“What’s Ethics Got To Do With It”

Presentation to the Canberra Evaluation Forum

Gary KentHead 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.