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Research Ethics & Integrity: An Introduction
Presentation by Kristie Westerlaken Policy Officer, Research Ethics and Integrity
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Human Research: What is it?
Interviews Surveys Focus Groups Observations Chat rooms Psychological, physiological, medical testing or treatment Body organs, tissues, fluids or exhaled breath Data mining - identifiable, re- or non-identifiable information – published or unpublished
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Background to Human Research Ethics
World War II See Unit 731 (Japanese) for biological and chemical warfare Mengele – 1500 sets of imprisoned twins Luftwaffe – freezing experiments Dachau – Malaria treatment Etc, well documented episodes of inhumanity. Following the Doctors’ Trials at Nuremberg the Tribunal delivered their opinion on medical experimentation on human beings – The Nuremberg Code (1947). Nuremberg Code
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2. UN Declaration of Human Rights Declaration of Helsinki (WMA)
World Medical Association developed a set of ethical principles for the medical community regarding human experimentation – Helsinki 1966. Self – determination Informed Consent Ethical Principals and the Guidelines for the Protection of Human Subjects of Research – Belmont Report (1979) Respect for Persons Beneficence Justice Background cont’d 2. UN Declaration of Human Rights Declaration of Helsinki (WMA) Belmont Report tutorial/define.htm
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Background cont’d: Scandals
Tuskegee Alabama Clinical study that recruited 399 African Americans with syphilis. Research into the natural progression of the untreated disease in hopes of justifying treatment programs. Investigators failed to treat patients appropriately after the validation of penicillin as an effective cure. Necessity of informed consent Communication of diagnosis Accurate reporting of results Federal legislation following Belmont report into Institutional Review Boards. Tuskegee Study of Untreated Syphilis in the Negro Male
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Background cont’d: Scandals
Philip Zimbardo – 1971 24 undergraduates were selected to play the roles of prisoners and guards in a mock prison. Role play – but went beyond the boundaries. One-third of guards judged to exhibit ‘sadistic’ tendencies. Stanley Milgram – 1963 How much pain an individual would inflict on another simply because s/he were ordered to by a scientist. Obedience of authority v individual morality Replicated Nazi criminality. 2. Stanford Prison Experiment 3. Milgram Experiment (Yale) Obedience to Authority – an experimental view (1974) "The social psychology of this century reveals a major lesson: often it is not so much the kind of person a man is as the kind of situation in which he finds himself that determines how he will act." (1974)
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Background cont’d: Scandals
Watch Queen Observation of homosexual acts in public toilets. Recorded car licence plates. Learned of names and addresses from friendly policemen while pretending to be a market researcher. As a public health surveyor interviewed men he had observed. Most men married and secretive about homosexual activity. Laud Humphreys – The Watch Queen in the Tea Room (1967)
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Social scientists do not have an inalienable right to conduct research involving other people
(Oakes, 2002).
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Principles of Ethical Conduct in Human Research – 4 values
Research merit & integrity Respect for persons Beneficence Justice RELEVANT TO ALL HUMAN RESEARCH
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Governance of Research Ethics in Australia & Griffith University
National Statement on Ethical Conduct in Human Research (2007) Australian Gov’t National Health and Medical Research Council/Australian Research Council and Australian Vice-Chancellors’ Committee Australian Code for the Responsible Conduct of Research (2007) Griffith University Code for the Responsible Conduct of Research
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Practical Ethics Engage with ethics - NOT just form filling
Not someone else’s problem A continuing dialogue until research is completed Intent is to improve research design and quality of results Design Quality Conduct Office for Research
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Research Ethics Manuals
Human Ethics Research Ethics & Integrity Human Research Ethics Manual Office for Research
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Key Considerations Prior to Applying for Ethics
Specific participants: children & young people, women who are pregnant & human foetus, dependent or unequal relationships; highly dependent on medical care; cognitive impairment, intellectual disability, mental illness, illegal activity, Aboriginal & Torres Strait Islander Peoples, other countries Recruitment – Identification, first contact, incentives and risk Informed consent – voluntary, informed and understood Potential benefits – flow and description Potential risks – burden, balance, addressing and description Confidentiality – consent, identification, legislation and storage Other issues – use of third parties, phone-based, online and overseas
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Change to approved protocol Approval by multiple HREC
Applying for Ethics More than low risk Full Review Expedited Review 2 Low Risk Expedited Review 1 Negligible Risk Change to approved protocol Variation Approval by multiple HREC Prior Review Office for Research
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Expedited review National Statement Section 5.1.18-23
