Update to HDEC secretariat processing times
Due to changing demand and levels of resourcing in the team, we have made some changes to standard processing times for HDEC review. Specifically, you can now expect:
General correspondence
- Queries related to information that is clearly available on the website will not be responded to. If something is unclear, this should be specifically pointed to as part of the query
- Queries and correspondences will be responded to within 5-7 working days of receipt. In the event multiple are sent regarding the same query, this date will be determined by last received
- Advisor calls for advice strictly limited to complex issues that cannot be resolved over email
- ‘Generic’ requests for review of non-study specific related documentation no longer available
Post-Approval Form (PAF)/Expedited review
- Expedited applications will be validated and assigned for review within 7-9 working days of receiving them
- PAFs are assigned for review within 2-4 working days of receiving them
- The full 15 day clock should be expected to be used by the Committee to review anything submitted in ERM.
Full review times
- Submitting a full application before an agenda deadline does not guarantee assignment on the next agenda – please allow up to an additional 2-4 weeks for your application to be scheduled. Delays beyond this timeframe will be communicated with applicants if this occurs
- A maximum of 8-10 applications will be assigned per meeting to manage workloads
- Decision letters from applications discussed at full meetings will be sent within 4 weeks of the meeting
This communication overrides/supersedes any timeframes specified in our Standard Operating Procedures. While will make best endeavours to process things faster where we can, we are advising that you will now need to build the timeframes above into your planning processes. These timelines are under the provision that what is submitted to the HDEC is sufficient for review – incomplete submissions can expect further delays.
Urgent requests
Where possible, the secretariat will be able to respond to urgent requests to speed up any of these timeframes. These have to demonstrate they meet the following criteria:
- Would significantly impact the safety or wellbeing of a participant or potential participant where there is potential therapeutic benefit to study participation
- Would result in the termination of New Zealand participating as a site and feedback into the point above