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Ethics & Governance Metrics

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Research ethics and governance metrics

Improving research ethics and governance approval timelines, particularly for clinical trials, is a key priority for NSW.

The Office for Health and Medical Research collects data from NSW local health districts, specialty health networks and NSW Ambulance to generate ethics and governance metrics for health and medical research, including clinical trials.

Why we collect ethics and governance metrics

The ethics and governance metrics collected by the Office for Health and Medical Research provide quantitative evidence and enable an accurate portrayal of approval timelines for health and medical research projects in NSW.

Work is currently being undertaken to collect quarterly data for start-up times and report on all the performance of all Research Offices. Analysis of these dataset will identify start-up time improvement opportunities across the state.

This Metrics Manual document outlines Key Performance Indicator (KPI) thresholds and illustrations of measurement calculations.

METRICS Manual 

Metrics Activity Reports

Financial Year 2021/22:

Q3 2021
Q4 2021
Q1 2022
Q2 2022

 

Frequently Asked Questions

The information below should assist to understand the metrics we are collecting, and how to improve start-up timelines.

What does it mean for Metric 3 (Ethics) to start its count from the first full HREC Meeting submission deadline?

For any application submitted for Human Research Ethics Committee (HREC) review, the research officers will assign the application to a full HREC Meeting, if they assess it to be eligible and necessary to be tabled at a HREC meeting.

The submission closing date or submission deadline for the first full HREC meeting the application is assigned to will be the Metric 3 start date.

When will Metric 4 (Governance) start its count if I submit the site application a week after receiving Ethics approval?

In the circumstance where site applications are submitted after ethics approval is granted, Metric 4 (Governance) will start counting when the site application is submitted. Please make sure to fill in the relevant fields in the site application and project registration forms in the research ethics and governance information system, confirming ethics approval has already been granted.

We have submitted a site application along with the ethics application in the research ethics and governance information system, or REGIS  but haven’t received ethics approval. When will the Metric 4 (Governance) start its count?

The site application can be submitted at the same time as the ethics application. Once submitted the site application will go to the relevant heads of departments of a NSW Health Organisation for approval before it goes to the research governance office (RGO).

The Governance Metric 4 will start counting when the relevant ethics approval is granted in REGIS.

When will Metric 4 (Governance) start to count if my ethics application is obtained from a National Mutual Acceptance (NMA) HREC in another jurisdiction?

The site application can be submitted at any stage after the ethics application has been submitted to the NMA HREC. As soon as you receive the Ethics approval letter it should be uploaded as this will ensure the RGOs understand your research documents are finalised from the ethics review and trigger the count for site application review days, which is part of the Key Performance Indicator for the research governance process.

What can researchers do to help accelerate the ethics and site review?

The Research Office websites have information specific to the HREC and sites – please refer to the specific website for the Research Office you are dealing with. In general, research officers recommend you to plan ahead and proactively communicate.

It’s always a good idea to talk to the HREC Executive Officer/ Site Research Officer before making the submissions. They can flag any common pitfalls for you to avoid.

If you are unsure about the questions Research Officers are asking you, or would like to understand why your application is not progressing, call or contact the Research Offices or HREC executive officers for more information.

Research Ethics and Governance during Covid-19 Pandemic

NSW’s overall performance

Table 1. Performance of NSW HREC and Sites in COVID-19 research start-up times across all risk categories

  • Ethics applications are approved < 2 weeks
  • Site applications are approved < 1 week
  • Average study start-up time is < 6 weeks (end-to-end)

Figure 1. (A) Heatmap illustrating the distribution of approved COVID-19 research across NSW local health districts. (B) Breakdown of COVID-19 applications by research category. (C) Schematic representation of the breakdown of approved COVID-19 research by ethics review pathway and corresponding ethics review times (clock-on).

Figure 2. (A) The distribution of approved COVID-19 research sites across NSW LHDs. (B) Breakdown of COVID-19 site applications by research category. (C) Schematic representation of the breakdown of approved COVID-19 site-specific application (SSA) by ethics review pathway and corresponding SSA review times (clock-on).

Updated 1 month ago