Research in Pregnant Women: The Challenges of Informed Consent

Helmreich, Rebecca Jo; Hundley, Vanora; Norman, A; Ighedosa, Joyce; Chow, Erica

doi:10.1111/j.1751-486x.2007.00250.x

Cited by 20 publications

(27 citation statements)

References 29 publications

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“…The timing of consent for intrapartum research has been discussed previously . Higher rates of consent during labor may be the result of women being fearful that a refusal to participate would affect their clinical care.…”

Section: Discussionmentioning

confidence: 99%

When should women be recruited to intrapartum research projects? A retrospective review

Phipps¹,

Vries²,

Kuah

et al. 2013

Acta Obstet Gynecol Scand

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Intrapartum research is associated with low rates of recruitment and these rates may be improved by asking women to provide informed consent during labor rather than the antenatal period. It is important to consider ways to facilitate randomized controlled trials involving women in labor to advance evidence-based care in this environment. This should include prospective research that seeks to define the best approach to patient recruitment.

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Section: Discussionmentioning

confidence: 99%

When should women be recruited to intrapartum research projects? A retrospective review

Phipps¹,

Vries²,

Kuah

et al. 2013

Acta Obstet Gynecol Scand

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“…The challenges of recruiting and gaining consent to participate in clinical trials are well recognised, especially when the research is undertaken in emergency situations or in particular patient groups such as pregnant or recently pregnant women [1–3]. This is because the ability of the person to make an informed decision may be partly or severely compromised [4, 5].…”

Section: Introductionmentioning

confidence: 99%

Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting

et al. 2017

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BackgroundObtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women’s and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment.MethodsInterviews with staff (n = 27) and participating women (n = 22). Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants’ views about the consent procedures used.ResultsWomen and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment.ConclusionsWhile alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways.Trial RegistrationThis qualitative research was undertaken as part of the GOT-IT Trial (trial registration number: ISCRTN 88609453). Date of registration 26/03/2014.

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“…Moreover, in relation to the case of labour, the acute situation and following problems with informed consent could often be prevented. From the start of a pregnancy it is known that a woman will at some point be in that acute situation, and by informing and obtaining consent about existing studies for which they might be asked at an earlier stage in the pregnancy, recruitment during labour could be prevented 20 46. Such innovate strategies are already successfully implemented in practice 54.…”

Section: Discussion Of the Resultsmentioning

confidence: 99%