The high costs of getting ethical and site-specific approvals for multi-centre research
نویسندگان
چکیده
Background Multi-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals. Methods We collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget. Results The total costs of gaining approval were 38 % of the budget for a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety. Conclusions Improvements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked.
منابع مشابه
Developing effective and efficient study specific training to enable rapid study start up
Study specific training is an essential but often understated component of the study set up process for individual site personnel. One of the many challenges for the trial manager is to ensure study staff are appropriately trained without compromising rapid study start-up, quality of training, ethical compliance, GCP, running costs. A variety of training methods exist with different studies emp...
متن کاملAerodynamic design and economical evaluation of site specific horizontal axis wind turbine (HAWT)
This paper presents the aerodynamic design and economical evaluation of a 200 kW site specific wind turbine for the province of Semnan in Iran. By designing site specific wind turbines, the cost of energy which is calculated out of the annual energy production and also the cost of manufacturing the rotor are minimized. The aerodynamic design is based on the well-known blade element momentum...
متن کاملThe challenge of getting a high quality of RNA from oocyte for gene expression study
The extraction of intact RNA from oocyte is quite challenging and time-consuming. A standard protocol using commercial RNA extraction kit, yields a low quantity of RNA in oocytes. In the past, several attempts in getting RNA for gene expression study ended up with a few different modified methods. Extraction of high-quality RNA from oocyte is important before further downstream analyses such as...
متن کاملFuturology of Multi-Criteria Decision Making Techniques Using Philosophical Assumptions of Paradigms in Scenario Writing
There are many opportunities and threats in the decision-making environment for managers, and an organization must use research and information systems to change, monitor, and anticipate this environment. Futurism reflects how tomorrow reality gives birth to tomorrow's reality is. The purpose of this research; Analyzing the role of futures studies in the existing patterns of critical factors of...
متن کاملContent analysis of university board of trustees' approvals, with emphasis on the financial implications of approvals and scope; Case study of selected second level universities
The present study was conducted to investigate the structure and composition of the Board of Trustees and to evaluate the performance of the boards of trustees of second level universities in Iran. This research was conducted in the form of content analysis, quality of approvals and the pattern governing the decision-making process with emphasis on the financial effects of approvals and the sco...
متن کامل