Research Ethics and Integrity Flashcards

Ethics and Integrity

Introduction

• Calvin's perspective: "Get what you can while the getting's good." Might makes right, and winners write history books.
• Waver sin's view: No belief in ethics; it's a dog-eat-dog world. The ends justify the means.

Ethics vs. Integrity

• Research Integrity: Encompasses honesty, rigor, and transparency throughout the research process.
  • Applies to all types of research.
  • Guided by the Australian Code for the Responsible Conduct of Research.
• Research Ethics: Addresses moral considerations and ethical treatment of research subjects.
  • Focuses on informed consent, participant welfare, and ethical implications.
  • Governed by guidelines like the National Statement on Ethical Conduct in Human Research.

Core Principles of Integrity

• Honesty
• Rigour
• Transparency
• Fairness
• Respect
• Recognition
• Accountability
• Promotion

Researcher Responsibilities

• Be safe.
• Keep records.
• Share findings and data.
• Be honest and accurate.
• Maintain rigour and objectivity.
• Cite well.
• Acknowledge and share contributions.
• Be a good peer reviewer.
• Disclose conflicts of interest.
• Respect culture and heritage.
• Supervise well.
• Undertake training.
• Use funds as agreed.
• Consider the uses of your research.
• Seek advice.
• Report problems.

When Research Goes Wrong

• Fabrication, Falsification, Misrepresentation:
  • Fabrication of research data or source material.
  • Falsification of research data or source material.
  • Misrepresentation of research data or source material.
• Plagiarism:
  • Plagiarism of someone else’s work.
  • Duplicate plagiarism (self-plagiarism) without acknowledgement.
• Research Data Management:
  • Failure to appropriately maintain research records.
  • Inappropriate destruction of research records.
  • Inappropriate disclosure of, or access to, research records.
• Peer Review:
  • Failure to conduct peer review responsibly.
• Conflicts of Interest:
  • Failure to disclose and manage conflicts of interest.
• Authorship:
  • Failure to acknowledge contributions of others fairly.
  • Misleading ascription of authorship.
• Supervision:
  • Failure to provide adequate guidance or mentorship on responsible research conduct.
• Conducting research without ethics approval.
• Failing to conduct research as approved by ethics.
• Conducting research without required approvals, permits, or licenses.
• Misuse of research funds.
• Concealment of breaches.
• Not meeting required research standards.

Ethics Codes in Australia

• National Statement on Ethical Conduct in Human Research (2023).
• AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research.
• Australian code for the care and use of animals for scientific purposes (8th Edition 2013).
• National Framework of Ethical Principles in Gene Technology 2012.

Ethics and Compliance Approvals

• All researchers and research students must have research proposals reviewed if they work with people, animals, biohazards, or genetic modification.

Why Ethics?

• Protects participants, animals, and the environment.
• Protects researchers.
• UWA's institutional values include honesty and respect for the community and staff.

What is Research?

• The creation of new knowledge and/or the use of existing knowledge in a new and creative way.
• May include synthesis and analysis of previous research.

Who is a Researcher?

• Academic employees.
• Research adjuncts.
• Research students (Honours, Masters, Doctoral).
• Early career Postdoctoral staff with a research component to their study.
• Honorary Research Fellows.
• Visiting research appointments.

The National Statement

• The National Statement on Ethical Conduct in Human Research (2023) provides guidelines to assess if research meets ethical standards.

Is it Human Research?

• Human research is research conducted with or about people, or their data or tissue.

Values and Principles

• Merit and integrity (Justifiable, appropriate methods, competence, facilities).
• Justice (fair, accurate, access).
• Beneficence (minimise risk & discomfort, participants informed).
• Respect (dignity, beliefs, customs, culture, privacy, right to decide).

Participant Categories

• People in other countries (their rules apply).
• Children and young people (capacity, coercion, conflict with parents).
• People in dependent or unequal relationships (students, employees, prisoners).
• Women who are pregnant and the human fetus.
• Highly dependent on medical care, unable to give consent.
• Cognitive impairment, intellectual disability, or mental illness.
• People who may be involved in illegal activities.
• Aboriginal and Torres Strait Islander Peoples.

Risk in Human Research

• Some human research is low or negligible risk (no risk of harm).
• Examples of Harm:
  • Physical harm: including injury, illness, pain or death;
  • Psychological harm: including feelings of worthlessness, distress, guilt, anger, fear or anxiety related, for example, to disclosure of sensitive information, an experience of re-traumatisation, or learning about a genetic possibility of developing an untreatable disease;
  • Devaluation of personal worth: including being humiliated, manipulated or in other ways treated disrespectfully or unjustly;
  • Cultural harm: including misunderstanding, misrepresenting or misappropriating cultural beliefs, customs or practices;
  • Social harm: including damage to social networks or relationships with others, discrimination in access to benefits, services, employment or insurance, social stigmatisation, and unauthorised disclosure of personal information;
  • Economic harm: including the imposition of direct or indirect costs on participants;
  • Legal harm: including discovery and prosecution of criminal conduct.

