Application for Human Research Ethics Approval

What type of project is this? (Tick as many as apply)

•  Funded Consultancy
•  Class Research Project
•  Postgraduate Diploma
•  Clinical Trial
•  Undergraduate Research
•  Masters by Research
•  Staff Research Project
•  Honours Research
•  PhD
•  Other
•  Masters by Coursework

Risk Assessment Refer to the National Statement, 

Human research may lead to harm, discomforts or inconveniences for participants or others. The review pathway for your application depends on the identified level of risk associated with your project.

Low/negligible risk

Low and negligible risk research describes research in which the only foreseeable risk is discomfort or inconvenience. Research in which the risk for participants is more serious than discomfort is not low risk.

Above low risk

If risks associated with your research may be more than discomfort and become distress, you should select ‘above low risk.’

Please also select this option if your research is with one or more of the following participant groups (and please select those that apply):

•  Women who are pregnant and the human foetus (N.S. 4.1)
•  People highly dependent on medical care who may be unable to give consent (N.S. 4.4)
•  People with a cognitive impairment, an intellectual disability, or a mental illness (N.S. 4.5)
•  People who may be involved in illegal activities (N.S. 4.6)
•  Aboriginal and Torres Strait Islander Peoples (N.S 4.7)
  See also the
• Please also select this option if your research involves/requires any of the following (and please select those that apply):
•  Active concealment or planned deception or aims to expose illegal activity (N.S. 2.3.4);
•  A waiver of consent for use of personal information in medical research, or personal health information (N.S. 2.3.9); or
•  The collection of human biospecimens for research purposes (including biobanks) (N.S. 3.2.1).

RESEARCHER TRAINING

All researchers at Federation University are required to undertake training in responsible research conduct (see Australian Code for the Responsible Conduct of Research, R16 ).

LAY DESCRIPTION

Sate the research question/challenge addressed by this project. Provide a brief description of the project including key aspects of the research design (e.g., who will be participating, what information will be collected and by what means, what participants will be required to do, etc.). The lay description must be in everyday, jargon-free language that is comprehensible by the average educated layperson . This may be the same or similar to the project description given in your Plain Language Information Statement (PLIS). Define any technical terms or discipline-specific phrases and use the full form of all acronyms the first time they are used

The aim of the project research is to handle the challenge of improving cardiovascular health in certain areas of Australia where there is limited access to healthy food and education about heart health. The Indigenous community members of age above 20 years will be included facing limited access to healthy food options. Participants will be asked to share their dietary habits, lifestyle choices, and any existing health conditions. This type of information will be collected through conducting surveys and interviews, ensuring it is easy and comfortable for them to participate. After obtaining this information, this project will adopt an all-encompassing strategy to deliver comprehensive education on heart health. Since each community is distinct, we will design our educational initiatives to match their particular requirements. Hosting workshops, providing user-friendly educational materials, and providing specialized support are all necessary to achieve this. Additionally, we will work with local organizations to provide access to inexpensive, wholesome, and fresh foods, giving them the resources, they need to make better dietary decisions. Our ultimate objective is to equip people and families with the information and tools they need to live heart-healthy lifestyles. We hope to lower the risk of heart disease and improve the general well-being of these communities by managing this critical problem. We can make cardiovascular health attainable for everyone, regardless of location, through accessible knowledge and increased food access. Our dedication to achieving equitable health outcomes and a healthy future for all is embodied in this project.

RESEARCH AIMS & SIGNIFICANCE

State the aims, and significance of the project referencing current literature where appropriate. If relevant, state the specific hypothesis to be tested. Provide justification as to why your research should proceed, including an explanation of any expected benefits to the community and its potential to contribute to existing knowledge. Refer to section 1 of the National Statement on Ethical Conduct in Human Research for discussion of the values of respect, research merit and integrity, justice and beneficence. (1500 words max. excluding references)

Background

Cardiovascular disease (CVD), which includes illnesses like heart disease and stroke, is a major cause of death and disability in communities and healthcare systems around the world (). It continues to be a major contributor to avoidable fatalities in Australia, placing a significant strain on financial and public health resources (Gomez-Delgado et al., 2021). Although improvements in CVD therapies and interventions have been made possible by advances in medical science, addressing the root causes of this widespread health problem remains a multifaceted and formidable challenge (Aljuraiban et al., 2020). Lack of access to nutritious food and in-depth heart health education, particularly in neglected and underprivileged regions across the country especially among the Indigenous community, are major risk factors for CVD (Gomez-Delgado et al., 2021). These regions are frequently referred to as "food deserts," because people have fewer options for obtaining healthy, fresh foods (Kaiser et al., 2021). The term "food desert" aptly describes the barren landscape of affordable, healthy food options in areas where the Indigenous community mostly resides such as north-eastern regions of New South Wales, leaving the residents with fewer choices for nourishing their bodies.

