Human Research Ethics Committee Approval Research Articles

Intubation of a Paediatric Manikin in Tongue Oedema and Face-to-Face Simulations by Novice Personnel: a Comparison of Glidescope, Airtraq and Direct Laryngoscopy

Glidescope and Airtraq were designed for facilitating intubation and for teaching regarding the airway anatomy. We aimed to evaluate their efficacy in normal airway, tongue oedema and face-to-face orotracheal intubation models when used by novice personnel. After the local human research ethics committee approval, 36 medical students who were in the beginning of their third year were enrolled in this study. After watching a video regarding intubation using one of these devices, the students intubated a paediatric manikin with a Glidescope or Airtraq via the normal airway, tongue oedema and face-to-face approach. Although the insertion and intubation times were similar among the groups, the intubation success rate of the Glidescope was higher in the normal airway (100% vs 67%) and tongue oedema (89% vs. 50%) compared with the Airtraq (p=0.008 and p=0.009). The success rates with the paediatric manikin by the face-to-face approach were similar among the groups (50%) (p=0.7). The need for manoeuvres in the Glidescope was lower in the normal and tongue oedema models (p=0.02 and p=0.002). In addition, oesophageal intubation was low in the control and tongue oedema models with the Glidescope (p=0.03 and p<0.001). Novice personnel could more easily intubate the trachea with the Glidescope than with the Airtraq. Intubation with the Glidescope was superior to that with the Airtraq in the normal and tongue oedema models. The face-to-face intubation success rates were both low with both the Glidescope and Airtraq groups.

Why should ethics approval be required prior to publication of health promotion research?

Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.

Data linkage capabilities in Australia: practical issues identified by a Population Health Research Network ‘Proof of Concept project’

Objective:To describe the practical issues that need to be overcome to conduct national data linkage projects in Australia and propose recommendations to improve efficiency. Methods:Review of the processes, documentation and applications required to conduct national data linkage in Australia. Results:The establishment of state and national data linkage centres in Australia has placed Australia at the forefront of research linking health‐related administrative data collections. However, improvements are needed to reduce the clerical burden on researchers, simplify the process of obtaining ethics approval, improve data accessibility, and thus improve the efficiency of data linkage research. Conclusions:While a sound state and national data linkage infrastructure is in place, the current complexity, duplication and lack of cohesion undermines any attempts to conduct research involving national record linkage in a timely manner. Implications:Data linkage applications and Human Research Ethics Committee approval processes need to be streamlined and duplication removed, in order to reduce the administrative and financial burden on researchers if national data linkage research is to be viable.

Plerixafor (AMD3100) induces prolonged mobilization of acute lymphoblastic leukemia cells and increases the proportion of cycling cells in the blood in mice

The CXCR4 antagonist Plerixafor (AMD3100) induces the rapid mobilization of hematopoietic stem and progenitor cells into the blood in mice and humans. AMD3100 similarly induces the mobilization of human acute lymphoblastic leukemia (ALL) cells into the blood in mice. In this study, the temporal response of pre-B ALL cells to AMD3100 was compared with that of normal hematopoietic progenitor cells (HPC) using an NOD/SCID xenograft model of ALL and BALB/c mice, respectively. ALL cells remained in the circulation up to 6 hours after AMD3100 administration, by which time normal HPCs were no longer detectable. AMD3100 also increased the proportion of actively cycling ALL cells in the peripheral blood. Together, these data suggest that ALL cells are more sensitive to the effects of bone marrow disruption than normal progenitors. Using the NOD/SCID xenograft model, we demonstrated that AMD3100 increased the efficacy of the cell cycle specific drug vincristine, resulting in reduced disease levels in the blood and spleens of animals over 3 weeks and extended the survival of NOD/SCID mice with ALL. These data demonstrate that mobilizing agents can increase the therapeutic effect of cell cycle dependent chemotherapeutic agents.

Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa

Tuberculosis (TB) vaccine trials in South Africa must be approved by the Medicines Control Council (MCC) and by a human research ethics committee (HREC). Delays in regulatory and ethical approval may affect operational and budget planning and clinical development of the product. Our aim was to analyse the time to regulatory and ethical approval for TB vaccine trials conducted by the South African Tuberculosis Vaccine Initiative (SATVI) and to evaluate factors that influence time to final approval. Sixteen new TB vaccine clinical trials conducted by SATVI between 2004 and 2012 on infants, children, and adults were included. The period between submission and final approval was determined for protocols submitted to the MCC and the University of Cape Town HREC. Median approval time following first submission to the MCC was 122 days (IQR 112 - 168; range 71 - 350), and for protocol amendments 103 days (interquartile range (IQR) 76 - 141; range 23 - 191; n=30). Median time following first submission for HREC approval was 60 days (IQR 33 - 81; range 18 - 125), and for amendments 6 days (IQR 4 - 13; range 1 - 37; n=30). There was no significant difference in approval time by trial phase, year of submission, revisions required, study population, sample size, or whether a clinical research organisation (CRO) was used. The time needed for regulatory and ethics approval was highly variable, but MCC approval for first submissions took twice as long as HREC approval and was the primary determinant of time to final approval. National regulatory capacity should be strengthened to facilitate the conduct of new TB vaccine trials in this country with its high burden of TB.

Long-Term Urethral Function Measured by Uroflowmetry After Hypospadias Surgery: Comparison with an Age Matched Control

Long-term outcomes of hypospadias surgery, particularly urinary function, have not been examined thoroughly. Uroflowmetry can be used to evaluate long-term functional outcomes by assessing flow shape and the rate of micturition. We assessed urethral function using uroflowmetry in adolescents after undergoing hypospadias repair in infancy and compared this with age matched controls. After human research ethics committee approval (HREC 28111A), 17 boys 13 to 15 years old with no history of urological or neurological disorders underwent uroflowmetry (65 separate voids) to determine standard values for boys of this age. Then 60 boys age 13 to 15 years who had undergone treatment for hypospadias in early infancy were seen for long-term followup and underwent uroflow assessment. Standard urinary flow rates were established in the 13 to 15-year-old control group and represented on a nomogram. In the boys who underwent hypospadias surgery the urine flow rates were significantly lower compared to the control nomogram (p <0.0001), with half the patients having uroflow rates below 1 SD from the control mean but without symptoms. Boys with significant preoperative chordee were more likely to have poorer urinary flow (p <0.04). A poor urinary flow rate also was significantly associated with post-void residual bladder volume (p <0.03). There was no correlation with original meatal location, number of operations, presence of postoperative complications, current anatomy and lower urinary tract symptoms (eg post-void dribble, hesitancy, incontinence). At long-term followup after hypospadias surgery urinary flow rates were significantly lower compared to age matched controls but still fell within the normal range. In the hypospadias cohort there was no significant association with lower urinary tract symptoms and poor urinary flow. Detection of poor urinary flow may indicate incomplete bladder emptying. The presence of severe chordee preoperatively is a significant risk factor for poor urinary flow rates on long-term followup.

Multi‐centre research in Australia: Analysis of a recent National Health and Medical Research Council‐funded project

Human research ethics committees provide essential review of research projects to ensure the ethical conduct of human research. Several recent reports have highlighted a complex process for successful application for human research ethics committee approval, particularly for multi-centre studies. Limited resources are available for the execution of human clinical research in Australia and around the world. This report overviews the process of ethics approval for a National Health and Medical Research Council-funded multi-centre study in Australia, focussing on the time and resource implications of such applications in 2007 and 2008. Applications were submitted to 16 hospital and two university human research ethics committees. The total time to gain final approval from each committee ranged between 13 and 77 days (median = 46 days); the entire process took 16 months to complete and the research officer's time was estimated to cost $A34 143. Obstacles to timely human research ethics committee approval are reviewed, including recent, planned and potential initiatives that could improve the ethics approval of multi-centre research.