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1.5 Day HDR/RHD Workshop: Ethics and Integrity in Research with Humans Program Monday 1 & Tuesday 2 December 2014 Flinders in the City Victoria Square Supported by Flinders University, the University of Adelaide and the University of South Australia

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1.5 Day HDR/RHD Workshop: Ethics and Integrity in

Research with Humans

Program

Monday 1 & Tuesday 2 December 2014

Flinders in the City Victoria Square

Supported by Flinders University, the University of Adelaide and the University of South Australia

PROGRAM

Day 1: Monday 1 December

Time Room Topic Presenter

9 – 9:30 am Foyer Level 1 Registration & Pre-Workshop Evaluation

9:30 – 9:35 am Room 1 Day 1 Announcements & Housekeeping

9:35 – 10:30am Room 1 Themes in Research Ethics Dr Peter Wigley

10:30 – 11am Morning Tea

11 am – 1 pm Concurrent Sessions (breakouts): Ethical Considerations to Specific Research Methods or Fields

various presenters:

Room 1 Qualitative (social sciences and humanities)

Professor Paul Ward

Room 2 Clinical Research (interventions, therapies; including clinical trials)

Dr Tim Porter

Room 2.2 Laboratory Research with Humans (human tissue samples, genetics, stem cells)

Dr Judy Ford

1 – 1:50 pm Foyer Level 1 Lunch 1:50 – 2:30 pm Room 1 Research with Vulnerable Participants Associate Professor David Hunter

2:30 – 3:10 pm Room 1 Ethics with Indigenous Peoples and Communities

Associate Professor Steve Hemming

3:10 – 3:20 pm Room 1 Q&A with Associate Professor Hunter and Associate Professor Hemming

3:20 -3:30 pm Stretch Break

3:30 – 4:30 pm Room 1 Research Integrity and Research Misconduct

Dr Peter Wigley

4:30 pm Day 1 Close

Day 2: Tuesday 2 December

8:45 – 9 am Foyer Level 1 Sign-In

9 – 9:05 am Room 1 Announcements

9:.05 – 10:05 am Room 1 Applying for HREC Approval: Preparing and submitting an ethics application, and

Dr John Semmler and Associate Professor Bernie Hughes

10:05 – 10:30 am Morning Tea

10:30 – 11:30 am Room 1 Flinders University students’ breakout

Dr Mariette Berndsen and Professor David Gordon

Room 2.1 UniSA students’ breakout Associate Professor Bernie Hughes

Room 10.1 University of Adelaide students’ breakout Dr John Semmler

11:30 – 11:45 am Room 1 Post- Workshop Evaluation Activity

11:45 – 12 noon Collect Certificate & Workshop Close

PROGRAM

PRESENTERS

Dr Peter Wigley After obtaining a PhD in molecular biology (gene regulation) from The University of Adelaide, Peter conducted biomedical research as a postdoctoral fellow in Australia and the USA. Back in Adelaide, he then worked as a research manager and project manager in the biotechnology and pharmaceutical industries, focusing on early-phase drug development. More recently, Peter worked at Flinders Partners, the technology transfer arm of Flinders University, before joining the University as Manager, Research Ethics and Integrity, at the start of 2013. Peter oversees the operation and administration of the University's Social and Behavioural Research Ethics Committee, Animal Welfare Committee and Institutional Biosafety Committee, as well as managing matters relating to research integrity and research misconduct. Professor Paul Ward Professor Paul Ward is Head of the Discipline of Public Health at Flinders University, Australia. Paul is a social scientist with a background in medical sociology, geography and health services research. His main research interests are around socio-spatial inequalities and inequities in health, medicine usage and the provision of health and social care. He also has a particular interest in research around lay and professional perceptions, knowledge and understandings of health, healthcare, medicines, and risk, and how these perceptions vary spatially and by soci-cultural group. Given his experience in both qualitative and quantitative research, he has an interest in research which seeks to utilize the benefits of a pluralistic and multi-disciplinary approach. Paul is a former Chair of the Social and Behavioural Research Ethics Committee at Flinders University. Dr Tim Porter Tim Porter is a Senior Consultant Anaesthetist at Flinders Medical Centre and in private practice. His main clinical interest is in high risk obstetric anaesthesia, and he teaches midwives, medical students, junior doctors, trainee and qualified anaesthetists and practising obstetricians, both at Flinders and throughout Australia and New Zealand. He also has a Masters degree in Bioethics from Sydney University, and is a Deputy Chair of the Southern Area Clinical Human Research Ethics Committee. He sits on a number of professional committees at a local and federal level. Dr Judy Ford Dr Judy Ford is a Geneticist and Health Consultant who currently works at the University of SA as a Research Education Adviser. Her previous work has included leading diagnostic and research genetics departments, being CEO and Managing Director of a private genetics company and Professional Speaker, Writer, Counsellor and Legal Expert. Her broad experience has given her considerable experience in issues concerning the ethics and safety of research. Judy graduated with first class Honours and a Doctorate of Philosophy in Genetics from the University of Sydney and went on to work in the field of Human Genetics for 30 years. Her career has given her unique knowledge and perspective. As an internationally renowned geneticist and cell biologist she studied the mechanisms underlying illness, especially fertility problems, ageing and cancer. She then moved on to research the daily lifestyle and environmental factors that are affecting people’s cells and health. She has published about 85 research papers, taught at all education levels and spoken extensively nationally and internationally. She has written three books for the general public and developed several health information websites. In 2001, the SA Investigator Science Centre named Dr Ford, one of 14 South Australian Key Contributors to Scientific Innovation of the last Century. Dr David Hunter David Hunter is a philosopher by background and has sat on eight research ethics committees in four countries in the past thirteen years. His research focuses on the regulation of human behaviour with research ethics as a key area. He edits the journal Research Ethics, was a co-author of the European Textbook on Ethics in Research and has provided training for over thirty research ethics committees.

PROGRAM

Associate Professor Steve Hemming Steve Hemming is Research Coordinator at Yunggorendi First Nations Centre, Flinders University and lectures in Australian Studies, Indigenous Studies and Cultural Studies at Flinders University. He was a long-time curator in the South Australian Museum's Anthropology Division and has been working with Indigenous nations in South Australia for thirty years. He has worked for Indigenous organisations as a community researcher and native title anthropologist. More recently his research has focused on the colonial genealogies of cultural heritage and natural resource management and traditionalist understandings of Indigenous culture. He is also working on community development and governance programs with the Ngarrindjeri nation in South Australia. Dr John Semmler John Semmler is a Senior Lecturer in Physiology at the University of Adelaide. He is an experienced neurophysiologist and has been conducting innovative human research on the mechanisms responsible for changes in motor performance throughout the lifespan. He has published approximately 50 original articles in leading international journals that have received in excess of 1700 citations. His research has been funded by the National Health and Medical Research Council of Australia and the Australian Research Council, and has trained several postdoctoral fellows; research assistants and PhD students that have been supported by these grant funds. He performs many roles involving expert peer review, and holds an appointment on the Editorial Board of the Journal of Applied Physiology. He is currently Convener of the University of Adelaide Human Research Ethics Committee, on which he has served since 2005. Associate Professor Bernie Hughes Bernie Hughes has chaired the University of South Australia (UniSA) Human Research Ethics Committee since mid 2011. Leadership roles at UniSA have included Division of Health Science Dean Research, Acting Head and Associate Head Academic of the School of Pharmacy and Medical Sciences. Bernie’s teaching interests include biochemistry, cell biology and research ethics. His main research contribution has largely been in the areas of cell signalling in carbohydrate metabolism, and muscle chloride ion channel regulation (career h index of 21). Dr Mariette Berndsen Mariette Berndsen has been a member of the Social and Behavioural Research Ethics Committee at Flinders University since 2004. Mariette is also the chairperson of the low-risk ethics committee at the School of Psychology (Flinders University). Mariette teaches social psychology and emotions. Research interests include prejudice, intergroup conflict, and the role of emotions in fostering commitment to social change.

Day 1: Themes in Research Ethics Dr Peter Wigley

1

Themes in Research Ethics

Dr Peter Wigley

Manager, Research Ethics and Integrity

Themes in Research Ethics

Dr Jennie LouiseDiscipline of Public Health

University of Adelaide

Overview of the Session

Research, Researchers and Research Ethics

Values and Principles for Ethical ResearchMerit and Integrity

Beneficence

Respect

Justice

ThemesRisks

Informed Consent

Broad Aims of this Session

Gain an understanding of why we put so much effort into getting it right with research with our fellow human beings

Help you locate your own research

Help you locate yourself in relationship with your potential participants

Applies to clinical research, and social and behavioural research; with human participants, or their tissues, or data

Research

Practice characterised by a goal Produce knowledge and understanding

Technologies, etc.

Training of researchers

Underlying aim: social benefit

Research Integrity and Research Ethics

“Investigation undertaken to gain knowledge and understanding or to train researchers”

Researchers

Socially defined role Privileges

Trust

Role Responsibilities To use privileges of the role only in a way that is consistent with the aim of research

In short: to conduct research ethically

Day 1: Themes in Research Ethics Dr Peter Wigley

2

What is ethical conduct of research?

Consistent with achieving the goals of research Produce knowledge and understanding Train researchers

Social benefit

But without unacceptable harms, risks or costs

Produce knowledge and social benefit, within appropriate boundaries

Unethical Research

Fails to achieve the goals Doesn’t produce knowledge

May produce misinformation

Causes harm

To participants, their community, society

To other researchers and the practice of research

But I’m not an evil scientist!

Unethical research can be the result of many different factors, including Lack of information, experience or reflection about ethical issues Fail to identify or address ethical issues

Structure of incentives Publishing, time constraints, need to get results

Lack of ethical culture or commitment to ethical conduct in research ‘tick‐box’ approach to ethics

History of Research Ethics

The Nuremberg Code (1947)

Thalidomide (1957)

US FDA – testing for safety and efficacy (1962)

Declaration of Helsinki (WMA, 1964)

National Statement on Ethical Conduct in Human Research (Australia, 2007)

Universal Declaration of Human Rights (1948)

The International Bill of Human Rights

Examples of Unethical Research

Little Albert (USA, 1920)

Nazi experimentation (Germany, WW2)

Tuskegee Syphilis Study (USA, 1932‐1972)

Milgram Experiment (USA, 1961)

Tea Room Trade (USA, 1965‐68)

Stanford Prison Experiment (USA, 1971)

Key Principles of Research Ethics

Merit and Integrity

Beneficence (& non‐maleficence)

Respect for persons

Justice

National Statement on Ethical Conduct in Human Research(ARC, NHMRC, Universities Australia)

Day 1: Themes in Research Ethics Dr Peter Wigley

3

Merit and Integrity

About achieving the goals of research ‐ potential for benefit Aims of research

Design and methods of research

Integrity Commitment to the aims of research

Conduct research honestly and openly

Unless these criteria are met, research involving humans is not justifiable

Beneficence

(Doing good)

Welfare of participants

Benefit to society

Consider welfare and interests Of participants, others who are affected

Involves attention to cultural and social implications of the research

Respect

“Each human being has value in himself or herself” Not simply a means to an end

Respect  Capacity to make autonomous decisions

A person’s beliefs, values, culture Confidentiality and privacy

Protection of those with diminished capacity or who are vulnerable

Justice

Distributive Benefits and burdens of research are fairly distributed

Procedural Recruitment, selection, inclusion, exclusion, withdrawal, etc., are conducted fairly

Key Themes in Human Research Ethics

Risks vs. Benefits Do the potential benefits of the research justify the risks?