Food shortages severely restrict people's capacity to choose heart-healthy diets, leading many of them to turn to processed, high-sugar, and high-sodium foods (Aljuraiban et al., 2020). This ultimately contributes to an increase the health-risk factors like obesity, high blood pressure, as well as increased cholesterol levels. These unhealthy dietary patterns, exacerbated by the absence of accessible alternatives, directly correlate with an increased risk of heart disease and other cardiovascular conditions (Gomez-Delgado et al., 2021). Furthermore, the chain of cardiovascular risk continues to be perpetuated by the absence of thorough education on heart health (Gomez-Delgado et al., 2021). The basic concepts of heart health, preventative actions, and lifestyle changes that might greatly lower one's risk of CVD aren't widely recognized by a large number of people in underprivileged communities (Kaiser et al., 2021). This knowledge gap hinders their ability to make informed choices about diet, exercise, and overall wellness, which increases the risk of CVD in these populations.

Aims and Objectives

The main aim of the project is to reduce the incidence of cardiovascular disease (CVD) and enhance the overall heart health of communities facing challenges related to limited access to healthy food and heart health education. Based on the main aim of the project, some objectives can be framed

• To Assess Current Dietary and Lifestyle Patterns in target communities with a focus on understanding the factors contributing to CVD risk.
• To design and implement customized heart health education programs, tailored to the specific needs and knowledge gaps of the community.
• To collaborate with local business organizations to enhance the availability and affordability of fresh, nutritious foods in underserved areas, promoting heart-healthy dietary choices.

Significance of project

A considerable burden on global healthcare systems and communities, cardiovascular disease (CVD) continues to be a major global health concern affecting a significant number of preventable fatalities (Zaman et al., 2020). In Australia, CVD is a leading cause of mortality and morbidity, impacting diverse populations (Zaman et al., 2020). The project, "Enhancing Cardiovascular Wellness in Communities with Limited Healthy Food Access and Comprehensive Education," is of utmost importance because it deals with two intertwined issues like limited access to healthy food and inadequate heart health education, with a particular focus on underserved communities, including Indigenous communities (Kaiser et al., 2021).

Addressing food shortages and CVD risks

Food shortages are specifically characterized by a lack of access to fresh, affordable, and nutritious foods (Gomez-Delgado et al., 2021). The individuals residing in certain areas rely on convenience stores or fast-food outlets, which tend to offer highly processed, high-sugar, and high-sodium options, which contribute significantly to cause risk factors like obesity, high blood pressure, and elevated cholesterol levels (Parekh et al., 2022). The challenges brought on by a lack of availability to good food are made worse in these areas, particularly Indigenous people, by the convergence of financial disadvantages and remoteness from other areas (Kaiser et al., 2021).

The project's immense significance stems from its ability to reduce the harmful effects of food shortages on people's health, particularly in Indigenous communities (Seivwright et al., 2020). By actively engaging with these communities to improve access to fresh and nutritious foods, the project aligns with ethical values such as respect, justice, and beneficence (NHMRC, 2018). With the help of this project, it can be acknowledged that health disparities often arise from structural inequities, such as unequal access to health resources, rather than just individual choices (Parekh et al., 2022).

Respect for the autonomy and dignity of Indigenous communities is crucial to the project’s approach. The project recognizes rich cultural diversity and traditions of Indigenous communities, which have an impact on their food preferences and habits (Parekh et al., 2022). In order to ensure that health promotion strategies fit the particular needs and values of these communities, the interventions are made to respect and incorporate these cultural features (Seivwright et al., 2020). By ensuring that all individuals, regardless of their background, have equitable opportunities to make heart-healthy dietary choices, this project promote health equity and social justice.

Benefits of implementing customized heart health education programs

Respect for cultural diversity: Promoting and customizing heart health education like conducting community-based workshops, and using culturally relevant education materials eventually recognizes and honors the diverse cultural values of Indigenous people (Zwack et al., 2023). These communities often possess distinctive views on health and well-being that are firmly ingrained in their traditions and values. Customized programs show reverence for these cultural aspects, reinforcing the principle of respect as outlined in the National Statement on Ethical Conduct in Human Research (NHMRC, 2018). This project ensures that health promotion initiatives are culturally relevant, encouraging trust and collaboration between researchers and the community.

Project integrity: The project's integrity and the research's significance are demonstrated by the customization of heart health education programs. It acknowledges the possibility that various communities, especially Indigenous populations, may respond poorly to a standardized strategy. By customizing care interventions to community-specific knowledge gaps and needs, the project initiative adheres to the high standards of evidence-based research, ensuring that interventions are informed and effective (Zwack et al., 2023).

Improved Engagement and Outcomes: This project which focuses on customized education programs enhance community engagement and participation. People are more likely to actively participate and implement the knowledge they learn when treatments are tailored to their own circumstances (Haynes et al., 2021). This is in line with the beneficence principle as outlined in the National Statement on Ethical Conduct in Human Research since it can result in better health outcomes, decreased CVD risk factors, along with ultimately enhances overall wellbeing for people and communities (NHMRC, 2018).

Empowerment and Justice : Indigenous people are given the opportunity to take control of their cardiovascular health through customized education programs like community-based workshops, using culturally relevant education materials like visual aids, pamphlets etc (Haynes et al., 2021). By addressing their specific knowledge gaps and educational needs, these programs promote justice by providing equitable access to knowledge (NHMRC, 2018). With a focus on reducing health inequities that have adversely affected Indigenous groups historically, this project strategy aligns with the ethical values of justice and beneficence.

