number of women (five),
185
to ensure consistency, but it is possible that variation between the facilitators may have had an
186
effect on the responses. We were fortunate that our study group was highly educated which
187
improved comprehension of the study and its issues. It does, however, mean that our results
188
may not reflect the opinion of women with differing education levels and our results may not
189
be applicable to other populations. We also assume that our sample is representative of our
190
population as a whole, which of course, may not be the case. We excluded multiparous
191
women in order to reduce the potential confounding effect of different previous experiences
192
of childbirth/labour, although we accept that further work could usefully explore this group’s
193
attitudes as well. Also, due to time constraints of the investigators, the patients in the study
194
were recruited over a period of 10 weeks rather than sequentially.
195
In conclusion, opinions vary between investigators and researchers as to the pros and
196
cons of seeking consent for research during labour, but it is important that debate on such
197
topics involve the primary stakeholders – i.e. the women themselves. Our study has revealed
198
considerable variation in their views, but also clear preferences that must be considered when
199
designing, or participating in, research projects. Further work is required to explore these
200
preferences in different patient populations, and in different settings.
201 202
Disclosure
203
This project was supported by departmental funds only and the authors have no conflicts of
204
interest to declare.
205 206
References
207
1. General Medical Council. Good Practice in Research and Consent to Research. London:
208
GMC, 2010. http://www.gmc-
209
uk.org/static/documents/content/Good_practice_in_research_and_consent.pdf [accessed
210
March 2014].
211
2. Doyal L. Informed consent in medical research: journals should not publish research to
212
which patients have not given fully informed consent –with three exceptions. BMJ 1997;
213
314: 1107-11.
214 215
3. Reid R, Susic D, Pathirana S, Tracy S, Welsh AW. The ethics of obtaining consent in labour for research. Aust N Z J Obstet Gynaecol 2011; 51: 485-92.
7
216
4. Russell IF. A prospective controlled study of continuous spinal analgesia versus repeat
217
epidural analgesia after accidental dural puncture in labour. Int J Obstet Anesth 2012; 21:
218
7–16.
219 220 221 222 223 224 225 226 227
5. Joynt GM. Obtaining informed consent for clinical trials – seldom easy, often difficult, and sometimes impossible. Int J Obstet Anesth 2012; 21: 4–6. 6. Paech M. “Just put it in!” Consent for epidural analgesia in labour. Anaesth Intensive Care 2006; 34: 147-149. 7. Jackson GN, Sensky T, Reide P, Yentis SM. The capacity to consent to epidural analgesia in labour. Int J Obstet Anesth 2011; 20: 269-270. 8. Black JD, Cyna AM. Issues of consent for regional analgesia in labour: a survey of obstetric anaesthetists. Anaesth Intensive Care 2006; 34: 254-260. 9. US Food and Drug Administration. Protection of human subjects; informed consent and
228
waiver of informed consent requirements in certain emergency research.
229
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm118995.ht
230
m [accessed March 2014].
231
10. Tri-council policy statement: ethical conduct for research involving humans (TCPS 2). 2nd
232
ed. Government of Canada, Panel on research ethics, 2010.
233
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default [accessed
234
March 2014].
235
11. Bethune L, Harper N, Lucas DN, Robinson NP, Cox M, Lilley A, Yentis SM.
236
Complications of obstetric regional analgesia: how much information is enough? Int J
237
Obstet Anesth 2004; 13: 30-34.
238
12. Jackson GN, Robinson PN, Lucas DN, et al. What mothers know, and want to know,
239
about the complications of general anaesthesia. Acta Anaesthesiol Scand 2012; 56: 585-
240
588.
241 242
13. Flory J, Emanuel E. Interventions to improve research participant’s understanding in informed consent for research. JAMA 2004; 292: 1593-1601.
243 244
8
245
Legend to Figure
246
Fig. 1 Scores for acceptability (1 = unacceptable; 10 = ideal) of various options for the
247
consent process in a study of accidental dural puncture during labour, presented to 100
248
women. Ant = in antenatal clinic; Req = during labour after request for epidural; Tap = after
249
accidental dural puncture but before treatment; Rx = after treatment of accidental dural
250
puncture (‘retrospective consent’); Nil = waived consent. Horizontal lines = median, boxes =
251
interquartile range and whiskers = range. P < 0.0001 for all comparisons except those
252
indicated.
