A review of system safety failure probability objectives for Unmanned Aircraft Systems

Unmanned Aircraft Systems (UAS) are one of a number of emerging aviation sectors. Such new aviation concepts present a significant challenge to National Aviation Authorities (NAAs) charged with ensuring the safety of their operation within the existing airspace system. There is significant heritage in the existing body of aviation safety regulations for Conventionally Piloted Aircraft (CPA). It can be argued that the promulgation of these regulations has delivered a level of safety tolerable to society, thus justifying the “default position” of applying these same standards, regulations and regulatory structures to emerging aviation concepts such as UAS. An example of this is the proposed “1309” regulation for UAS, which is based on the 1309 regulation for CPA. However, the absence of a pilot on-board an unmanned aircraft creates a fundamentally different risk paradigm to that of CPA. An appreciation of these differences is essential to the justification of the “default position” and in turn, to ensure the development of effective safety standards and regulations for UAS. This paper explores the suitability of the proposed “1309” regulation for UAS. A detailed review of the proposed regulation is provided and a number of key assumptions are identified and discussed. A high-level model characterising the expected number of third party fatalities on the ground is then used to determine the impact of these assumptions. The results clearly show that the “one size fits all” approach to the definition of 1309 regulations for UAS, which mandates equipment design and installation requirements independent of where the UAS is to be operated, will not lead to an effective management of the risks.

UAS Classification: Key to effective airworthiness and operational regulations

This presentation discusses some of the general issues relating to the classification of UAS for the purposes of defining and promulgating safety regulations. One possible approach for the definition of a classification scheme for UAS Type Certification Categories reviewed.

Overview of Australian Civil UAS Regulations and Supporting Research

This presentation provides a review of current civil unmanned aircraft system operations and applications, the operational environment and aviation safety regulations in Australia. A summary of current regulatory reform efforts is also provided. The presentation includes new and existing research programs established to address the technical and social issues facing the unmanned aircraft systems industry and aid the regulatory reform process.

Decision support for the safe design and operation of unmanned aircraft systems

Unmanned Aircraft Systems (UAS) describe a diverse range of aircraft that are operated without a human pilot on-board. Unmanned aircraft range from small rotorcraft, which can fit in the palm of your hand, through to fixed wing aircraft comparable in size to that of a commercial passenger jet. The absence of a pilot on-board allows these aircraft to be developed with unique performance capabilities facilitating a wide range of applications in surveillance, environmental management, agriculture, defence, and search and rescue. However, regulations relating to the safe design and operation of UAS first need to be developed before the many potential benefits from these applications can be realised. According to the International Civil Aviation Organization (ICAO), a Risk Management Process (RMP) should support all civil aviation policy and rulemaking activities (ICAO 2009). The RMP is described in International standard, ISO 31000:2009 (ISO, 2009a). This standard is intentionally generic and high-level, providing limited guidance on how it can be effectively applied to complex socio-technical decision problems such as the development of regulations for UAS. Through the application of principles and tools drawn from systems philosophy and systems engineering, this thesis explores how the RMP can be effectively applied to support the development of safety regulations for UAS. A sound systems-theoretic foundation for the RMP is presented in this thesis. Using the case-study scenario of a UAS operation over an inhabited area and through the novel application of principles drawn from general systems modelling philosophy, a consolidated framework of the definitions of the concepts of: safe, risk and hazard is made. The framework is novel in that it facilitates the representation of broader subjective factors in an assessment of the safety of a system; describes the issues associated with the specification of a system-boundary; makes explicit the hierarchical nature of the relationship between the concepts and the subsequent constraints that exist between them; and can be evaluated using a range of analytic or deliberative modelling techniques. Following the general sequence of the RMP, the thesis explores the issues associated with the quantified specification of safety criteria for UAS. A novel risk analysis tool is presented. In contrast to existing risk tools, the analysis tool presented in this thesis quantifiably characterises both the societal and individual risk of UAS operations as a function of the flight path of the aircraft. A novel structuring of the risk evaluation and risk treatment decision processes is then proposed. The structuring is achieved through the application of the Decision Support Problem Technique; a modelling approach that has been previously used to effectively model complex engineering design processes and to support decision-making in relation to airspace design. The final contribution made by this thesis is in the development of an airworthiness regulatory framework for civil UAS. A novel "airworthiness certification matrix" is proposed as a basis for the definition of UAS "Part 21" regulations. The outcome airworthiness certification matrix provides a flexible, systematic and justifiable method for promulgating airworthiness regulations for UAS. In addition, an approach for deriving "Part 1309" regulations for UAS is presented. In contrast to existing approaches, the approach presented in this thesis facilitates a traceable and objective tailoring of system-level reliability requirements across the diverse range of UAS operations. The significance of the research contained in this thesis is clearly demonstrated by its practical real world outcomes. Industry regulatory development groups and the Civil Aviation Safety Authority have endorsed the proposed airworthiness certification matrix. The risk models have also been used to support research undertaken by the Australian Department of Defence. Ultimately, it is hoped that the outcomes from this research will play a significant part in the shaping of regulations for civil UAS, here in Australia and around the world.

