Human Research Ethics Application System (HREAS) Assignment

Assignment Task

You will prepare a plan for a research study, building on your critique in task 1 to justify the research question, rationale, methods, practical and ethical aspects, and outcomes relevant to the Australian context.

A research study description is a mandatory requirement as part of a Human Research Ethics Application (HREA) application. The NHMRC developed the Human Research Ethics Application (HREA) form as a concise application to facilitate timely and efficient ethics review for research involving humans. HREA assists researchers to consider the ethical principles of the National Statement on Ethical Conduct in Human Research (2007) in relation to their research.

Research cannot commence without approval from a relevant ethics committee, and most ethics committees require a completed HREA form as part of their assessment processes. The research study description should provide the background, rationale and methodological approach of a research study being hypothetically proposed in accordance with principles of research conduct that minimizes risk and promotes quality outcomes. Your research study description should conform to the following report format and use of headings. The following format is an adapted version of the project description requested as part of a Human Research Ethics Application (HREA) application.

1. Study Scope, Aims, Themes or Question

1.1 Study theme or question

Briefly describe the purpose of the research and clearly state the overarching aim or research question.

1.2 Study background and specific aims

Provide a rationale, with supporting literature, for the study by describing how the research will fill any gaps, contribute to the field of study or contribute to existing or improved practice. Include a literature review of recent relevant literature that has attempted to address the identified research gaps. Clearly state the research questions, aims, objectives, or hypotheses pertinent to addressing the identified gaps. This section should also note the expected outcomes gained from undertaking the study.

2. Study Design 

2.1 Setting

Describe the research study setting (e.g. physical sites, online forums and alternatives).

2.2 Methodological approach

Critically appraise and synthesize evidence to support the proposed choices of method/s (tied to project aims/objectives).

2.3 Participants

Describe the target population and participants, the inclusion and exclusion criteria, and the sample size (literature or a sample size calculation should be included to justify the proposed sample required).

2.4 Participant recruitment strategies and timeframes

Describe the approach/es to providing information to participants and consent in support of the proposed strategy, and reference should be made to the relevant parts of the National Statement on Ethical Conduct in Human Research.

2.5 Research Activities

Describe what will happen in this study, including the benefits and risks of participation, participant commitment, project duration, and participant follow-up. Reference to the relevant parts of the National Statement on Ethical Conduct in Human Research should be made.

2.6 Data Collection/Gathering

Describe and cite supporting literature for all the information or variables that will be collected and how the collection will occur.

2.7 Data Management

Describe how data and information collected will be stored, how and by whom it can be accessed, and how it will be archived and destroyed. Refer to the relevant parts of the Australian Code for the Responsible Conduct of Research 2018 and Supplementary guides.

2.8 Data Analysis

Describe and cite supporting literature about how information and data will be measured and analyzed.

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