Contribution to Existing Knowledge

This project aims to contribute significant improvements to the body of knowledge in a number of crucial areas relating to food deserts, cardiovascular disease prevention, and heart health education (Zwack et al., 2023). While previous research has delved into these areas separately, there is a distinct lack of comprehensive interventions that effectively combine efforts to address limited healthy food access and deliver culturally sensitive heart health education, particularly in Indigenous communities (Thomas et al., 2021). An innovative contribution to the literature is the project's integrated approach, which combines efforts to increase food access and provide culturally appropriate heart health education. By recognizing the interconnectedness of these challenges, the project provides a comprehensive model for addressing CVD risk in underserved populations (Thomas et al., 2021).

A sophisticated understanding of how to effectively offer health interventions in Indigenous communities while respecting their cultural traditions and values is sometimes lacking in existing studies. The project's focus on cultural sensitivity and specially designed interventions for Indigenous populations provide insightful information about the best ways to interact with and empower these groups (Parekh et al., 2022). This valuable knowledge from this particular project can inform future public health initiatives seeking to reduce health disparities among Indigenous groups.

In addition, this project aims to produce insightful data on how well community-based interventions like providing access to healthy food and providing customized education programs can lower the risk factors of heart, particularly in Indigenous populations (Thomas et al., 2021). The study intends to provide empirical data to the field by conducting thorough assessments of dietary patterns, lifestyle decisions, and heart health knowledge before and after applying interventions. Since the goal of this research is to generate solid information that can guide and influence future therapies and policies targeted at lowering the prevalence of CVD in Indigenous communities, it closely complies with the ethical criteria of research integrity and beneficence (NHMRC, 2018). Therefore, it can be said that by providing a comprehensive and culturally sensitive project approach, it not only adds to the body of academic literature but also offers useful advice for organizations working to promote heart health among Indigenous peoples and reduce health disparities.

References

Aljuraiban, G. S., Gibson, R., Oude Griep, L. M., Okuda, N., Steffen, L. M., Van Horn, L., & Chan, Q. (2020). Perspective: the application of a priori diet quality scores to cardiovascular disease risk—a critical evaluation of current scoring systems. Advances in Nutrition , 11(1), 10-24. https://doi.org/10.1093/advances/nmz059

Gomez-Delgado, F., Katsiki, N., Lopez-Miranda, J., & Perez-Martinez, P. (2021). Dietary habits, lipoprotein metabolism and cardiovascular disease: From individual foods to dietary patterns. Critical reviews in food science and nutrition , 61(10), 1651-1669. https://doi.org/10.1080/10408398.2020.1764487

Haynes, E., Walker, R., Mitchell, A. G., Katzenellenbogen, J., D'Antoine, H., & Bessarab, D. (2021). Decolonizing Indigenous health: Generating a productive dialogue to eliminate rheumatic heart disease in Australia. Social Science & Medicine , 277, 113829. https://doi.org/10.1016/j.socscimed.2021.113829

Kaiser, J., van Daalen, K. R., Thayyil, A., Cocco, M. T. D. A. R. R., Caputo, D., & Oliver-Williams, C. (2021). A systematic review of the association between vegan diets and risk of cardiovascular disease. The Journal Of Nutrition , 151(6), 1539-1552. https://doi.org/10.1093/jn/nxab037

National Health and Medical Research Council (NHMRC), (2018). National Statement on Ethical Conduct in Human Research (2007). www.nhmrc.gov.au/guidelines/publications/e72

Parekh, T., Xue, H., Cheskin, L. J., & Cuellar, A. E. (2022). Food insecurity and housing instability as determinants of cardiovascular health outcomes: a systematic review. Nutrition, Metabolism and Cardiovascular Diseases , 32(7), 1590-1608. https://doi.org/10.1016/j.numecd.2022.03.025

Seivwright, A. N., Callis, Z., & Flatau, P. (2020). Food insecurity and socioeconomic disadvantage in Australia. International Journal Of Environmental Research And Public Health , 17(2), 559. https://doi.org/10.3390/ijerph17020559

Thomas, M. K., Lammert, L. J., & Beverly, E. A. (2021). Food insecurity and its impact on body weight, type 2 diabetes, cardiovascular disease, and mental health. Current Cardiovascular Risk Reports, 15, 1-9. https://doi.org/10.1007/s12170-021-00679-3

Zaman, S., MacIsaac, A. I., Jennings, G. L., Schlaich, M. P., Inglis, S. C., Arnold, R., ... & Bhindi, R. (2020). Cardiovascular disease and COVID‐19: Australian and New Zealand consensus statement. Medical Journal of Australia , 213(4), 182-187. https://doi.org/10.5694/mja2.50714

Zwack, C. C., Smith, C., Poulsen, V., Raffoul, N., & Redfern, J. (2023). Information needs and communication strategies for people with coronary heart disease: a scoping review. International Journal of Environmental Research and Public Health , 20(3), 1723. https://doi.org/10.3390/ijerph20031723