253
9
254
Fig. 1 P < 0.01 P < 0.01 NS
NS
10
8
6
4
2
0
Ant
Req
Tap
255 256
10
Rx
Nil
257 Table 1 Options for the consent process in a study of accidental dural puncture during labour, presented 258 to 100 women. Timing of consent
Scripted explanation offered
Antenatal period
We would discuss the study including the risks and benefits in the antenatal clinic. It means that this could be done thoroughly and we could answer any questions. However, not all the women we approach will go on to have an epidural, and out of those who do, only a tiny number will have an accidental dural puncture – so this would mean a lot of time and effort is wasted, both for you and us!
In labour, after an
The study would be discussed and consent taken whilst the woman was in labour
epidural is
but before the epidural was put in. This way, only women having an epidural would
requested
be approached. However, it would delay pain relief whilst the discussion took place and again, the vast majority of the women would not have an accidental dural puncture and so the discussion would be unnecessary for most of them.
After accidental
Only women with an accidental dural puncture will be approached, so this would
dural puncture has
avoid approaching lots of women unnecessarily. However, the discussion would
occurred but before
have to take place whilst the woman is in pain, and would again, delay pain relief.
treatment
Also, we’d feel anxious about leaving a needle in the woman’s back during this time.
After accidental
The accidental dural puncture will be treated without delay, but whether this is with
dural puncture has
one treatment or the other will be randomly decided (not according to the choice of
occurred and after
the anaesthetist) and the woman would not know this at the time. It also means that
treatment*
there would be no extra delay before effective pain relief. However, it does mean that the women would have been enrolled into the study without her knowledge or permission, and that the treatment she received may not have been the anaesthetist’s usual choice. Although the woman would be asked for her ‘consent’ afterwards, she can only refuse for her information to be used in the study, not for the treatment allocation itself since it would already have been given.
Waived consent
This would mean that the women would be included in the study without the need for their consent (to the study) at any time, so long as the study had been approved by the hospital and an independent ethics committee to ensure that the proposed study was acceptable and safe.
259
*as used in Russell’s study6 although treatment was not randomised for each participant but for each
260
unit in six-month blocks.
11
S0959-289X(14)00036-3 http://dx.doi.org/10.1016/j.ijoa.2014.03.004 YIJOA 2273
To appear in:
International Journal of Obstetric Anesthesia
Accepted Date:
5 March 2014
Please cite this article as: George, R.T., Butcher, M., Yentis, S.M., Pregnant women’s views on informed consent for research in labour, International Journal of Obstetric Anesthesia (2014), doi: http://dx.doi.org/10.1016/j.ijoa. 2014.03.004
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
1
IJOA 13-00191
2
ORIGINAL ARTICLE
3
Pregnant women’s views on informed consent for research in labour
4
R.T. George, M. Butcher, S.M. Yentis
5
Magill Department of Anaesthesia, Chelsea and Westminster Hospital, London, UK
6 7
Short title: Women’s views on consent for research
8 9
Correspondence to: RT George, Department of Anaesthesia, St. George’s Hospital,
10
Blackshaw Road, London, SW17 0QT
11
Email: [email protected]
12
1
13
ABSTRACT
14
Background: Studies of the optimal treatment of accidental dural puncture occurring during
15
epidural insertion in labour are difficult for practical reasons and because of the ethical issues
16
around seeking consent. In a recent study of accidental dural puncture, participants were
17
assigned to one of two treatment groups and only informed about the study and consent
18
sought, after treatment. We sought the views of parturients on the timing of consent for such a
19
study.
20
Methods: After ethical approval and written consent, 100 nulliparous women in the third
21
trimester of pregnancy completed a structured, facilitated questionnaire, rating the
22
acceptability of the consent process occurring: (i) in antenatal clinic; (ii) after the epidural was
23
requested in labour; (iii) after the accidental dural puncture had occurred but before treatment;
24
(iv) after the allocated treatment; or (v) without consent (waived consent). Results were
25
analysed with the Friedman and Wilcoxon signed-rank tests.
26
Results: Antenatal consent was considered the most acceptable option, whilst consent on
27
request for epidural analgesia and after accidental dural puncture were least acceptable.
