The high costs of getting ethical and site-specific approvals for multi-centre research

Abstract

BackgroundMulti-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.MethodsWe collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.ResultsThe 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.ConclusionsImprovements 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.

Multi‐centre ethics and research governance review can impede non‐interventional clinical research

“…Greater consistency and reduced duplication of the necessary documentation, both across and within state jurisdictions, are warranted. Obtaining duplicative signatures, reformatting of documents to various different site requirements and repetitive uploading are neither time nor cost‐effective . Clay‐Williams et al .…”

“…Research ethics and governance processes are core to ensuring that research is ethical, feasible and meets all relevant regulatory and legislative requirements. In the context of multi‐centre research, complicated approval processes have led to increased costs and time restraints for researchers . During the past decade, the process for gaining multi‐centre ethics approval in Australia has been overhauled to improve efficiency, minimise duplication and reduce approval times and costs.…”

“…In the context of multi-centre research, complicated approval processes have led to increased costs and time restraints for researchers. [1][2][3][4][5][6][7][8][9][10][11][12] During the past decade, the process for gaining multi-centre ethics approval in Australia has been overhauled to improve efficiency, minimise duplication and reduce approval times and costs. In 2007, the Harmonisation of Multi-Centre Ethical Review (HoMER) project was introduced, 13 whereby a multi-centre study could undergo a single ethical review by a certified lead Human Research Ethics Committee (HREC), which would then be accepted by other HREC within the same jurisdiction.…”

Have centralised ethics and governance applications improved the time‐variable, and approval process to conduct research in Victorian hospitals?

“…We recently completed a medical records review of oesophageal cancer treatment in 18 Victorian hospitals (5 private), and experienced considerable delays in SSA approval (median 61.5 working days; range 26–98), and time to commence data collection after SSA approval (median 18 working days; range 12–56). Similar to previous experiences, we found an inflexible approach regarding governance requirements, which appear ideally suited to clinical trials, but not low‐risk research projects, a barrier to conducting timely multi‐site research projects.…”

Ethics and governance is becoming unethical: time for some common sense?

“…The process becomes so cumbersome when it involved multiple institutions. The delays and costs associated with ethics and site‐specific approval for multi‐centre research has been pointed out by a number of authors . The reason for bringing this particular event to attention is that it is a particularly egregious example of the onerous requirements for multi‐centre research for a request that could not possibly be more low risk.…”