BETH5104 Bioethics, Law and Society introduces students to interrelationships between health care, ethics, and the law. Students will explore the moral basis of law and the means by which law in turn, influences and directs clinical practice and health policy. We also look at the limits of law in solving ethical dilemmas, and consider what happens when the law falls out of step with the moral institutions of health care providers, patients, and the general public. Over the course of the semester, students will learn to critically read and analyse primary sources of law relevant to bioethics. Students will then examine a number of areas of law that have particular significance for bioethics and society including the law of consent, medical negligence, advance directives, maternal-foetal conflicts, abortion, reproduction, end-of-life decision-making, tissue regulation and infectious disease. Learning activities in BETH5104 include lectures, case discussions (during lectures), problem-based learning, online learning activities and written assessments.

Medicines save lives but they can be costly and can have serious adverse effects. Value-laden decisions are continuously being made at individual, institutional, national and international levels regarding the medicines we need, want and can afford. In this unit of study, we will explore and critique global and national policies and processes related to medicines, examining how research and development agendas are set; how medicines are assessed and evaluated; and how new technologies are translated into practice. We will also explore broader trends such as globalisation, commercialisation and changing consumer expectations. By the end of the course, students will understand the forces shaping the development, regulation, funding and uptake of medicines both nationally and internationally, and the political, ethical, legal and economic issues that are at stake. This course is designed to appeal to a wide range of students from ethics, law, public health, health care, policy, communications, economics, business, politics, administration, and biomedical science.

On completion of this unit students should be able to derive and compare population measures of mortality, illness, fertility and survival, be aware of the main sources of routinely collected health data and their advantages and disadvantages, and be able to collect primary data by a well-designed survey and analyse and interpret it appropriately. Content covered in this unit includes: routinely collected health-related data; quantitative methods in demography, including standardisation and life tables; health differentials; design and analysis of population health surveys including the roles of stratification, clustering and weighting.

This unit introduces the concept of clinical epidemiology and provides students with core skills in clinical epidemiology at an introductory level. Topics covered include asking and answering clinical questions; basic and accessible literature searching techniques; study designs used in clinical epidemiological research; confounding and effect modification; sources of bias; interpretation of results including odds ratios, relative risks, confidence intervals and p values; applicability of results to individual patients; critical appraisal of clinical epidemiological research literature used to answer questions of therapy (RCTs and systematic reviews), harm, prognosis, diagnosis, screening and clinical guidelines.

This course is specifically designed for health professionals who are working in health care. It will equip participants with underpinning knowledge about patient safety. The course modules cover quality and safety principles, professionalism and ethics, risk management and risk information, complexity theory, clinical governance and the impact of adverse events, methods to measure and make improvements in health care. The modules, tools and the discussions are designed to enable participants to change behaviours by understanding the main causes of adverse events-poor team work, busyness, hierachies. The course provides foundation knowledge about quality and safety; governments around the world are concerned to address unsafe care. The course will better prepare health professional to understand the complexity of health care and take steps to minimise the opportunities for errors and address vulnerabilities in the system.

Students will work at their own pace through 9 modules covering research integrity, medical style, abstracts, presentations and posters, constructing a paper, data visualisation, manuscript submission, responding to reviewers comments, publication dissemination, and reviewing a paper. This unit aims to teach students the principles of research integrity in writing for medical journals, typical issues they may face, and link to resources to help them maintain integrity through their publishing careers. It will guide them to reliable evidence based resources to improve their conference abstract, presentation and poster design, and manuscript style and writing.. Students will learn about reporting guidelines, common pitfalls in writing and presenting research, choosing a journal, keywords, improving tables and figures for manuscripts through open source software, copyright, writing cover letters and response letters to reviewers. Students will learn about measuring research impact and ways to improve your research reach, dealing with the media and press releases, using social media in dissemination, digital archiving and basic skills needed to act as a quality peer-reviewer. This is an online unit, but those needing to study in block mode will do online study as well as a workshop.

This unit of study introduces the student to basic concepts behind diagnostic and screening tests, including: test accuracy, sources of bias in test evaluation, critical appraisal of test evaluation studies, principles and use of evidence in making decisions about population screening. It will then move to more advanced topics including: application of test results to individual patients, place of tests in diagnostic pathways, impact of tests on patient outcome, tests with continuous outcome, receiver-operator characteristic curves, systematic review of diagnostic tests, predictive models, monitoring, diagnostic tests in the health system, and over-diagnosis. After completing this unit of study, the student should have a comprehensive understanding of contemporary issues and the methodology underlying, diagnostic and screening test evaluation and application.

