What Should I Provide as Part of My Application?

Introduction

This is one of the most common questions we are asked, and it is a fair one. Nobody wants to over-prepare and waste time on documents the committee does not need, and nobody wants to under-prepare and have their application delayed because more information is required before review can commence. This resource sets out what we typically expect to see, why we ask for it, and what to do in the situations where some of those documents genuinely cannot exist at the point of application.

It builds on our companion guide, Navigating Our Application Forms, and on the requirements of the National Statement on Ethical Conduct in Human Research 2025 (the “National Statement”).

Start from what you already have

In our guide to the application forms, we set out a core feature of our approach that distinguishes us from most HRECs. If you have written a high-quality evaluation plan or research plan, you have probably already done most of the work. Our forms are designed so that you can point us to your existing documents rather than copy information across into a form originally designed for clinical trials. The ethics of a project live in the documents you will actually use, so those documents are what our committee wants to see.

That principle shapes the list below. We are not asking you to manufacture new paperwork for the sake of it. We are asking you to provide the materials that show how the project meets the principles of the National Statement, materials most of which you will have created as part of designing the work.

What we expect to see for most applications

For the majority of applications, the following set of documents allows us to make an informed decision. Not every project will need every item, and in many cases several of these will sit inside a single document. Where a piece of information is already covered in your project plan, simply point us to it. There is no value in uploading your interview guide separately if it already sits in your methodology section.

• A protocol or project plan. This is the backbone of the application. It might be an evaluation plan or framework, or a research plan, but whatever you call it, it should set out the objectives, the rationale and the methodology. Alongside it, we expect a data management plan that describes how information will be generated, stored, used, disclosed, retained and disposed of, in line with paragraph 3.1.44 of the National Statement. We have written about this in more detail, with a downloadable template, in our resource on ethical data management in evaluation and research.
• Information on the skills and experience of the people conducting the project. This is usually a set of short CVs or biographies, but the format matters less than the substance, and we have accepted everything from formal CVs to LinkedIn profiles. We need enough information to be confident that the team as a whole, rather than any one individual, has the capability to carry out the work safely and competently. For an evaluation of a program serving people who have experienced trauma, for example, it matters that the team includes people with relevant interviewing experience.
• Participant information sheets and consent forms. These should align with the consent requirements set out in Chapter 2.2 of the National Statement: participation must be voluntary and based on sufficient information and adequate understanding. If you are not sure where to start, our participant information and consent forms page explains what a good form contains and includes a plain English template you can adapt. Remember that consent should be proportional to the risk and sensitivity of the project, so a short in-line preamble for an online market research survey can be entirely appropriate where a multi-page form would not be.
• Project-specific recruitment materials. Posters, flyers, social media posts and recruitment emails should be provided where they are relevant to your methods. Not every project will have these. A market research project drawing on an existing panel will recruit very differently from a social research project advertising through community noticeboards. We want to see what potential participants will actually encounter, because that is the information on which they will decide whether or not to take part.
• Data collection instruments. These are the tools you will use to gather information from participants: survey questionnaires, interview guides, focus group schedules, observation protocols. They let the committee see exactly what participants will be asked, which is often where ethical considerations become concrete, for example, whether a question on a sensitive topic is necessary and appropriately framed. Instruments often sit within the project plan, and where they do you can simply point us to them. Where your instruments are still to be developed such as in a co-designed project see When the documents do not exist yet below.
• Consultation plans and data analysis plans, as relevant. If your project involves stakeholder or community consultation, or if your data analysis approach carries ethical implications worth setting out, include these. Many projects fold this content into the main plan, which is fine.
• Risk management protocols. If your project plan already describes how you will identify and manage risks, you do not need a separate document. If it does not, provide one. Your risk management approach should address the ethical risks participants may face through their involvement (harm, discomfort, burden and inconvenience, as appropriate) and how the project identifies and mitigates each of them.
• Distress protocols, as relevant. Where a project touches on sensitive subject matter or has the potential to surface strong emotional responses, we expect to see how the team will respond if a participant becomes distressed. An evaluation of a family violence support program is a clear case where a distress protocol is essential. An anonymous survey on commuting habits, less so.

Why we ask for the documents, not just the form

Our reasoning here is the same one we set out in the guidance on our forms. The committee wants to review the documents you will actually be using, because that is where ethical practice is demonstrated in concrete terms. A declaration that you will protect participant privacy is reassuring. A data management plan that shows encrypted storage, restricted access and a defined retention period is evidence. Working from your existing documents also reduces duplication of effort, which saves you time and money in the application process.

There is a practical reason this matters for the speed of your review. When our reviewers assess an application, they make a finding against each relevant requirement of the National Statement. Where your application provides the evidence, they can record that the requirement is met. Where it is silent, the only finding available to them is that there is insufficient information, and that triggers a formal request for more information to be provided, which pauses your review until you respond. 

