Ready to turn compliance into a strategic advantage? This short introduction promises a practical, 12-step path that helps Australian researchers move from uncertainty to a clear process for approval and publication.
The decra ethics checklist pdf distils mandatory steps — HREC project number, a project protocol, expert peer review, HREA entry in ERM, the Victorian Specific Module and state modules, investigator CVs, the ethics checklist and fees — into an easy-to-follow sequence.
Applications include the application form and protocol plus participant information, recruitment material and consent. All documents should use clear information for non-specialists and respect people’s need for plain language.
Review reaches beyond committees: institutions, sponsors, regulators and journal editors will look at your studies. This guide helps you label documents, manage version control and align principles and guidelines with multi-site projects and publications.
Each section links purpose to practice and offers examples, tools and a repeatable process you can trust across projects. Use this guide as a living companion from first draft to final approval.
Key Takeaways
- Follow a 12-step process that simplifies governance and submission.
- Prepare plain-language participant information and consent for accessibility.
- Ensure protocols, CVs and peer review are ready before submission.
- Manage document labelling and version control for multi-site studies.
- Think beyond committees: prepare for institutional, sponsor and publisher scrutiny.
Why this DECRA ethics checklist matters for Australian researchers
Strong oversight turns good ideas into trustworthy studies that communities can rely on. Good preparation protects people, boosts research integrity and helps projects reach publication and impact.
Aligning research ethics with people, practice, and impact
Simple, clear participant information and respectful recruitment are where ethical principles meet everyday practice. Plain-language summaries make applications readable for non-specialist reviewers and speed the review process. Well-documented consent, data stewardship and role authorisations (CPI/PI) show governance in action and support timely starts for funded projects.
The role of ethics committees and institutional oversight
Ethics committees are one node in a larger system that includes sponsors, regulators, and journal editors. Each reviewer looks for consistent submissions: HREA completion in ERM, local HREC project numbers and linked modules.
| Stakeholder | What they check | Practical action |
|---|---|---|
| Ethics committees | Participant safety, consent wording, risk management | Provide plain-language information and clear protocols |
| Institutional governance | Authorisations, insurance, site approvals | Include CPI/PI letters and site documentation |
| Publishers & regulators | Transparency, data handling, declarations | Keep version control and consistent records |
- Tip: Treat review as collaborative improvement, not a hurdle.
- Outcome: Clear applications reduce queries and help studies start on time.
Download the DECRA Ethics Checklist PDF
Ready to move from concept to submission? This downloadable file is arranged into clear sections that mirror the 12-step sequence used by major Victorian institutions. It guides teams through local HREC numbers, full protocol components, statistical input, peer review proformas, HREA in ERM, VSM/WASM, CVs, the ethics checklist and fees via RMH invoice or internal transfer.
What’s inside: sections, examples, and tools you can use today
Immediate call to action: download the file to get templates, annotated examples and a proforma that streamlines submissions.
- Annotated labeling examples, protocol templates and a completed proforma to follow.
- Practical tools: data collection inventories, version-control tips and reviewer response templates.
- Examples showing how statistical advice becomes a clear methods and analysis plan.
- Support materials for assigning roles, tracking governance and reducing revision cycles.
| Item | What it includes | Action |
|---|---|---|
| Protocol template | Title, authors, compliance, sites, versions | Complete and attach with HREC number |
| Peer review proforma | Statistical notes, methodology checks | Incorporate reviewer feedback before HREA |
| Document tools | Label examples, version control, CV checklist | Apply to all submission files |
| Practical guides | Data tool lists, reviewer response templates | Use on day one to coordinate studies |
Why it helps: the file condenses institutional guidelines into one process map so teams can move confidently from planning to submission, reduce queries and accelerate review.
Understand the ethics application landscape in Australia
Navigating approvals in Australia means mapping several layers of review and governance from the start. An application meets an ethics review panel and parallel governance checks from institutions, sponsors and regulators. Each reviewer focuses on different risks and responsibilities.