Consent Do we have informed and voluntary agreement from subject participants to the risks of the research?

Risks: Harms and Discomforts

Described by likelihood & severity

Range of possible harms Physical ‐ injury, illness, pain

Psychological/emotional

Social

Economic/legal

Discomfort and inconvenience: Physical, emotional (anxiety)

Time filling out forms, participation

Not just to participants

Day 1: Themes in Research Ethics Dr Peter Wigley

4

Minimising and managing risks

Monitoring For harms and further consequences

Procedures for any harms that occur For participants

For the research

Willing Acceptance of Risks

Some participants may be willing to accept higher risks e.g., if there is direct benefit to them, their family, their community

However, the greater the risk, the more important it is that: There is appropriate management

Participants clearly understand the nature of the risk

Consent

Participants in research must give consent which is: Voluntary

Based on sufficient information

Based on an adequate understanding of the research and the implications of participation

Complications in Consent

Sometimes research requires: Working with those whose ability to consent is impaired or absent

Working with vulnerable populations

Deception or concealment

Can be justified as long as certain conditions are met

Absent or Impaired Capacity

Person temporarily or permanently lacks capacity to give consent Use of proxy decision makers ‐ act consistently with the person’s best interests

No reasonable alternative, and research justified by benefits

Low risk to participants

Deception or Concealment

Observation

Limited disclosure or active deception

Requires No reasonable alternative No increased risk of harm resulting from concealment or deception

Reasonable to think participants would have consented

Extent of deception/concealment is clearly defined and justified

Where possible, disclosure occurs after conclusion of the research

Day 1: Themes in Research Ethics Dr Peter Wigley

5

Next steps for you…

Don’t say ‘I’m an ethical person so that’s enough’. It’s a start but it’s not enough!

Inscribe the ‘National Statement on Ethical Conduct in Human Research’ upon your heart 

Prepare your application carefully and thoroughly

Your supervisor should assist you

Accept feedback from your Ethics Committee    …they are working with you

Conditional approvals are common

Resources

NHMRC Human Research Ethics webpage

http://www.nhmrc.gov.au/health‐ethics/human‐research‐ethics

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects

http://www.cioms.ch/publications/layout_guide2002.pdf

University Websites

http://www.adelaide.edu.au/ethics/human/ 

http://w3.unisa.edu.au/res/forms/ethics.asp#human

http://www.flinders.edu.au/research/researcher‐support/ethics/ethics_home.cfm (with links to SBREC & SAC HREC)

Day 1: Ethical Considerations to Specific Research Methods or Fields Qualitative

Professor Paul Ward

1

Ethics in/of Qualitative Research

Paul Ward

Professor of Public Health&

Chair, Social and Behavioural Research Ethics Committee

Aims of session

> To provide a forum for discussing/debating research ethics and ethical issues in qualitative research

> To provide an overview of qualitative research

> To provide an overview of research ethics

> To discuss the implications for qualitative research

Why am I talking about ethics?

> Researcher with experience of undertaking (ethical) research (qualitative and quantitative)

> Experience of submitting applications to Human Research Ethics Committees

> Chair of the Social and Behavioural Research Ethics Committee at Flinders University

What is qualitative research?

What is qualitative research?

> Describes a broad range of theoretical perspectives and research strategies

> Based on – interpretivism (how individuals/groups interpret their

worlds)– inductive approach (developing theory – understanding

rather than explaining)

> Has its roots in social sciences – mainly sociology and anthropology

Types of research questions

> Describing or answering questions about a particular, localised occurrence or context

> Understanding the perspectives of particular groups towards events, beliefs or practices (dentists, GPs, nurses, patients, homeless etc)

> Exploring complex research area where little is known (theory generation)

> …….. Answering the WHY question……..– Why do young girls continue to smoke?– Why do young men engage in many high-risk activities?– Why are some health care services inequitable provided?

> ………providing CONTEXT and UNDERSTANDING……

Day 1: Ethical Considerations to Specific Research Methods or Fields Qualitative

Professor Paul Ward

2

Some benefits of qualitative research

> The potential to illuminate everyday life – to better understand the familiar and strange

> Can provide specific, concrete details to guide an understanding of a particular setting

> Can provide interpretation of local meanings that activities and practices have for a group engaged in them

> To illuminate differences across settings – how different GPs interpret guidelines/ diagnose flu/ prescribe antibiotics etc

Characteristics of qualitative research (1)

> Natural context – occur in ‘natural’ settings– Places where people interact (GP/dental surgery, classroom, street

corner etc)– Study of inanimate objects (how health care/policy is developed or

organised)

> Non-manipulative – study situations/objects ‘intact’ – Researcher observes, interviews, records, describes settings ‘as

they are’

> Researcher as ‘instrument’ – researchers engages in a situation and attempts to make sense of it– Data collected through human observation– Data interpretation through human perceptions

> Subjectivity of researcher – insights, experiences, perceptions of researcher are important part of the study

Characteristics of qualitative research (2)

> Interpretive character – researcher attempts to explain ‘why’ and ‘how’ something is happening - focus is on meaning rather than specific behaviours

> Focus on process, rather than outcome – how and why things happen

> Depth (rather than breadth) of understanding –hence the smaller number of cases

> Inductive analysis – research begins with open-ended questions rather than attempting to test a priori hypotheses.

> Context sensitivity – findings are placed in social, historical and spatial context – limiting generalisations

Characteristics of qualitative research (3)

> Empathic neutrality – complete objectivity is not possible – but pure subjectivity undermines credibility– Attempt to understand (not prove) something– Goal is not to advocate or to advance personal agendas– Personal experience is included as part of relevant data, although non-

judgemental stance towards whatever content may emerge from data

> Reflexivity – attempting to include the role of the researcher in the whole process (question construction, design, analysis etc)

> Flexibility of design – research is open to adaptation as understanding deepens or situations change

> Focus on ‘emic’ perspectives – write from the perspectives of the participants (emic) rather from the researcher’s own perspective (etic).– Perspectives of the participants in the study– What are they thinking, why are they thinking it, what are their

assumptions, motives, goals values etc.

Some limitations> Subjectivity is inherent

– In ALL research (not just qualitative)– Reflexivity is championed in qualitative

> Labour/ time intensive– Underestimation of the vast amount of time it takes to undertake the

data collection, arrange the interviews/ focus groups, transcribe the data, undertake data analysis etc

> Misunderstanding of novice researchers– Many researchers think it is a ‘soft option’, but have little

understanding of the complexities involved– Quality and trustworthiness of studies are then compromised

> Limited generalisability – ‘moderatum generalisability’– However, this is not the point of qualitative studies, therefore seems

an inappropriate standard by which to judge

Summary

> Qualitative research has its own epistemological, methodological and theoretical underpinnings – it is NOT just a tool-bag of techniques– Interpretivism – understanding and interpreting the social world

(contrasting and contested realities)– Inductivism – theory development– Approaches such as ethnography, phenomenology, grounded theory

etc

> Really important NOT to judge qualitative research by the same criteria one would use to judge quantitative research –– the whole point of qualitative research is different– therefore it would be wrong to use the same criteria of generalisability/

representativeness,reliability etc. – More useful to use concepts such as validity, thoroughness,

trustworthiness, transparency and meaningfulness

Day 1: Ethical Considerations to Specific Research Methods or Fields Qualitative

Professor Paul Ward

3

Ethical issues in/of qualitative research

Overarching Principles of Ethical Research

> Research Merit and Integrity

> Respect

> Beneficence

> Justice

****** Need to think about what these mean for

qualitative research*******

Plan

> Take each ethical principle in turn, and look at 3 issues

– What is meant by the overarching principle?

– What are the specific implication for qualitative research(ers)?

– How do HRECs assess this?

Research Merit and Integrity - Overarching principle

A commitment to:

> the search for knowledge

> recognised principles of research conduct

> honest and ethical conduct of research and dissemination and communication of results.

Research Merit and Integrity – specificity for qualitative research

> Duty to provide sufficiently detailed account/analysis of study– So that others can assess the relevance of findings to their

circumstances

> Socially intimate nature of qualitative research – the negotiation and re-negotiation of relationships– may threaten integrity of researcher or research– may need to modify or discontinue research

> Research vs therapeutic relationship– Some professional skills my become relevant during interview (e.g.

counselling)• Need to question the ethical acceptability of exercising those skills

in a research relationship• A duty to inform participants if/when you are acting in a non-

research professional role (e.g. mandatory reporting, medical etc)

Research Merit and Integrity – requirements of ethics committees

Application Form – Section C: Project DetailsIn order for the Committee to assess the application against this principle, the following need to be clearly explained: > the nature of the project, > its significance, > its objectives and > the veracity of its research method

Day 1: Ethical Considerations to Specific Research Methods or Fields Qualitative

Professor Paul Ward

4

Respect – Overarching principle

Regard for the welfare, rights, beliefs, perceptions,

customs and cultural heritage, both individual and

collective, of persons involved in the research.

Respect – specificity for qualitative research

> Consent issues– Respecting cultural difference or political sensitivities

• Formal, written consent• Oral consent

– Implied consent• Do not require Consent Forms for questionnaire survey –

consent is implied by sending it back> Transcription issues

– Need to question whether respect for participant requires that the accuracy and completeness of transcripts should be verified by participant

> Data control issues– Need to question the level of control that participants should have

over their data• Reviewing transcripts, assessing reports, publications etc• Making sure they are being ‘represented’ in a respectful manner

Respect – requirements of ethics committees

Various sections of the application form help the Committee deliberate on this principle, in particular:

Section D: Participant Information – recruitment, consent, confidentiality, anonymity and information provision to participants

These are key ethical issues, and are often passed over summarily, without full disclosure.

Failure to provide adequate information leaves the Committee unable to determine whether the National Statement’s standards have been met.

