Research ethics

Ethics is one of the main branches of philosophy that examines the rational justification for our moral judgements. Ethics is commonly understood as norms that distinguish between right or wrong and acceptable or unacceptable behaviour. Ethics is linked to ideas of ‘moral character’ and is concerned with how we treat one another. A central question in ethics is “What is good?” or “What is right?”

Research Ethics is a sub-branch of ethics. Research Ethics is concerned primarily with ensuring life, health, and the rights of persons are protected. Research Ethics governs the standards of conduct for researchers and is often written as codes and guidelines that set out what is considered the highest standard of research behaviour. 

All research involving human participants must be reviewed by an appropriately qualified and independent review body to ensure that planned and implemented research is ethical and that any potential risks are minimised, mitigated, or managed.

Guidelines for research ethics

In Australia, all medical and health research involving human participants is guided by the National Statement on Ethical Conduct in Human Research (the National Statement) National Statement on Ethical Conduct in Human Research (2023).  The National Statement sets out four values and principles intended to guide all research involving human persons: Research Merit and Integrity, Justice, Beneficence, and Respect. 

Research specifically with Aboriginal and Torres Strait Islander participants must follow the AIATSIS Code of Ethics that requires “review from a HREC that has Aboriginal and Torres Strait Islander membership and experience in reviewing Aboriginal and Torres Strait Islander research A Guide to applying: The AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research. (See also the National Statement, section 4.7, pp 79-81.)

All research involving humans must comply with ethical guidelines, namely:

National Statement on Ethical Conduct in Human Research (2023) 

Australian Code for the Responsible Conduct of Research (2018)

AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (2020)

A Guide to applying: The AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research

NHMRC Indigenous Ethical Guidelines

NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects – WMA – The World Medical Association.

Risk level and ethics review options

Researchers have options for the ethics review of their research, and these options relate to the level of risk of the project.

Within the Tasmanian Department of Health and the Tasmanian Health Service, all lower risk research is reviewed by the Low Risk Human Research Ethics Committee (LRR Ethics Committee). Low risk refers to “research in which there is no risk of harm, but in which there is a risk of discomfort and in which there may also be a foreseeable burden (low risk research) or research in which there is no risk of harm or discomfort but which includes a potential for minor burden or inconvenience (minimal risk research)” (National Statement 2023), and may also include some Quality Improvement (QI) and audit projects.

All higher risk research that involves more than a minimal or low risk and has a potential for harm is reviewed by an external Human Research Ethics Committee (HREC). 

Both the LRR Ethics Committee and external HRECs more broadly, are responsible for ensuring that research projects are “consent-worthy” before any potential research participants are invited to participate. 

National mutual acceptance (NMA) scheme

The National Mutual Acceptance (NMA) Scheme is a national system for the mutual acceptance of single scientific and ethical review of multi-centre human research projects conducted in publicly funded health services across Australian jurisdictions. The NMA Scheme is recognised as a key enabler for clinical trials and research conducted in Australia. NMA is part of a broader ethics and governance reform that aims to reduce the duplication in the conduct of scientific and ethical reviews of multi-jurisdictional research. The scientific and ethical review of a multi-centre human research project must be conducted by an NMA Certified Human Research Ethics Committee. All states and territories now participate in the scheme. 

If an ethics application requires consideration by an NMA HREC, please refer to the full list of NMA certified HRECS on the NMA website: National Mutual Acceptance - Clinical Trials and Research.

Low risk research pathway

Within the Tasmanian Department of Health all lower risk research and QI/Audit projects requiring ethics review will be reviewed by the Low Risk Human Research Ethics Committee (LRR Ethics Committee).

Low risk research ethics committee membership

The LRR Ethics Committee is constituted in line with the National Statement and includes a minimum of eight members, namely:

• A chairperson, with suitable experience, including previous membership of an HREC, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under the National Statement.
• At least two members who bring broader community or consumer perspectives and who have no paid affiliation with the Department of Health (DoH), the Tasmanian Health Service, Ambulance Tasmania or any agency associated with the DoH.
• At least one member with knowledge of, and current experience in, the professional care, counselling, or treatment of people; for example, a nurse, medical practitioner, or allied health professional.
• At least one member who performs a pastoral care role in a community, for example, an Aboriginal and/or Torres Strait Islander Elder or community leader, a chaplain or a minister of religion or another religious leader. 
• A qualified lawyer, and where possible one who is not engaged to advise the institution on research-related or any other matters.
• At least two members with current research experience relevant to research proposals to be considered at the meetings they attend.

The LRR Ethics Committee also maintains a "Pool of Experts". This is a pool of additional members whose expertise is drawn upon as required to assist with scientific review, ethical deliberations, and decision-making.

Research ethics committee procedures

• Low Risk Research Procedure
• Low Risk Research Ethics Committee
• Ethics Review Administration
• Handling Conflict of Interest
• Handling Participant Queries and Complaints
• Selection and Training of Ethics Committee
• Exemptions
• Onboarding and Offboarding Low Risk Research Ethics Committee Members

Research ethics review process

Meeting dates and deadlines 2024

Preparing an ethics application

All proposed research projects, and QI/Audit projects requiring ethics oversight must undergo ethics review. 

If applying to the DoH Low Risk Ethics Committee, researchers must first contact the Research Ethics Office. Applications must then be submitted through REGIS. The documents required for a complete Ethics application depend on the type of research project to be conducted. A description of research types and the associated mandatory documents can be found below. 

• View the Mandatory Document Checklist

Submissions

Ethics applications to be considered for the low risk research pathway are to be submitted through REGIS.