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.

Thermo-Mechanical Properties of Poly ε-Caprolactone/Poly L-Lactic Acid Blends: Addition of Nalidixic Acid and Polyethylene Glycol Additives Journal of the Mechanical Behavior of Biomedical Materials

The search for ideal biomaterials is still on-going for tissue regeneration. In this study, blends of Poly ε-caprolactone (PCL) with Poly l-lactic acid (PLLA), Nalidixic Acid (NA) and Polyethylene glycol (PEG) were prepared. Mechanical and thermal properties of the blends were investigated by tensile and flexural analysis, DSC, TGA, WXRD, MFI, BET, SEM and hot stage optical microscopy. Results showed that the loading of PLLA caused a significant decrease in tensile strength and almost total eradication of the elongation at break of PCL matrix, especially after PEG and NA addition. Increased stiffness was also noted with additional NA, PEG and PLLA, resulting in an increase in the flexural modulus of the blends.
Isothermal degradation indicated that bulk PCL, PLLA and the blends were thermally stable at 200°C for the duration of 2h making extrusion of the blends at this temperature viable. Morphological study showed that increasing the PLLA content and addition of the very low viscosity PEG and powder NA decreased the Melt Flow Indexer and increased the viscosity.
At the higher temperature the PLLA begins to soften and eventually melts allowing for increased flow and, coupling this with, the natural increase in MFI caused by temperature is enhanced further. The PEG and NA addition increased dramatically the pore volume which is important for cell growth and flow transport of nutrients and metabolic waste.

An Inclusive Design Dialogue on Ethics and Aesthetics

One of the many definitions of inclusive design is that it is a user-led approach to design. To date its focus has been on ‘critical’ users, in particular disabled people. As such, there is pressure to design environments that meet the often urgent and complex demands of these users. Designers, uncertain of their knowledge, rely heavily on user input and guidance, often resulting in designs that are ‘solution’ driven (rather than solution seeking) and short term; users focus on what they need, not what they might need. This paper argues that design needs to reclaim an equal presence within inclusive design. It proposes that the ‘weakness’ of design lies in the uneasy and at times conflicting relationship between ethics and aesthetics. The paper itself is constructed around a dialogue between two academics, one concerned with critical user needs, the other with aesthetics, but both directed towards the support of design quality

Research Ethics in Divided and Violent Societies: Seizing the Ethical Opportunity

This chapter explores how to conduct social research in divided and violent societies by developing the concept of the ‘ethical opportunity’. The ‘ethical opportunity’ is situated in a brief discussion of ‘action’ and feminist approaches to research. It argues that seizing the ethical opportunity requires researchers to: plan for their personal safety, plan for participants’ personal safety and plan how they will communicate and disseminate their results. It draws on the author’s personal experience researching in South Africa, Zimbabwe and Northern Ireland, concluding that it is in the communication and dissemination phase that researchers’ hopes for ‘making a difference’ may be realised or dashed. It cautions would-be researchers to manage their own – and research participants’ – expectations about what social research can achieve. Its effects may not often be as transforming and liberating as idealistic researchers hope for, but that should not dissuade them from striving towards those ends.

“How Can a Woman Who Has Been Raped Be Believed?”: Andrea Dworkin, Sexual Violence and the Ethics of Belief

In June 2000, Andrea Dworkin, an American feminist activist and author, published an account of being raped in a Paris hotel room a year earlier. The story was met with widespread disbelief, including from feminist readers. This article explores the reasons for this disbelief, asking how and why narratives of rape are granted – or denied – truth status by their readers. The article argues for understanding the conferral of belief as a narrative transaction involving the actions of both narrator and reader. It posits that Dworkin was widely seen as an unreliable narrator but argues that for ideologically charged narratives such as rape narratives judgements of reliability and belief inevitably draw upon the normative standpoint of the reader. I suggest that there are opposing criteria for establishing the truth of rape narratives; a ‘factual’ or legal model, which sees rape narratives as requiring scrutiny, and an ‘experiential’ model, located within certain strands of feminist politics, which emphasises the ethical importance of believing women’s narratives. The article finishes with a consideration of the place of belief within an ethics of reading and reception of rape narratives.

Can Consent Training End Sexual Violence On Campus?: Students, Consent and Sexual Ethics

The ongoing, potentially worsening problem of sexual violence and harassment on university campuses has emerged in the last few years as an area of concern. Female students have been identified as one of the most likely groups to experience sexual violence and this violence is exacerbated by contemporary student cultures around alcohol consumption and gendered and sexual norms. University campuses have also become central to prevention efforts in many countries due to their relatively accessible populations and an ability to implement social policies at an institutional level.
Many of these measures are based around promoting or educating students about sexual consent, and particularly notions of affirmative consent, expressed as ‘Yes means Yes’. However, there exists little research around sexual ethics with students exploring whether consent is in fact the best way to tackle cultural problems of sexual violence on campus. This paper makes use of existing literature on sexual ethics and focus group research undertaken with Australian university students to argue for an approach to the problem of sexual ethics on campus that is broader than simply focusing on training programs in sexual consent. It identifies a number of limitations to the consent framework and argues that prevention efforts need to more seriously engage with broader cultural norms around heterosexuality and gendered relationships.

Improving antimicrobial release kinetics from hydrophobic polymer implants via ion pairing to combat biomedical-device related infection

Purpose The aim of this study is to improve the drug release properties of antimicrobial agents from hydrophobic biomaterials using using an ion pairing strategy. In so doing antimicrobial agents may be eluted and maintained over a sufficient time period thereby preventing bacterial colonisation and subsequent biofilm formation on medical devices. Methods The model antimicrobial agent was chlorhexidine and the selected fatty acid counter ions were capric acid, myristic acid and stearic acid. The polymethyl methacrylate films were loaded with 2% of fatty acid:antimicrobial agent at the following molar ratios; 0.5:1M, 1:1M and 2:1M and thermally polymerized using azobisisobutyronitrile initiator. Drug release experiments were subsequently performed over a 3-month period and the mass of drug released under sink conditions (pH 7.0, 37oC) quantified using a validated HPLC-UV method. Results In all platforms, a burst of chlorhexidine release was observed over the initial 24-hour period. Similar release kinetics were observed between the formulations during the initial 28 days. However, as time progressed, the chlorhexidine baseline plateaued after 56 days whereas formulations containing the counterions appeared to continuously elute linearly with time. As can be observed in figure 1, the rank order of total chlorhexidine release in the presence of 0.5M fatty acid was myristic acid (40%) > capric acid (35%) > stearic acid (30%)> chlorhexidine baseline (15%). Conclusion The incorporation of fatty acids within the formulation significantly improved chlorhexidine solubility within both the monomer and the polymer and enhanced the drug release kinetics over the period of study. This is attributed to the greater diffusivity of chlorhexidine through PMMA in the presence of fatty acids. In th absence of fatty acids, chlorhexidine release was facilitated by dissolution of surface associated drug particles. This study has illustrated the ability of fatty acids to modulate chlorhexidine release from a model biomaterial through enhanced diffusivity. This strategy may prove advantageous for improved medical devices with enhanced resistance to infection.