Janet Cohen Executive Officer

Human Ethics Monash Research Office

September 2012

Ethics in Research & the Application Process

2

What is Research?

“the systematic study of materials and sources in order to establish facts and reach new conclusions ”

“includes work of direct relevance to the needs of commerce, industry, and to the public and voluntary sectors; scholarship; the invention and generation of ideas, images, performances, artifacts including design, where these lead to new or substantially improved insights; and the use of existing knowledge in experimental development to produce new or substantially improved materials, devices, products an processes, including design and construction.” NS 2007

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What is Ethical Research?

“ethical research is more than just doing

the right thing. It involves acting in the

right spirit, out of an abiding respect and

concern for one’s fellow creatures”

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What is Human Research? – Research

involving human participants includes

• surveys, interviews or focus groups

• undergoing psychological, physiological or medical

testing or treatment

• being observed by researchers

• researchers having access to their personal documents or

other materials

• the collection and use of their body organs, tissues or

fluids or exhaled breath

• access to their information (in individually identifiable, re-

identifiable or non-identifiable form) as part of an existing

published or unpublished source or database

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National Statement on Ethical Conduct in

Human Research (2007) Developed jointly by National Health and Medical Research Council, Australian

Research Council and Australian Vice-Chancellors’ Committee

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Purpose of the National Statement

To promote ethically good human research

The National Statement clarifies the responsibilities of

-institutions and researchers for the design, conduct and dissemination of results of human research (Monash University)

-review bodies (MUHREC)

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National Health and Medical Research

Council (NHMRC) requirements

All institutions/organisations that receive

NHMRC funding for research

– Establish a Human Research Ethics

Committee (HREC)

– Review any research involving humans

whether relating to health or not and

whether funded by the NHMRC or not

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What are the roles of the HREC?

• Review applications

• Provide advice

• Education

• Protection

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Merit and

Integrity Respect

Beneficence Justice

Core

research values

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Research merit and integrity

Research should

• be justifiable by its potential benefit

• use methods suitable to achieve its aim

• be based on current literature

• ensure that respect for participants is not compromised

• be supervised by persons with suitable experience, qualifications and competence

• be conducted using appropriate facilities and resources

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Justice Just research requires

• fair exclusion and inclusion of participants

• fair recruiting processes

• no unfair burden on participants

• fair distribution of benefits of participation

• no exploitation of participants

• fair access to the benefits of research

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Beneficence

The likely benefits of the research must justify any risks of harm

or discomfort to participants

– Design research to minimise risks of harm or

discomfort to participants

– Clarify potential risks and benefits to participants

– Researchers are responsible for participants’

welfare

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Respect

Respect for human beings is a recognition of their intrinsic value.

Respect includes

•Regard for the welfare, rights, beliefs, perceptions, customs and cultural heritage

•Respect for the privacy, confidentiality and cultural sensitivities of participants

•Respect for human beings making their own decisions

•Protection of vulnerable persons

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Theme: Consent

• Voluntary participation

• Consent must be obtained except in specific circumstances

Consent may be expressed orally, in writing or some

other means depending on

–the nature, complexity and risk of research

–the participants’ personal and cultural circumstances

• Informed decision

Participants must have sufficient information to understand the purpose, demands, risks and potential benefits.

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Human Ethics at Monash University

• Monash University Human Research

Ethics Committee (MUHREC) – Human Ethics Office, Research Office

• MUHREC reports to

– Australian Health Ethics Committee (AHEC)

– Monash Academic Board

– Health Services Commissioner

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Constitution of MUHREC

Chair

Lay

people

Lawyer Research

expertise

Pastoral

Care

Counseling

Care

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Ethics Review

Process

Form 1

(NLR)