Beneficence – Overarching principle

Minimisation of risks of harm or discomfort to

participants in research projects.

Beneficence – specificity for qualitative research

> Anonymity issues– Potential to identify individuals/groups – key informants, small

communities etc – ‘problem representation’– Extra care in anonymising data (if possible) – If not – informed

consent

> Debriefing, counselling– Often covers very sensitive issues – need clear protocols for

dealing with distress – for participants and researchers

> Impact of inter-personal relationships– Need to be clear in REC proposal of ANY anticipated impacts of

inter-personal relationships (distress, expectations, power etc)

Beneficence – requirements of ethics committees

Section F: Specific Ethical MattersPeople do not exist merely for the benefit of researchers. The National Statement requires that researchers address the well being of participants. To assess whether researchers do so, the Committee looks for information about:

> The value and benefits of the project to participants;> The burdens and risks associated with the project and how they

will be addressed;> Feedback and Debriefing;> Data control and management issues for participants.

Day 1: Ethical Considerations to Specific Research Methods or Fields Qualitative

Professor Paul Ward

5

Justice – Overarching principle

Fair distribution of the benefits and burdens of

participation in research and, for any research

participant, a balance of burdens and benefits.

Justice – specificity for qualitative research

> Criteria for inclusion/exclusion of participants are often complex in qualitative research

– Need to be explicit about these and be able to justify them

> Are certain populations under/over researched?

Justice – requirements of ethics committees

Section F: Specific Ethical Matters

> The value and benefits of the project to participants.

> The burdens and risks associated with the project and how they will be addressed.

Some other issues for ethics of qualitative research

> Focus groups– Data control issues – if 1 person wants their data to be removed, how

does one do this within the context of a discussion - and make it amenable to analysis?

> Covert research– deception is considered unacceptable, except for:

• the nature of the subject matter precludes alternative methods ofdata collection

• the information sought is ‘essential’ (to target particular behaviour)– If considering, you need to ask yourself:

1.does the potential value of the research justify the deception?2.will people be hurt by the deception?3.whether the potential value was actually realised?4.whether subjects were actually hurt?

Some other issues for ethics of qualitative research

> Snowball sampling– Cited a great deal in ethics committee applications – usually not

thought through or explained in detail• How will 1st person be sought? (contact/recruitment)• Exactly what will they say to potential participants? (informed

consent)• Can any of this be governed – so that contact, recruitment, consent

is done in an ethically sound manner?

> Contact/recruitment– Often complex in qualitative research– May have a number of co-existing strategies (posters, flyers.

newspaper adverts, snowballing, GP registers…..)– Don’t usually have sampling frames to draw from (electoral role, white

pages etc)– NEED to explain in great detail to HREC

Some other issues for ethics of qualitative research

> Power

– During contact/recruitment –

• be aware of potential for coercion, conflict of interest etc

– In interaction

• you will have a privileged position – people will divulge things to you that are personal, sensitive etc

– In writing phase

• ‘problem representation’ – the power to affect the ways that particular groups are viewed

Day 1: Ethical Considerations to Specific Research Methods or Fields Qualitative

Professor Paul Ward

6

Summary

> Ethics are vitally important in all research– Involves more than just obtaining ethics committee approval (i.e.

jumping over the hurdle)

> All research involves issues of – ‘doing no harm’ and ‘doing good’– not deceiving participants by providing full and open information– maintaining confidentiality– considering your participants in terms of willingness and ability to make

informed decisions

> Qualitative research has some addition elements:– Close, personal relationships (social intimacy)– Some difficulties with assuring anonymity– Data control – and if so, which data, when where, how?– Issues with ‘other’ professional roles – counselling, therapeutic

relationships, professional duties of care etc

Useful Websites

SBREC:

http://www.flinders.edu.au/research/researcher-support/ethics/committees/social-

behavioural.cfm

National Statement:

http://www.nhmrc.gov.au/publications/synopse

s/e35syn.htm

Day 1: Ethical Considerations to Specific Research Methods or Fields Large Scale Studies Angela Gialamas

1

Ethical considerations for large scale studiesAngela Gialamas

School of Population Health

adelaide.edu.au

My background

• Worked on many large-scale studies:– Randomised Controlled Trial (n=~5000 adult patients)

• Currently using the Longitudinal Study of Australian Children (n=5107 children)

• Also working with a group led by Prof John Lynch using data linkage to investigate the social, health and clinical factors associated with children’s development, school readiness and academic achievement (n=~126,000 children)

University of Adelaide 2

What are large-scale studies

University of Adelaide 3

What are large scale studies?

• Quantitative research methodologies are usually associated with large-scale studies

• A large-scale study is a research project that usually requires a large sample

• It is unethical to conduct a study that is not powered to detect a meaningful effect

University of Adelaide 4

Research design

• Cross-sectional

• Cohort

• Data Linkage

• Randomized controlled trials

University of Adelaide 5

Cross-sectional studies

• It measures the prevalence of a health outcome; determinants of health in a population at a particular point in time

• Exposure and outcome are established at the same time

• Usually surveys

University of Adelaide 6

Day 1: Ethical Considerations to Specific Research Methods or Fields Large Scale Studies Angela Gialamas

2

Cross-sectional studies

ADVANTAGES

• Quick

• Simple

• Low to moderate cost

DISADVANTAGES

• Doesn't provide a good source for establishing causality as exposure and outcome are measured at the same time

• Self-report –socially desirable answers/recall bias???

University of Adelaide 7

Cohort Studies

• Following one or more group of individuals (cohort) that is disease free and for which exposure can be or has been ascertained

• Follow the cohort through time to determine what diseases or outcomes develop

• Prospective or Retrospective

• Can be population or exposure based

University of Adelaide 8

Cohort Studies

ADVANTAGES

• Efficiencies in time and resources

• Possible to establish timing and directionality

• Multiple exposures and outcomes can be assessed in the same study

DISADVANTAGES

• Large sample size usually required

• Long follow-up periods

• Potential losses to follow-up

University of Adelaide 9

Data Linkage

• Data linkage is a method for joining together information from different sources that are thought to relate to the same person, family, place or event

• Data already collected (e.g. Perinatal birth outcomes)

• SA NT DataLink provides an electronic mechanism for facilitating access to linked data for research

University of Adelaide 10

Data Linkage

ADVANTAGES

• Allows you to study populations

• Reduced use of identified data

• Look at large volumes of data from various sources & make links between those datasets

DISADVANTAGES

• Quality of data

• Limited nature of the data (restricted to the data that they collect)

University of Adelaide 11

Ethical issues in/of large-scale studies

University of Adelaide 12

Day 1: Ethical Considerations to Specific Research Methods or Fields Large Scale Studies Angela Gialamas

3

Principles of Ethical Research

• Research merit and integrity

• Justice

• Respect for persons

• Beneficence (and non-maleficence)

University of Adelaide 13

http://www.nhmrc.gov.au/guidelines/publications

Research Merit and Integrity

Search for knowledge and the potential for benefit

Honest and ethical conduct of research and dissemination of results

What to consider in large-scale studies:– Is this research important

– Are the aims and objectives of the research clear

– Can the research method answer the question validly

University of Adelaide 14

Justice

Fair distribution of the benefits and burdens of participation in research and, for any research participant,

a balance of burdens and benefits

What to consider in large-scale studies:– Is selection of participants equitable

– Are the benefits of the research equitably distributed to participants and others who could benefit

University of Adelaide 15

Respect for persons

Regard for the welfare, rights, beliefs, perceptions, customs and cultural heritage, both individual and collective, of

persons involved in the research

What to consider in large-scale studies:– What kind of informed consent (if any) is necessary

– How is participants privacy addressed

– How is participants confidentiality addressed

– Who will have access to the data

– How will you disseminate results

– What will you do with the data after the research is finished

University of Adelaide 16

Beneficence/Non-maleficence

Minimisation of risks of harm or discomfort to participants in research projects

What to consider in large-scale studies:– Protect participant’s welfare by maximizing possible benefits

while minimizing risks

– Need to adequately assess risks and benefits

University of Adelaide 17

Real life case study

Early Childhood Development Data Linkage Demonstration Project

The effects of early life conditions and experiences on child development and learning: a whole of population study

Principal Investigator: Prof John Lynch, School of Population Health, University of Adelaide

University of Adelaide 18

Day 1: Ethical Considerations to Specific Research Methods or Fields Large Scale Studies Angela Gialamas

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How we addressed the principle: Research Merit and Integrity

University of Adelaide 19

Purpose of Study

• Studies suggest that particular demographic, social, health and behavioural experiences may be important for healthy development of children (Heckman, 2006) and may also have far reaching influences into adulthood (Lynch et. al, 2006)

• Children’s health and development is important for

– readiness to learn

– academic achievement at school

– future health, social and economic capability

• Ensuring that all children have the best start in life is a national and state priority

University of Adelaide 20

Aim and objectives

AimThis project sets out to investigate how a range of social, health, maternal and other early life conditions and experiences up to age five affects school readiness outcomes and school achievement

Objectives1. Investigate the effect of pregnancy complications, poor birth outcomes and socio-economic disadvantage at birth that influence school readiness and achievement among South Australian children

University of Adelaide 21

Study Design

Retrospective population-based study using linked data from pre-existing Government administrative databases

University of Adelaide 22

Data Sources

University of Adelaide 23

Department for Education and Child Development

SA Health

Consumer and Business Services

WCHN, SA Health

Births and Deaths

Running Records

NAPLAN

School Enrolment Census

Perinatal statistics

Emergency Department presentations

Hospital inpatient statistics

Child Health Record

Pathways to Parenting

ESL Scope and Scales

Dental

Department of Education, Employment &Workplace 

Relations

Australian Early Development  Index

University of Adelaide 24

Data Linkage Method to preserve privacy

www.santdatalink.org.au

Day 1: Ethical Considerations to Specific Research Methods or Fields Large Scale Studies Angela Gialamas

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How we addressed the principle: Justice

University of Adelaide 25

Participants

Inclusion criteria:

• All South Australian children born 1999-2005 and their corresponding data until 31/12/2011

Exclusion criteria:

• None

No active recruitment as research is using de-identified data from pre-existing databases

University of Adelaide 26

How we addressed the principle: Respect

University of Adelaide 27

Informed Consent

The condition for consent was justifiably waived

• Using a de-identified dataset (e.g. no names)

• Safeguards relating to the storage, access & use of the data

• Only aggregated statistical data reported

• Public health benefits - help better target services

University of Adelaide 28

But…..

