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. For a one-year, negligible-risk project examining biobank operations conducted at three separate Australian institutions, we found that the researcher time required to meet regulatory requirements was eight times greater than that required for the approved research activity. In total, 76 business days were required to obtain the necessary approvals, and site-specific processes required twice as long as primary Human Research Ethics Committee and Research Governance Office processes. We describe the impact of this administrative load on the conduct of a one-year, externally-...