Project Description - Protocol Template - greater than low risk research

Sep 2, 2026

Project Description/Protocol template outlining how to present scientific and academic background and research context for an ethics review submission using HREA. It specifies that headings should be selected according to relevance and that alternative protocol templates may apply to clinical trial proposals. Guidance covers where to map existing documents to template fields, avoids duplicating information between systems, and encourages language understandable to non-technical ethics reviewers. Recommended sections span roles, resources, background, design, participants, activities, data handling, analysis, outcomes, investigational product details, and closure.

LanguageEnglish

CategoryForms

FormatDOCX

Pages3

Reading Time1 min

AccessFree to download

Purpose and submission guidance

Key requirements for HREA

Relevance of template headings

Recommended content sections

Title and project team roles

Resources and background

Research questions and expected outcomes

Project design and participant details

Research activities and participant follow-up

Data collection, management, analysis, and linkage

Outcome measures and investigational drug/device details

Results, dissemination, closure, and data sharing

Project Description/Protocol Note that: the purpose of a Project Description is to provide the scientific and academic background and context of a research project; a Project Description is a mandatory component of a submission using the HREA; the section headings in this Project Description template represent a structure for presentation of information about a research project that meets the needs of an ethics review body; not all headings or sub-headings in this template are relevant for each research project; submissions of clinical trial proposals may use alternative protocol templates, such as the HYPERLINK "http://www.spirit-statement.org/" \t "_blank" SPIRIT statement; researchers may choose to submit an existing document (such as a protocol or project description that has already been developed) instead of developing a new document; if researchers choose to submit an existing document instead of using one of the templates provided, they may need to provide indications to the ethics review body of where in the submitted document the content corresponding to the relevant fields in the template are located; there is no need to duplicate information in the HREA into the Project Description or vice versa; and language that is understandable to non-technical reviewers should be used. Researchers are strongly encouraged to address the following headings in their Project Description. Each dot point provides an example of the information that researchers might want to include, if relevant to their project. Title Acronym (if appropriate) Version number Project Team Roles & Responsibilities Names, affiliations, positions and responsibilities of investigators and other key project team members (as required in addition to that outlined in the HREA) Resources Resources necessary for the project to be conducted Funding/support being sought or secured Background Literature review Rationale/Justification (i.e. how the research will fill any gaps, contribute to the field of research or contribute to existing or improved practice) Research questions/aims/objectives/hypothesis Expected outcomes Project Design Research project setting (physical sites, online forums and alternatives) Methodological approach Rationale for choices of method/s (tied to project aims/objectives) Participants Description and number Inclusion and exclusion criteria Sample size and statistical or power issues Participant recruitment strategies and timeframes (as required in addition to that outlined in the HREA) Approach/es to provision of information to participants and/or consent (as required in addition to that outlined in the HREA) If necessary, the type of consent provided to different participant groups, when and where, and any arrangements to confirm that consent. If necessary, details of who will be confirming or re-negotiating consent with participants and the process/es that will be undertaken Research Activities: What you are going to do? Participant commitment Project duration Participant follow-up Data Collection/Gathering: What information are you going to collect/gather? (as required in addition to that outlined in the HREA) Data collection/gathering techniques: How will you collect/gather the information? Impact of and response to participant withdrawal Data Management: How will you store, provide access to, disclose, use/re-use, transfer, destroy or archive the information that you collect/gather? (as required in addition to that outlined in the HREA) Data Analysis: How will you measure, manipulate and/or analyse the information that you collect/gather? Matching and sampling strategies Accounting for potential bias, confounding factors and missing information Statistical power calculation Data Linkage: What linkages are planned or anticipated? Outcome measures For research involving an investigational drug or device as part of a clinical trial: What is/are the drug(s) and/or device(s): Approved name Trade name (if any) Manufacturer Supplier of

FAQs

What is the purpose of a Project Description in this template?

It provides scientific and academic background and research context for an ethics review submission. It is a mandatory component for submissions using HREA.

Which headings from the template should be included?

Researchers are strongly encouraged to address the provided headings, but not all sections are relevant to every research project. Choose the headings that meet the ethics review body’s needs.

Can researchers submit an existing protocol or project description instead of using the template?

Yes. If an existing document is used, the researcher may need to indicate where the content corresponding to relevant template fields is located in the submitted document.

Sep 2, 2026

Upload by Emma Wilson