In this unit of study, we aim to introduce you to systematic reviews and meta-analyses of relevance to healthcare with a particular focus on systematic reviews of randomized controlled trials. Students can choose to learn in online or normal day (on-campus) mode. All students will work through four online modules, delivered over twelve weeks, addressing the following topics at an introductory level: What and why systematic reviews (and meta-analysis); How to formulate answerable healthcare questions and searching for systematic reviews; how a systematic review is conducted and understanding the principles of meta-analysis; and how to appraise, interpret and apply the results of systematic reviews (and meta-analyses). Students will have the opportunity to discuss unit of study learning materials in online tutorials or via weekly (on-campus) tutorials. Readings and other learning materials will be available via eLearning.

This unit of study will focus on the strengths and weaknesses of different clinical study designs. Designs considered will include cohort (retrospective and prospective), cross-sectional, case-control and randomized controlled designs. The different phases of clinical trial designs in the development of therapies will also be examined including phase I (first in man), phase II/pilot and phase III comparative designs. Extension and adaption of randomized designs will also be covered including cluster and factorial designs and adaptive pilot studies. Students will gain the skills necessary to choose between these designs for best practice. Types of outcomes (continuous, categorical, time-to-event) will be discussed. Methods of allocating participants to interventions (randomization), as well blinding and allocation concealment will be covered together with aspects of protocol development. On completion of this unit, the student will be familiar with the differences between study types and study designs, as well as the principles and practice of randomisation. It is also expected that the candidate will be able to develop stratified randomisation schemes for their own studies.

Candidates will be taught skills to design and interpret equivalence trials, non-inferiority trials and cluster randomised trials. Specialised designs including enrichment and discontinuation designs will be discussed and special aspects relating to cross-over studies will be taught. Techniques to validly incorporate composite, co-primary and surrogate endpoints will be covered. Distinctions between event and chronological time directed outcomes will be discussed. Skills to incorporate sub-studies into clinical research projects will be covered in this unit.

This unit aims to provide students with an understanding of the main concepts and analytical methods of health economics, political economy and finance to examine the workings of health systems in Australia and comparable countries. Topics covered include the debates over the public-private mix and governance and accountability - who makes decisions about funding priorities? To whom should decision makers be held accountable and for what aspects of their work? How does health finance shape broader policy reform, such as universal health coverage?
Learning outcomes. By the end of this unit students will be able to: (i) apply basic concepts and methodologies of health economics and political economy in policy analysis; (ii) understand the role of economic analysis in planning and evaluating health policy change; (iii) understand the main models and debates regarding health system funding and the implications for equity, delivery and governance of health services; (iv) be familiar with theoretical frameworks underlying health economics and current debates over health finance.(v) apply this knowledge to current Australian and global health systems and debates over reform.

Candidates will work on an independent research project in an area of specific interest relevant to their master's degree. The project may take the form of analysis of an existing data set, a systematic review of the literature, a case series, survey or other project acceptable to the project supervisor. In some streams, critical care for example, projects may be available for students to select. It is essential, where there is the use of patient information or recruitiment of patient study subjects, that appropriate ethics approval is gained from the governing body where the project will take place. The candidature will be guided through the steps required to plan and execute a substantial research project, and prepare a scholarly work which may be a paper for publication. A candidate must enrol in a minimum of 12 credit points of project units of study in order to submit their final written work.

Candidates will work on an independent research project in an area of specific interest relevant to their master's degree. The project may take the form of analysis of an existing data set, a systematic review of the literature, a case series, survey or other project acceptable to the project supervisor. In some streams, critical care for example, prjects may be available for students to select. It is essential, where there is the use of patient information or recruitment of patient study subjects, that appropriate ethics approval is gained from the governing body where the project will take place. The candidate will be guided through the steps required to plan and execute a substantial research project and prepare a scholarly work which may be a paper for publication. Where appropriate students will prepare a work suitable for publication. A candidate must enrol in a minimum of 12 credit points of project units of study in order to submit their final written work.

Candidates will work on an independent research project in an area of specific interest relevant to their master degree. The project may take the form of anlysis of an existing data set, a systematic review of the literature, a case series, survey or other project acceptable to the project supervisor. In some streams, critcal care for example, projects may be available for students to select. It is essential where there is the use of patient information or recruitment of patient study subjects that appropriate ethics approval is gained from the governing body where the project will take place. The candidate will be guided through the steps required to plan and execute a substantial research project and prepare a scholarly work which may be a paper for publication. A candidate must enrol in a minimum of 12 credit points of project units of study in order to submit their final written work.