28
Consent after treatment and waived consent were rated in-between these extremes. There was
29
a statistically significant difference between these three groups (P < 0.0001). There was a
30
wide range of opinions on each option presented.
31
Conclusions: Antenatal consent was the preferred option but if this is not possible and the
32
need for the research is strong, consent for the use of women’s data after intervention, or
33
waived consent, is acceptable to many women. It is important to seek the views of the
34
participants themselves before planning research with difficult ethical aspects.
35 36
Key words: Consent, Research, Labour
37 38
Introduction
39
There are strong moral and legal arguments for obtaining informed consent before recruiting
40
participants to a clinical trial.1 On occasion, this may be difficult or impossible and Doyal has
41
defined three situations in which informed consent for research is not necessary: i) when the
42
proposed participant does not have capacity; ii) when the proposed research involves
43
epidemiological examination of medical records; and iii) when the proposed research involves
44
examination of tissue from anonymous donors.2
45 46
During labour, concerns over the capacity of parturients and the practical difficulties in ensuring a full consenting process at a time of rapidly changing circumstances can make
2
47
consent for research particularly challenging.3 This has implications for anaesthetic research,
48
since anaesthetists’ first encounter with their obstetric patients is often during labour.
49
A recent publication by Russell described a study conducted at several centres,
50
comparing two methods of management of an accidental dural puncture (ADP) during labour
51
epidural insertion.4 Immediate management of ADP involves either placing the epidural
52
catheter intrathecally through the needle or removing the needle and resiting the epidural at a
53
different lumbar interspace. It is not known which of these two methods of management is
54
preferable in terms of risks and/or benefits, hence Russell conducted a prospective study.
55
Russell had argued successfully to the Research Ethics Committee (REC) that
56
obtaining informed consent for the study before insertion of the epidural was
57
impractical/impossible as it would mean seeking consent from a very large number of
58
women, of whom only a small minority would request epidural analgesia, sustain an ADP and
59
be eligible for recruitment. Further, seeking consent at the time of the ADP was also
60
impractical and unreasonable as it would be difficult to explain the subtleties of the treatment
61
arms whilst the woman was still in pain/distress and awaiting effective analgesia. Also, once
62
an ADP was diagnosed, the imperative was to finish the procedure, and leaving the epidural
63
needle in the woman’s back during potentially prolonged subsequent discussion (and further
64
painful contractions) may risk further harm. Similarly, initiating a randomisation process at
65
that time would also be difficult and potentially delay treatment.
66
In Russell’s study,4 the above dilemmas were addressed as follows: first, units were
67
randomly assigned to one treatment or other for successive periods of six months for a total of
68
two years, to avoid the need for randomisation at the time of ADP. Second, the requirement
69
for informed consent before ADP and its treatment was waived by the REC and consent for
70
the use of the woman’s data was sought at “a convenient time” after she was comfortable or
71
had delivered her baby. Whilst this latter measure may have reduced the harm from breach of
72
autonomy, in that the women were given a chance to remove their data from analysis, it does
73
not negate the fact that they had been recruited for inclusion in a clinical trial without their
74
knowledge. Further, their inclusion potentially exposed them to increased risk if, for example,
75
the epidural had been extremely difficult to site. In such circumstances, the anaesthetist(s)
76
might ordinarily choose intrathecal placement of the epidural catheter rather than try to resite
77
it according to the study protocol. This possibility is supported by the protocol violations that
78
occurred, nearly always in the resite epidural group, indicating difficulties with equipoise.4
79 80
Russell’s study was accompanied by an editorial in which the ethical issues raised by the study were discussed;5 in particular, whether the requirement for informed consent should
3
81
have been waived by the REC and whether full transparency and disclosure, and proper
82
randomisation, should have been guaranteed. Overall, the editorial was critical of the ethical
83
aspects of the study design, but supportive of the journal’s decision to publish the paper.
84
Questions remain over the appropriate management of ADP during labour, but studies
85
such as Russell’s highlight the ethical dilemma about how to conduct such research. The one
86
voice not yet heard, however, is that of the mothers themselves. The aim of this study was to
87
obtain the views of parturients on the appropriateness, need and timing for consent for such
88
intrapartum research, so that their views could inform the debate.