All research that involves no more than low risk Expedited Ethical Review Level 1 (Negligible Risk) - E1(NR). Submitted online and reviewed by the Office for Research (≈5 working days) Expedited Ethical Review Level 1 – E1: more than negligible risk, but no more than a low risk and no major ethical issues. Submitted online and reviewed by HREC Chair or Deputy Chair (≈ 10 working days) Expedited Ethical Review Level 2 – E2: risks and/or ethical issues may be present but addressed by research design. Submitted online and reviewed by HREC Panel (≈ 15 working days). Prior Review – already approved by another HREC. Cover form plus approval. Reviewed by the Office for Research (≈ 5 working days) Office for Research
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Expedited Review - How to Apply
Portal Research My Ethics New Application Submit Online Office for Research
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Full HREC review National Statement Section 5.1.6
All research that involves more than low risk Interventions and therapies, including clinical and non-clinical trials, and innovations Human genetics Human stem cells Women who are pregnant and the human foetus People highly dependent on medical care who may be unable to give consent, People with a cognitive impairment, an intellectual disability, or a mental illness Aboriginal and Torres Strait Islander People and Communities People who may be involved in illegal activities Office for Research
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Full Review - How to Apply
NHMRC Human Research Ethics Portal National Ethics Application Form Submit NEAF PDF to Office for Research Reviewed by Office for Research (possible expedited?) Referred to next HREC meeting Office for Research
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Ethical Review Results
RE-SUBMIT: application has gaps and flaws that are so frequent and/or serious that the application should not proceed without major revision. The HREC provides detailed guidance on what should be included in a resubmitted application. PROVISIONAL: gaps and flaws so a range of conditions is set by HREC that must be addressed before the research can start. CONDITIONAL: very few or no gaps and flaws and a smaller range of conditions is still set by HREC that must be addressed, but the research can start from the date of the conditional approval. The conditions are addressed while the research is under way. Provisional becomes conditional when most of the conditions are met. Provisional and conditional approvals become full approvals when all of the conditions are met. All of the review pathways (E1, E2, Prior Review and Full Review) utilise the provisional-conditional system. Office for Research
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What happens if the unexpected happens?
National Statement Chapter 5.5 requires appropriate, adequate, regular monitoring and reporting of approved research. Monitoring is institution and researcher responsibility. Advise your supervisor, REA and the Office for Research as soon as possible. Your first priority and ours is to: ensure immediate safety, minimise further risk, and protect future interests of participants, public, yourselves and the institution. Office for Research
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FAQs what are common mistakes made in the process?
Failure to plan/review ethics manual Omitting informed consent materials Omitting detailed information (e.g. brief lit review) that outlines the basis for the research aims/methodology Omitting detailed information relating to recruitment (e.g. sample size, how will you identify, approach, etc.) Supervisor must be identified as contact/Chief Investigator – Student = “Student Researcher” Lack of information relating to data storage, access, destruction what happens if I need to change or modify my protocol? Request a variation – to ethics team
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Research Integrity – It is all about you
Genuine Search for Knowledge Good Training Good Records Publication & Presentation Peer Review Office for Research
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Research Integrity Core Principles Honesty in all aspects of research.
Accountability in the conduct of research. Professional courtesy and fairness in working with others Good Stewardship of research on behalf of others
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Research Misconduct human research conducted without ethics approval
conduct of human research inconsistent with ethics approval failure to report and manage adverse events failure to protect participant safety, privacy, confidentiality fabrication of results falsification or misrepresentation of results plagiarism misleading ascription of authorship failure to declare and manage serious conflicts of interest Australian Code Griffith Code National Statement GUREM Booklet 7 Office for Research
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Conclusion: Why does research ethics matter?
Responsibility to participants – animal or human Professional obligations Use of public funds = obligation to community University reputation Future access to populations & sites Requirements of research funding bodies (state, federal & international) Requirements of many journals for publication Requirements of the University’s insurer (indemnification of researchers)
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Resources http://www.nhmrc.gov.au/
Griffith University Human Research Ethics Manual Supervisor Research Ethics Advisor (REA)
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Contacts Systems Support Officer Rhiannon Campbell 373 54855
Marnie Lawson Manager Rick Williams Policy Officer, Human Ethics Kristie Westerlaken Policy Officer, Animal Ethics Amanda Fernie
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