research ethics office for research gary allen chris rose’meyer rhiannon campbell research ethics...

Research Ethics

Office for ResearchGary Allen

Chris Rose’Meyer

Rhiannon CampbellResearch Ethics Administrator

ph: 3735 4855 fax: 07 3735 7994 email: [email protected]

Education Research Ethic AdvisorsDr Leonie Rowan

Dr Sue Whatman

Dr Christine McDonald

Photo: Australian HES 11/11/09

Office for Research - 2012

Overview

1. What is human research?

2. Why research ethics matters?

3. History of the governance of human research ethics – Response to international scandals

4. Governance in Australia

5. Using the National Statement (2007)

6. Griffith University


What is Human Research?Examples of human

research

Interviews

Surveys

Focus Groups

Observations

Chat rooms

Testing

Identified personal information not on the public record.

Human research is conducted with or about people, or their data or their tissue.

Persons Born Overseas (Percent)*

Census Year 2001Local Government AreaASGC Version

http://maps.oesr.qld.gov.au/thematics/index.jsp?p_usertype_id=2


Office for Research | [email protected] | © Griffith University 2012

Why research ethics matters?

Responsibility to participants

Reputation of the University

Requirements of research funding bodies, state, federal and international

Requirements of the University’s insurer – indemnification of researchers

Future access to populations and sites

Use of public funds carries with it obligations to the community

Professional obligations

Requirements of many journals


History of the governance of human research ethics

Response to international scandals

Why Human Research Ethics?

World War II See Unit 731 (Japanese) for biological

and chemical warfare Mengele – 1500 sets of imprisoned twins Luftwaffe – freezing experiments Dachau – Malaria treatment And many more well documented

episodes of inhumanity.

Following the Doctors’ Trials at Nuremberg the

Tribunal delivered their opinion on medicalexperimentation on human beings – The Nuremberg Code (1947).

History of Research Ethics

1.Nuremberg Code

http://www.ushmm.org/research/doctors


Nuremberg Codehttp://ohsr.od.nih.gov/guidelines/nuremberg.htm

1.The voluntary consent of the human subject is absolutely essential

2.The experiment should be such as to yield fruitful results for the good of society

3.The experiment should be so designed and based on the results of animal experimentation

4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury

5.No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur;

6.The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7.Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8.The experiment should be conducted only by scientifically qualified persons

9.During the course of the experiment the human subject should be at liberty to bring the experiment to an end

10.During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage


Nuremberg Codehttp://ohsr.od.nih.gov/guidelines/nuremberg.htm

1.The voluntary consent of the human subject is absolutely essential

2.The experiment should be such as to yield fruitful results for the good of society

3.The experiment should be so designed and based on the results of animal experimentation

4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury

5.No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur;

6.The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7.Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8.The experiment should be conducted only by scientifically qualified persons

9.During the course of the experiment the human subject should be at liberty to bring the experiment to an end

10.During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage


Beneficence

Voluntary participation

Informed Consent

Scandals – Deception / Consent

Watch Queen Observation of homosexual acts in

public toilets.

Recorded car licence plates.

Learned of names and addresses from friendly policemen while pretending to be a market researcher.

As a public health surveyor interviewed men he had observed.

Most men married and secretive about homosexual activity.

3. Laud Humphreys – The Watch Queen in the Tea Room (1967)

http://bioethics.net/


International research ethics frameworks for human research

World Medical Association developed a set of ethical

principles for the medical community regarding Human experimentation – Declaration of Helsinki

1966.http://www.wma.net/en/30publications/

10policies/b3/index.html

1. Self – determination2. Informed Consent

Ethical Principals and the Guidelines for the Protection of Human Subjects of Research –

Belmont Report (1979) http://ohsr.od.nih.gov/guidelines/belmont.html

1. Respect for Persons2. Beneficence3. Justice

2. UN Declaration of Human Rights

3. Declaration of Helsinki (WMA)

4. Belmont Report

http://www.mcmaster.ca/ors/ethics/tutorial/define.htm


Personal responsibility: Reflective practice John Hopkins Hospital Baltimore

Office of Human Research Protection suspended supported medical research projects involving humans.

» 2400 federally funded human experiments

» 15 000 patients and volunteers

» $419M for research ($277 in experiments involving humans)

Death of volunteer at university’s asthma and allergy centre.

Use of unapproved drug (hexamethonium) without informing IRB

Lack of reflective practice as earlier volunteers were also incapacitated – this should have been reported as an adverse event.

