1 / 20

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.

hija
Download Presentation

Human Research Ethics

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related