Revised amendment process

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Animal ethics process
improvements
Dr Paul Taylor, Director, OREI
[email protected], 42047
Overview
• A note on metrics
• New application form and revised governance
• New amendments process
• Other changes
•
Shepherds
•
Conditions
•
Standards
•
Committees
Metrics
BIP Metrics were wrong
• “2% first pass approval rate for ethics processes”
• “marquis” metric
• Took the number of outright approvals assessed in 2013 and divided
by total number of applications and amendments assessed
• Did not consider ‘approved – contingent’ as approval even though
work can begin
Revised metrics for new applications
• First pass approval rates = number of applications authorised to
commence / number of new applications
35% for 2013 across all AECs
Revised metrics for amendments
• First pass approval rates (amendments) = number of amendments
authorised to commence / number of amendments
63% in 2013 across all AECs
Comparisons
• In 2014, USyd reported 59% first pass approval* rate for animal
ethics applications
• There is (always) room for improvement
• What can we learn from them?
* Calculated as authorised to commence work
Reminder of BIP
recommendations
Summary of BIP recommendations
• Revised application form
• Reduced governance (sign-off)
• Poor systems infrastructure
• Committee membership
New application form and
governance
Governance
Now
From June 18
•Sign-off in Themis from all named
•Sign-off only required by PI
investigators required prior to
•Other named investigators notified at
submission
submission and approval providing
•“Work-arounds” – either OREI
opportunity to confirm their
approves or waits until all signed off
involvement with PI
before issuing approval
•Allows identification of applications
•Takes 14 days on average
that you are named in
✔
Current application form
• Clunky, repetitive, difficult to navigate, repetitive
• Difficult to share/collaborate
• 36 questions over 18 screens
• Sequence of questions in Themis does not map to sequence in
output…difficult to construct argument
• In 2013 for Biochem AEC, 29% of applications were returned
because of problems with Project Description
Principles of the new form
• Ask for information once
• Ask only relevant questions
• Enable sharing and ease of use (sticking in pictures, flow charts,
timelines)
• Compliant with Code requirements and principles
• Allow an argument to be constructed… “this research needs to done
because it matters, the benefits are potentially good. The impacts on
the animals have been minimised. The benefits of the research
outweigh the risks or impacts on the animals”
New application process/form
• 6 screens in Themis plus 20 questions in a Word document
• Much easier to share/collaborate
• Much easier to add images and figures
• Simplified questions in a logical order
• Asks for information only once
• Feedback from consultation was generally very positive
• One form for all application types
• Allows a ‘story’ to be told
✔
1. Application details
2. Animals requested
3. Personnel
4. Attachments
5. Lodgement
6. Confirmation
Quick tour of the new form…
New application process from June 18
• Final version of the application form will be made available soon
• Also providing guidance on how to complete it
• Also providing a range of templates covering different sorts of
research
• No more paper copies to deliver!
New amendment process
Revised amendment process
• Simplified form needs a simplified amendment process
• One pager that allows for speedy processing of new investigators,
some increases in animal numbers, extensions of time etc
• Clarify what can be an amendment and what needs to be a new
application
• Details coming soon…
Other process improvements
Shepherds
• Improving interaction between researchers and committee members
• Shepherds allocated for each application
• Encouraged to contact to researcher to clarify technical questions or
inconsistencies in the application
• Allows for these to be reported back at the meeting rather than as
matters to follow up afterwards
✔
Conditions
• We can make better use of conditions of approval
• So, instead of asking for clarification or additional information and
where there is a reason, an application could approved with specific
conditions.
• Application mentions use of both 21 and 17 gauge needles. AEC’s
view is that 21 is acceptable but 17 is not. Approval provided on the
condition that only 21 gauge needles are used. No further interaction
required…
✔
Standards
• Guidelines for best practice in common techniques (e.g.
anaesthesia, micro pumps)
• Developed with input from researchers; lots of consultation
• Mandatory requirements plus areas where there is flexibility will be
highlighted
• Staged introduction
• Useful for both researchers and AEC members in understanding
expectations and procedures used
✔
Committee membership
• Statutory requirement for only 4 members; some AECs had up to 15
members
• Adding to complexity of review?
• Now, 3 out of 4 AECs have 8 members (4th to follow soon)
• Calling for expressions of interest for new members in all categories
soon
✔
Overview
BIP Recommendation Status
Delivery date
Revised application
form
Complete
June 18
Reduced governance
(sign-off)
Complete
June 18
Poor systems
infrastructure
Underway
Committee
membership
Underway
For 2016
Other (non-BIP)
activities
Underway
From August
meetings
Comments
✔
✔
IT project to
identify suitable
alternative
Recruitment drive
to commence
soon. Numbers
already reduced
We’ve listened, we’re listening and we’re doing
• June 18 is a big day!
• 20 questions and 6 screens cf 36 questions over 18 screens
• Expect that these changes will result in faster ethics approvals
• Broader system changes (or a new system) would allow for further
increases in efficiency (for example, in comms between AEC
members and researchers, immediate feedback)
• Application quality is a key factor in determining outcome
• Comments and suggestions always welcome to [email protected] or [email protected]
Acknowledgements
• Dr Daniel Barr, Sebastian Gimenez, Tim Anning, Faye Bulled, Lei
Shong Lau
• Strategy&
• Research Chancellery
• AECs and AWEC
• Academic contributors to workshops and all who provided comment
on consultation documents
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