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Human Research Ethics Committee

Human Research Ethics Committee. REPORT TO RESEARCHERS FROM THE ACT HEALTH HREC Louise Morauta August Marchesi Walter Abhayaratna Frank van Haren August 2016. ACT Health HREC. Human Research Ethics Committee. Provides independent review of human research proposals Appointed by ACT Health

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Human Research Ethics Committee

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  1. Human Research Ethics Committee REPORT TO RESEARCHERS FROM THE ACT HEALTH HRECLouise MorautaAugust MarchesiWalter AbhayaratnaFrank van HarenAugust 2016

  2. ACT Health HREC Human Research Ethics Committee • Provides independent review of human research proposals • Appointed by ACT Health • Constituted according to National Statement on Ethical Conduct in Human Research • Only HREC certified by NHMRC for single review of multi-centre trials in ACT • Reports to ACT Health and NHMRC • Also accountable to researchers for our services and performance

  3. Two decision-making bodies Human Research Ethics Committee HREC • 18 members • approved 76 proposals in 2015 LRSC • 3 members • approved 138 proposals in 2015

  4. What HREC did in 2015 Human Research Ethics Committee • 87 proposals considered • 76 proposals approved within year • 5 proposals not approved • 5 proposals pending at end of year* • 94% approval rate (excluding *)

  5. What LRSC did in 2015 Human Research Ethics Committee • 173 proposals reviewed • 138 proposals approved within year • 21 proposals not approved • 5 proposals pending at end of year* • 9 referred to main committee* • 87% approval rate (excluding * above)

  6. Our performance: NHMRC requirements met Human Research Ethics Committee • At least one third of members from outside ACT Health • ACT HREC: 11 out of 18 external • Gender balance in membership • ACT HREC: 10 male, 8 female • At least 2 current researchers • ACT HREC: 8 out of 18

  7. Our performance: HREC approval rates Human Research Ethics Committee Overall HREC approval rates (94 proposals) • 94% approved within year in 2015 Latest NHMRC national figures (25,000 submissions pa) • 2013 91% approved within year • 2014 94% approved within year

  8. Our performance: time taken to approval Human Research Ethics Committee • For HREC we use the method used across other jurisdictions • We count the number of calendar days • From closing date for submissions to the meeting at which first consideration occurs • To date on which approval letter is signed by Chair • Less the number of days the proposal was back with the researcher for revisions

  9. HREC calendar days to approval in 2015 Human Research Ethics Committee • 50% in 31 days • 80% in 34 days • average 33 days • 96% within NMA benchmark of 60 days • In 2014-15 certified committees in other NMA jurisdictions averaged 82% within the 60 day benchmark for clinical trials

  10. LRSC calendar days to approval in 2015 Human Research Ethics Committee • same method as for HREC but without the deduction for time with researcher. Total time taken from meeting due date to approval • 50% in 6 days • 80% in 10 days • average 8 days • no comparable figures for other jurisdictions

  11. Researcher compliance issues Human Research Ethics Committee • In April 2015 • 7% projects had run out of ethics approval • 32% had overdue annual reports • Implications for participants, researchers and ACT Health • New overdue reminder system in April 2015 • Excellent result: overdue reports and approvals have now been eliminated

  12. Breaking news for health researchersin the ACT Human Research Ethics Committee • In December 2015 ACT Health approved exemption from duplicate local ethics approval in the ACT for projects with ethics approval from NHMRC certified HRECs in other jurisdictions • Projects still required ACT Health governance approval • 13 projects exempt in last 6 months • Only a one-way arrangement

  13. At last a level playing field! Human Research Ethics Committee • August 2016 a historic milestone for ACT researchers • ACT now a full member of the NMA scheme • Projects approved by ACT Health HREC are now exempt from ethical approval in other NMA jurisdictions such as NSW, Vic, Qld, SA • Makes cross border studies involving NSW patients and services much easier

  14. Available to all health researchers in the ACT Human Research Ethics Committee • As long as proposals are approved by the ACT Health HREC • Benefits researchers at ANU and UC as well as at ACT Health • Streamlined ethics approval arrangements already in place between ANU and UC and ACT Health HREC • Great benefit to health researchers who want to expand studies outside ACT

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