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Pastor-Sanz, Laura; Fogelholm, Michael; Feskens, Edith; Westerterp-Plantenga, Margriet; Schlicht, Wolfgang; Brand-Miller, Jennie; Raben, Anne – Journal of Research Administration, 2021
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…
Descriptors: Research Administration, Medical Research, Institutional Cooperation, Administrative Organization
Emma Law; Isabel Smith – Research Ethics, 2024
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…
Descriptors: Ethics, Research Methodology, Integrity, COVID-19
Yamanaka, Mayumi; Suzuki, Mika; Sato, Keiko – Research Ethics, 2021
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…
Descriptors: Patients, Researchers, Medical Research, Information Utilization
Nicholls, Stuart G. – Research Ethics, 2017
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…
Descriptors: Ethics, Research Methodology, Medical Research, Health Sciences
Whitney, Simon N. – Research Ethics, 2016
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…
Descriptors: Risk Management, Advisory Committees, Research Administration, Governance
Clyde-Smith, Jodi – Journal of Higher Education Policy and Management, 2014
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…
Descriptors: Risk Management, Research and Development Centers, Governance, Medical Research