Ethics and Governance Seminar Series

Whether you are starting, joining or ending a project, look no further than the Monash Health ‘Ethics and Governance 4 Part Series: Beginning to End and More’ Seminars.

The seminars have been specifically designed to cover the main areas of research ethics and governance, step by step from pre-submission, to submission, to project conduct and close out.

The seminars also provide an overview of ethics and governance, guidelines, ethics submissions for all risk categories, Site Specific Applications and Governance, as well as, several main topics such as informed consent, safety, post approval submissions, monitoring and a wide selection of associated topics.

Session 1

  • Guidelines, Legislation, Policies and Procedures
  • Human Research Ethics Applications
  • ERM – Ethical Review Manager
  • Ethics Documents – HREA – Protocol – VSM – IB – PICF – Radiation
  • Low Risk Projects
  • Quality Assurance Projects

Ethics and Governance Seminar Presentation – Session 1 (29 October 2020)

Ethics and Governance Presentation Video – Session 1 (29 October 2020)

Session 2

  • Site Specific Assessment (Governance) Applications
  • ERM – Ethical Review Manager
  • Supporting Departments
  • Participant Information and Consent Forms
  • Good Clinical Practice Training
  • Legal Documents – Agreements – Indemnities – Insurance
  • Monash University Financial Arrangements and Invoicing

Ethics and Governance Seminar Presentation – Session 2 (12 November 2020)

Ethics and Governance Presentation Video – Session 2 (12 November 2020)

Session 3

  • Responsibilities – Investigators – Sponsors
  • Study Site Master File and Essential Documents
  • Delegation, Training, Investigational Product, Case Report Forms
  • Data, Privacy, Recruitment
  • Informed Consent – Witnesses, Translations, Vulnerable Patients
  • Incompetent Patients – Medical Treatment Planning and Decisions Act.

Ethics and Governance Seminar Presentation – Session 3 (24 November 2020)

Ethics and Governance Presentation Video – Session 3 (24 November 2020)

Session 4

  • Post Approval Submissions
  • HREC & SSA Amendments
  • Safety Reporting
  • Protocol Breaches
  • Annual Research Progress Reports
  • Audits
  • Intellectual Property
  • Supplementary information

Ethics and Governance Seminar Presentation – Session 4 (30 November 2020)

Ethics and Governance Presentation Video – Session 4 (30 November 2020)