The National Statement on Ethical Conduct in Human Research requires that all projects approved through a Full HREC or a Lower Risk Review pathway report back to the HREC on a regular basis and at the end of the project. However, we recognise that additional reporting can be a burden, and that the main function of these reports as a way to maintain contact with you throughout your project is the more important thing. At Iris Ethics, we want to be seen as your trusted advisors in ethical practice, so our reporting process is designed to be an easy way to check in with us, and to be a touch point for engagement over the lifetime of your project.
Why annual and final reports are needed
The National Statement sets out at subsection 5.4.8 requirements for ethics review bodies to require reporting at least on an annual basis and at the end of every project reviewed:
At regular periods – reflecting the degree of risk, and at least annually and at the completion of the project – researchers should provide reports to the relevant ethics review body(ies) and institution(s), including information on:
(a) progress to date, or outcome in the case of completed research
(b) the security of project-related data and information
(c) compliance with the approved proposal
(d) compliance with any conditions of approval.
As well as being a compliance obligation, the requirement for annual and final reviews provide a point of ongoing contact between our HREC and your team. It's an opportunity for you to reflect on project progress, identify where delivery has potentially diverged from original plans, and identify if there's a need to make amendments to the original ethics clearance.
For our HREC, the reporting process ensures that any issues are reported to us, and that we have a chance to ensure that divergence from plans or new ethical issues are identified and addressed. We also are interested in seeing your projects succeed, and reporting allows you to tell your story of how things have happened.
How to submit reports
We have a single form for both annual and final reports, which you can see here. Our systems are set up so that we will send a reminder to you around the time the report is due, with the link to the reporting form. While we love it when people are proactive about reporting, we also understand that this kind of task often falls off the radar in projects. Hence a gentle reminder.
The form fields
There are instructions on the form, but we’ll cover them here too. They’re pretty straightforward:
- Please complete all the sections of the form
- But if you have your own reporting form or other documents that support your report, you can send that in instead. As long as all the sections of the form are covered off, we’re happy.
First page
This is pretty self-explanatory, and covers the details of the project and the type of report. But we also know that this report can be a prompt for reflection, so we ask whether:
- The project completion date needs to be extended
- You need to make any amendments to the original approval; if you do, we get in touch with you to follow up.
Second page
This page has two parts:
- The project summary, where you can outline what has been completed since approval or the last report. If you want to attach things (like public-facing outputs, longer reports etc.) you can just refer to them here and submit your report with them attached
- The declaration and signature of the Principal Investigator
That’s it.
Submitting the form
Submitting the form is also easy – you can do it three ways:
- Completing and submitting the form online directly (best where there aren’t attachments)
- Uploading the completed form and attachments through our secure online portal for your project
- Emailing the completed form and attachments to [email protected]
Approval process and timing
We aim to review your report as a priority, usually within the next business day. You will receive confirmation that we have reviewed your report. If our secretariat team identifies issues or needs clarification, we'll reach out to you.
Remember: If urgent safety issues arise requiring immediate changes to protect participants, activities should cease pending review (consistent with National Statement paragraphs 5.4.11 and 5.4.15-5.4.17). Contact us immediately if you're in this situation.
Summary
Reporting is a vital requirement of the ethical approval process. But we know that excessive reporting can take time away from doing what’s important for your stakeholders. So we’ve developed a system that balances meeting requirements with efficiency. We hope it works for you, but if you think it can be improved further, feel free to let us know.