Low and Negligible Risk Research Project Description HUMAN RESEARCH ETHICS

Purpose

The Project Description is a mandatory component of submission of the Human Research Ethics Application (HREA) form. It is uploaded as part of your HREA through the UQ MyResearch system.

The Project Description provides the background, rationale and methodological approach of a research project being submitted for ethics review.

This template has been developed specifically to meet the needs of ethics review processes at UQ for Low and Negligible Risk (LNR) research. The information contained in this form and the HREA will assist reviewers in assessing the application against the principles outlined in the National Statement on Ethical Conduct in Human Research (2007, updated 2018), namely:

Research Merit and Integrity

Justice

Beneficence

Respect

There is no need to duplicate information in the HREA into the Project Description or vice versa. It is recommended that you familiarise yourself with requirements of the MyResearch HREA so that information is not inadvertently duplicated in this Project Description. For example, for LNR research, information related consent, recruitment, risks and benefits is addressed in the HREA and does not need to be duplicated in the Project Description.

To assist in completing this template, examples are provided of the type of information required in each section.

In completing this form please:

Use plain/lay language, defining all technical terms and avoiding acronyms.

Keep to the section limits without altering font size (Calibri 11 pt) or margins (2.5 cm). Each section (questions 2-4) should begin on a separate page.

Be as concise as possible; it is not necessary to exhaust the page limits.

Project Details	As listed in your HREA form in MyResearch
Title
MyResearch application #
Lead/Chief Investigator
Project Description version/date

Research Scope, Aims, Themes or Questions (maximum one page)	What is the research theme or question that this project is designed to explore? (NS 3.1) Why is the exploration of this theme or answer to this question worth pursuing? (NS 3.1)
Research theme or question Briefly describe the purpose of the research and the overarching aim or research question.
Background and specific aims Outline the current state of research/knowledge/discourse in the area and the specific project questions, aims or hypotheses. The description should demonstrate the need for the research and that it is based on a thorough review of the current literature; an extensive literature review is not required. Key references can be appended to this form.
Significance How does your research help to fill a gap in the literature/knowledge; what are the expected outcomes and contributions?

Research Methods (maximum two pages)	How will the planned methods explore the theme or achieve the aims of the research? (NS 3.1) Demonstrate that the research has merit (NS 1.1)
Note: Questions related to recruitment, consent, data and privacy are addressed in the HREA. Consent forms, recruitment materials, non-standard questionnaires and measures must be attached to the HREA.
Research participants or data Who are the research participants (demographics)? How will you engage with them? AND/OR What is the nature and specific source of the data or information to be collected/gathered/used and how will it be obtained?
Methodology and timeline Describe the research approach and timeline.
Sampling strategy What is the sampling approach (e.g., selection criteria, target sample size)? Justify your sampling strategy.
Measures and procedures List standard measures (e.g., questionnaire, age), procedures (e.g., treadmill testing, structured interviews) and materials. Provide details of new measures/materials. Where relevant, attach instruments or materials to the HREA.
Data analysis Describe the data analysis plan (e.g., what are the strategies for matching and sampling, or for accounting for potential bias, confounding factors and missing information). What are the outcome measures/variables?
Other information related to research methods (where relevant) e.g., Incentives or reimbursements to be offered; debriefing procedures; procedures to allow participants to withdraw from the project (and the implications for compensation/incentives); for data linkage research, how will you manage any risk that linking databases of non-identifiable data could subsequently result in the individuals being identified?
Research merit
Describe how the methods, measures, procedures and analysis will allow you to meet the research aims?

Other ethical issues (maximum half page)	Dissemination of project outputs and outcomes (NS 3.1.69) Other ethical issues to your research project?
Research Outputs What is the plan for reporting, publishing or otherwise disseminating the outputs/outcomes of the research (note: providing outcomes to research participants is addressed in the HREA)?
Additional information Provide any other information you would like to convey to the reviewers that is not addressed elsewhere in this document or the HREA.