This article is part of the Iris Ethics Knowledge Base; you can find a directory of all articles here.
Overview
Provide the documents your project will actually use, not paperwork manufactured for the application. If you have written a high-quality evaluation or research plan, most of what is needed already exists; point the Panel to it rather than copying content into a separate document. Where the application is silent on a requirement of the National Statement, the only finding available to reviewers is that there is insufficient information, and that triggers a formal request for more information, which pauses the review.
What most applications need
- A protocol or project plan, setting out the objectives, rationale and methodology, together with a data management plan describing how information will be generated, stored, used, disclosed, retained and disposed of, in line with paragraph 3.1.44 of the National Statement. See Data management for more detail and a template.
- Information on the skills and experience of the people delivering the project (short CVs or biographies are sufficient), enough to show the team as a whole can carry out the work safely and competently.
- Participant information sheets and consent forms, aligned with the consent requirements in Chapter 2.2 of the National Statement: participation must be voluntary and based on sufficient information and adequate understanding. See Information required for what a compliant participant information sheet contains.
- Project-specific recruitment materials (posters, flyers, social media posts, recruitment emails), where relevant to your methods.
- Data collection instruments: surveys, interview guides, focus group schedules, observation protocols, wherever they are not already contained in the project plan.
- Consultation and data analysis plans, where the project involves stakeholder consultation or the analysis approach carries ethical implications.
- Risk management protocols, addressing the risks of harm, discomfort, burden and inconvenience participants may face and how each is mitigated. See Risk assessment checklist.
- Distress protocols, where the subject matter could reasonably surface a strong emotional response.
Not every item applies to every project, and several often sit inside a single document; do not split content out of your project plan solely to create separate uploads.
When a document truly does not exist yet
Co-designed projects, developmental evaluation, participatory action research and other adaptive designs legitimately develop some instruments and materials after the project begins. This does not mean the application itself can be left incomplete. At the point of application the Panel must still be able to assess:
- the methodology, including how the co-design or iterative development process will run and what governs it;
- the ethics of that development process, including whether contributors to it (for example, reference group members) will become participants in their own right because their input will be recorded, analysed or reported;
- the risk envelope: who is involved, what topics arise, and how foreseeable risks will be managed; and
- the fixed infrastructure: the data management plan, the team's capability, and the consent approach.
Where a document cannot yet exist, describe the gap rather than leaving it silent: state what is missing, why it cannot exist yet, how it will be developed and by whom, and when it will be ready, with confirmation that it will come back for review before use. Any instrument or participant-facing document developed after approval must be reviewed and approved before it is used; continued ethics approval is conditional on submitting amendments for approval (NS 5.4.10). Where the staged development is clearly set out in the application, Iris Ethics can typically grant approval conditional on later review of the outstanding materials, administered as a minor amendment (Amendments) at no extra cost, provided the later materials stay within the approved scope and risk profile.
Related resources
This page was last updated on 16 September 2026.
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This article makes reference to the National Statement on Ethical Conduct in Human Research 2025. It is intended as practical guidance and does not constitute legal advice.
AI Disclosure: Resources in this library were prepared using Large Language Models with input from Iris Ethics staff who guided the scope and design. Subsequent revisions and final versions were developed and approved by Iris Ethics staff.