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
Research
The purpose of the code is to guide institutions
and researchers in responsible research
practices and promote integrity in research.
Mawson
Institute
Mawson
Institute
Sansom
Institute
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.
Hawke Research Institute
Mawson
Institute
Mawson
Institute
for
Sustainable
Scieties
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
Mawson
Institute
Ethical Review
Mawson
Institute
Mawson
Institute
•
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)
•
•
•
•
•
•
Mawson
Institute
Mawson
Institute
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.
Training
Mawson
Institute
Mawson
Institute
•
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
Australian Code
Mawson
Institute
Mawson
Institute
•
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
•
Mawson
Institute
Mawson
Institute
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
Mawson
Institute
Mawson
Institute
Australian Code
What is “research”?
Mawson
Institute
Mawson
Institute
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
Mawson
Institute
Mawson
Institute
•
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.
Publication of
Research Findings
Mawson
Institute
Mawson
Institute
•
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.
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.
Mawson
Institute
Mawson
Institute
•
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'.
•
Mawson
Institute
Mawson
Institute
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
Mawson
Institute
Mawson
Institute
Governance Framework endorsed by Academic
Board in March 2008
RIACC: Terms of
Reference
Mawson
Institute
Sansom
Mawson
Institute
•
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.
RIACC: Terms of
Reference
Mawson
Mawson
Institute
Institute
forInstitute
Telecommunications Research
•
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.
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
Mawson
Institute
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
National Statement
Mawson
Institute
Mawson
Institute
•
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.