The lesson of John Hopkins (2001)

http://www.hopkinsmedicine.org/



Governance in AustraliaImplementation of international standards and expansion beyond

clinical work

Australian national framework


NHMRC Statement on Human Experimentation and Supplementary Notes (First published 1966, multiple revisions, last revised 1992)

National Statement on Ethical Conduct in Research Involving Humans (1999)

National Statement on Ethical Conduct in Human Research (2007)

Australian Code for the Responsible Conduct of Research (2007) – Research Integrity not research ethics, but an important document for your research

National Statement on Ethical Conduct in Human Research (2007)



Principles of ethical conduct

• Merit and integrityo Genuine search for knowledgeo Based on literature, prior research and / or

established problemo Sufficient expertise and resourceso Any conflicts of interest addressed

• Respect for personso Intrinsic value of humans, rather than

resourceso Welfare, beliefs, perceptions, customs and

cultural heritageo Privacy, confidentiality and cultural

sensitivitieso Honour assurances providedo Respect the capacity for self determination


Principles of ethical conduct

• Beneficenceo Responsibility to minimise harmso Not non-maleficenceo Not overstating the benefitso Benefits must justify the riskso Fair flow of benefits versus burdenso Genuinely informed consent

• Justiceo Fair selection and inclusiono Distributive justiceo No unfair burdeno Fair flow of / access to benefitso No exploitationo Impact on prejudice and discrimination

In the National Statement (2007) Different research methods and

disciplines:» Qualitative research» Human tissues» Clinical trials» Databanks

Different types of participants» Children» Overseas» Aboriginal and Torres Strait Island people

Ethical review» Membership and role of HRECs» Low risk and negligible risk» Duplication of review

Researcher responsibilities Institutional responsibilities

Since the 1999’s first edition explicitly expanded the scope beyond clinical to all human research.



Using the National Statement (2007)Research ethics in practice


Risks in human researchA common mistake researchers make is to describe a project as involving no risks

When what they actually mean is that there are strategies in place to negate or minimise the risks

Risks in Human Research What are some of the risks of

Human Research.» Physical (Injury, illness, harm)

» Psychological (significant distress)

» Social (impact on social networks, access to services and support)

» Economic (loss of income, earnings and cost to participants)

» Legal (exposure to civil or criminal proceedings)

» Humiliation (devaluation of worth)

» Environment (see Code not NS)

Recognition of burden on participants.

Another common mistake is to assume that risks only refers to physical or perhaps also significant psychological harms.


Risks in Human Research

Assessing RisksTo whom do the risks apply?

» Participants, potential participants, third parties, environment, and / or researchers.

Addressing risks» Are there alternatives?» Can risks be negated or

minimised?» Can risks be managed?

Can the risks be justified?

Disclosure to potential participants

Yet another common mistake is to focus only on the risks to the participants.


Justifying the risks in Human ResearchAssessing BenefitsWhat are the benefits?To whom do the benefits flow?

» Directly to participants and/or participant community (people like the participants)

» Other stakeholders / wider society» Sponsors / Griffith University» Researchers

Recognising uncertainty in research

Justifying research with minimal benefit

Describing benefits to potential participants

As we know, there are known knowns. There are things we know we know. We also know there are known unknowns. That is to say we know there are some things we do not know. But there are also unknown unknowns, the ones we don't know we don't know.

Donald Rumsfeld

http://www.wisdomquotes.com/003223.html


Have you “Done” ethics yet? Research ethics is first and

foremost a personal responsibility

It is a design, conduct and quality issue

Researchers should engage with the ethical principles and review process

See the process as a continuing professional responsibility until the research is completed

Not form filling – someone else’s problem

Objective is to help you improve design and quality of the research

This is not an expression we like to hear because…


LimitationsClinical Research Precedents and scandals relate

primarily to medical research. More easily quantifiable risks

Quantitative Assumptions Sample size Consent (verbal)

Western Liberal – Democratic expectations

Consent Attitudes towards personal

burdens vs collective benefits Standard of care

It is important to recognise that the National Statement has its limitations



Human research ethics at Griffith University

Proportional, transparent and collegiate


Sources of guidance, information and resources

Research Ethics Manual

Office for Research – Process and system questions

Office for Research – Responding to ethical review feedback

Psychology REA(s)

HDR Supervisor

Office for Research – Application of ethical principles to your work and / or policy questions

Griffith University – Levels of Ethical review

Full ReviewMore than low risk

Allow approximately 40 days for the initial review

Full ReviewMore than low risk


Expedited Review 2Low Risk + Significant ethical issues


Expedited Review 2Low Risk + Significant ethical issues


Expedited Review 1Low Risk + Minimal ethical issues


Expedited Review 1Low Risk + Minimal ethical issues


Expedited Review 1 (NR)Negligible Risk


Expedited Review 1 (NR)Negligible Risk



How to Apply


Recruitment – see also Booklet 21


Impacts on Recruitment


Steps to Success


General Tips


Other issues to be considered


Contacts


•Chris Rose’Meyer x 27227

•Gary Allen (x 27226)

research ethics office for research gary allen chris rose’meyer rhiannon campbell research ethics...

Documents

research ethics office

research ethics matters

human subject

human beings

injuryno experiment

essentialthe experiment

good of societythe experiment

griffith universityoffice