• Many large-scale studies DO require informed consent

• Participants should know what they are being asked to do – information sheet

• A participant will normally be asked to sign a consent form

• There should be no pressure to participate

• Participants must be aware that they are free to withdraw from the study at any time

University of Adelaide 29

Privacy

• Initial linkage which involves identifying information is not performed by the research team

• Only de-identified linkage keys are provided to the research team

• The use of de-identified data protects participants privacy

• All information for reports and publication will only consist of aggregated statistical data

• Reporting of small cell sizes will be avoided

University of Adelaide 30

Day 1: Ethical Considerations to Specific Research Methods or Fields Large Scale Studies Angela Gialamas

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Confidentiality

• Custodians forward the linkage key and the required participant data to the Principal Investigator

• The computer on which the cleaning and merging is undertaken is password protected with a lockable screen saver that shuts down after five minutes of non-use

• All data during the research project stored on a computer file on a secure server located at eResearch SA

University of Adelaide 31

Confidentiality

• The file servers and tape backup systems are located in locked computer rooms that are only accessible to eRSA system administrators

• High security username/password for accessing the files

• An ‘activity log’ will be used for the monitoring and reporting of users of the dataset

• Access to the dataset is limited to the research team named in the application

University of Adelaide 32

Confidentiality

• All paper copies of statistical analyses will be physically stored in secure locked filing cabinets in the research offices of those named in the application

• Paper based waste containing sensitive information will be securely disposed of (cross shedding)

University of Adelaide 33

Distribution of information

• Research team does not have access to identifying information therefore no results will be provided to individual participants

• Results of the research will be made publicly available through peer-reviewed publication, conference presentations, electronic summaries on the SA NT DataLink website and government reports

University of Adelaide 34

Retention

Approved for indefinite retention of the research dataset

How we justified this:

The dataset has important community value

however

A review of whether the dataset is required for re-appraisal, scientific validation, or continued future research will be

undertaken every three years

University of Adelaide 35

Retention: Management of your research data

• Retaining your data after your research is complete is important and part of the Code of Responsible Conduct

• Work with your supervisor to agree on a plan for the appropriate management and back-up of your data

• At the end of your study all data and materials go to your primary supervisor for archiving – but please check with your supervisor!

University of Adelaide 36

Day 1: Ethical Considerations to Specific Research Methods or Fields Large Scale Studies Angela Gialamas

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How we addressed the principle: Beneficence/Non-maleficence

University of Adelaide 37

Benefits

• Ensuring that all children have the best start in life is a national and state priority

• Project can help us better understand the factors that influence children's development, better target services and guide future research

• Uses a whole of population approach to characterise children by using multiple datasets and indicators of functioning

• Develop new skills and capabilities in the use of linked data in South Australia

University of Adelaide 38

Identifying Potential Risks

• Inadvertent adverse impact upon individuals or communities as a result of the presentation of the results

• Processes put in place to address this potential risk:

– re search results will be disseminated responsibly and respectfully

– results will include researcher contact details

– If a member of the public has any questions or concerns regarding the ethical conduct of the research, the relevant HREC Executive Officer will be notified

University of Adelaide 39

Your project: ethical considerations

• Work in pairs

• Describe your project

• What type of study design is it?

• What are the ethical considerations?

• (complete the form – refer to the checklist)

University of Adelaide 40

Ethical Considerations for Your Research Project

Purpose of study (background, aim, objectives, benefits)

Component Description What to think about

Purpose of study Provide a description of the background, purpose, aim and objectives of the study.

Is this researchjustified?Who benefits? How?What are the aim and objectives

Take home messages

• Ethics is important in all research

• Ethics approval must be obtained before your study starts – NO RETROSPECTIVE APPROVAL

• All research involves doing ‘no harm’ and doing ‘good’

• It takes time to develop a high quality ethics application

• Get advice from your supervisor(s), peers, University HREC

University of Adelaide 41

Day 1: Ethical Considerations to Specific Research Methods or Fields Clinical Research – Dr Tim Porter

1

Research ethics

DrTim Porter

BEc, MBBS, FANZCA, MBioethics

Senior Consultant Anaesthetist, Flinders Medical Centre

Deputy Chair, Southern Adelaide Clinical Human Research 

Ethics Committee

Why do research at all?

Why do research at all?

• Evidence based medicine

• Improve quality of treatments

• Understand disease mechanisms

• Improve population health

• Economic reasons

• Developing and validating tests

• Professional responsibility

History of dodgy research• Pre‐war USA

– Malaria study

– Monster study

• World War II

– US

– Australia

– Nazis

Should we use the results from these studies?

Nuremburg doctors’ trial and the development of the 

Nuremburg Code

Day 1: Ethical Considerations to Specific Research Methods or Fields Clinical Research – Dr Tim Porter

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Tuskegee Syphilis Experiment

• Belmont report

• Office for Human Research Protections

• Federal laws requiring Institutional Review 

Boards

Declaration of Helsinki

• World Medical Association 1964 – current

• Directed at physicians but intended to be 

used by other medical researchers

What about Australia and NZ?

• Orphanages

• Stolen generation

• British nuclear tests

• NZ Cervical cancer study

Australian Code for the Responsible Conduct of Research

The National Statement and Ethics Committees

Basic ethical principles used when considering research projects

• Beneficence

• Non‐maleficence

• Autonomy

• Justice

Day 1: Ethical Considerations to Specific Research Methods or Fields Clinical Research – Dr Tim Porter

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Informed consent

• Requires

– Capacity

– Freely given

– Specificity

Information about what is intended to happen

SACHREC

• Scope

• Types of review

• Expediting reviews

– Applications

• Annual monitoring

• So, with all these statements and review 

processes, where do we stand?

– Hexamethonium study

– Fraud

Special groups

Special groups

• People with mental illness

• Aboriginal and Torres Strait Islanders

• Children

• 3rd party consent

• Use of 3rd world participants

• Prisoners

• Animals

• Genetic studies

Animal research

Day 1: Ethical Considerations to Specific Research Methods or Fields Clinical Research – Dr Tim Porter

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Genetic research

Case study

• New, first in human weight control vaccine with good 

efficacy in monkeys is to be trialled in 4 healthy student 

volunteers

• This involves

– Vaccine administration in a controlled setting

– Overnight stay in a research clinic

– 4 x 2‐hour visits with blood collection over the next 6 weeks

• What are the ethical considerations?

• Should participants be paid, and if so, how much?

Questions?

Further information

• World Medical Association website

• NH&MRC website

• SAC HREC site

– http://www.flinders.sa.gov.au/research/pages/ethics/6590/

[email protected]

Day 1: Ethical Considerations to Specific Research Methods or Fields Laboratory Research with Humans

Dr Judy Ford

1

Laboratory research with human materials

Dr Judy FordECSA Training Workshop

Email: [email protected]

Laboratory research (human) Tissue culture

Working with cell lines Obtaining new samples

Human genetics Rights of individuals, families and communities Rights of knowing & not knowing Confidentiality & privacy

Stem cells and other embryonic tissue Special legislation and responsibilities

Cell cultures

Origin of culture

ethical issues

Stability of culture

validity issues

Tissue samples Already stored

Where and how was it obtained? Local – your research must meet Institutional

policy and any limitations Overseas – check source, year and regulations at

source

Collected for your project Was the donor alive or dead?

Living donorClarify

Issues of identification

Communication of results Consent for use

Specific Extended Unspecified

CadaverClarify

Wishes of deceased

If no expressed wishes then wishes of next of kin disposal of the body or tissues

after use

Day 1: Ethical Considerations to Specific Research Methods or Fields Laboratory Research with Humans

Dr Judy Ford

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Right to know

Human geneticsChoice NOT to

know

Unexpected information

Human geneticsChoice NOT to know

Requires HREC clearance unless:

1. Unidentifiable data

2. Negligible risk

Unexpected information

Right to know

Human genetics

• Plan for both expected information and things that you “may discover”

• Consider the clinical and personal relevance of findings

• Consider the clinical certainty of findings – does your research provide sufficient evidence?

Rights to know

Human genetics

• How will information be given?

• How will you retain confidentiality?

• Is there any risk from knowing?

Rights to know

Human genetics

• Prepare and follow plan to withhold

• Plan option for possible later contact (change of mind)

• Is there anyone else who has a right to know?

• How can others receive information without breaching rights of the participant?

Choice NOT to know

Human geneticsPotential NEGATIVE effects of knowledge

• Misuse

• Misrepresentation

• Discrimination

• Disrespect or harm

• Can you protect against potential harm?

Day 1: Ethical Considerations to Specific Research Methods or Fields Laboratory Research with Humans

Dr Judy Ford

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Human genetics – common issues

Families are potentially identifiable

Whole communities are affected

Complex family dynamics and privacy

issues

Possible legal ramifications of findings

Human geneticsGeneral information re consent

• possible legal ramifications

• possible future research

• proposed storage of material and data

• proposed confidentiality

• option to withdraw at any time

• not all genes will be revealed!

Stem cells and embryonic tissue

Embryonic: 3-5 days development after blastocyst

Primordial germ cell

Somatic “adult” includes foetal, umbiliacal, mesenchymal, haematopoietic

Stem cells and embryonic tissue

Governed by several different regulations and Acts

• Human tissue samples

• RIHE Research involving Human embryos 2002 and NH & MRC (2004)

• State government laws

• Human tissue samples

• Chapter 4.1 National Statement - Women who are pregnant and the human foetus

Stem cells and embryonic tissue

Types of research:

Applications – new and developing therapies

Pure research – cell capabilities

- understanding disease processes

Pregnant women & human foetus (not assisted reproduction)

Wellbeing of mother & child always takes precedence

Must consider any negative effects/risks of research

Must be willing to involve others in decisions

Separate all consent & information from clinical care

Must minimise pain and distress for mother and infant

Day 1: Ethical Considerations to Specific Research Methods or Fields Laboratory Research with Humans

Dr Judy Ford

4

Human foetus ex utero(terminated pregnancy or death in utero)

Must justify use of material

Must obtain informed consent

Must be willing to involve others in decisions

Separate all consent & information from clinical care

Must minimise pain and distress for mother and infant

Can withdraw consent at any time

Must give details of long-term possibilities of research

Open data

We are now encouraged to publish our data on-line with an individual d.o.i. You need to either include this in your initial ethics application or submit a new application that addresses this.

Think through the possibilities!

Henry Ford

"Thinking is the hardest work there is, which is the probable reason why so few engage in it."

Day 1: Research with Vulnerable Participants Associate Professor David Hunter

1

[email protected]

Research Involving Those Who May Be Vulnerable

1. Identifying Vulnerable Groups and their Needs

Examples:

Research with suffers of dementia or mental illness

Research with asylum seekers and survivors of violence

Research with older people and their carers

Research with children

Research with addicts

Research with the terminally ill

Research with disabled people

Research with those requiring emergency medical intervention

Research involving the recently bereaved.