From ethics review to governance: who reviews what
HREC panels assess participant safety, consent and study design. Institutional governance looks at authorisations, insurance and site approvals. Sponsors and regulators check compliance, while journal editors scan for transparency ahead of publications.
Keeping your information clear and free of technical jargon
Plain English speeds decisions. Remove complex terms so non-specialist reviewers and community members can grasp risks and protections quickly.
“Applications must be understandable by non-specialists with no complex technical terms.”
Practical tips:
- Use headings that mirror committee forms and governance templates.
- Label where CPI/PI authorisations sit in ERM and attach supporting letters.
- State risk, consent and data handling in simple phrases — for example: “We will store de-identified data on a secured server.”
Align your text with local guidelines and use consistent templates. Clarity helps people — participants, investigators and approvers — see responsibilities and protections at a glance, reducing queries and accelerating the review pathway.
Set up your project identifiers: HREC project number and EPIC EMR
Assigning clear project identifiers early saves time and keeps approvals linked across systems.
Obtaining a local HREC project number
Email research@mh.org.au using the official template to request a local HREC project number. Start here to avoid downstream delays when you upload forms, submit governance documents, or share files with partners.
How to derive and use the EPIC EMR number
Use the ERM code to form the EPIC EMR identifier. For example, HREC/123456/MH-2020 becomes RMH123456. This example shows the five or six digits you need to include.
Label every document with both numbers
Include the HREC project number and the EPIC EMR number on every file name, header, footer and email subject line. Add them to participant-facing information so submissions remain consistent across reviewers.
- Adopt a naming convention: ProjectCode_HREC2022.999_RMH123456_v1_2025-06-01.docx.
- Record version number and date to keep the record auditable and reviewer-friendly.
- Store identifiers in a central project register so uploads and correspondence always match.
Why this matters
Correct identifiers link your data, approvals and correspondence across institutions and governance teams. Add these numbers to templates and tools from day one to reduce rework and speed approvals.
Build a robust project protocol and data collection tools
Start with a protocol that explains who does what, where, and how data will be handled. A strong protocol must be an operational document, not a grant summary.
Core protocol elements
Include project title, full list of authors and affiliated organisations, a statement on ownership and a clear compliance declaration.
Record version number and date in the footer and list all study sites with site-specific activities so governance teams can follow responsibilities.
Data management and risk assessment
Keep the data management plan and risk assessment as standalone or clearly signposted documents. These show stewardship, storage, access controls and breach responses.
Data collection tools and methods
Attach questionnaires, assessment tools and data collection sheets. Align each tool to the analysis plan and objectives.
Pilot-test instruments for clarity and burden, document changes and record rationale in the protocol to support reviewers.
- Why not a grant proposal: proposals lack operational detail, risk controls and the full analysis plan reviewers require.
- Map measures to outcomes in a transparent analysis plan to support future publications and reproducibility.
- Maintain a version history and include change logs for committees and auditors.
Get statistical input to strengthen your research question and analysis
Engage a statistician early to transform a promising idea into a robust study. Seek design-stage input to sharpen the research question and pick a study design that can answer it.
Design-stage support: study design, sample size, analysis plan
Early statistical support helps set defensible sample sizes and clear assumptions. Document power calculations, effect sizes and sensitivity checks in the analysis plan.
Why grant proposals aren’t enough
Grant text shows intent but not operational detail. Committees need an analysis plan that links methods to endpoints and data collection tools.
| Item | Purpose | Action |
|---|---|---|
| Sample size calculations | Defendable recruitment targets | Include assumptions, power and effect size in protocol |
| Randomisation & methods | Reduce bias and clarify procedures | Describe sequences, allocation and handling of missing data |
| Analysis plan | Transparent data handling and tests | Align endpoints, instruments and decision rationale |
- Tip: Record why decisions were made to aid reviewers and future replication.
