“What’s Ethics Got To Do With It”
Presentation to the Canberra Evaluation Forum
Gary Kent
Head Governance
Australian Institute of Health and
Welfare
What is Ethics?
• Internet Encyclopaedia of Philosophy defines ethics
as:
– ‘the branch of philosophy that involves
systematizing, defending, and recommending
concepts of right and wrong conduct’
• This talk is about a specific branch of ethics.
• That dealing with research conducted with or about
people, or their data or their tissue.
What is ‘human research’?
• Examples of human research include:
– Interviews
– Surveys
– Focus Groups
– Observations
– Chat rooms
– Testing.
The Nuremberg Code (1947)
• Voluntary, well-informed, understanding consent of
the human subject in a full legal capacity.
• Research
– Should aim at positive results for society that
cannot be procured in some other way
– Should be based on previous knowledge that
justifies the experiment
– Should be set up in a way that avoids unnecessary
physical and mental suffering and injuries
– Should not be conducted when there is a risk of
death or disabling injury
– Risks should be in proportion to (that is, not
exceed) the expected humanitarian benefits.
• Preparations and facilities must be provided that
adequately protect the subjects against the
experiment’s risks.
• The staff who conduct in the experiment must be
fully trained and qualified.
• Human subjects must be free to quit the experiment
at any point when physically or mentally unable to go
on.
• Medical staff must stop the experiment when they
observe that continuation would be dangerous.
Helsinki Declaration (1966)
Basic principles –
• Respect for the individual.
• Individual’s right to self-determination and to make
informed decisions regarding participation in
research, both initially and during the course of the
research. The investigator's duty is solely to the
patient.
• While there is always a need for research, the
subject's welfare must always take precedence over
the interests of science and society Ethical
considerations take precedence over laws and
regulations.
• The recognition of the increased vulnerability of
individuals and groups calls for special vigilance.
• When the research participant is incompetent,
physically or mentally incapable of giving consent, or
is a minor.
• then allowance should be considered for surrogate
consent by an individual acting in the subjects best
interest.
– in which case their consent should still be
obtained if at all possible
Australia
• National Statement on Ethical Conduct in Human
Research (2007), as amended.
– developed jointly by the National Health and
Medical Research Council (NHMRC), the Australian
Research Council and Universities Australia
– its first predecessor was the Statement on Human
Experimentation, issued by the NHMRC in 1966
• Australian Code for the Responsible Conduct of
Research (2007).
– it guides institutions and researchers in
responsible research practices and promotes
research integrity
National Statement on Ethical Conduct
in Human Research
• The National Statement is intended for use by:
– any researcher conducting research with human
participants
– any member of an ethical review body reviewing
that research
– those involved in research governance
– potential research participants.
• Compliance with the National Statement is a
prerequisite for receipt of NHMRC funding.
• The National Statement focusses on the following
key values:
– respect
– research merit and integrity
– justice
– beneficence.
Privacy
• The Privacy Act 1988 (Privacy Act) establishes
obligations for private and public entities regarding
the collection, use and disclosure of personal
information.
• The Australian Privacy Principles (APPs) in the Act
govern these activities when undertaken by
Commonwealth agencies, including AIHW.
• NHMRC guidelines under section 95 of the Privacy
Act
– where an agency seeks to release personal
information for the purposes of medical research
which would otherwise constitute a breach of the
Privacy Act, the agency must be satisfied that
• the research has been approved by an
appropriately constituted Ethics Committee
• complies with the Guidelines.
The AIHW Ethics Committee
• Committee membership is
– Chair
– Director of the Institute
– a nominee of the State and Territory Registrars of
Births, Deaths and Marriages
– Individual with research knowledge and
experience
– a minister of religion
– a legal practitioner;
– representatives of general community attitudes;
and
– Individual with knowledge or experience in
medical research.
Functions of the Committee
• Sets the rules for use of AIHW unit record data.
• Considers the ethical implications of all proposed
projects.
• Advises the Institute as to whether projects satisfy
the criteria developed by the Committee.
• Monitors existing projects and determines whether
they continue to conform to standards approved by
the Committee.
• Provides a yearly report to the NHMRC.
2011 review of AIHW Ethics
arrangements
• In 2011 reviewed the effectiveness and
appropriateness of AIHW’s Ethics arrangements.
• Terms of Reference:
– Examine the AIHW’s ethics policies and processes
– Ensure that the AIHW is meeting its statutory,
regulatory and related obligations
– Ensure that the AIHW has appropriate policies and
procedures in place that provide for efficient,
accessible and transparent processes and
arrangements.
• Key findings included:
 the Committee’s existing terms of reference, should be
updated to unambiguously convey to internal and
external researchers those matters which are required to
be placed before the AIHW Ethics Committee.
 priority should be given to the creation of a register of
Ethics Committee-approved data collections and a
program developed for the audit of critical data sets.
 the Committee’s review criteria, practice and procedures
should be reviewed on a regular basis against current
legislative and regulatory practice and other sources of
best practice and recommended guidance.