Human Ethics at ECU

Topic = Guest lecture 1 - Human Ethics at ECU (what, how and why)

Introduction to Ethics at Edith Cowan University (ECU)

  • Conceptual Definition of Ethics: Ethics are norms of conduct that distinguish between acceptable and unacceptable behaviour.

  • Societal Context: Ethical standards are integrated into various facets of society, including:     

  • Schools     

  • Workplaces     

  • Social settings     

  • The Law


  • The "Common Sense" Paradox: While ethics are often thought of as "common sense," the existence of frequent ethical disputes suggests widespread disagreement. Examples of complex ethical disputes include:     

  • Abortion     

  • Capital Punishment     

  • The War on Drugs

  • Evolution of Ethics: Ethical practices and standards are not static; they evolve over time.

The Importance of Ethics in Research

  • Truthfulness in Reporting: Ethical guidelines enforce honesty and prohibit the fabrication, falsification, or misrepresentation of data.

  • Case Study: Dr. William McBride:     

  • Background: An Australian gynecologist famous for identifying risks associated with Thalidomide.     

  • 1972 - Thalidomide: Thalidomide, a sedative used for anxiety, was linked to birth defects. McBride was awarded $40,000 for his work and used the funds to start a research center for birth defects.     

  • 1978 - Debendox: McBride claimed Debendox (an anti-nausea medication) also caused birth defects.     

  • Ethics Breach: Investigations revealed that McBride's evidence was entirely anecdotal and he had lied in his reports. Proper subsequent research did confirm Thalidomide's links to birth defects, but McBride's misconduct undermined research integrity.


  • Public Accountability: Researchers are often funded by "public money" and must remain accountable to the public through:     

  • Prevention of research misconduct.     

  • Management of conflicts of interest (e.g., funding sources).     

  • Protection of human and animal subjects.

  • Maintaining Public Support: Without public trust, it is difficult for researchers to find funding or recruit participants.

Famous Historical Examples of Unethical Research

  • Tuskegee Syphilis Experiment (1930s-1970s): A study on the natural progression of untreated syphilis in African American men who were misled and denied treatment.

  • The "Monster Study" on Orphans (1939): A stuttering experiment performed on orphan children in Davenport, Iowa, which resulted in psychological harm.

  • Stanford Prison Experiment (1971): A study on the psychological effects of perceived power, involving students acting as prisoners and guards, which quickly became abusive.

Regulatory Framework: The National Statement

  • National Statement on Ethical Conduct in Human Research (2007):     

  • Consists of guidelines formulated in accordance with the National Health and Medical Research Council Act 1992.     

  • Significant Update: 2018.


  • ECU Ethical Principles:     

  • Research Merit and Integrity: The research must be worthwhile, robust, competent, and honest.     

  • Justice: Ensures fair participant recruitment, equitable distribution of research burdens, and avoidance of exploitation.     

  • Beneficence: The potential benefits of the research must outweigh the risks to participants.     

  • Respect: Protection of privacy, confidentiality, and sensitivity to cultural differences.

Risks and Benefits in Human Ethics

  • Identifying Risk Factors: Researchers must consider variables such as nationality, age, and sex for all potential participants.

  • Scope of Ethics: Ethics approval is required even for simple activities, such as a classroom quiz. Questions must be reviewed for potential offense.

  • Avoiding Coercion: Personal relationships with potential participants do not grant a researcher the right to coerce them into a study.


  • Risk Tiers:     

  • Negligible Risk: Activities like anonymous Qualtrics surveys. These are easier to obtain ethics approval for.     

  • Complex Risks: Physical studies (e.g., studying muscle contractions on stairs) require details on variables like the number of stairs and their height.

Sensitive Information and Privacy

  • Definition: Sensitive information is any data that could cause harm to an individual if used inappropriately.

  • Privacy Act 1988 (Commonwealth):     

  • Regulates the handling of personal information in Australia.     

  • The act governs all personal information collected.     

  • Referenced update: Compilation No. 76 (23 August 2017), Act No. 92, 2017.


  • Management of Sensitive Data:     

  • Researchers must document the form of material (e.g., Questionnaire, video, telephone, verbal).     

  • Access Control: Data must be stored in a password-protected environment or a locked room with limited access.     

  • Beliefs and Delicate Questions: Questions regarding elections, religion, or criminal history (e.g., "Have you ever been in jail?") must be handled delicately, often by de-identifying responses.

Informed Consent and Participant Considerations

  • Informed Consent Requirements:     

  • Information letters must be accurate.     

  • Participants must have the right to withdraw at any time.     

  • Data should be de-identified where possible.     

  • Participants must be informed that they are in control and that the research benefits a specific cohort.


