Untested Stem Cell Treatments: An Analysis of Australia's Current Regulatory Regime.

Stem cell therapies have emerged as a miracle cure that could treat diseases and conditions. The past decade has seen the rapid growth of private clinics in some nations, including Australia, offering stem cell treatments largely untested and unsupported by clinical trials. These putative treatments have caused adverse events, some of which were serious and even fatal. The unscrupulous businesses exploit vulnerable and desperate patients who falsely believe these unproven therapies are their only salvation to cure different illnesses and conditions. This article emphasises the importance of strict oversight to ensure that only safe stem cell products reach patients, given the largely vulnerable patient base and the magnitude of risks involved. It examines the effectiveness of Australia's regulatory environment governing stem cell therapies to restrict the advertisement of dangerous and unproven stem cell therapies and the enforceability of these measures.

How Australia's Policymakers Can Ethically Approach Human Germline Genome Editing Technology.

This article undertakes an analysis of Australia's laws affecting human germline genome editing (HGGE). It draws on research from various ethical frameworks to analyse the values underpinning existing policy and which could underpin future approaches on HGGE. The article emphasises the importance of protecting egalitarianism, mitigating inequality risks, and ensuring stigmas around people with genetic conditions targeted by HGGE are not perpetuated. Doing so makes the philosophical case for a policy allowing HGGE for research use and considers the potential for limited clinical uses as we advance. The article recommends law reform in Australia in the form of an ongoing legislative review every three years, with the first review considering research and informed consent. The second considers appropriate clinical uses based on medical risk and what is agreed upon to be a list of considerations of a severe enough disease to be treated by HGGE. It gives examples of what the reform might look like, pending public engagement methodologies advocated. Finally, this article recommends considering ancillary legal issues raised by HGGE, including anti-discrimination and potential protections from liability.

The Regulation and Governance of Clinical Trials: Past and Present Considerations to Ensure Ethical Treatment of Human Participants.

Clinical trials are crucial in determining whether novel medical interventions are effective and safe. The use of human participants in such trials is also vital, as animal testing and computer simulation are no substitutes for testing people. Regulation aimed to ensure ethical and safe practices when using human participants, had its beginnings at a global level in response to World War II atrocities. Since that time, there has been an exponential rise of clinical trials, driven mostly by large pharmaceutical companies and for-profit contract research organisations motivated to find preventions and cures for illness and disease, and profit. In turn, there is an ever-growing demand for clinical trial human participants. This article considers historical and contemporary instances of when such trials have gone wrong, and examines the development, and importance of comprehensive, robust, and responsive regulation and governance of clinical trials at both international and domestic levels of which researchers must be aware.