This paper describes a scoping review of China's academic resource databases, relevant official websites, news reports and public accounts spanning a period from the end of 2019 to the end of 2022, to investigate the challenges in scientific integrity and ethical soundness of research conducted during and immediately after the COVID-19 pandemic in…

A multi-centre clinical trial involves the implementation of the same clinical protocol at several independent investigational centres. Multi-centre clinical trials may be preferable to single-centre trials, but their implementation and management is more complex. EU-funded collaborative projects involve several participating organizations and…

During the COVID-19 pandemic, the race to find an effective vaccine or treatment saw an 'extraordinary number' of clinical trials being conducted. While there were some key success stories, not all trials produced results that informed patient care. There was a significant amount of waste in clinical research during the pandemic which is said to…

Global health emergencies often lead to a proliferation of health-related research and resultant data, which is shared across borders to help control the outbreak of disease and support decision-making regarding public health interventions. However, efforts to share data can be hindered by diverse international ethical and legal frameworks. The…

The Confidentiality Advisory Group (CAG) is a specialised body that advises the Health Research Authority (HRA) and the Secretary of State for Health on requests for access to confidential information, in the absence of informed consent from its owners. Its primary role is to oversee the safe use of such information and to counsel the governing…

Very few attempts have been made to survey patient opinions, particularly regarding the use of residual biospecimens and health information in research, to clarify their values. We conducted a questionnaire survey that targeted outpatients of a university hospital to gauge their awareness levels and understand patient perspectives on research that…

Proposed changes to the Common Rule are proffered to save almost 7,000 reviews annually and consequently vast amounts of investigator and IRB-member time. However, the proposed changes have been subject to criticism. While some have lauded the changes as being imperfect, but nevertheless as improvements, others have contended that 'neither the…

Background: This article charts the relationships between the model of evidence-based practice (EBP), healthcare markets where providers are increasingly competing through the adoption of EBP-certified interventions, and the cultivation of experiential knowledge within self-help and mutual aid groups (MAGs). After 35 years of neoliberal reform,…

Institutional Review Boards (IRBs) and their federal overseers protect human subjects, but this vital work is often dysfunctional despite their conscientious efforts. A cardinal, but unrecognized, explanation is that IRBs are performing a specific function -- the management of risk -- using a flawed theoretical and practical approach. At the time…

Enterprise risk management strategies were used to develop a regulatory and operational framework for a new multi-partner Research Institute that will house up to 900 staff from four different institutions in Queensland, Australia. The Institute will operate in a business environment while functioning as a research resource for the higher…

Challenges that face the academic research enterprise are numerous. These concerns include, but are not limited to: declines in extramural funding for investigatorinitiated research, an aging faculty workforce (the average age of securing a faculty's first R01 is over 42), insufficient funds to support faculty laboratories, and limited access to…

Institutions of higher education that use animals in laboratory research have become targets of intense scrutiny regarding the treatment of those animals, the value of research, and the amount of federal funds they receive. The largest and most active animal-rights organization is People for the Ethical Treatment of Animals. (MLW)

When federal regulations governing human subjects research were modified, the State University of New York at Albany chose the consensual approach to revise its institutional policy. The process is described and its advantages and disadvantages are identified. (Author/MLW)