research ethics and responsible research at unisa

Research ethics and responsible research at UniSA

Presented By:

Prof Ian Richards

Dr Mark Hochman

National Statement and the Code

National 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 ResearchThe purpose of the code is to guide institutions and researchers in responsible research practices and promote integrity in research.

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http://www.nhmrc.gov.au/publications/synopses/e72syn.htm



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.

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National Statement

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

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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.


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 InstituteMawson Institute

Training

• Training program for REAs

• Program for Supervisors and HDR students

• Collaborative project.o An overview of ethics and integrity in

research with humanso Ethical considerations for specific

research methods and approacheso Applying for HREC approval


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.


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.


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


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.


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.



• 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.



• 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.


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).


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


Governance Framework endorsed by Academic Board in March 2008

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.

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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.

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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 InstituteMawson Institute

National Statement

Implementation Timeline:•Governance

o New Governance framework approved March 2008

o RIACC held its first meeting 18 April 2008o Change current policies and procedures to

ensure compliance: End 2008o Appointment of Research Ethics Advisors:

September 2008o Establishment of Reference Group of

senior researchers: June/July 2008.

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National Statement

• Communication and Education o HDR workshops held in February 2008o Monthly Research EDGE newsletter

implementedo REA training and workshops: October 2008o Supervisor training developed: End of

2008, and roll out 2009.

• Processes and Systemso Online Ethics Approval System: mid 2009.