There are three overriding ethical concerns with such research:

(i) Whether or to what extent consent can be obtained

(ii) What additional safeguards against harm are required for such groups, including anonymity and confidentiality?

(iii) Will excluding them from research be harmful?

2. Consent and Competence

To what extent can those deemed incompetent to consent be the subjects of research?

This raises concerns over two main groups:

(i) Adults lacking capacity

(ii) Children

Day 1: Research with Vulnerable Participants Associate Professor David Hunter

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Questions for discussion:

What kind of research is acceptable?

What issues surrounding consent are raised?

What is the role of representatives of the incompetent subject?

Consent legitimises the potential risks and harms inherent in research through:

Respecting the autonomy of the subject

Protecting their welfare,

But if consent is to play the legitimising role, it must be stringent – informed, voluntary and competent.

For an individual to consent they must be:

capable of receiving and retaining relevant information

capable of using that information to make a decision without being excessively influenced by others.

The requirement for competence throws up a number of challenging issues both for researchers and research ethics committees alike. If competence presupposes capacity:

1. How do we define ‘capacity’ and how do we judge who has it?

2. Is it ever ethically acceptable to include incompetent individuals in research?

3. What alternative procedures or safeguards should be followed to protect the interests of subjects who are incapable of giving valid consent?

3. Incompetent Adults

Proxy consent can be understood in a number of ways:

(i) Previously expressed wishes:

This applies to subjects who were formerly competent and who have previously expressed an autonomous preference relevant to the current situation (e.g. an advance directive).

In this case, the proxy’s role is limited to evidence-provision.

(ii) Substituted judgement/hypothetical consent

The proxy attempts to construct an idea of what the subject would consent to if she were in

Day 1: Research with Vulnerable Participants Associate Professor David Hunter

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a position to decide one way or the other.

This standard cannot be applied, however, to cases where the subject has never been competent.

(iii) Best interests standard

In the absence of any evidence about a patient’s autonomous wishes we have to fall back on ‘pure beneficence’.

With the proxy clause in place, what does this mean in terms of Constraints on research involving incompetent adults?

Three scenarios are now distinguished in the regulations:

(1) Informed consent was given before the subject became incompetent (Advance Directives) - their participation is allowed but they have the right to withdraw at any time.

(2) Informed consent was refused before the subject became incompetent - subject’s participation in the trial is NOT permitted.

(3) Informed consent was neither given or refused before the subject became incompetent - the informed consent must be obtained from the legal representative but various extra restriction apply:

The subject must be informed about the research according to their ability to understand.

The subject’s explicit wish to abstain or withdraw must be considered by the proxy (but this is not binding as the Advance Directives are).

No financial inducements are allowed to either subject or representative.

There must be grounds for expecting the benefits of the research will outweigh the risks.

4. Children as Research Subjects

Two difficulties in relation to consent stand out in the case of children:

(i) The range of gradations of competence

(ii) Parents are likely to be closely concerned with what’s going on; so parental rights and welfare may also have to be taken into account.

It should be noted that parental consent itself may not be sufficient, especially where it might be inferred that a child refused consent themselves. Consent should be obtained from the child in addition to parental consent, in line with the child’s capacity to consent. If they are unable to consent then wherever possible they should provide “assent” to their involvement.

Day 1: Research with Vulnerable Participants Associate Professor David Hunter

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Additional Requirements

The minor must be informed of the risk and benefits of the research (according to ability to understand).

A minor ‘capable of forming an opinion and assessing the information’ can refuse participation or withdraw - this is the requirement of Gillick competence.

The minor must suffer from the particular condition to be studied or the study can only be carried out on minors. Hence it must be the case that there is some special imperative why the child has to be involved.

Is non-therapeutic research on (non-competent) minors to be ruled out? No, provided that:

It could not be carried out on competent adults instead

The purpose of the research is to obtain knowledge that is directly relevant to the health or well-being of the subjects (or at least indirectly relevant through improving understanding of that condition)

The research is likely to benefit the subject (or again at least indirectly through benefiting similar others)

That there is no indication that the subject is unwilling to participate.

There is no risk (or at best minimal risk) to the subject

That consent has been obtained from the subject’s guardian or nearest relative.

Is non-therapeutic research on all minors to be ruled out?

No:

Young people aged 16-18 with sufficient understanding are able to consent to participate in research independently of their parents and guardians.

Children under 16 are able to give their full consent providing they have been counseled and do not wish to involve their parents and they have sufficient maturity to understand the nature, purpose and likely outcome of the proposed research.

However, participation in the research must still be in the child’s best interests.

Moreover, HRECs should be wary of allowing the participation of a child in a project where parental consent was not forthcoming (or a competent child was not in agreement).

Day 1: Research with Vulnerable Participants Associate Professor David Hunter

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To summarise the position on using children in research:

1. The relevant knowledge should not be obtainable by research with adults, and older children should be used in preference to younger ones.

2. The project should have an identifiable prospect of being of benefit to children.

3. Where the research is not expected to benefit the individual child directly the risk must be ‘minimal’ or ‘negligible’.

Special concerns over obtaining consent from children include:

A greater likelihood of deference;

The need to communicate in a manner comprehensible to the subjects (e.g. child-oriented information sheets);

The need to check comprehension, especially understanding significance of longer term risks;

A child’s level of understanding may vary (up or down), particularly over the course of a lengthy study.

5. Safeguarding Against Harm

What additional factors besides establishing competence to consent should be taken to safeguard vulnerable groups from harm?

Privacy, anonymity and confidentiality are likely to be particularly important and sensitive.

Safeguards to minimise any inconvenience, intrusion, embarrassment, coercion or distress should be written into the research protocol

Researchers should make themselves aware of relevant services (e.g. counselling) in case support needs emerge during the research. This is particularly important where the participant has been discussing painful or difficult experiences.

Consent procedures should be explored and monitored constantly, particularly for non-verbal cues indicating comprehension and misunderstanding in light of many subjects’ relative lack of independence and autonomy.

Although the safety of the research subject is the researcher’s main priority, they should pay heed to the well-being of associated third parties, such as families and carers, including intruding into their privacy or revealing confidential information.

Research involving “vulnerable groups” may necessitate Criminal Records Bureau disclosure to ensure that their background is suitable for working with children and vulnerable adults.

Day 1: Research with Vulnerable Participants Associate Professor David Hunter

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Additional safeguards for research involving children

Children need particularly careful consideration with respect to establishing and monitoring consent.

Informed consent from young people should be actively and directly sought using communication methods that maximise their understanding of the research.

Confidentiality is important and information sharing should be proportionate to the risk of harm. However, the first concern must be the safety of children and young people. An appropriate person or authority must be informed promptly of any reasonable concern that children are at risk of abuse or neglect, when that is in a child’s best interests or necessary to protect other children.

Participation in the research should be made as rewarding and enjoyable as possible;

Interviewing children should either be undertaken by two researchers or in areas where the researcher and child are not entirely alone to protect the researcher as well as the child;

Consider the gender of interviewers where appropriate, for example in research involving children who have been sexually abused;

Bibliography

Appelbaum, P. and Grisso, T. (1988) ‘Assessing patients’ capacities to consent to treatment’, N Engl J

Med, 319: 1635-8. Archard, David, (1995), Children: Rights and Childhood, London, Routledge Beauchamp, T. & Childress, J. 2001, Principles of Biomedical Ethics, Oxford University Press. Chapter 3,

‘Respect for Autonomy’ Brock, D. & Buchanan, A. (1989) Deciding For Others: The Ethics of Surrogate Decision Making CUP. DOH 2001: Department of Health, Good Practice in Consent: implementation guide,

http://ww.doh.gov.uk/consent/implementationguide.pdf GMC 1998: General Medical Council, Seeking Patients’ Consent: the ethical considerations,

http://www.gmc-uk.org Gert, B; Culver, C. & Clouser, K. (1997) Bioethics: A Return to Fundamentals OUP. Grisso, T & Appelbaum, P (1998) Assessing Competence to Consent to Treatment OUP. Gutheil,T. and Appelbaum, P. (1983) ‘Substituted judgment: best interests in disguise’, Hastings Center

Report, 13, 3: 8-11. Gunn, M. (1994) ‘The meaning of incapacity’, Medical Law Review, 2, 1: 8-29. Law Commission (1995) Law Commission Report No.231: Mental Incapacity HMSO. Lord Chancellor’s Department (1997) Who Decides?: Making Decisions on Behalf of Mentally

Incapacitated Adults The Stationary Office. Lord Chancellor’s Department (1999) Making Decisions: The Government’s Proposals for Making Decisions

on Behalf of mentally Incapacitated Adults The Stationary Office. O’Neill, O. and William Ruddick (eds) (1979), Having Children: Philosophical and Legal Reflections on Parenthood, New York OUP

Schoeman, F. (1980) ‘Rights of children, rights of parents, and the moral basis of the family’ Ethics v. 91.1

Tobias, J. & Doyal, L. 2000, Informed Consent in Medical Research, BMJ Books White, B. (1994) Competence to Consent, Georgetown UP.

Day 1: Research Ethics with Indigenous Peoples and Communities Associate Professor Steve Hemming

1

Flinders Research Ethics and Indigenous Peoples

presented by

Ali Gumillya Baker and Steve Hemming

Ethics and Integrity in Research with Humans Workshop

Wed 25 June 2014

YunggorendiFirst Nations Centre

acknowledgement

To Country

We acknowledge the Kaurna people – the traditional owners of the lands and waters on which the city of Adelaide was built.

Tarndanyunga Kaurna Yerta

We have shelter, food and an income from living on Kaurna lands. We also have love, care and a sense of being a part of an extended family made by Aboriginal people and non-Aboriginal friends because we are on Kaurna country. We are grateful. This is an expression of respect and we view any acknowledgement as a significant and symbolic marker of cultural protocol.

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Aims of Session

Raise awareness of Flinders University Research Ethics policy and practice in relation to Indigenous peoples.

Understand the ethical imperatives of research, including the implications of culturally appropriate and sensitive research with Indigenous peoples.

4/07/20145

Aims of Session cont.

• Develop a coherent, personal and professional research approach that is informed by understandings about Indigenous history and Indigenous aspirations for self-determination.

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Research and Indigenous Peoples:A Historical Context

• Throughout history a poor relationship existed between Indigenous peoples and research.

• The act of research is inextricably linked with Colonialprocesses.

‘…research has not been neutral in its objectification of the ‘other’…Indigenous peoples want greater participation and control’…

(Linda Tuhiwai Smith 1999:39)

Day 1: Research Ethics with Indigenous Peoples and Communities Associate Professor Steve Hemming

2

4/07/20147

Historical Context: Major Tensions

• Some research framed by researcher’s priorities and interest rather than the needs of Indigenous Individuals and or communities.

