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

BACKGROUND AND OBJECTIVE: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.

The Application of Computational Chemistry and Chemometrics to Developing a Method for Online Monitoring of Polymer Degradation in the Manufacture of Bioresorbable Medical Implants

Bioresorbable polymers such as PLA have an important role to play in the development of temporary implantable medical devices with significant benefits over traditional therapies. However, development of new devices is hindered by high manufacturing costs associated with difficulties in processing the material. A major problem is the lack of insight on material degradation during processing. In this work, a method of quantifying degradation of PLA using IR spectroscopy coupled with computational chemistry and chemometric modeling is examined. It is shown that the method can predict the quantity of degradation products in solid-state samples with reasonably good accuracy, indicating the potential to adapt the method to developing an on-line sensor for monitoring PLA degradation in real-time during processing.

Changing policy and legislation in special and inclusive education: a perspective from Northern Ireland

It is now 15 years since the signing of the 1998 Belfast (or ‘Good Friday’) Peace Agreement which committed all participants to exclusively democratic and peaceful means of resolving differences, and towards a shared and inclusive society defined by the principles of respect for diversity, equality and the interdependence of people. In particular, it committed participants to the protection and vindication of the human rights of all. This is, therefore, a precipitous time to undertake a probing analysis of educational reforms in Northern Ireland associated with provision in the areas of inclusion and special needs education. Consequently, by drawing upon analytical tools and perspectives derived from critical policy analysis, this article, by Ron Smith from the School of Education, Queen’s University Belfast, discusses the policy cycle associated with the proposed legislation entitled Every School a Good School: the way forward for special educational needs and inclusion. It examines how this policy text structures key concepts such as ‘inclusion’, ‘additional educational needs’ and ‘barriers to learning’, and how the proposals attempt to resolve the dilemma of commonality and difference. Conceived under direct rule from Westminster (April 2006), issued for consultation when devolved powers to a Northern Ireland Assembly had been restored, and with the final proposals yet to be made public, this targeted educational strategy tells a fascinating story of the past, present and likely future of special needs education in Northern Ireland. Before offering an account of this work, it is placed within some broader ecological frameworks.

Punctal plug: a medical device to treat dry eye syndrome and for sustained drug delivery to the eye

Punctal plugs (PPs) are miniature medical implants that were initially developed for the treatment of dry eyes. Since their introduction in 1975, many PPs made from different materials and designs have been developed. PPs, albeit generally successful, suffer from drawbacks such as epiphora and suppurative canaliculitis. To overcome these issues intelligent designs of PPs were proposed (e.g. SmartPLUG™ and Form Fit™). PPs are also gaining interest among pharmaceutical scientists for sustaining drug delivery to the eye. This review aims to provide an overview of PPs for dry eye treatment and drug delivery to treat a range of ocular diseases. It also discusses current challenges in using PPs for ocular diseases.