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Human Research Ethics

Human Research Ethics. A/Prof Michael Grimm Presiding Member Human Research Ethics Committee A. Overview. What is ethical human research? What is the HREC? Who should apply to HREC? How does a researcher apply to HREC? What about HREA panels? What are the typical pitfalls? Questions.

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Human Research Ethics

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  1. Human Research Ethics A/Prof Michael Grimm Presiding MemberHuman Research Ethics Committee A

  2. Overview • What is ethical human research? • What is the HREC? • Who should apply to HREC? • How does a researcher apply to HREC? • What about HREA panels? • What are the typical pitfalls? • Questions

  3. What is ethical human research? • 1947 - Nuremberg trials • 1948 - UN Declaration of Human Rights • 1964 - Declaration of Helsinki • 1966 - Statement on Human Experimentation (NHMRC) • 1966 - UN Covenant on [Human] Rights • 1972 - Tuskegee syphilis study revelations • 1986 - NZ cervical cancer study revelations • 2006 - Phase 1 trial of CD28 antibodies, UK • 2006 - Latrobe/UNSW sexual health study

  4. What is ethical human research? • Community expectations: • highest standards of academic and ethical integrity • code of ethics applicable to all research which either involves humans directly, or impacts upon them either directly or indirectly

  5. What is ethical human research? • National Statement on Ethical Conduct in Research involving Humans (1999): • NHMRC • ARC • AVCC • Academies of Science, Humanities, Social Sciences, Engineering & Technology • http://www.nhmrc.gov.au/publications/synopses/_files/e35.pdf

  6. What is ethical human research? Key issues to consider: • Harm • physical, psychological, financial, social, cultural • to individuals (participants or researchers) or to groups • Privacy and confidentiality • Research design • Legal requirements • Privacy • Working with children • Human tissue

  7. What is ethical human research? Key concepts to consider: • Integrity • commitment to the search for knowledge • Respect for persons: • autonomy of individuals and groups • protection for those with diminished autonomy • Beneficence: • maximise benefits and minimise harms • Justice: • balance benefits and burdens of research

  8. What is ethical human research? • Ultimately grey at the edges • guidelines, not laws • different institutions = different HRECs • broad membership of HREC

  9. What is the HREC? • Seven or more members including: • a chairperson • two lay members (one male, one female) • at least one member with relevant knowledge and experience in the common research domains at UNSW • at least one member with knowledge and experience in health care • at least one minister of religion • at least one lawyer

  10. What is the HREC? • Predominantly volunteers • Two parallel committees • Ethics secretariat (staff of 4) • Approximately 75/month: new applications, modifications, ratifications • Supervises >60/month “low risk” applications through HREAPs

  11. Who should apply to the HREC? • Any research involving humans carried out: • on UNSW staff, students or affiliates • by UNSW staff , students or affiliates • on UNSW premises • using UNSW equipment • Except, where there is no risk of: • harm • invasion of privacy/breach of confidentiality

  12. How does a researcher apply to HREC? • Downloadable UNSW form with embedded guidelines/links, or NEAF • Timing - monthly deadlines (1st Tues) • Head of School review and signature • Other governance requirements: • Research services, Biosafety committee, OGTR, etc

  13. How does a researcher apply to HREC? • NEAF • National Ethics Application Form • An attempt to standardise across jurisdictions and research fields • Web-based: https://www.neaf.gov.au/

  14. What about HREA panels? • Nine Faculty and School-based panels • Research with “minimal ethical impact” • Downloadable form – simple, short • Brief project description • Timing - variable deadlines

  15. What about HREA panels? • “Minimal ethical impact” • little or no risk of harm (physical, emotional, cultural, financial) • non-sensitive subject matter • no significant likelihood of invasion of privacy, or breach of confidentiality

  16. What are typical pitfalls? • Recruitment of subjects - “arm’s length” • Opt in vs opt out • Incentives and inducements • Nature of research and associated risks • Privacy and confidentiality issues • Written informed consent • Subject Information Sheet and Consent form

  17. Concluding comments • Facilitating ethical research is the goal of the HREC • Non-adversarial approach • Timely review • Raising awareness of ethical concerns • “Expert” assistance available ethics.sec@unsw.edu.au

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