• Researchers and universities determining what is researched; the way research is conducted; and the effect of research findings on Indigenous peoples.

(Zane Ma Rhea and Irabinna Rigney 2002:8)

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Historical Context: Major Tensions cont…

• Reduction of Indigenous ownership & Intellectual property.

• Lack of mutual respect in research & ongoing consultation.

• In an effort to stop exploitative, unethical research practices, consultation and collaboration with Indigenous Individuals and or communities are fundamental’.

(Gus Worby and Daryle Rigney 2002:28)

4/07/20149

Fundamental Goals of Ethics

• Good ethical practice involves developing a collaborative & mutually respectful research partnership between the researcher and Indigenous peoples.

• Establish relationship prior to starting research.

• Respect Indigenous community governance structures.

Australian Institute of Aboriginal &Torres Strait Islander Studies (AIATSIS)

Indigenous people are full participants in research projects that concern them.

There is a shared understanding of the aims and methods of the research.

Research must be founded in meaningful engagement and reciprocity between the researcher and Indigenous people.

AIATSIS Guidelines for Ethical Research in Australian Indigenous Studies www.aiatsis.gov.au/_files/research/ethics.pdf

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4/07/201411

Principles to Ethical Practice

Principle 1: Recognition of the diversity and uniqueness of peoples, as well as of individuals, is essential.

Recognise the diversity of Indigenous peoples, including their different languages, cultures, histories and perspectives.

.

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Principles to Ethical Practice

Principle 2: The rights of Indigenous peoples to self-determination must be recognised.

Research projects must be conducted in accordance with the United Nations Declaration on the Rights of Indigenous Peoples, No. 4

Self Determination and full participation (appropriate to their skills and experience)

Day 1: Research Ethics with Indigenous Peoples and Communities Associate Professor Steve Hemming

3

Principles to Ethical Practice

Principle 3: The rights of Indigenous peoples to their intangible heritage must be recognised.

Indigenous peoples’ rights to maintain, control, protect and develop their intangible heritage, including their cultural heritage, traditional knowledge, traditional cultural expressions and intellectual property.

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Principles to Ethical Practice

Principle 4: Rights in the traditional knowledge and traditional cultural expressions of Indigenous peoples must be respected, protected and maintained.

Principles to Ethical Practice

Principle 5: Indigenous knowledge, practices and innovations must be respected, protected and maintained.

Acknowledging respecting Indigenous knowledge, practices and innovations is not only a matter of courtesy but also recognition that such knowledge can make a significant contribution to the research process.

4/07/201415

Principles to Ethical Practice

Principle 6:

Consultation, negotiation and free, prior and informed consent are the foundations for research with or about Indigenous peoples.

4/07/201416

Principles to Ethical Practice

Principle 7: Responsibility for consultation and negotiation is ongoing.

Consultation and negotiation is a continuous two-way process. Ongoing consultation is necessary to ensure free, prior consent.

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Principles to Ethical Practice

Principle 8: Consultation and negotiation should achieve mutual understanding about the proposed research.

Consultation involves an honest exchange of information about aims, methods and potential outcomes (for all parties).

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Day 1: Research Ethics with Indigenous Peoples and Communities Associate Professor Steve Hemming

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Principles to Ethical Practice

Principle 9: Negotiation should result in a formal agreement for the conduct of a research project.

The aim of the negotiation process is to come to a clear understanding that results in a formal, negotiated agreement (preferably written) about research intentions, methods and potential results.

4/07/201419

Principles to Ethical PracticePrinciple 10: Indigenous people have the right to full participation appropriate to their skills and experiences in research projects and processes.

Participation, collaboration and partnership

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Principles to Ethical Practice

Principle 11: Indigenous people involved in research, or who may be affected by research, should benefit from, and not be disadvantaged by, the research project.

Research in Indigenous studies should benefit Indigenous peoples at a local level, and more generally.

Benefits, outcomes and giving back

4/07/201421

Principles to Ethical Practice

Principle 12: Research outcomes should include specific results that respond to the needs and interests of Indigenous people.

Tangible benefits that in a form that is useful and accessible.

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Principles to Ethical Practice

Principle 13: Plans should be agreed for managing use of, and access to, research results. Indigenous peoples make significant contributions to research.

Acknowledgement and negotiation of rights.

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Principles to Ethical Practice

Principle 14: Research projects should include appropriate mechanisms and procedures for reporting on ethical aspects of the research and complying with these guidelines.

4/07/201424

Day 1: Research Ethics with Indigenous Peoples and Communities Associate Professor Steve Hemming

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Common feedback on ethic applications

• Anonymity

• Cultural Sensitivities

• Benefit of the research to the community

• Ownership of Knowledge

• Authority of Voice

• Silences in the Research Findings

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Common feedback on ethics applications cont.

• Language (first Language speakers, Aboriginal English)

• Legislative considerations (eg. Parks and Wildlife Heritage Act)

• Gender considerations

• University Responsibility

4/07/201426

4/07/201427

Conclusion

Flinders University is committed to:

Supporting research that contributes to improved outcomes for Indigenous peoples and their communities.

thank you

• www.flinders.edu.au/yunggorendi

• www.facebook.com/YunggorendiCentre

Day 1: Research Integrity and Research Misconduct Dr Peter Wigley

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Research Integrity and

Research Misconduct

Dr Peter WigleyManager, Research Ethics and Integrity

Flinders University

With thanks to Dr Vicki XafisThe University of Adelaide

Research Integrity

• The responsible conduct of research

– honesty, accountability, good stewardship, research quality

• Research misconduct

Australian Code for the Responsible Conduct of Research(ARC, NHMRC & Universities Australia, 2007)

Part A: Principles and Practices to Encourage Responsible Research

Part B: Breaches of The Code, Research Misconduct,

and the Framework for Resolving Allegations

The Code will be revised in 2014-16

http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/r39.pdf

Why Adhere to the Code?

• Want to conduct and report research responsibly

• Disciplinary action and penalties; loss of job and income

• Inability to access future funding

• Reputation tarnished

• Impact on health and relationships

• Impact on colleagues and collaborators

• Condition of funding from the ARC and NHMRC

• Undermines public trust and support for research

• Raises concerns about the evidence upon which decisions are made

Learning about RCR

• Supervisors

• Mentors

• Colleagues

• The Code

• Other Guidelines

• University policies

• Training

• If you don’t know, or you’re unsure – find out!

Why Engage in Misconduct?

• Ignorance

• Lack of training

• Lack of appreciation of the consequences

• Sloppy practices

• Slippery slope

• Greed

• Pressure to publish or obtain grant funding

• Competition

Day 1: Research Integrity and Research Misconduct Dr Peter Wigley

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The Code – Part A

Principles and Practices

to Encourage Responsible Research

1. General Principles of Responsible Research

2. Management of Research Data and Primary Materials

3. Supervision of Research Trainees

4. Publication and Dissemination of Research Findings

5. Authorship

6. Peer Review

7. Conflicts of Interest

8. Collaborative Research Across Institutions

A – 1. General Principles of Responsible Research

RESPONSIBILITIES OF INSTITUTIONS

• Promote the responsible conduct of research

• Establish good governance and management practices

• Train staff

• Promote mentoring

• Ensure a safe research environment

RESPONSIBILITIES OF RESEARCHERS

• Maintain high standards of responsible research

• Report research responsibly

• Report research misconduct

• Respect research participants (human, animal) and the environment

SPECIAL RESPONSIBILITIES

• Aboriginal & Torres Strait Islander peoples (other Guidelines; Yunggorendi)

• Consumer & community participation in research (health; NHMRC Statement)

A – 2. Management of Research Data and Primary Materials

RESPONSIBILITIES OF INSTITUTIONS

• Retain research data and primary materials

• Identify ownership

• Provide safe and secure storage

• Ensure security and confidentiality of access

RESPONSIBILITIES OF RESEARCHERS

• Retain research data and primary materials

• Manage storage

• Maintain confidentiality

See guidelines in the Code for different categories of research data

– generally: minimum of 5 years retention after publication

And: General Disposal Schedule No. 24 – State Records

A – 3. Supervision of Research Trainees

RESPONSIBILITIES OF INSTITUTIONS

• Set standards for supervision and mentorship

• Induct research trainees

RESPONSIBILITIES OF RESEARCHERS / SUPERVISORS

• Ensure training

• Seek guidance

• Mentor and provide support

• Ensure valid and accurate research

• Ensure appropriate attribution

RESPONSIBILITIES OF RESEARCH TRAINEES

• Undertake induction and training

• Seek guidance

A – 4. Publication and Dissemination of Research Findings

RESPONSIBILITIES OF INSTITUTIONS

• Promote responsible publication and dissemination of research findings

• Protect confidentiality, and manage intellectual property

• Support communication of research findings to the wider public

RESPONSIBILITIES OF RESEARCHERS

• Disseminate research findings

• Ensure accuracy of publication and dissemination

• Cite the work of other authors fully and accurately

• Avoid multiple submissions of research findings

• Obtain permission for republishing (e.g., for reviews)

• Disclose research support accurately

• Register clinical trials (ANZCTR)

• Manage confidentiality

• Responsibly communicate research findings in the public arena

A – 5. Authorship

RESPONSIBILITIES OF INSTITUTIONS

• Have criteria for authorship (reflecting the Code)

RESPONSIBILITIES OF RESEARCHERS

• Follow criteria / policies on authorship

• Agree on authorship (as early as possible)

• Include all eligible authors

• Do not allow unacceptable inclusions of authorship (e.g. ‘honourary’)

• Acknowledge other contributions fairly

• Extend the authorship policy to web-based publications

• Maintain signed acknowledgments of authorship for all publications – original, hand-written signatures (if possible; or email / fax)

Day 1: Research Integrity and Research Misconduct Dr Peter Wigley

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Authorship Criteria

Attribution of authorship depends to some extent on the discipline, but in all cases, authorship must be based on substantial contributions in a combination of:

• Conception and design of the project

• Analysis and interpretation of research data

• Drafting significant parts of the work or critically revising it so as to contribute to the interpretation

NHMRC: 2 of these 3 may suffice

A – 6. Peer Review

RESPONSIBILITIES OF INSTITUTIONS

• Encourage participation in peer review

RESPONSIBILITIES OF PEER REVIEWERS

• Conduct peer review responsibly

RESPONSIBILITIES OF RESEARCHERS

• Do not interfere during the peer review process

• Participate in peer review

• Mentor trainees in peer review

• Declare conflicts of interest

A – 7. Conflicts of Interest

RESPONSIBILITIES OF INSTITUTIONS

• Maintain a policy

• Manage conflicts of interest

RESPONSIBILITIES OF RESEARCHERS

• Disclose conflicts of interest

Possible Conflicts of Interest

• Consultancies

• Membership of committees, boards of directors, advisory groups, or selection committees

• Receipt of cash, services or equipment from outside bodies to support research activities

A – 8. Collaborative Research Across Institutions

RESPONSIBILITIES OF INSTITUTIONS

• Establish agreements for each collaboration

• Manage conflicts of interest

• Manage access to research data and materials

RESPONSIBILITIES OF RESEARCHERS

• Comply with multi-institutional agreements

• Declare conflicts of interest

The Code – Part B

Breaches of The Code, Research Misconduct,

and the Framework for Resolving Allegations

9. Breaches of the Code and Misconduct

10. Concepts and Definitions

11. Responsibilities

12. The Framework for Resolving Allegations

B – 1. Concepts and Definitions

Breach is a less serious deviation from the Code that is appropriately remedied within the institution.