  • Special Considerations (National Ethics Guidelines Chapter 4): Certain groups require specific ethical attention:     

  • Individuals incapable of consent (e.g., terminal, intensive care, unconscious, or emergency patients).     

  • Individuals with cognitive impairment or mental illness.     

  • Research involving illegal activities.     

  • Aboriginal and Torres Strait Islander peoples.


  • Risk Reduction Strategies: Researchers should be authentic and transparent about the "how" and "why" of the study to make participants feel calm and confident.

Participant Identifiability Levels

  1. Individually Identifiable: Data from which the identity of a specific individual can reasonably be ascertained (e.g., name, image, date of birth, global identifier, or address).

  2. Re-identifiable: Data where identifiers have been removed and replaced by a code. It remains possible to re-identify the person by using the code or linking different data sets.

  3. Non-identifiable: Data that has never been labeled with individual identifiers or from which identifiers have been permanently removed. A subset includes data that can be linked to other data to show it is about the same subject without revealing their identity.

The ECU Ethics Journey and REMS

  • Research Ethics Management System (REMS): The online portal for ethics applications.

  • The Proportional Review Checklist (PRC): A two-part screening tool to determine the review pathway.

Proportional Review Checklist - Part 1 (PRC-1)

  • Prior Review: For projects already reviewed by another institution.

  • Mandated Review: For researchers who know their activity requires a full review.

  • Scope Checker: Determines if the work falls under the definition of human or animal research ethics.

  • Exemption Test: Checks if the research is exempt (e.g., use of existing data, archival research, quality assurance/audit, creative/journalistic output).

  • Development Phase: A 6-month period allowing the team to finalize procedures and instruments.

Proportional Review Checklist - Part 2 (PRC-2): Risk Rating

  • The system evaluates risk across six categories:     

  • 1. Physical     

  • 2. Social     

  • 3. Psychological     

  • 4. Economic     

  • 5. Legal     

  • 6. Environmental


  • Risk Rating Questions:     

  • 1. What is the initial risk rating before mitigation?     

  • 2. Describe mitigation activities to minimize risk.     

  • 3. What is the residual risk rating after mitigation?


  • Risk Levels:     

  • Negligible Risk: Reviewed by the Negligible Risk Subcommittee.     

  • Low Risk: Reviewed by HREC School Subcommittees.     

  • High Risk: Requires a full review by the Human Research Ethics Committee (HREC).

Institutional Ethics Structure at ECU

  • Academic Board: The delegating authority.

  • Human Research Ethics Committee (HREC): Reviews high-risk human research.

  • Animal Ethics Committee (AEC): Reviews animal research.

  • HREC Executive: Monitors REMS and Chair roles.

  • HREC School Subcommittees: Review low-risk research.

  • Negligible Risk Subcommittee: Review negligible-risk research.

Components of an Ethics Application

  • Qualifications: Identifying the team's expertise and the benefit of their involvement.

  • Aims and Themes: Defining research questions and their benefit to stakeholders.

  • Methods: Detailing the design, instruments (including psychometric properties), and how methods achieve the aims.

  • Recruitment: Nature of the participant pool, screening processes, and formal recruitment documents (flyers, emails).

  • Consent: Informed consent procedures, deception strategies (if applicable), and debriefing processes.

  • Data Management: Specifying project dates, collection methods, locations, storage (ECU centrally provisioned storage), and retention periods (stipulated by Western Australian University Sector Disposal Authority - WAUSDA).

  • Supporting Documents: Information letters, consent forms, invitation emails, interview questions, and supervisor consent.

Ethics Exercises and Reviewer Perspectives

Exercise 1: Writing Qualifications

  • Effective Example: "Dr. Balmer is a researcher and senior lecturer at ECU… offers ongoing support concerning recruitment, data collection, and logistics… experience will guide student X through this process well." (This emphasizes the specific role and benefit to the project rather than just listing degrees).

Exercise 2: Review Pathway Classification

  • Evaluation of toxic buildup of mould on scales in a fish factory: Full HREC.

  • Student evaluation of an assessment item via Questionnaire: Low Risk.

  • Analysis of student feedback via UTEI University Evaluations: Exempt.

  • Recruit carers of the sick or elderly for a questionnaire: Full HREC.

  • Blood collection added to an existing exercise study: Low Risk.

Identification Terminology for Reviewers

  • Individual Identifiability: Individuals are identifiable when identity can be reasonably ascertained via name, image, DOB, or address.

  • Re-identifiability: Using human tissue samples where details are replaced by a code, but genetic or similar profiling remains linked to a potential identity.

  • Non-identifiability: Participants have no contact with investigators and data can never be linked back to a specific individual.