1. Research ethics and responsible research at UniSA Presented By: Prof Ian Richards Dr Mark Hochman

2. National Statement and the Code National Statement on Ethical Conduct in Human Research 2007National Statement on Ethical Conduct in Human Research 2007. The purpose of the National Statement is to promote ethical human research. Australian Code for the Responsible Conduct of Research The purpose of the code is to guide institutions and researchers in responsible research practices and promote integrity in research. Mawson Institute Sansom Institute

3. National Statement The revised NS includes provision for institutions to establish different levels of ethical review for research with different levels of risk: o 'negligible risk' - no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience. o 'low risk' - the only foreseeable risk is discomfort. o 'more than low risk' - the foreseeable risk is more than discomfort. Mawson Institute Hawke Research Institute for Sustainable Scieties

4. National Statement University Response: Established the National Statement Steering Committee responsible for: o overseeing the development of an ethical review structure providing for different levels of ethical review for research with different levels of risk; o managing the implementation of an online research ethics approval system; o ensuring that the University is positioned to meet the requirements of the National Statement; and o overseeing the changes to current Human Research Ethics Committee business processes. Mawson Institute

5. Ethical Review Applications which qualify as E1 will be reviewed by the Chair or Deputy Chair of HREC. Applications which qualify as E2 will be reviewed by a panel consisting of the Chair or Deputy Chair of HREC, an academic staff member with relevant qualifications and research experience and an external member of HREC. Applications which qualify as E3 must be reviewed by UniSA’s HREC. Course approvals - umbrella ethics approvals for courses in which a cohort of students undertake short duration research projects. Mawson Institute

6. Research Ethics Advisors (REAs) Provide a local level of advice and assistance to researchers; Conduct local seminars/ workshops on research ethics and research conduct. Provide a communication conduit between their local area and UniSA’s HREC Provide input to the formulation of new policies and procedures Facilitate greater communication between elements and the ethics committees. Be available to serve on the Panel for Expedited Review ( Level 2) for applications from their local grouping and to serve on HREC as required. Mawson Institute

7. Training Training program for REAs Program for Supervisors and HDR students Collaborative project. o An overview of ethics and integrity in research with humans o Ethical considerations for specific research methods and approaches o Applying for HREC approval Mawson Institute

8. Australian Code The Code replaces the Joint NHMRC/AVCC Statement and Guidelines on Research Practice (1997). Endorsed by the NHMRC, ARC and Universities Australia. The Code advocates and describes best practice in research for researchers and institutions, as well as setting out a framework for handling breaches of the Code. Mawson Institute

9. Australian Code The Code is in two parts: o Part A advocates and describes best practice for both institutions and researchers. o Part B provides a framework for handling breaches of the Code and research misconduct. Mawson Institute

10. Australian Code The Code specifies; o Responsibilities of institutions and o Responsibilities of researchers Main topics addressed: o Management of research data and primary materials o Supervision of research trainees o Publication and dissemination of research findings o Authorship o Peer review o Conflicts of interest o Collaborative research across institutions Mawson Institute

11. Australian Code What is “research”? o The Code defines “research” as original investigation undertaken to gain knowledge, understanding and insight. o It is broad: there is no simple, single way to define research for all disciplines. Mawson Institute

12. Publication of Research Findings Researchers have a responsibility to their colleagues and the wider community to disseminate a full account of their research as broadly as possible. The account should be complete, and, where applicable, include negative findings and results contrary to their hypotheses. Mawson Institute

13. Publication of Research Findings Researchers must, where feasible, also provide research participants with an appropriate summary of the research results. Researchers must take all reasonable steps to ensure that their findings are accurate and properly reported. If they become aware of misleading or inaccurate statements about their work, they must correct the record as soon as possible. Mawson Institute

14. Publication of Research Findings It is not acceptable to include the same research findings in several publications o except in rare circumstances eg review articles, anthologies, collections, or translations into another language. A publication must include information on all sources of financial and in-kind support for the research and any potential conflicts of interest. Researchers must acknowledge the host institution and funding sources of the research. Mawson Institute

15. New Governance Framework University Response: The Code requires that institutions provide an appropriate research governance framework through which research is assessed for 'quality, safety, privacy, risk management, financial management and accountabilities of those who play a part in research'. Establishment of Research Integrity, Accountability and Compliance Committee (RIACC). Mawson Institute

16. New Governance Framework What is RIACC and what does it do? An overarching committee reporting to Academic Board. Oversees research ethics, integrity and compliance issues and deal with those that require an institutional response. Responsible for overseeing incorporation of the National Statement and Australian Code requirements Mawson Institute

17. Governance Framework endorsed by Academic Board in March 2008

18. RIACC: Terms of Reference To promote the responsible conduct of research and ensure that the institution has in place policies and processes which meet the requirements of the Australian Code. To monitor institutional compliance with appropriate legislation and codes governing research ethics, integrity and safety. Mawson Institute Sansom Institute

19. RIACC: Terms of Reference To monitor the provision of training and education programs and other resources, to ensure University staff and students are aware of compliance and accountability requirements arising from adherence to national research ethics, integrity and safety legislation and codes. To approve annual research ethics and safety reports as required by legislation prior to submission to external regulatory bodies. Mawson Institute Institute for Telecommunications Research

20. RIACC: Membership Prof Caroline McMillen, Deputy VC, Research and Innovation (Inaugural Chair) Prof Ian Richards, Chair HREC and Chair NS Steering Committee Prof Mary Barton, Chair, Institutional Biosafety Committee and Animal Ethics Liaison Committee Dr Euan Smith, Chair, Chemical Hazards Sub-Committee Dr Mark Hochman, Director: Research and Innovation Services Prof Nanthi Bolan, Acting Dean of Graduate Studies Representative, Advisors on Research Integrity (to be appointed) Prof Patrick James, Representative of the Heads of School Assoc Prof Pat Buckley, Representative of the Deans of Research Mr Mark Gladigau, Acting Director, Human Resources Ms Vicki Allen, Ethics and Compliance Officer (Executive Officer) Mawson Institute

21. National Statement Implementation Timeline: Governance o New Governance framework approved March 2008 o RIACC held its first meeting 18 April 2008 o Change current policies and procedures to ensure compliance: End 2008 o Appointment of Research Ethics Advisors: September 2008 o Establishment of Reference Group of senior researchers: June/July 2008. Mawson Institute

22. National Statement Communication and Education o HDR workshops held in February 2008 o Monthly Research EDGE newsletter implemented o REA training and workshops: October 2008 o Supervisor training developed: End of 2008, and roll out 2009. Processes and Systems o Online Ethics Approval System: mid 2009. Mawson Institute