- Outcome: Strong planning improves participant welfare and study value.
Secure expert peer review before submission
Secure, independent critique of your protocol can reveal risks and practical fixes before formal submission. A completed Peer Review Proforma gives review panels confidence in design, feasibility and ethical soundness.
Peer review proforma: required content and timing
Submit the proforma after the scientific protocol is finalised and before you lodge with HREC. Allow time to locate a reviewer, receive feedback and incorporate changes into the submission.
Finding reviewers and addressing feedback in the review process
Seek reviewers with relevant expertise and independence from your team. University departments, clinical networks and professional societies are reliable sources.
- Document all reviewer comments and record how you addressed each point.
- Respond constructively: amend protocol text or add a rationale where changes are not made.
- Keep a short change log to attach to your application so committees can track decisions.
Practical examples of typical reviewer concerns: unclear endpoints, participant burden, and data handling. Pre-empt these by clarifying measures, estimating time burden, and stating storage and de-identification plans.
“Rigorous peer input improves study quality and readiness for publications.”
Note: commercially sponsored clinical trials often follow different review routes, but an internal scientific review remains valuable. Encourage peer support across teams — it lifts principles and practice across all research.
Complete the Human Research Ethics Application in ERM
Preparing a coherent HREA submission in ERM makes review smoother and keeps your project on track. Take time to align every field with your protocol and participant information before you submit.
Authorisations: CPI vs PI for multi-site and single-site projects
Who signs matters. For multi-site projects the Chief Principal Investigator (CPI) must authorise the application. For single-site work the Principal Investigator (PI) signs off. This keeps governance clear and avoids downstream queries.
HREA in Ethics Review Manager: paperless workflow for projects
ERM is a paperless information management system that tracks versions, numbers and correspondence across the project life cycle. Complete the HREA online, but draft answers offline first to mirror your protocol and participant materials precisely.
Practical steps to reduce queries and speed approval:
- Enter consistent project titles, HREC project number and EPIC EMR identifier so uploaded documents match the application.
- Ensure answers reflect the protocol and participant information to avoid contradictory statements.
- Assign a team member to check attachments, CVs and consent forms against a pre-submission list.
- Note that RMH HREC does not accept the Low Negligible Risk (LNR) VIC form. Plan a full HREA submission where required.
- Use ERM to track correspondence and version history through the project lifecycle.
| Stage | Action | Benefit |
|---|---|---|
| Draft offline | Prepare answers and copy into ERM | Fewer typing errors and consistent wording |
| Authorisation | CPI signs multi-site; PI signs single-site | Clear governance and faster institutional checks |
| Identifiers | Confirm HREC and EPIC EMR number in all files | Linked records across systems and reviewers |
| Final check | Team member verifies attachments and forms | Reduces queries and speeds approvals |
Outcome: A complete, coherent application in ERM reduces review time and supports timely starts for your studies.
Victorian Specific Module and state requirements
State-specific modules ensure local rules are matched to your project paperwork. For any study with a Victorian site, the Victorian Specific Module (VSM) is mandatory and must be completed alongside your main application.
When to use the Victorian Specific Module
Mandatory: include the VSM for all projects that list a Victorian site. Plan this at the same time as the HREA so answers and uploaded files stay consistent.
Western Australian Specific Module for WA sites
If your studies include a Western Australian site, complete the Western Australian Specific Module (WASM) in addition to other requirements. Treat both modules as part of a single submission workflow.
- Check site numbers, site-specific activities and investigator details match the protocol and identifier used elsewhere.
- Maintain a module matrix for multi-site projects to track obligations across jurisdictions.
- Finalise protocol and project identifiers before populating modules to avoid rework.
- Keep module templates as living documents to simplify amendments and maintain consistent information.
Accurate, consistent module data speeds governance and supports alignment between principles and practical review.
