Potential solutions to improve the governance of multicentre health services research

To the Editor:

As Clay-Williams and colleagues,1 we have also experienced frustration at the time-consuming, expensive2 and protracted processes required as a prerequisite before undertaking research involving identified patient data across Australia. Ironically, in the case of clinical quality registries, we collect data designed to measure quality of care so that patients may benefit from improved clinical processes. Yet, the system conspires to delay and undermine these efforts.

There are lessons we have learned in developing clinical quality registries that deal with some governance issues identified by Clay-Williams and colleagues. They describe developing a legal agreement, which 21% of hospitals refused to accept. The Southern Eastern Border States (SEBS) Committee was developed with representatives of health departments from Victoria, New South Wales, Queensland and South Australia to streamline and prevent duplication of legal agreements.3 We worked with a SEBS Committee representative to develop special clauses and conditions to include in the Medicines Australia Clinical Trials Research Agreement schedule, subsequently endorsed by the SEBS Committee. Participating sites, both public and private, recognise and routinely accept this agreement. This same committee, or one with a similar construct, could determine nationally whether research is low risk to address the confused and contradictory advice given by ethics committees.

We agree that standardisation of forms and processes is required — participating sites should not be permitted to introduce their own forms, causing confusion to researchers and introducing additional delays. A national information portal and repository for protocol amendments which governance officers can access to review or approve changes would be welcomed. However, while Clay-Williams and colleagues recommend that there should be no requirement for principal investigators to be employees of the participating site, we believe that for clinical quality registries, having a local principal investigator provides a vital link between researchers and local staff.

As previously suggested,4 limits should apply on an acceptable time period to provide a definitive determination on study conduct within an institution, as occurs in Europe with clinical trials.5 It is unacceptable that this process lasts more than 60 days. As researchers usually have no capacity to have an impact on institutional authorisation processes, greater accountability should vest with governance offices. The current costly and dysfunctional system is stifling research in Australia.