BACKGROUND: It is widely acknowledged that the pregnant population is a vulnerable and potentially disadvantaged one with regard to research. We sought to evaluate compliance with this concept by examining current Australian practices of obtaining consent for research during labour through the published literature and from Australian Human Research Ethics Committees (HRECs) as well as reviewing the relevant literature. METHODS: We surveyed Australian HRECs requesting information about their opinions and/or practices surrounding the ethics of research consent during labour or birth. In addition, a literature search was performed to find randomised controlled trials (RCTs) involving interventions during labour in Australia in the last five years. RESULTS: Of the HREC respondents, 75% believed it to be ethical to obtain consent for research in labour, 87% would require additional expert assistance to approve, 57% felt the partner should be involved and all proposed research scenarios were thought to require protocol changes. Recent local RCTs reflected a variety of consent strategies, each having their limitations. CONCLUSIONS: An under-used but potentially useful strategy may be staged recruitment and consent. Despite the evidence supporting labour as a time requiring increased acuity for informed consent, there is little to suggest that this knowledge is being applied to current Australian HREC and RCT practices. We suggest that further practical guidelines be devised to aid researchers and human ethics committees.
BACKGROUND: It is widely acknowledged that the pregnant population is a vulnerable and potentially disadvantaged one with regard to research. We sought to evaluate compliance with this concept by examining current Australian practices of obtaining consent for research during labour through the published literature and from Australian Human Research Ethics Committees (HRECs) as well as reviewing the relevant literature. METHODS: We surveyed Australian HRECs requesting information about their opinions and/or practices surrounding the ethics of research consent during labour or birth. In addition, a literature search was performed to find randomised controlled trials (RCTs) involving interventions during labour in Australia in the last five years. RESULTS: Of the HREC respondents, 75% believed it to be ethical to obtain consent for research in labour, 87% would require additional expert assistance to approve, 57% felt the partner should be involved and all proposed research scenarios were thought to require protocol changes. Recent local RCTs reflected a variety of consent strategies, each having their limitations. CONCLUSIONS: An under-used but potentially useful strategy may be staged recruitment and consent. Despite the evidence supporting labour as a time requiring increased acuity for informed consent, there is little to suggest that this knowledge is being applied to current Australian HREC and RCT practices. We suggest that further practical guidelines be devised to aid researchers and human ethics committees.
Authors: Nigel Lee; Lena B Mårtensson; Caroline Homer; Joan Webster; Kristen Gibbons; Helen Stapleton; Natalie Dos Santos; Michael Beckmann; Yu Gao; Sue Kildea Journal: BMC Pregnancy Childbirth Date: 2013-05-03 Impact factor: 3.007
Authors: Lydia L Shook; Jessica E Shui; Adeline A Boatin; Samantha Devane; Natalie Croul; Lael M Yonker; Juan D Matute; Rosiane S Lima; Muriel Schwinn; Dana Cvrk; Laurel Gardner; Robin Azevedo; Suzanne Stanton; Evan A Bordt; Laura J Yockey; Alessio Fasano; Jonathan Z Li; Xu G Yu; Anjali J Kaimal; Paul H Lerou; Andrea G Edlow Journal: BMC Med Res Methodol Date: 2020-08-26 Impact factor: 4.615