Human Research Ethics Committee

1. Human Research Ethics Committee HREC DECISIONS IN 2013 Louise Morauta August Marchesi 12 August 2014 CHARM

2. Human Research Ethics Committee Two decision-making bodies HREC • 16 members • considered 110 proposals in 2013 LRSC • 2 members (one rotating) in 2013 (now 3 permanent members) • considered 185 proposals in 2013

3. Human Research Ethics Committee Three decisions available to HREC and LRSC1. Approve proposal as is at meeting2. Chair to approve out-of-session after minor amendments specified by committee 3. Resubmission required – has to come back to committee

4. Human Research Ethics Committee Decisions in 2013 Decision HREC LRSC Approved 27% 54% OOS approval 46% 41% Resubmission 24% 3% N= 110 185

5. Human Research Ethics Committee HREC approval rates • 92% approved within 2013 • 95% approved by 30 July 2014 NHMRC national figures (25,000 submissions pa) • 2010 94% approved within year • 2011 93% approved within year • 2012 94% approved within year

6. Human Research Ethics Committee Measuring how long it takes to approval • Counted in calendar days • From closing date for submissions to the meeting at which first consideration occurs • To date on which approval letter is signed • Same method for HREC and LRSC • HREC meets monthly, LRSC usually every 2 weeks

7. Human Research Ethics Committee Calendar days to approval LRSC: • 50% in 7 days • 80% in 15 days HREC: • 50% in 51 days • 80% in 96 days

8. Human Research Ethics Committee HREC by type of decision Approved at meeting: 80% in 28 days Approved OOS: 80% in 87 days Resubmission required: 80% in 151 days

9. Human Research Ethics Committee Time with researcher vs time with ethics Mean times in calendar days Approved at meeting: 28 days ethics Approved OOS: 36 days ethics + 37 days researcher Resubmission required: 44 days ethics + 65 days researcher

10. Human Research Ethics Committee HREC OOS times • Designed to speed process up • Letters usually go out within 3 days of HREC meeting • An average of 37 days turn around from researchers back to HREC • Fastest OOS approval times are under 40 days • But only 50% in 63 days and 80% in 87 days

11. Human Research Ethics Committee Most common problems in 26 HREC resubmissionsresearch design 58%risks to participants 46%privacy problems 19%waiver of consent 15%

12. Human Research Ethics Committee Mapping to 4 National Statement criteria1. research merit and integrity - research design 2. beneficence - risks versus benefits from research 3. justice 4. respect – privacy, waiver of consent

13. Human Research Ethics Committee HREC resubmission hot spots • investigator led projects (N=22) 50% • social research projects (N=38) 34% • research design in social research projects (N=38) 30% • overall rate (N=110) 24%

14. Human Research Ethics Committee Problems in HREC OOS approvals • main problems are in Patient Information and Consent Forms (PICFs) • PICFs do not cause resubmissions on their own • common pattern of problems

15. Human Research Ethics Committee Can we do better than this? • 24% proposals to HREC required resubmission • 50% investigator led proposals required resubmission • 85% social research resubmissions had research design problems • average 73 days to approval for HREC OOS approvals