Research Misconduct is a more serious or deliberate deviation, involving:

• Intent and deliberation, recklessness, or gross and persistent negligence

• Serious consequences, such as false information on the public record, or adverse effects on research participants, animals or the environment.

Examples of Misconduct• Plagiarism; fabrication (inventing data); falsification (manipulating data)

• Failure to declare or manage a serious conflict of interest

• Failure to follow research proposals approved by an Ethics Committee

• Wilful concealment or facilitation of research misconduct by others

• Repeated or continuing breaches of the Code

Day 1: Research Integrity and Research Misconduct Dr Peter Wigley

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Research Misconduct 1

Higher misconduct rates than we might hope or expect

• 2% of scientists admit to at least one episode of data fabrication or manipulation (Fanelli, PLoS ONE 4(5), e5738, 2009 – review & meta-analysis of surveys)

• The retraction of two-thirds of 2,047 biomedical and life sciences papers listed as retracted in PubMed (1970s onwards) was due to misconduct

(Fang et al., PNAS 109, 17028-33, 2012)

• US Office of Research Integrity received 400 allegations in 2012

• NHMRC received 52 allegations over the 5 years from 2008 to 2012

• I witnessed 2 cases of misconduct at close range, and knew of 3 others

Research Misconduct 2High Profile Cases

• Jan Hendrik Schön (Germany; semiconductors) – data fabrication and falsification

• Hwang Woo-Suk (South Korea; stem cells, cloning) – data fabrication and falsification

• Diederik Stapel (Netherlands; social psychology) – fabricated data in at least 55 papers

• Yoshitaka Fujii (Japan; anaesthesiology) – fabricated data in at least 172 papers

• Eric Poehlman (US; ageing) – falsified data in as many as 17 grant applications;

first academic in the US jailed for falsifying data in a grant application (1 year).

• Monash Uni VC – plagiarism allegations; he admitted two cases, and resigned

• University of QLD, 2013 (Parkinson’s disease) – "no primary data can be located, and no evidence has been found that the study described in the article was conducted.“

• Andrew Wakefield – paper linking MMR vaccine to autism; retracted by the journal

B – 2. Responsibilities

A number of people have responsibilities for resolving allegations of breaches of the Code and research misconduct, including:

• CEO – Vice-Chancellor, who has overall responsibility for the process

• Delegated Officer – Deputy Vice-Chancellor, Research (DVCR)

• Designated Person – who receives a written allegation, conducts a preliminary investigation, and provides advice to the Delegated Officer

• Research Integrity Advisors, appointed by the institution to advise those making, or considering making, allegations

• Head of Department, School or Research Centre/Institute

• Research supervisors

• Researchers

B – 3. Handling Allegations 1

Initial Contacts

• Supervisor

• Department/School Head, RHD/HDR Coordinator, Associate Dean Research

• Research Integrity Advisor

But note any issues or conflicts of interest

Breaches of the Code that do not constitute research misconduct should, as far as possible, be handled at the local level.

Preliminary Investigation by the Designated Person.

If a Formal Inquiry of misconduct is warranted (decided by VC/DVCR)

• Internal institutional research misconduct inquiry; or

• Independent external research misconduct inquiry

– depending on the seriousness of the consequences

B – 3. Handling Allegations 2

Procedural fairness (natural justice)

• Allegations and findings in writing

• Fair hearing

• No bias on the inquiry panel

• Possibility of appeal

Outcomes

• Allegations found to be unjustified; or

• Misconduct established

disciplinary action*

advise stakeholders

correct the public record (e.g., retraction)

*consistent with the current Uni-Staff Agreement

B – 3. Handling Allegations 3

Serious Potential Consequences

Perpetrator

• Job loss

• Reputation and career ruined

• Criminal charges? (e.g. for grant funding fraud)

Others

• Affects colleagues, students, collaborators, other researchers in the field

• Reputation of Department / School / Faculty / Institution

• Repayment of grant funds

Whistleblowers must be protected from adverse consequences

But malicious whistleblowing is as serious as misconduct

Day 1: Research Integrity and Research Misconduct Dr Peter Wigley

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What sort of ‘activities’ might constitute misconduct?

1. Falsifying or ‘cooking’ research data

2. Ignoring major aspects of human ethics requirements

3. Not properly disclosing involvement in companies whose products are based on one’s own research

4. Minor errors in data collection, later corrected

5. Relationships with students, research subjects or clients that may be interpreted as questionable

6. Using another’s ideas without obtaining permission or giving due credit

7. Unexpected adverse events in human subjects

8. Unauthorised use of confidential information in connection with one’s own research

9. Failing to present data that contradict one’s own previous research

10. Circumventing certain minor aspects of human ethics requirements

Adapted from Martinson, Anderson & de Vries Nature 2005 435:737-738

And these?

11. Overlooking others' use of flawed data or questionable interpretation of data

12. Changing the design, methodology or results of a study in response to pressure from a funding source

13. Publishing the same data or results in two or more publications

14. Including as authors research assistants who only collect or generate data

15. Withholding details of methodology or results in papers or proposals

16. Using inadequate or inappropriate research designs

17. Providing research participants with summaries of research findings

18. Dropping observations or data points from analyses based on a gut feeling that they were inaccurate

19. Inadequate record keeping related to research projects

Adapted from Martinson, Anderson & de Vries Nature 2005 435:737-738

Day 2: Applying for HREC Approval Dr John Semmler and Associate Professor Bernie Hughes

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Applying for HREC ApprovalDr John Semmler

Convenor, University of Adelaide HREC

Session Outline

• Institutional Ethics Committees: functions and

membership

• Levels of Review

• Researcher Responsibilities

• Key factors for HREC approval

Functions of HREC

• Apply the principles set out in the National Statement on Ethical Conduct in Human Research (Australian Govt 2007) to safeguard the dignity, rights, and safety of actual or potential research participants

• To consider the ethical implications of all proposed research projects on humans and to determine whether or not they are acceptable on ethical grounds

• To provide for surveillance of research projects until completion so that the Committee may be satisfied that they continue to conform with approved ethical standards

• To maintain a record of all proposed research projects

Membership of HREC

• The minimum membership of an HREC is eight:– the Convener, an academic seen as being impartial

– an academic who is a lawyer

– one member with experience in pastoral care (e.g. Aboriginal elder, minister of religion)

– one member with experience in professional care or counselling (e.g. nurse or allied health professional)

– two members with current research experience

– a layman not associated with the Institution

– a laywoman not associated with the Institution

• The composition shall reflect equal numbers of men and women of varying age groups

Levels of Review

• Research that involves more than low risk (harm)– Must be reviewed by HREC– Has potential to cause harm (physical, psychological, social,

economic, legal)

• Research involving no more than low risk (discomfort)– Can be given non-HREC review by a sub-committee of the HREC

or executively approved by the HREC Convener.– Examples of discomfort include minor side-effects of medication and

anxiety induced by an interview

• Research that involves negligible risk (inconvenience)– Can be exempted from review, provided it involves the use of

existing collections of data and records that contain only non-identifiable data about human beings. (NS 5.1.22)

– Examples include filling in a form, participating in a street survey, or giving up time.

5

Levels of Review• Research eligible for low risk review must satisfy both of the

following conditions:– Describes research in which the only foreseeable risk is discomfort– It is not included in the following categories:

• the use without consent of personal information in medical research, or personal health information (NS 2.3.5).

• interventions and therapies: including clinical and non-clinical trials, and innovations (NS 3.3)

• human genetics (NS 3.5)• human stem cells (NS 3.6)• women who are pregnant and the human fetus (NS 4.1)• people highly dependent on medical care who may be unable to give

consent (NS 4.4)• people with a cognitive impairment, an intellectual disability, or a mental

illness (NS 4.5)• children and young people (with some exceptions) (NS 4.2)• people who may be involved in illegal activities (NS 4.6)• Aboriginal and Torres Strait Islander peoples (NS 4.7)• people in other countries (with some exceptions) (NS 4.8).

6

Day 2: Applying for HREC Approval Dr John Semmler and Associate Professor Bernie Hughes

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Researcher Responsibilities

• Demonstrate that the research has merit.

• Proposals should be clear and comprehensive, and written in lay language.

• Disclose amount and sources of funding.

• Inform all institutions involved in the research at an early stage.

• Disclose any actual or potential conflict of interest (application and reporting).

• Provide annual reports on research progress and report any adverse or unexpected outcomes promptly.

University of Adelaide 7

Key factors for HREC approval

• Research merit and safety– Justify research

– team experience

– appropriate facilities

• Acceptable balance of risks and benefits to participant– Risks of discomfort or harm to participants is balanced by the

likely benefit gained

– Withholding a known effective treatment is unethical

• Informed Consent– Is the participant fully informed of the point of the research and

the burdens to participation?

– Competence to provide consent

– Refusal to participate must be respected

University of Adelaide 8

Key factors for HREC approval• Privacy and confidentiality issues

– Privacy Act 1988 Commonwealth statute: limits on storage, security, access to, use and disclosure of personal information

• Recruitment– Voluntary choice, free of coercion or inducements

– The initial contact/approach with participants must be ethically appropriate

• Participant information sheet– The Information Sheet should provide participants, at their level

of comprehension, with sufficient information about their participation in the study to enable their fully informed consent

– use simple language; avoid technical words or jargon

– the sheet must be translated if non-English speakers are used as participants

– the sheet should supplement a verbal explanation of the studyUniversity of Adelaide 9

• Educating Professionals • Creating and Applying Knowledge • Engaging our Communities

Common Problems in Ethics Applications

Bernie Hughes, Chair UniSA HREC

Common concerns‐ “How?”