89 90
Methods
91
Following Research Ethics Committee approval and with written informed consent; 100
92
nulliparous women in the third trimester attending routine antenatal clinic appointments at our
93
hospital, and with English as their first language, were recruited to the study. They were
94
interviewed in the antenatal clinic after their routine midwife or obstetrician appointment.
95
Baseline information including age, gestation and level of education was collected. The
96
interview was facilitated by an investigator (RG or MB) and consisted of a questionnaire,
97
following a written, standardised, structured outline explanation of: (i) epidurals, ADP,
98
postdural puncture headache and the treatment options; and (ii) ethical aspects of research
99
into ADP during labour, including informed consent and randomisation. This initial
100
explanation took approximately10 min and participants were asked to confirm understanding
101
of each subsection before moving on to the next. It was also stressed that the purpose of the
102
interview was to explore their views about the process of conducting studies into ADP, not
103
about ADP or epidurals themselves Women were then asked to rate the acceptability of
104
various options for the consent process for a study into ADP during labour (Table 1), using a
105
score from 1 (unacceptable) to 10 (ideal). Data were analysed with the Friedman test and
106
Wilcoxon signed-rank tests, with P < 0.05 indicating statistical significance.
107 108
Results
109
Complete datasets were obtained from all 100 women recruited. Mean ± SD age was 34 ±4
110
years and median (IQR [range]) gestation was 34 (32-37 [27-41]) weeks. For the highest level
111
of education achieved, 39% of women had obtained a postgraduate degree or equivalent, 51%
112
an undergraduate degree, 9% General Certificate of Education Advanced level (A levels,
113
standard UK exams sat at age 17-18 years) and 1% General Certificate of Secondary
114
Education examinations (GCSEs, standard UK exams sat at age 14-16).
4
115
Scores for the acceptability of the various consent options are shown in Figure 1.
116
Antenatal consent was scored the most acceptable, with consent on request for epidural
117
analgesia and consent after ADP (but before treatment) the least acceptable. Each option was
118
scored by some women as the least acceptable and by others as the most acceptable.
119 120
Discussion
121
The two main findings of our study are first, that the women considered antenatal consent to
122
be the most acceptable option, whilst consent on request for epidural analgesia and after ADP
123
were the least acceptable. Consent for the use of their data and waived consent were ranked
124
in-between. Second, there was considerable variation in women’s views as to the acceptability
125
of the various consent options presented to them. By definition, the nature of an ethical
126
dilemma is that there is no clear answer, and a balance of harms and benefits must be set in
127
context and weighed against each other in reaching a course of action. Whilst antenatal
128
explanation and consent were scored as most acceptable by the women in our study, they also
129
understood that requiring this option would essentially make such a study impossible. They
130
also were aware that without such a study, we would be unable to obtain the knowledge
131
required to offer the optimal treatment for ADP. We did not ask the women for their reasons
132
for assigning a particular score, but it is possible that those scoring this option low did so
133
because they recognised the impracticality of this option.
134
The women surveyed generally rejected the two options that would potentially delay
135
the provision of pain relief in labour: namely, consent on request for an epidural and consent
136
before treatment of a recognised ADP. We suggest that in practice, these options would be the
137
most difficult to achieve because of the issues around the level of capacity of women in
138
labour and the need to explain quite complex information relating to the study, above that
139
routinely required for epidural analgesia per se.6-8 We find it interesting that even for these
140
options, there were some women who assigned scores of 10/10 despite confirming their
141
understanding of the implications.
142
Consent for the use of their data, the approach taken in Russell’s study,4 and waived
143
consent, suggested as an option by Joynt in his editorial,5 were scored equally by the women
144
in our study, and more acceptable than consent before siting the epidural or treatment of ADP,
145
although less than antenatal consent. In some ways this would lend support to Russell’s
146
methodology, if one discounts antenatal consent as being impractical and if one accepts that
147
there is a need for such a study in the first place. Joynt argued that there are two possible
148
reasons why waived consent is morally preferable to consent for use of the women’s data.
5
149
Firstly, it permits proper randomization at participant level rather than the unit allocation
150
methodology used in Russell’s paper (thus increasing the benefits of the study considerably
151
by strengthening the evidence provided). Secondly, it allows full transparency and disclosure
152
(e.g. by advertising the study antenatally). If one accepts these arguments, then the similarity
153
between the scores given to the consent for the use of their data and waived consent options
154
would favour the latter.
