The ethics of obtaining consent in labour for research.

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.

Somatosensory test responses in children with growing pains.

PURPOSE: To further the understanding of growing pains (GP), in particular, the nature of this pain disorder. METHODS: This study included 33 children aged 5-12 years who met criteria for GP (cases) and 29 children without GP of similar age and sex (controls). Nineteen controls were siblings of cases. GP was diagnosed by standard consensus questionnaires. A questionnaire addressed characteristics of the pain and family history of GP. Evidence for peripheral neuropathic disorder was tested by somatosensory testing and provocation tests of peripheral nerves. Somatosensory testing by a blinded researcher involved threshold determination and/or response magnitude to nonpainful stimuli including touch, dynamic brush, cold, vibration, and deep pressure applied to limb and abdominal sites. RESULTS: Distributional, temporal, and quality characteristics of the pain were in accordance with published descriptions. There was no indication of primary musculoskeletal disorder. No evidence was found that GP is a peripheral neuropathic pain syndrome. There were minor but statistically significantly increased responses to cutaneous cold, vibration, and to deep pressure stimuli in cases compared to controls, evident in a wider distribution than the symptomatic lower limbs. CONCLUSION: GP is a regional pain syndrome with evidence in this study of mild widespread disorder of somatosensory processing.