Lisa Eckstein
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View article: The role of HRECs in regulating medical research: from peer review to regulation
The role of HRECs in regulating medical research: from peer review to regulation Open
In Australia, Human Research Ethics Committees (HRECs) play a ubiquitous role reviewing human subjects research, as do Institutional Review Boards in the US and elsewhere. While HRECs were established as peer review bodies, we argue they s…
View article: Empowering human research ethics committees to review genomics applications: evaluating the utility of a custom online education resource
Empowering human research ethics committees to review genomics applications: evaluating the utility of a custom online education resource Open
View article: Exploratory interviews with Australian clinical research staff on how they communicate with participants
Exploratory interviews with Australian clinical research staff on how they communicate with participants Open
View article: Ethical Issues Faced by Data Monitoring Committees: Results from an Exploratory Qualitative Study
Ethical Issues Faced by Data Monitoring Committees: Results from an Exploratory Qualitative Study Open
To protect research participants and ensure scientific integrity in clinical trials, independent data monitoring committees (DMCs, also known as data and safety monitoring boards) increasingly oversee randomized clinical trials and recomme…
View article: Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials: a qualitative descriptive study
Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials: a qualitative descriptive study Open
Introduction A data monitoring committee (DMC) is an independent group of experts who assess the ongoing scientific and ethical integrity of a study through periodic analyses of study data. The objective of this study was to explore the ex…
View article: Australian Attitudes Towards Waivers of Consent Within the Context of Genomic Data Sharing
Australian Attitudes Towards Waivers of Consent Within the Context of Genomic Data Sharing Open
This research identifies the circumstances in which Human Research Ethics Committees (HRECs) are trusted by Australians to approve the use of genomic data – without express consent – and considers the impact of genomic data sharing setting…
View article: Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?
Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here? Open
Implementation of decentralized approaches can improve access to clinical trials. The Australian government has focused on a teletrial model, which resources and upskills health care organisations to enable collaboration in trials to exten…
View article: Better Mechanisms Are Needed to Oversee HREC Reviews
Better Mechanisms Are Needed to Oversee HREC Reviews Open
Hawe et al. raise concerns about Human Research Ethics Committees (HRECs) taking a risk-averse and litigation-sensitive approach to ethical review of research proposals. HRECs are tasked with reviewing proposals for compliance with the Nat…
View article: Integrating Public Participation, Transparency and Accountability Into Governance of Marketing Authorisation for Genome Editing Products
Integrating Public Participation, Transparency and Accountability Into Governance of Marketing Authorisation for Genome Editing Products Open
Public participation, transparency and accountability are three of the pillars of good governance. These pillars become particularly important for innovative, personalised health technologies, because of the tendency of these technologies …
View article: Australian human research ethics committee members’ confidence in reviewing genomic research applications
Australian human research ethics committee members’ confidence in reviewing genomic research applications Open
View article: The Essential Role of Data and Safety Monitoring Boards (DSMBs) in Ensuring the Ethics of Global Vaccine Trials to Address Coronavirus Disease 2019 (COVID-19O)
The Essential Role of Data and Safety Monitoring Boards (DSMBs) in Ensuring the Ethics of Global Vaccine Trials to Address Coronavirus Disease 2019 (COVID-19O) Open
Coronavirus disease 2019 (COVID-19) vaccines are being developed and implemented with unprecedented speed. Accordingly, trials considered ethical at their inception may quickly become concerning. We provide recommendations for Data and Saf…
View article: Toward better governance of human genomic data
Toward better governance of human genomic data Open
View article: A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing
A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing Open
Sharing of genomic and associated data is essential to clinical practice and biomedical research, and is increasingly encouraged by journals and funding bodies. Grappling with the range of legal and ethical issues raised by genomic data sh…
View article: Clinical and radiological follow-up after free vascularised fibula transplantation for bone defects of the upper extremity with MRI and MR-angiography
Clinical and radiological follow-up after free vascularised fibula transplantation for bone defects of the upper extremity with MRI and MR-angiography Open
Background Vascular patency of free vascularised fibula grafts can be postoperatively assessed by island flap which is not always possible or angiography which is invasive. Bone healing is examined based on radiographs with scoring systems…
View article: Driving innovation through collaboration: development of clinical annotation datasets for brain cancer biobanking
Driving innovation through collaboration: development of clinical annotation datasets for brain cancer biobanking Open
Background A key component of cancer research is the availability of clinical samples with appropriately annotated clinical data. Biobanks facilitate research by collecting/storing various types of clinical samples for research. Brain Canc…
View article: Assessing the legal duty to use or disclose interim data for ongoing clinical trials
Assessing the legal duty to use or disclose interim data for ongoing clinical trials Open
Randomized controlled clinical trials, leading to large-scale meta-analyses, are considered the gold standard for research evaluating new drugs and other therapeutic interventions. To promote scientific integrity and prevent the adoption o…
View article: Consent insufficient for data release
Consent insufficient for data release Open
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View article: Correction to: Australia: regulating genomic data sharing to promote public trust
Correction to: Australia: regulating genomic data sharing to promote public trust Open
View article: Australia: regulating genomic data sharing to promote public trust
Australia: regulating genomic data sharing to promote public trust Open
View article: Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic.
Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic. Open
View article: Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic
Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic Open
View article: Broad Consent for Research With Biological Samples: Workshop Conclusions
Broad Consent for Research With Biological Samples: Workshop Conclusions Open
Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding withou…
View article: Regulatory Challenges of Synthetic Biology Trials and Other Highly Innovative Investigational Products
Regulatory Challenges of Synthetic Biology Trials and Other Highly Innovative Investigational Products Open
While synthetic biology remains in the early stages of innovation, achieving its posited goal of improving human health will depend on future clinical trials. This article raises questions about Australia’s capacity to ensure that clinical…