Low Risk Review

• Low Risk Review Panel = Online Assessment.
• At least two independent reviewers.
• Do not physically meet.
• Dynamic, no deadlines, dependent on reviewers.
• For all applications a quality review is performed by the office.

Detecting Harm: Examples

• Example 1: Graphic videos of fatal accidents shown to emergency responders without informed consent.
• Example 2: Collection of sacred plants from an Indigenous community without permission.
• Example 3: Genetic predisposition to substance addiction study in a rural community leading to stigmatization.

Higher Risk Research

• Concealment.
• Tissue Samples.
• Pregnant women / foetus.
• Medically dependent.
• Dependent / Unequal Relationships (prisoner / student / patient).
• Cognitive impairment.
• Illegal activity.
• Focus on Aboriginal & Torres Strait Islander including Culture, lands, knowledge, art.

Surveys

• If you are asking questions and collecting answers, it’s human research.
• If you’re asking questions that aren’t likely to result in harm, it will be low risk.
• Participants can ask for their data to be removed at any time.

Commercial Human Cell Lines

• Collected with ongoing consent (there should be proof of this from the company)
• Low Risk Review (fast turn around)
• BUT MUST STILL HAVE ETHICS Approval

The AIATSIS Code Requirements

• Consult with traditional owners for all research which is:
  • involving Indigenous people (as either participant or partner/stakeholder);
  • that deals with, affects, or incorporates ICIP or other data, including language, stories, songs, dance, artworks, cultural practices, ceremonies, sites, objects, artefacts, family histories, agricultural, scientific or ecological knowledge (of plants and animals, medicines, land management);
  • on or in or in relation to Indigenous lands or waters, including accessing Country to take samples.

Animal Research

• All research Involving animals needs Animal Ethics Committee Approval

Animal Ethics Code

• The Animal Welfare Act 2002 [The Act] | State Government [https://www8.austlii.edu.au/cgi-bin/viewdb/au/legis/wa/consol_act/awa2002128/]
• The Australian code of practice for the care and use of animals for scientific purposes (2013) [The Code] | NHMRC

Principles of Animal Ethics

• Respect for animals and providing for the wellbeing of animals involved
• Using animals only when it is justified
• High standards of scientific integrity
• The 3 Rs:
  • Replacement of animals with other methods
  • Reduction in the number of animals used
  • Refinement of techniques to minimise the adverse effects on animals.

Genetic Modification

• GENE TECHNOLOGY ACT 2000 (AUSTRALIA)

Biohazards and Biosafety

• Ensuring the safety of the researchers
• Ensuring the safety of others in the research environment
• Protecting the environment from exposure to GMO and biohazards. PC1, PC2, PC3 & PC4. (OGTR / UWA)
• Accomplished by multiple levels of containment, and independently reviewed and certified facilities and projects.

Ethics Processes at UWA

• Apply for Ethical review (Online ROAP Application Form)
• Assess Risk
• Endorsement/ Quality check (Ethics Office)
• Committee Agenda (Committee requires modifications; Ethics Committee)
• Guidance
• Approved
• Conduct research according to approved protocol
• Report Progress; Report Complete; Adverse Event
• Amendment
• Publication

Tips for Writing Applications

• Allow Time
• Communicate clearly.
• Self-explanatory and self-sufficient
• Use the guidelines
• Complete package
• Label documents
• Place yourself in the role of a participant

Common Issues in Human Ethics

• Research team members
• Incorrect HoS
• Research design-time commitment, Surveys (anonymous or not)
• Lack of Clinical Trial protocol document
• Sample size
• Recruitment process
• Data management
• Risk identification & mitigation strategies
• PIF- student details instead of CI

Low Quality Ethics Applications

• Non-compliant studies
• Insufficient protection of participants/animals/environment
• Risk to University (compliance, reputational, legal)
• Lengthy application turnaround times
• Multiple rounds of reviews/modifications
• Misaligned expectations.

Authorship

• An author MUST have all four of these:
  • Substantial contributions to the work
  • Drafting or reviewing the writing
  • Final approval
  • Accountability for all aspects

Authorship Taxonomy (CRedIT)

• Conceptualisation
• Methodology
• Software
• Validation
• Formal analysis
• Investigation
• Resources
• Data Curation
• Writing-original draft
• Writing- review and editing
• Visualisation
• Supervision
• Project administration
• Funding acquisition

Authorship Agreements

• Talk to each other and get agreement!
• Authorship on a paper, presentation, or other scholarly work indicates a substantial contribution to a project and accountability for the results.
• Authorship decisions often affect reputations and careers, and they can be a source of tension, even within healthy collaborations.