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Human Research Ethics Committee

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Title: Human Research Ethics Committee Author: august marchesi Last modified by: august marchesi Created Date: 7/31/2014 12:48:23 AM Document presentation format – PowerPoint PPT presentation

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Title: 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
    58risks to participants 46privacy
    problems 19waiver 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 (N22) 50
  • social research projects (N38) 34
  • research design in social research
  • projects (N38)
    30
  • overall rate (N110)
    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
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