This unit of study provides a broad overview of the process of translating a new drug, formulation and/or pharmaceutical delivery device from a laboratory setting to a final approved product. It is targeted at people in the pharmaceutical industry, advisors in the regulatory sector and those wishing to enter the industry. Three core areas are covered: (1) the regulatory organisation, (2) requirements during drug discovery, manufacture and clinical trials, and (3) post-registration pharmacovigilance. Students will gain knowledge of the Therapeutic Goods Administration (TGA) and guidelines for the registration and regulation of medical devices and medicines. Students will also learn the importance of international regulations, harmonisation and application to the Australian market. The unit will also cover R and D; manufacturing and clinical trial requirements; the concepts of good laboratory and manufacturing practices (GMP, GLP) and quality by design (QbD); as well as regulator accepted laboratory methodologies used for submission of product dossiers. The basics of clinical trial design will be analysed, as well as concepts of pharmacokinetics, dynamics and clinical endpoints for registration of new products using case studies and online tutorials. Special requirements for the registration and testing of generic medicines will also be part of the unit.

This unit of study develops knowledge in current state-of-the-art therapeutic technologies. The principles of mode of action are investigated along with methods of manufacture and registration. The unit is targeted at people in the pharmaceutical industry, advisors in the regulatory sector and those wishing to enter the industry. It covers 4 core areas, reflecting different aspects of medicines regulation in Australia: (1) biologicals and personalised medicine, (2) cell based products, (3) medical devices and (4) classical formulations. The principles that underpin biologics are covered in terms of targeting and manufacture along with the application of genomics in personalised medicine. Students will investigate the processes of manufacture and regulation of vaccine medicines, including requirements for fast-tracking approval. Cellular immunotherapy for cancer treatment is an emerging area. Students will gain knowledge of the different types of therapies within this space. Registration of medical devices will be covered. Case studies of each class of medical device (I-IV) will be studied and evaluated, including the challenges associated with bringing these devices to market. Classical formulations (i.e. oral, repiratory and injectable dosage forms) will be covered and advances within the field such as regulation of nanotechnology discussed.

This unit of study will provide students with the knowledge and skills to identify and evaluate complex technical problems and develop an implementation plan to address the problem. The unit will involve case studies from industry experts and application of international standards. Students will select a problem from examples provided and work through the steps to develop an implemetation plan. In additional to submitting written reports, students will present their final implementation plan in a webinar.

This capstone unit develops the critical thinking needed to transform a new therapeutic drug or device into a commercially viable product. Students will critically appraise scientific and clinical data and information in order to prepare a final scientific dossier that would be suitable for submission to the TGA, EMA or FDA. Students will work in groups to determine the submission strategy and assign individual components where each student solves a clinical/scientific question related to one core aspect of the process (i.e. manufacturing, stability, clinical trial or other suitable component of the process). The group will meet at the face to face workshop to compile the dossier before presenting tho their peers and industry experts.

This unit aims to provide students with an introduction to statistical concepts, their use and relevance in public health. This unit covers descriptive analyses to summarise and display data; concepts underlying statistical inference; basic statistical methods for the analysis of continuous and binary data; and statistical aspects of study design. Specific topics include: sampling; probability distributions; sampling distribution of the mean; confidence interval and significance tests for one-sample, two paired samples and two independent samples for continuous data and also binary data; correlation and simple linear regression; distribution-free methods for two paired samples, two independent samples and correlation; power and sample size estimation for simple studies; statistical aspects of study design and analysis. Students will be required to perform analyses using a calculator and will also be required to conduct analyses using statistical software (SPSS). It is expected that students spend an additional 2 hours per week preparing for their tutorials. Computing tasks are self-directed.

In this unit, students learn how to communicate effectively with respect to health risks, both to individuals with health concerns, and with respect to risks to the public. The first half covers individual health risk communication in clinical settings, including: theories of health communication, patient centred care and shared decision making; evidence-based communication skills; research paradigms including interaction analysis; cross-cultural communication in health care; discussing prognosis; and informed consent. The second half explores risk communication for public health, including: how to effectively manage outbreak or other crisis situations; how to communicate about issues where the risk is low but ublic concern is high (such as with respect to the fluoridation of water); and how to best manage controversies. We teach theories of risk perception and communication with particular application to public health incident responses. We give practical guides to media messages, risk message framing, public engagement, traditional and social media, and the ethical aspects of public communication. The unit offers students the opportunity to learn from outstanding guest lecturers who work in these areas and interactive opportunities for students to try their skills in risk communication and decision making.