Investigator credentials and supporting information
Start your investigator dossier with clear, current credentials that show capability and oversight. Reviewers look for concise evidence of leadership, supervision and technical skill. A clean dossier reduces queries and builds trust in your projects.
Current CVs for Principal and Coordinating Investigators
Provide a current PI CV if one has not been lodged within the past three years. Email the file to research@mh.org.au by the submission deadline to avoid processing delays.
Include recent publications, relevant training, and certifications. Highlight supervisory roles and governance experience in a short leadership summary so reviewers can assess oversight quickly.
Using the Investigator Curriculum Vitae form when needed
If an investigator does not have a full CV, submit the Investigator Curriculum Vitae form as an alternative. Complete all sections, note key skills and attach supporting certificates for clinical or research training.
- Align investigator roles and site responsibilities with protocol entries and ERM fields.
- Keep a central credentials folder to store CVs, certifications and role letters for all studies.
- Present leadership and supervision succinctly: two to four lines per role works best.
Why this matters: strong investigator credentials support research quality and give reviewers confidence in study oversight. Check deadlines and email submissions to research@mh.org.au to keep governance on schedule.
| Document | What to include | Benefit | When to send |
|---|---|---|---|
| Current PI CV | Publications, training, leadership summary | Confirms capability and oversight | If no CV lodged in past 3 years |
| Investigator CV form | Key roles, registrations, brief experience | Fast alternative for missing CVs | At submission or by deadline |
| Credentials folder | CVs, certificates, role letters, updates | Streamlines multi-site submissions | Maintain continuously |
| ERM role entries | Match protocol responsibilities | Reduces queries and aligns governance | Before HREA finalisation |
Fees, invoices, and submission timing
Payments and timing can make or break a smooth submission—plan them early.
The Royal Melbourne Hospital now requires all governance and review fees via an RMH invoice or an internal journal transfer. See the Office for Research fees page for the full schedule and up-to-date guidelines (last updated 29 July 2024).
RMH invoices and internal transfers: how payments work
Build the cost and the expected payment date into your project timeline so finance approval does not delay lodgement. Coordinate with your finance team early to set up cost centres and transfer arrangements.
- Payment methods: RMH invoice or internal journal transfer only; fee schedules on the Office for Research page.
- Documentation: attach proof of payment or internal transfer documents when requested to speed processing.
- Identifiers: always include the HREC project number and EPIC EMR identifier on invoices and correspondence for accurate matching.
- Timing: align submission with committee meeting calendars to reduce waiting time and avoid extra cycles.
- Recordkeeping: keep a finance log linked to your ERM record for audit trails and clear reconciliation.
“Confirm the current fee process before submission—policy changes are possible and can affect timelines.”
Practical tip: recheck the Office for Research page before you submit. The last update was 29 July 2024, and a quick verification can prevent last-minute surprises.
DECRA ethics checklist pdf
This fast compliance route maps each requirement to a practical task you can assign and track.
The 12-step fast compliance path at a glance
Grouped snapshot: obtain a local HREC project number; derive your EPIC EMR (for example HREC/123456/MH-2020 → RMH123456); prepare a detailed protocol with data management and risk assessment; attach data collection tools; secure statistical input and peer review; complete the HREA in ERM with CPI/PI authorisations; add VSM/WASM as needed; supply investigator CVs or the form; finalise the ethics checklist and pay fees via RMH invoice or internal transfer.
Grouping tasks to work in parallel
- Identifiers and version control
- Protocol build and data tools
- Scientific review then formal application
- Governance checks and payment
Version control and document labelling to streamline approvals
Keep a single source of truth for data tables, participant information and analysis plans. This reduces contradiction across forms and speeds reviewer confidence.
Example label: RMH123456_2022.999_Protocol_v1.2_2024-08-15.pdf. Assign an owner to each section and hold short stand-ups until submission is lodged.
“Aligning information across forms is the fastest way to compliance.”