A framework for testing robust autonomy of UAS during design and certification

As the number of Uninhabited Airborne Systems (UAS) proliferates in civil applications, industry is increasingly putting pressure on regulation authorities to provide a path for certification and allow UAS integration into regulated airspace. The success of this integration depends on developments in improved UAS reliability and safety, regulations for certification, and technologies for operational performance and safety assessment. This paper focusses on the last topic and describes a framework for quantifying robust autonomy of UAS, which quantifies the system's ability to either continue operating in the presence of faults or safely shut down. Two figures of merit are used to evaluate vehicle performance relative to mission requirements and the consequences of autonomous decision making in motion control and guidance systems. These figures of merit are interpreted within a probabilistic framework, which extends previous work in the literature. The valuation of the figures of merit can be done using stochastic simulation scenarios during both vehicle development and certification stages with different degrees of integration of hardware-in-the-loop simulation technology. The objective of the proposed framework is to aid in decision making about the suitability of a vehicle with respect to safety and reliability relative to mission requirements.

Building the safety case for UAS operations in support of natural disaster response

A framework supporting the systematic development of safety cases for Unmanned Aircraft System (UAS) operations in a broad range of civil and commercial applications is presented. The case study application is the use of UAS for disaster response. In those States where regulations do not preclude UAS operations altogether, approvals for UAS operations can be granted on a case-by-case basis contingent on the provision of a safety case acceptable to the relevant National Airworthiness Authority (NAA). A safety case for UAS operations must show how the risks associated with the hazards have been managed to an acceptable level. The foundational components necessary for structuring and assessing these safety cases have not yet been proposed. Barrier-bow-tie models are used in this paper to structure the safety case for the two primary hazards of 1) a ground impact, and 2) a Mid-Air Collision (MAC). The models establish the set of Risk Control Variables (RCVs) available to reduce the risk. For the ground-impact risk model, seven RCVs are identified which in combination govern the probability of an accident. Similarly, ten RCVs are identified within the MAC model. The effectiveness of the RCVs and how they can implemented in terms of processes, policies, devices, practices, or other actions for each of the case-study applications are discussed. The framework presented can provide for the more systematic and consistent regulation of UAS through a "safety target" approach.

Regulation of lipid biosynthesis by phosphatidylinositol-specific phospholipase C through the transcriptional repression of upstream activating sequence inositol containing genes

The regulation of phospholipid biosynthesis in Saccharomyces cerevisiae through cis-acting upstream activating sequence inositol (UAS(ino)) and trans-acting elements, such as the INO2-INO4 complex and OPI1 by inositol supplementation in growth is thoroughly studied. In this study, we provide evidence for the regulation of lipid biosynthesis by phosphatidylinositol-specific phospholipase C (PLC) through UAS(ino) and the trans-acting elements. Gene expression analysis and radiolabelling experiments demonstrated that the overexpression of rice PLC in yeast cells altered phospholipid biosynthesis at the levels of transcriptional and enzyme activity. This is the first report implicating PLC in the direct regulation of lipid biosynthesis. (C) 2012 Federation of European Biochemical Societies. Published by Elsevier B.V. All rights reserved.