155
There is little expert guidance or precedent for this option in the UK but both the USA
156
and Canada have published guidance about when research can take place with waived
157
consent, although this guidance relates primarily to pre-hospital care.9,10 A number of women
158
in our study stated that they were happy to be included in research without consent because
159
they trusted the research process and recognised the potential benefit to society. Joynt has also
160
pointed out that studies involving waived consent are required to demonstrate ‘additional
161
stringent safeguards’ in order to protect patients.7
162
The variability in the participants’ responses add to the dilemma in that for each
163
option, scores ranged from the least possible to the maximum possible. Similar broad ranges
164
in women’s views exist for the amount of information they would wish to receive before
165
consenting to regional or general analgesia/anaesthesia,11,12 and highlight the difficulty in
166
satisfying all parturients and potential participants. Such variability also reinforces the need to
167
involve consumers in the decision-making process for studies such as Russell’s. One could
168
argue that ideally, each participating unit should have sought the views of its local population
169
before taking part in the study. The involvement of patients in the research process is now an
170
established concept (http://www.ukcrc.org/patientsandpublic/ppi/) although anaesthetists
171
might initially consider such involvement less suitable for anaesthetic research than other
172
areas.
173
Our study has a number of limitations. The study was questionnaire-based and the
174
complex nature of the subject would mean that if the participants had not understood the
175
concepts being raised, their answers may not be valid. We attempted to minimise this risk in
176
several ways. First, we carefully structured the questionnaire and made it as simple as
177
possible, assessing and improving its readability using MS Word (see
178
http://office.microsoft.com/en-gb/word-help/test-your-document-s-readability-
179
HP010148506.aspx) before piloting and adapting it before starting the study. Second, we only
180
included women for whom English was their first language. Third, each interview was
181
conducted with an investigator facilitating the explanation and the questionnaire, checking
182
that the participant understood each concept before moving to the next. In different fields, it
6
183
has been shown that facilitation improves understanding of questionnaire studies.13 The
184
interviewers initially worked together for the interviews of a small number of women (five),
185
to ensure consistency, but it is possible that variation between the facilitators may have had an
186
effect on the responses. We were fortunate that our study group was highly educated which
187
improved comprehension of the study and its issues. It does, however, mean that our results
188
may not reflect the opinion of women with differing education levels and our results may not
189
be applicable to other populations. We also assume that our sample is representative of our
190
population as a whole, which of course, may not be the case. We excluded multiparous
191
women in order to reduce the potential confounding effect of different previous experiences
192
of childbirth/labour, although we accept that further work could usefully explore this group’s
193
attitudes as well. Also, due to time constraints of the investigators, the patients in the study
194
were recruited over a period of 10 weeks rather than sequentially.
195
In conclusion, opinions vary between investigators and researchers as to the pros and
196
cons of seeking consent for research during labour, but it is important that debate on such
197
topics involve the primary stakeholders – i.e. the women themselves. Our study has revealed
198
considerable variation in their views, but also clear preferences that must be considered when
199
designing, or participating in, research projects. Further work is required to explore these
200
preferences in different patient populations, and in different settings.
201 202
Disclosure
203
This project was supported by departmental funds only and the authors have no conflicts of
204
interest to declare.
205 206
References
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1. General Medical Council. Good Practice in Research and Consent to Research. London:
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GMC, 2010. http://www.gmc-
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uk.org/static/documents/content/Good_practice_in_research_and_consent.pdf [accessed
210
March 2014].
211
2. Doyal L. Informed consent in medical research: journals should not publish research to
212
which patients have not given fully informed consent –with three exceptions. BMJ 1997;
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314: 1107-11.
214 215
3. Reid R, Susic D, Pathirana S, Tracy S, Welsh AW. The ethics of obtaining consent in labour for research. Aust N Z J Obstet Gynaecol 2011; 51: 485-92.
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4. Russell IF. A prospective controlled study of continuous spinal analgesia versus repeat
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epidural analgesia after accidental dural puncture in labour. Int J Obstet Anesth 2012; 21:
218
7–16.