Low Risk Form

MOU with major

hospitals

Expedited Review Committee Review

Multicentre

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Low Risk Form

submitted to HE

Office

No issues

Allocate to

experienced

Committee

member

Project

Approved/Research

can start

Issues

emailed to

researchers

Researchers

email response

Reader

decides it’s

not LR

Researcher

may be

required to

resubmit on

Form 1

Proceed as

Form 1

Issues

2 weeks

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Form 1 (NLR) Form

submitted to HE

Office

Committee

meeting

Allocate hard copies

to members for

Committee meeting

Project

Approved/Research

can start

Issues

emailed to

researchers

Researchers

email response

No

issues

About 6

weeks

Issues

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Types of review

• Low risk projects (LR forms) – The foreseeable risk is no more than discomfort

– Reviewed by the Chairs/experienced members within 2 week of receipt

– Can be submitted at any time

• Full review (Form 1) – used for all research where the foreseeable risk to participants is more

serious than discomfort

– Reviewed by the full committee MUHREC

– Discussed at a meeting

– Can be submitted at any time and allocated to the next available meeting

• Multicentre projects – Where MUHREC is not the primary HREC

– Reviewed by the Chairs within 2 week of receipt

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Discomfort – Low Risk

• The only foreseeable risk to

participants (including researchers) is

one of discomfort

• Can involve body &/or mind

– anxiety induced by an interview – Minor side effects of medication

– minor discomfort associated with procedures eg blood

pressure

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Types of harm – Not Low Risk

• Physical &/or psychological harms – pain, distress

• Devaluation of personal worth – humiliated, manipulated, treated disrespectfully or unjustly

• Social harms – discrimination in access to benefits, services

• Economic harms – imposition of direct or indirect costs on participants

• Legal harms – discovery and prosecution of criminal conduct

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Applications on Form 1 – Not Low Risk

• Interventions/therapies, including clinical and non-clinical trials, and innovations

• Human genetics

• Human stem cells

• Women who are pregnant and the human foetus

• People highly dependent on medical care who may be unable to give consent

• People with a cognitive impairment, an intellectual disability, or a mental illness

• Aboriginal and Torres Strait Islander Peoples

• Research studying or exposing illegal activities

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When do I need ethics approval?

• Interview

• Survey

• Questionnaire

• Psychological testing

• Collecting and / or using tissues / body

fluids

• Using data already collected (database)

• Photography and audio/videotaping

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Exemptions from ethical review

MUHREC can exempt from ethical review research that

• involves no more than negligible risk to participants (no foreseeable risk of harm or discomfort and any foreseeable risk is no more than an inconvenience) and

• involves the use of existing data or records that contain only de-identifiable data about human beings (eg publicly available reports, literature)

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After approval

• Any change to research project

– Request for Amendments form

– Approval from MUHREC

• Annual Reports and Final Report

– Annual/Final Report form

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Causes of delays in approval

• Misclassifying the research category

• Incomplete forms

• Insufficient information in explanatory statements

• Missing permission letters, attachments, signatures

• Privacy issues

• Delays in responding to issues raised by MUHREC

• UAs (unexplained acronyms)

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Privacy and research ethics

• Protect the privacy of individuals

– Collection

– Use

– Disclosure

• Personal information

• Health information

• Sensitive information

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Privacy legislation

• Privacy Act 1988 (Cth)

• Information Privacy Act 2000 (Vic) – regulates all personal information (except health

information) that is collected or held by – the Victorian public sector; and

– organisations funded by the public sector

• Health Records Act 2001 (Vic) – regulates both public and private sector organisations

that handle personal health information

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Use and Disclosure of information – IPP2

• Only use or disclose information for the primary purpose for which it was collected or a directly related secondary purpose

• Use for secondary purposes should have the consent of the person.

– some use/disclosure may be allowed in certain

circumstances

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Issues to be addressed in applications

• What data are to be collected

• How identifiable is the data

• How the data is to be collected used and

disclosed

• Compliance with privacy legislation

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Data can be

• Identified allows the identification of a specific individual

name, date of birth or address

• Potentially identifiable (coded, re-identifiable) has identifiers removed and replaced by a code

possible to use the code to re-identify the person

• De-identified, (not re-identifiable, anonymous) identifiers have been removed permanently or if the data have never been identified

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Do I need to complete the privacy

provisions in Form 1?

project involves the

collection

use

disclosure

Identifiable health information, personal

information or sensitive information

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Low Risk Form

• How to complete a low risk form

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Human Ethics Office

Building 3E

Clayton Campus

Tel 9905 5490

Fax 9905 3831

muhrec@monash.edu

http://www.monash.edu.au/researchoffice/human/