Research governance review of a negligible-risk research project: Too much of a good thing?

Abstract

There are increasing concerns that research regulatory requirements exceed those required to manage risks, particularly for low-and negligible-risk research projects. In particular, inconsistent documentation requirements across research sites can delay the conduct of multi-site projects.

Australia: regulating genomic data sharing to promote public trust

“…The time taken to complete all submissions, including revisions and further communication, amounted to 74.5 working days, with an estimated overall cost of $60,471 (Johns et al 2017 ). Other studies report similar experiences (De Smit et al 2016 ; White et al 2016 ; Rush et al 2017 ).…”

“…Under the NSW process, a single-certified HREC provides ethics approval for all designated sites. A separate governance review—incorporating, for example, consideration of the available budget and insurance and indemnity arrangements—is required to be conducted by each institution before a research project can commence at the site (Rush et al 2017 ). In 2010, Queensland began to implement a process for single ethical review, with other states following in 2013 (Western Australia and South Australia) and 2015 (Victoria) (White et al 2016 ).…”

Why did we fail? Challenges recruiting parents with cancer into a psycho‐educational support program

“…While project planning had allowed for some time contingencies, the extent of these delays was unforeseen. Our experience draws attention to the impact of unwieldy governance requirements on research, particularly longitudinal studies with time‐limited funding …”

“No Country Bureaucratised its way to Excellence”: A Content Analysis of Comments on a Petition to Streamline Australian Research Ethics and Governance Processes

“…Barnett et al, 2016; Duplancic et al, 2019; Foot et al, 2018), “onerous and time-consuming” (Clay-Williams et al, 2018), and even “unethical” (McGiffin et al, 2019). Key problems identified include: duplication of effort (Rush et al, 2018), with the same ethical questions being considered by multiple groups (Barnett et al, 2016); inconsistencies between jurisdictions (Duszynski et al, 2019); delays in conducting research due to slow or overly bureaucratic approval processes (Guillemin et al, 2012; Rush et al, 2018; Scott et al, 2021); and overreach, as low or negligible risk research applications can experience a disproportionate level of scrutiny (Rush et al, 2018; Scott et al, 2020).…”