219 220 221 222 223 224 225 226 227
5. Joynt GM. Obtaining informed consent for clinical trials – seldom easy, often difficult, and sometimes impossible. Int J Obstet Anesth 2012; 21: 4–6. 6. Paech M. “Just put it in!” Consent for epidural analgesia in labour. Anaesth Intensive Care 2006; 34: 147-149. 7. Jackson GN, Sensky T, Reide P, Yentis SM. The capacity to consent to epidural analgesia in labour. Int J Obstet Anesth 2011; 20: 269-270. 8. Black JD, Cyna AM. Issues of consent for regional analgesia in labour: a survey of obstetric anaesthetists. Anaesth Intensive Care 2006; 34: 254-260. 9. US Food and Drug Administration. Protection of human subjects; informed consent and
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waiver of informed consent requirements in certain emergency research.
229
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm118995.ht
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m [accessed March 2014].
231
10. Tri-council policy statement: ethical conduct for research involving humans (TCPS 2). 2nd
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ed. Government of Canada, Panel on research ethics, 2010.
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http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default [accessed
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March 2014].
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11. Bethune L, Harper N, Lucas DN, Robinson NP, Cox M, Lilley A, Yentis SM.
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Complications of obstetric regional analgesia: how much information is enough? Int J
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Obstet Anesth 2004; 13: 30-34.
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12. Jackson GN, Robinson PN, Lucas DN, et al. What mothers know, and want to know,
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about the complications of general anaesthesia. Acta Anaesthesiol Scand 2012; 56: 585-
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588.
241 242
13. Flory J, Emanuel E. Interventions to improve research participant’s understanding in informed consent for research. JAMA 2004; 292: 1593-1601.
243 244
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245
Legend to Figure
246
Fig. 1 Scores for acceptability (1 = unacceptable; 10 = ideal) of various options for the
247
consent process in a study of accidental dural puncture during labour, presented to 100
248
women. Ant = in antenatal clinic; Req = during labour after request for epidural; Tap = after
249
accidental dural puncture but before treatment; Rx = after treatment of accidental dural
250
puncture (‘retrospective consent’); Nil = waived consent. Horizontal lines = median, boxes =
251
interquartile range and whiskers = range. P < 0.0001 for all comparisons except those
252
indicated.
253
9
254
Fig. 1 P < 0.01 P < 0.01 NS
NS
10
8
6
4
2
0
Ant
Req
Tap
255 256
10
Rx
Nil
257 Table 1 Options for the consent process in a study of accidental dural puncture during labour, presented 258 to 100 women. Timing of consent
Scripted explanation offered
Antenatal period
We would discuss the study including the risks and benefits in the antenatal clinic. It means that this could be done thoroughly and we could answer any questions. However, not all the women we approach will go on to have an epidural, and out of those who do, only a tiny number will have an accidental dural puncture – so this would mean a lot of time and effort is wasted, both for you and us!
In labour, after an
The study would be discussed and consent taken whilst the woman was in labour
epidural is
but before the epidural was put in. This way, only women having an epidural would
requested
be approached. However, it would delay pain relief whilst the discussion took place and again, the vast majority of the women would not have an accidental dural puncture and so the discussion would be unnecessary for most of them.
After accidental
Only women with an accidental dural puncture will be approached, so this would
dural puncture has
avoid approaching lots of women unnecessarily. However, the discussion would
occurred but before
have to take place whilst the woman is in pain, and would again, delay pain relief.
treatment
Also, we’d feel anxious about leaving a needle in the woman’s back during this time.
After accidental
The accidental dural puncture will be treated without delay, but whether this is with
dural puncture has
one treatment or the other will be randomly decided (not according to the choice of
occurred and after
the anaesthetist) and the woman would not know this at the time. It also means that
treatment*
there would be no extra delay before effective pain relief. However, it does mean that the women would have been enrolled into the study without her knowledge or permission, and that the treatment she received may not have been the anaesthetist’s usual choice. Although the woman would be asked for her ‘consent’ afterwards, she can only refuse for her information to be used in the study, not for the treatment allocation itself since it would already have been given.
Waived consent
This would mean that the women would be included in the study without the need for their consent (to the study) at any time, so long as the study had been approved by the hospital and an independent ethics committee to ensure that the proposed study was acceptable and safe.
259
*as used in Russell’s study6 although treatment was not randomised for each participant but for each
260
unit in six-month blocks.
11