• How will the participants be recruited?

• How will the researcher get the names and contact details of the participants?

• How will consent be obtained? Will it be genuinely voluntary?

• How will anonymity be maintained?

• How and where will the data be stored?

Day 2: Applying for HREC Approval Dr John Semmler and Associate Professor Bernie Hughes

3

Common concerns

Ethics vs. methodology:

“Unless proposed research has merit and the researchers who are to carry out the research have integrity, the involvement of human participants in the research cannot be ethically justifiable”. (NS p. 11)

Lack of connection between research aims and the research design

‐ will data collection achieve the aims of the project?

‐ what is the value and need for the research?

Common concerns

• People in dependent relationships: 

• “People in dependent relationships are vulnerable to being over‐researched because of the relative ease of access to them as research populations. Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as research participants.” (NS 4.3.4)

• Research in the workplace • using prior knowledge; uncovering 

illegal or unethical behaviour; expected outcomes

Common concerns

• Clarity of expression – English language

• Consistency – applications/ committee decisions

• Over‐researching of staff and students

• Approvals from other organisations

• Approvals from other HRECs  

Common concerns

• Risks to the participants and to the researcher • eg. home visits; domestic violence; 

criminal activity; emotional

• Unanticipated outcomes• eg. emotional upset; claims of 

discrimination; illegal activities; bullying; defamatory comments 

• Mandatory reporting/ police checks

• Research conducted overseas

• Indigenous research 

Common concerns

• Ownership 

• Ethics approval cannot be granted retrospectively

• Insurance is important and can be an issue for some projects

• Any changes to the original protocol (as approved) require further approval

Day 2: Applying for HREC approval – Flinders University breakout Dr Mariette Berndsen

1

Human Research Ethics at Flinders

Dr Mariette Berndsen

Lecturer in Psychology

Member SBREC

Overview

• 1. The SBREC process

• 2. Questions and discussion

• 3. Workshop your application

Research Ethics Governance at Flinders

Social and BehaviouralResearch Ethics

Committee (SBREC)

Full Committee

Low – Risk Process

Southern Adelaide Clinical Human

Research Ethics Committee (SAC

HREC)

Applying for ethics approval• The key starting point is the SBREC

website – there are a lot of key documents, guidelines, deadlines, etc on this website: http://www.flinders.edu.au/research/researcher-support/ethics/committees/social-and-behavioural-research-ethics-committee/social-behavioural.cfm

Applying for Ethics Approval• Step 1: Is my research low risk? Applications considered to

be low or negligible risk research (as defined by the National Statement) are now reviewed via a rolling review process and therefore can be submitted at any time

• Exempt ResearchResearch is deemed to be exempt from any ethical review if (1) it is negligible risk (as defined below) and (2) involves the use of existing collections of data or records that contain only non-identifiable data about human beings

• Negligible Risk ResearchThe expression 'negligible risk research' describes research in which there is no forseeable risk of harm or discomfort. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk

• Low Risk ResearchResearch is 'low risk' where the only forseeable risk is one of discomfort. Where the risk, even if unlikely, is more than serious than discomfort, the research is not low risk

Applying for Ethics Approval • Low risk applications require:

• (a) the Low / Negligible Risk Assessment Form (DOCX 40KB) ;(b) a fully signed copy of the SBREC Application Form; and(c) all relevant attachments (i.e. participant documents, surveys etc).

• The low risk process is not easier, but it is quicker

• Applications deemed to be low or negligible risk by the SBREC Chair will be allocated to the relevant sub-committee.

Day 2: Applying for HREC approval – Flinders University breakout Dr Mariette Berndsen

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Applying for Ethics Approval• Step 2: If my research is not low risk

• Full ethics applications are considered by the full SBREC committee, which meets once every 4 weeks.

• When the committee meets, the chair and three committee members will consider your application

• Who is on the committee?• (a) Chairperson

(b) Lay members who have no affiliation with the institution(c) A member with knowledge of, and current experience in, the professional care, counselling or treatment of people.(d) Minister of religion(e) Lawyer(f) Members with current research experience.

Applying for Ethics Approval• Step 3: How do I fill out the form? What does it

want from me?

• What the form requests is enough information to determine whether the research poses acceptable risks to participants and the researcher

• So, you must be very clear and definitive about your project, but concise is fine – the approval process does not seek your full thesis proposal

• Only three projects rejected in 5+ years.

Applying for Ethics ApprovalClose Date: 5

pmMeeting Date

19 January 2 February

9 February 2 March

10 March 30 March

7 April 27 April

4 May 25 May

1 June 22 June

29 June 20 July

27 July 17 August

24 August 14 September

21 September 12 October

19 October 9 November

16 November 7 December

Full applications require:

1 a fully signed copy of the SBREC Application Form; and

2 all relevant attachments (i.e. participant documents, surveys etc).

Key resources in applying for ethics approval

• Your supervisor

• Your peers

• The SBREC website

• School Research Ethics Advisers

Questions?

Day 2: Applying for HREC approval – University of Adelaide breakout Dr John Semmler

1

Applying for Human Research Ethics Approval For a research project with or about people, or their data or tissue.

What information do I need before I apply?• Read the guidelines on the University’s human research

ethics website at www.adelaide.edu.au/ethics/human/

• Read the relevant chapters in the National Statement on Ethical Conduct in Human Research (2007). This is constantly being updated so refer to the NHMRC website.

• Read the relevant sections of the Australian Code for the Responsible Conduct of Research (2007).

University of Adelaide 2

How do I determine which category of ethical review is required for my project?

• Research projects with different levels of risk to participants have different review requirements.

• There are 3 review categories: – research exempt from HREC review;

– research eligible for low risk review; and

– research requiring full HREC review.

• The Ethical Issues Checklist for Human Research is provided to assist researchers to determine the appropriate level of review.

University of Adelaide 3

Research that is Exempt from HREC review

• Researchers are required to keep an auditable record of research that is exempt from HREC review.

• The Ethical Issues Checklist has been created to assist researchers to meet this requirement.

• The completed checklist is to be signed by the researchers and kept with the other project records.

University of Adelaide 4

Who reviews low risk research applications?

• The University of Adelaide Human Research Ethics Committee, or

• The Low Risk Human Research Ethics Review Group (Faculty of Humanities and Social Sciences & the Faculty of the Professions), or

• The Low Risk Human Research Ethics Review Group (Faculty of Health Sciences) or

• The Psychology Low Risk Research Sub-Committee.

University of Adelaide 5

Which forms and document templates do I use?

• The same form is used for both low risk review and full review. You need to indicate on the form which category of review you require to assist with the preview of the application.

• Applications for ethical approval include the following documents:– 2014 Application for Ethics Approval– Participant Information Sheet– Consent Form– Contacts and Independent Complaints Procedure Sheet– Attach: survey instruments, questionnaires, focus group

questions/topics, letters of permission, recruitment flyers, etc

University of Adelaide 6

Day 2: Applying for HREC approval – University of Adelaide breakout Dr John Semmler

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When can I submit my completed application?

• Low Risk

– Anytime – applications are processed on a continuous basis, in date order of electronic receipt of the completed signed copy at [email protected]

– Application processing time is dependent on the quality of the application and the availability of reviewers. It can take longer at busy times of the year or when amendments and additional information is requested.

University of Adelaide 7

When can I submit my completed application?

• Full HREC Review– The Committee currently meets 7 times a year.

– Applications need to be received at the Secretariat by the application submission deadline date in order to be considered for the subsequent meeting.

– Applications must be submitted as one PDF version of the signed application (including all attachments) to [email protected]

– Submission deadline information is on the website at http://www.adelaide.edu.au/ethics/human/deadlines/

– Only submit a completed application as the Secretariat will not review draft versions prior to the Committee meeting.

University of Adelaide 8

How long does full review ethics approval take?

• Researchers receive feedback within 2-3 weeks following the Committee meeting. This may require applicants to provide further information and modification before final approval is granted.

• If an application is not approved a revised application will be considered at the next meeting.

• Ethics approval is granted for a period of three years subject to annual progress reporting.

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Common issues with applications

• Your supervisor should assist in completing the application, read it and approve its content prior to submission.

• Retrospective ethics approval for research activities that have already commenced cannot be granted by the HREC.

• Use simple, plain English language.

• Do not attach any academic research proposals.

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Why is there a hold-up with the review of my application?• The PDF copy has not been checked before sending.

– e.g. the ‘Do not print page’ is included, or there are blank pages left in, or it is formatted with content displayed sideways – these all take time to tidy up before the application can be reviewed

• External supervisors/researchers are missing from the application.

• Question(s) in the application have been left blank or the response states ‘Refer to attached document’ – all questions need to be answered in the form.

• Supporting documents are not attached.

• There are readability issues with the Information Sheet – ask a friend, relative or student to read yours and see if there are any information gaps.

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Monitoring and reporting

• Any variation to the approved research will require approval before commencement.

• It is a condition of approval that researchers immediately report to the Secretariat any: – serious or unexpected adverse effects on participants or others

involved in the project;

– unforeseen events that might affect continued ethical acceptability.

• An annual progress report will need to be submitted.

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Day 2: Applying for HREC approval – University of Adelaide breakout Dr John Semmler

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Single ethical review and approval

• In certain circumstances, the University of Adelaide accepts the ethics approvals granted to its staff and students by other Human Research Ethics Committees.

• If approval has been granted by one of the 5 SA Health HRECs, then additional approval from the University of Adelaide HREC is not required. These HRECS are:– Royal Adelaide Hospital Research Ethics Committee; – Human Research Ethics Committee (The Queen Elizabeth Hospital,

Lyell McEwin Hospital and Modbury Hospital);– Women's and Children's Health Network Human Research Ethics

Committee;– SA Health Human Research Ethics Committee;– The Southern Adelaide Clinical Human Research Ethics Committee

(Flinders Medical Centre and Repatriation Hospital).

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Single ethical review and approval (continued)

• Formal Notification to the University is required within fourteen days of receiving ethical approval from these HRECs.

• The Notification form and further information can be accessed at http://www.adelaide.edu.au/ethics/human/guidelines/

• If approval has been granted by another HREC, then you should contact the University HREC Secretariat to discuss whether you need to submit an application for review or whether you can submit a Notification of existing approval.

• The University HREC must have a record of your ethics approval (University or other) for you to be covered by the University’s insurance policy.

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Human Research Ethics Contacts

[email protected]

• Ms Sabine Schreiber Secretary, Human Research Ethics CommitteeT: (08) 8313 [email protected]

• ‘Currently being appointed’Executive Officer, Low Risk Human Research Ethics Review Groups (HUMSS/Profs) and (Health Sciences)T: (08) 8313 4725

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