Research governance authorisation: the next frontier
Samantha Hollingworth
A , Dan Mckavanagh B , Ian McPherson B , Euan Walpole B and Su-Yeon Yu C D
A School of Pharmacy, University of Queensland, 20 Cornwall Street, Woolloongabba, Qld 4102, Australia. Email: s.hollingworth@uq.edu.au
B Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Qld 4102, Australia. Email: Daniel.Mckavanagh@health.qld.gov.au; Ian.McPherson@health.qld.gov.au; euan.walpole@health.qld.gov.au
C National Evidence-based Healthcare Collaborating Agency, 173 Toegye-ro, Jung-gu, Seoul 04554, Korea.
D Corresponding author. Email: suyeon.yu@neca.re.kr
Australian Health Review 45(3) 389-392 https://doi.org/10.1071/AH20129
Submitted: 11 June 2020 Accepted: 27 October 2020 Published: 28 January 2021
Abstract
Objective There is much interest in examining the use of medicines and their real-world benefits and harms using routinely collected data sources such as patients’ electronic medical records in hospitals in order to optimise use and health outcomes. This study aimed to describe the process and challenges involved in obtaining ethical approval and research governance authorisation for a research project that started on 7 December 2018 in Queensland and make recommendations for improving the process.
Methods There were three aspects: (a) ethics approval; (b) governance – site-specific assessment (SSA); and (c) governance – Public Health Act (PHA) Application Assessment.
Results The process to satisfy all requirements took more than 1 year (371 days); ethics took 16 days and PHA approval 16 days. The major hurdle was the SSA, which took 98–274 days across five sites. The main issues were opaqueness in processes and inconsistences in approach leading to considerable frustration.
Discussion It is recommendeded that Research Governance Offices should be clear on the process and requirements. All Local Hospital Networks (LHN, Hospital and Health Services in Queensland) should develop and adopt a standardised low and negligible risk SSA approval process. Frustration of government officials and researchers led the National Health and Medical Research Council to streamline ethics approval processes, but the same cannot be said for the governance process. It is appreciated that LHN processes were developed for good and valid reasons, but the onerous and inconsistent application of these processes hinder timely and relevant research. It is time for action: follow the success of the ethics process to redesign governance.
What is known about the topic? Researchers are interested in examining the use of medicines and their real-world benefits and harms using routinely collected data sources such as patients’ electronic medical records in hospitals in order to optimise use and health outcomes. There are challenges in obtaining ethical approval and research governance authorisation for research projects.
What does this paper add? We identified that the main hurdle was obtaining site-specific agreements across numerous hospital sites.
What are the implications for practitioners? We recommend that Research Governance Offices should be clear on the process and requirements. All Local Hospital Networks (LHN, Hospital and Health Services in Queensland) should develop and adopt a standardised low and negligible risk SSA approval process. The ethics approval process has been streamlined in recent years so we need to follow this success to redesign governance.
Keywords: Big data, cancer, digital, routinely collected data, pharmacy.
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