When the documents do not exist yet

There are legitimate situations where some of these documents cannot be provided at the time of application. Co-designed projects, developmental evaluation, participatory action research and other adaptive designs are the clearest examples. In these approaches, the data collection tools and sometimes the recruitment materials are deliberately developed in partnership with participants or stakeholders after the project begins. Asking for a finished interview guide before the co-design process has happened would defeat the purpose of the approach and also contradict the principles of the National Statement.

We understand this, and we have built our process for it. But it is important to be precise about what can evolve and what cannot.

What must be settled at the point of application. An emergent design does not mean an emergent application. Even in the most adaptive project, the committee must be able to assess the following when you apply:

• The methodology, including the development process itself. How will co-design or iterative development actually run? Who is involved, how are decisions made, and what governs what the process can and cannot change?
• The ethics of the development process. People who take part in co-design workshops or reference groups preceding research/evaluation are not automatically research participants. The National Statement treats consultation and engagement of this kind as sitting outside human research. That changes where their contributions will be recorded, analysed or reported as part of the research or evaluation outputs, which is common in developmental designs. You need to tell us which applies to your project. Where contributions will form part of the evidence, address how these people will be recruited, informed, consented and supported, as you would for any participant. 
• The risk envelope. Who the project will involve, what topics it will touch, what the foreseeable risks are and how they will be managed. We cannot assess risk around a gap, so the boundaries of the project must be clear even where the instruments within those boundaries are not.
• The fixed infrastructure. The data management plan, the team’s capability, and your consent approach. The final wording of a participant information sheet may follow later; the approach to consent may not.

What every planned gap must state. Where a document genuinely cannot exist yet, do not leave a silent gap, describe it. Your application and project plan should set out, for each missing item:

1. What is not yet available: name the documents or tools.
2. Why it cannot exist yet: the design rationale, not just the schedule.
3. How it will be developed: the process that will produce it and who will shape it.
4. When it will exist: indicative timing relative to your project milestones, and confirmation that it will be submitted to us for review before it is used.

We cannot account for what we do not know about. A gap described in these terms is something we can review and approve around. An unexplained gap forces us to come back to you, which slows everyone down.

The table below summarises the list of documents discussed earlier, and flags which items can legitimately be developed after ethical approval for projects with evolving designs.

The non-negotiable. Any tool, instrument or participant-facing document developed after approval must be reviewed and approved before it is used with participants. Co-design does not exempt the later instruments from review; it changes when that review happens. Under the National Statement, continued ethics approval is conditional on conducting the project in line with the approved proposal and submitting amendments for approval (paragraph 5.4.10). Collecting data with instruments that have not been reviewed puts your approval, and your project, at risk.

How we handle it in practice. Where the staged development is clearly set out in your application, we can in most cases grant approval conditional on the subsequent review of the future materials. For administrative purposes we treat that later review as a minor amendment, which keeps the process light and comes at no extra cost to you. One caveat: minor amendment treatment applies where the later materials stay within the scope and risk profile we approved. If the development process takes the project somewhere new (e.g. different participant groups, more sensitive territory, materially changed methods or research questions) that is a substantive amendment, and the earlier you talk to us about it, the smoother it will be.

A worked example. A public health agency commissions an evaluation of a new community wellbeing program, to be co-designed with a reference group of program participants. At the point of application, the team can provide the evaluation framework, the data management plan, the team biographies, the recruitment approach, and a description of how reference group members will be recruited, informed and supported. If the reference group's discussions will themselves be recorded, analysed or reported as part of the evaluation's evidence, the members become participants in their own right, and the application should address their information and consent accordingly. What they cannot yet provide are the specific interview questions and the participant survey, because those will be shaped by the reference group over the first two months of the project. The right move is to say exactly that in the evaluation plan: describe how the reference group will inform the instruments, give the indicative timing, and confirm that the finished instruments will come back to us for review before any data is collected with them. On that basis we can grant conditional approval, and the later submission of the finished tools is handled as a minor amendment.

Summary

We have worked hard to make ethical review straightforward and to strip out unnecessary paperwork, without compromising the integrity and value of the ethical review process. We have also worked hard to create a process that reflects best-practice approaches in evaluation and research, including those that evolve in response to the input of participants and stakeholders. None of that changes the fact that we need enough information to make an informed decision about whether the proposed activities meet the requirements of the National Statement.

So our advice is simple. Provide what you can. Where something genuinely cannot be provided at the time of application, explain what is missing, why it is not yet available, how it will be developed, and when it will come back to us for review. A well-explained gap is something we can work with. An unexplained one usually means a delay.

If you are unsure whether a particular document is needed for your project, or how to describe a co-design or developmental stage in your plan, get in touch before you submit. A short conversation at the design stage almost always saves time later.

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This article draws on the National Statement on Ethical Conduct in Human Research (2025). It is intended as practical guidance and does not constitute legal advice. If you have questions what materials your project requires to apply for ethics review, get in touch.

AI Disclosure: Initial drafts of the content for this article 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.