Redox regulation of the mitochondrial K(ATP) channel in cardioprotection

The mitochondrial ATP-sensitive potassium channel (mK(ATP)) is important in the protective mechanism of ischemic preconditioning (IPC). The channel is reportedly sensitive to reactive oxygen and nitrogen species, and the aim of this study was to compare such species in parallel, to build a more comprehensive picture of mK(ATP) regulation. mK(ATP) activity was measured by both osmotic swelling and Tl(+) flux assays, in isolated rat heart mitochondria. An isolated adult rat cardiomyocyte model of ischemia-reperfusion (IR) injury was also used to determine the role of mK(ATP) in cardioprotection by nitroxyl. Key findings were as follows: (i) mK(ATP) was activated by O(2)(center dot-) and H(2)O(2) but not other peroxides. (ii) mK(ATP) was inhibited by NADPH. (iii) mK(ATP) was activated by S-nitrosothiols, nitroxyl, and nitrolinoleate. The latter two species also inhibited mitochondrial complex II. (iv) Nitroxyl protected cardiomyocytes against IR injury in an mK(ATP)-dependent manner. Overall, these results suggest that the mK(ATP) channel is activated by specific reactive oxygen and nitrogen species, and inhibited by NADPH. The redox modulation of mK(ATP) may be an underlying mechanism for its regulation in the context of IPC. This article is part of a Special Issue entitled: Mitochondria and Cardioprotection. (C) 2010 Elsevier B.V. All rights reserved.

Regulation of Synaptogenesis by the miRNA Pathway and FMR/P Bodies

Post-transcriptional regulation of mRNA is facilitated by different mechanisms, such as microRNA (miRNA) induced gene silencing or fragile X mental retardation protein (FMRP) mediated repression either independent of or acting through cytoplasmic RNA Processing bodies (P bodies). DPTP99A, Lar, and Wg have known functions during synaptogenesis and may be targets of miR-8. Here, we provide evidence that miR-8 regulates DPTP99A in vitro. Non-endogenous miR-8 expressed using an UAS driver regulates Lar. Endogenous miR-8 may regulate DPTP99A in vivo. Here we show that FMRP is capable of colocalizing with the P body components: DCP1, HPat, and Me31B, but not CCR4. We also show that RNAi against HPat and Me31B but not CCR4 and DCP1 are required for FMRP’s repression of a translational reporter in vivo. This functional analysis provides additional insight into another aspect of FMRP’s and P bodies’ ability to cooperatively control repression of mRNA targets.

Contemporary consumer law : the role and effectiveness of regulation in consumer protection

This issue of the Griffith Law Review focuses on consumer law, and the pervasive nature of this area of law. We are all consumers, but do not necessarily identify as such, nor are we a homogeneous group. The boundaries of

Regulation of human stem cell research in Australia

Australia is currently well placed to contribute to the global growth of human stem cell research. However, as the science has progressed, authorities have had to deal with the ongoing challenges of regulating such a fast moving field of scientific endeavour. Australia’s past and current approach to regulating the use of embryos in human embryonic stem cell research provides an insight into how Australia may continue to adapt to future regulatory challenges presented by human stem cell research. In the broader context, a number of issues have been identified that may impact upon the success of future human stem cell research in Australia.

Stem cell technologies : regulation, patents and problems

Human embryonic stem cell research promises to deliver in the future a whole range of therapeutic treatments, but currently governments in different jurisdictions must try to regulate this burgeoning area. Part of the problem has been, and continues to be, polarised community opinion on the use of human embryonic stem cells for research. This article compares the approaches of the Australian, United Kingdom and United States governments in regulating human embryonic stem cell research. To date, these governments have approached the issue through implementing legislation or policy to control research. Similarly, the three jurisdictions have viewed the patentability of human embryonic stem cell technologies in their own ways with different policies being adopted by the three patent offices. This article examines these different approaches and discusses the inevitable concerns that have been raised due to the lack of a universal approach in relation to the regulation of research; the patenting of stem cell technologies; and the effects patents granted are having on further human embryonic stem cell research.

Commercialisation of regenerative human tissue : Regulation and reform in Australia and England, Wales and Northern Ireland

The commercialisation of therapeutic products containing regenerative human tissue is regulated by the common law, statute and ethical guidelines in Australia and England, Wales and Northern Ireland. This article examines the regulatory regimes in these jurisdictions and considers whether reform is required to both support scientific research and ensure conformity with modern social views on medical research and the use of human tissue. The authors consider the crucial role of informed consent in striking the balance between the interests of researchers and the interests of the public.