Human Research and Ethics

University of Melbourne

Outline of this session This is a mandatory component of ‘why

we have Human Research Ethics’. I will quickly outline: Basic ethics principles Which projects need approval Current project exemptions Why you need ethics approval What ethics committees look out for University of Melbourne Human Ethics

Structure Supervisor’s Role Approval Process

Basic ethical principles Research merit and integrity

using appropriate methods and based on the current study of literature

Justice recruitment is fair and reasonable whereby it

doesn’t place an unfair burden on those participating

has a reasonable distribution of benefits and doesn’t exploit those who participate

Beneficence is the contribution of knowledge within the wider

community Respect

is abiding by the above three ethical principles and the right of the participant to say ‘no’

Which projects need approval?

Current University and NHMRC policy states that “all research projects involving human participants must be reviewed by institutional ethics committees”

See both University and NHMRC policies at - http://www.research.unimelb.edu.au/humanethics/aboutapproval/whyapproval.

Some projects are exempt from ethical review.

Projects which are exempt #1

Use of data freely available in the public domain

Research about a living individual using only public domain information

Pure observation studies of public behaviour

Pure observation studies in educational settings

Quality assurance projects

Projects which are exempt #2

Testing within standard educational requirements, following standard practices

Student education and training exercises (but no testing of each other allowed)

Student coursework assignments and essays, where no data is collected from human participants

University student evaluations of teaching

Taste and food quality evaluations

Why do I need ethics approval?

To protect the rights and welfare of human participants

To ensure that any risk of discomfort or harm to participants is minimal, and justified by the potential benefits of the research

To protect the University’s reputation for research that it conducts and/or sponsors

To minimise the potential for claims of negligence made against researchers and the University

To meet the University’s obligations under the NHMRC’s National Statement on Ethical Conduct in Human Research (March 2007)

What do ethics committees look out for?

Is there a risk of physical, psychological, spiritual or emotional harm?

Is there potential for infringement of privacy, confidentiality, or ownership?

Does the person’s involvement impose burdens that outweigh the benefit?

Issues for Ethics Committees

Aim of research Methodology:

Does what you say on the form match what you tell participants you are going to ask them to do? (in the Plain Language Statement)

Does what you are asking participants to do have the potential to yield the results you aim to find?

Experience and training of researchers Participants

who are they? how vulnerable are they?

Issues for Ethics Committees

Risks vs. Benefits

Risk Management immediate and later unexpected outcomes

Recruitment: how? by whom?

Issues for Ethics Committees

Dependent relationships: pupil/teacher; student/lecturer; family members; doctor/patient

Cross cultural research: cultural sensitivities, translating, interpreting

Confidentiality legal limits small sample size data storage

Issues for Ethics Committees

Plain language statement and consent form tailor to suit participants

Informed consent: clear full information voluntary choice to participate

Consent from whom: parental consent for minors legal guardians community/organisations?

Issues for Ethics Committees

Publication of results of research To participants, funding bodies, conference or

industry publications Funding for research

Internal (University) or external (ARC, NHMRC, Donor etc)

Conflict of interest? e.g. affiliations or beneficiaries, such as did the

school pay for this? Payment to participants: compensation vs.

inducement Needs to be reasonable

The University of Melbourne - Ethics

Structure One central Human Research Ethics Committee (HREC) – decides policy

Three Human Ethics Sub-Committees (HESC) – reviews and approves all standard projects Health Sciences HESC Behavioural & Social Sciences HESC Humanities & Applied Sciences HESC

Department HEAGs – reviews all projects and only approves minimal risk projects Melbourne Graduate School of Education HEAG

Process – Minimal Risk

Begin by preparing an application online via THEMIS

Complete, proof read and sign hard copy form

Submit to the Graduate School Human Ethics Advisory Group (HEAG) for review

If doing research in schools, don’t forget to obtain permission from relevant authority and lodge to HEAG

After review, the researchers attend to the recommendations and re-lodge revisions with HEAG

Low/minimal risk projects are approved by HEAG

Process - Standard Risk

Same as for low risk applications, with the addition

Standard risk projects are forwarded and undergo a subsequent review by the HESC at their monthly meeting

HESC then advises researchers regarding further amendments or grant approval

NOTE: Sensitive topics, data collection overseas or with ATSI, disabled, disadvantaged and migrant communities is deemed to be standard risk research

What is the supervisor’s role?

As a signatory of your application, the supervisor is responsible for: Briefing you about the ethics

requirements when you are preparing your project

Guiding you in the completion of the application

Guiding you in the ethical conduct of your research

Monitoring your project

Ethics Approval Process From submission to approval by the

committee/s can take: around four weeks for minimal risk applications;

and around six weeks for standard risk applications

Important to know when the ethics deadlines are

No work to commence until written approval received

All amendments require approval Any incidents or adverse effects are to be

reported to the ethics committee via the annual report

Annual report needs to be submitted for yearly renewal of your ethics approval

Approval can be renewed for up to 5 years

External Documents American Psychological Association ethical principles

of psychologists and code of conduct http://www.apa.org/ethics/code.html

Children and Young Persons Act 1989 (in relation to Mandated Reporting Requirements) http://www.dms.dpc.vic.gov.au/

Australian Association for Research in Education (AARE) Code of Ethics http://www.swin.edu.au/aare/ethcfull.htm

NHMRC statement on Human research ethics http://www.nhmrc.gov.au/publications/synopses/e35sy

n.htm Research in Government Schools

http://www.education.vic.edu.au/scln/research.htm Research in Catholic Schools

http://www.ceo.melb.catholic.edu.au/

Internal sites and documents

Graduate School of Education Human Ethics site

http://www.education.unimelb.edu.au/research/ethics/human_ethics.html

University of Melbourne Human Ethics site

http://www.research.unimelb.edu.au/humanethics/

University of Melbourne Human Ethics “hints” page

http://www.research.unimelb.edu.au/humanethics/external/hints/

Indigenous Research

Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research (NHMRC, June 1991) under reviewhttp://www.nhmrc.gov.au/issues/atsi.pdf

Guidelines for Ethical Research in Indigenous Studies (Australian Institute of Aboriginal and Torres Strait Islander Studies, 2000)

http://www.aiatsis.gov.au/corp/docs/EthicsGuideA4.pdf

The end…

Any questions?