Participant information, consent, and privacy by design
Clear participant information protects people and keeps studies trustworthy. Prepare recruitment materials and participant information statements in plain language. Use short sentences, headings and bullet lists so readers find key points fast.
Recruitment materials and plain-language participant information
Write who you are, what will happen, time commitment and risks in everyday words. Test drafts with laypeople to check clarity and remove confusing terms.
- Use short headings and a plain summary at the top.
- State how to join, how to withdraw, and contact details for questions.
- Version-label each file and keep a simple change log.
Consent process, data protection, and privacy considerations
Consent must be voluntary, informed and able to be withdrawn. Match consent language to protocol procedures so answers are consistent across documents.
Embed privacy by design: collect only the data you need, state retention periods and explain de-identification in plain terms. Describe who may see information and why, and show secure storage arrangements aligned with your data management plan.
“Minimise collection, explain uses clearly, and make withdrawal straightforward.”
Operational advice: provide secure workflows for queries and requests, record responses, and keep participant-facing materials auditable and up to date.
Qualitative studies, case studies, and special methods
Interviews and focus groups require clear, manageable rules to protect people and the research. Design your protocol to show how you will manage confidentiality, consent and sensitive topics.
Tailoring consent and facilitation for sensitive topics
Use staged consent: invite initial agreement for contact, then confirm consent before each interview or recording. Offer withdrawal options and provide support contacts for participants who may become distressed.
Method-specific risks and practical mitigations
- Manage group confidentiality with ground rules and reminders at each session.
- Reduce re-identification risk in small communities by aggregating quotes and removing location details.
- Address power dynamics by separating practitioner-researcher roles and offering neutral interview settings.
Handle audio and video carefully. Transcribe in secure software, remove direct identifiers, and store files in encrypted folders per your data management plan.
Practical examples: use plain prompts—”Tell me about your experience, in your own words”—and a short debrief script offering support and withdrawal steps.
“Document reflexivity and a researcher safety plan in the protocol to aid review and protect teams.”
Finally, describe sampling that respects time and autonomy, record all safeguards, and attach sample tools so reviewers see how practice meets guidelines.
Linking ethical principles to AI and data-intensive projects
AI and large-scale data projects demand that abstract principles turn into concrete steps at every stage of development. Researchers must show how high-level commitments become routine safeguards.
Australian AI Ethics Principles in practice: fairness, accountability, transparency
Translate principles into tasks: use diverse sampling, assign clear roles for accountability, and publish model documentation so reviewers can follow decisions.
- Problem framing: state purpose, limits and harms considered.
- Data sourcing: document provenance and representativeness.
- Model reporting: provide model cards and decision logs.
Avoiding bias and protecting privacy in data collection and analysis
Adopt minimisation, secure enclaves and differential privacy where suitable. Run bias audits and stratified performance reports to spot uneven outcomes.
- Example: reduce facial recognition bias with representative datasets and external audits.
- Example: avoid opaque scoring systems by publishing rationale and offering contestability.
“Document limitations and monitor impact — implementation is ongoing, not a single box to tick.”
Outcome: clear records, fairness metrics and continuous monitoring make systems safer and give committees the evidence they need.
Conclusion
A stepwise approach makes approvals predictable and keeps participants central. Follow the 12-step path—HREC number, a full protocol, statistical input, peer review, HREA in ERM with CPI/PI sign-off, VSM/WASM where needed, investigator CVs, the ethics checklist and fee arrangements—to move from intent to impact.
Use plain language in participant materials and clear templates for protocols and data tools. This reduces queries from reviewers and helps studies start on time. Keep version control and simple labels so governance teams can verify records quickly.
Embed ethical principles across development and implementation. Document decisions about data and AI, show peer review proformas, and align practice with local guidelines. Good work upfront cuts amendments later and supports strong research outcomes.
Act now: keep the checklist as a living reference, adapt it for each project, and apply it to move your project from proposal to published study with confidence.