Australian Code Responsible Conduct of Research

Sianna Panagiotopoulos Office for Research

Outline!!  Ethics vs Governance!

!  Australian Code for the Responsible Conduct of Research!

"  Responsibilities of institutions!"  Responsibilities of researchers

"  Responsibilities of researcher trainees!

!  Case studies: Hypothetical and Real!

!  Research Integrity Advisors!

Research Governance Handbook (NHMRC, 2011)

……. a framework through which institutions are

accountable for the scientific quality, ethical acceptability and safety of the research they allow to be conducted …….

…….regulations, principles and standards of good

practice….!

Research Governance is.... !

# Ethical protection of participants!

# Scientific integrity & experienced researchers!

# Health & safety!

# Information: privacy vs public access to findings!

# Financial and contractual arrangements!

# Quality research culture!

Research Governance is.... ! ! ! ! ! !!

Ethics !

#  scientific and ethical review of a research project by an HREC.!

#  Any accredited HREC can perform this function

Governance

"  assessment of overall feasibility and compliance with institutional requirements of a project by a research governance officer.

"  Performed at individual institutions

Ethics Review ! ! Research Governance !! !!

$  NEAF or other $  VSM Form $  Protocol $  Invest Brochure $  PICF $  Questionnaires $  Advertisements $  Participant material $  RSO & VSM reports

$  SSA Form $  Budget $  Indemnity $  Agreements $  Insurance $  CTN Form $  CVs $  Financial Declaration $  HREC Approval $  PICF – site specific $  RSO report & VSM

$  Annual reports

Guide ! ! ! ! !!

$  For all sectors $  PI/ trial co-ordinator $  RGO $  Sponsor (Pharma/CRO)

$  Good communication between sectors is essential

$  Collaboration is paramount

http://www.health.vic.gov.au/clinicaltrials/site-specific.htm

National Statement!  The essential document for all

researchers!

!  Sets national standards for institutions conducting research!

!  Provides guidance for researchers, HRECs and Institution!

!  Refer to when preparing your ethics application!!  (waivers, registries, databases…)!

Regulatory Document: Australian Code for the Responsible Conduct of Research!

!  Part A – principles and practices for encouraging responsible conduct of research

!  Part B – framework for resolving allegations of breaches of the Code and research misconduct.

http://www.nhmrc.gov.au/guidelines/publications/r39

Why is it important?!

Binding for institutions administering NHMRC and ARC funding!

Australian Code!$  General principles of responsible research.

$  Management of research data and primary materials.

$  Supervision of research trainees.

$  Publication and dissemination of research findings.

$  Authorship.

$  Peer review.

$  Conflicts of Interest.

$  Collaborative research across institutions.

Part A

Breach vs Misconduct Part B

Breach ! Research Misconduct!

•  less serious deviation

• eg. forgetting to lodge an authorship form before submitting a paper for publication!

•  more serious •  deliberate!

Types of misconduct(Section 10, Australian Code for Responsible Conduct of Research)!

•  fabrication, falsification or misrepresentation of results

•  conducting research without ethics

•  plagiarism or misleading ascription of authorship

•  failure to declare serious conflicts of interest

•  falsification or misrepresentation to obtain funding

•  risking the safety of human participants, or the wellbeing of animals

•  deviations from the Code that occur through gross or persistent negligence

•  willful concealment of research misconduct by others.

Hypothetical 1!•  Dr Jones is researching the interaction of school children during play.

She has ethics approval to observe children during their lunchtime subject to the school’s approval.

•  Her PhD student, Dan will work with her. He is competent and can work independently.

•  Dan spends the next few months observing at the schools. With a teacher’s permission, he videotapes some lunchtimes to provide context to his observations. Using the tape, Dan’s written answers accurately describe observations for Dr Jones’ research.

•  He notices some behaviour not targeted in Dr Jones research that may prove interesting for his own work. He takes the videotape home and sets it aside for later analysis, planning to discuss it with Dr Jones later.

•  The next week, parents at a participating school complain about children being videotaped at lunchtime.

•  Dr Matthews discovers that Dan made a videotape and took it home for later analysis. The school asks Dr Jones to return the tape.

ARMS Workshop April 2013

Hypothetical 1: Research traineesPart A, Section 3 RCR !

Supervisor •  ensure training •  mentor & provide

support •  ensure valid &

accurate research •  ensure appropriate

attribution

Trainee •  seek guidance •  undertake induction

& training

Hypothetical 2!•  Dr Fiedler works in the research office.

•  He receives a complaint by a junior researcher that their supervisor, Dr O’Connell has published articles based on the same data and research outcome in three different journals.

•  Following a preliminary investigation, Dr Fiedler agrees with the complainant and further, finds that the supervisor had signed journal publishing agreement with all of the publications stating that the information has not been published elsewhere.

ARMS Workshop April 2013 Hypothetical 2: Publication & DisseminationPart A, Section 4 RCR !

Researcher •  Disseminate all research findings (even if –ve) •  Ensure accuracy •  Multiple submissions of research findings

unacceptable •  Disclose research support •  Register clinical trials •  Manage confidentiality •  Responsibly communicate findings: media

Hypothetical 3!• As a PhD student at Altona University, Andrew carried out

research on a new drug for Alzheimer’s disease under Dr Brown’s supervision. Using this data, the research team designed a research project and successfully applied for a grant.

• However, before the project began, Andrew moved to Mind Institute to work on another project. When he sees an article based on the Altona University research project he is disappointed to find that he is not named as an author. He remembers signing an authorship agreement but he doesn’t have a copy of it.

• He contacts Dr Brown who explains that he isn’t considered an author because he didn’t work on the actual project and because the research project changed considerably from the initial grant proposal that he did work on.

ARMS Workshop April 2013

Hypothetical 3: AuthorshipPart A, Section 5 RCR !

Authorship based on 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

ADVICE: discuss authorship prior to starting research

Vipul Bhrigu!

•  University of Michigan •  Concealed camera caught

Bhrigu contaminating media with ethanol

•  Destroyed expts by Heather Ames, a graduate student in his lab

Hwang Woo-suk!

#  infamous for fabricating a series of experiments (stem cell research), !

#  two articles published in the journal Science in 2004 and 2005 where he reported to have succeeded in creating human embryonic stem cells by cloning.!

#  obtained human ova unethically from junior colleagues!

#  embezzled ($3 million) for personal purposes!

“Hwang is credited with perpetrating one of the biggest scientific frauds in modern history for his false claims about cloning human embryos and generating cloned stem cells” New York Times Mar. 1, 2014

23!

Complaints!

#  Contact person for complaints "  All PICF’s "  Website "  Independent of study

#  Talk to your supervisor, Head of Department #  Research Integrity Advisors appointed

"  Prof Jerums, Prof Frauman, Dr Jennifer Johns "  LICR, IBAS, Uni Melb

Monitoring research projects!#  Prior to audit: Project details & Approvals!#  Audit tool sent to PI before audit ( ~ 2 weeks)!#  Audit interview with PI +/- coordinator: !

"  Protocol: amendments, certificates, IB!"  Recruitment, PICF, withdrawals!"  Confidentiality: Data & samples storage & access!"  SAEs reporting, !"  Study management: training, self-audit tool!

#  Post Audit: Issues of concern, Further action !

What is monitored? eg!

#  Protocol: !"  Version and date of approval !

"  Amendments and approval certificates sighted !

"  Approved questionnaires / interview schedules used !

"  Any new safety information reported !

What is monitored? eg!

#  Participant information, consent and withdrawal: !"  PICF version being used, same as most recently approved !

"  Consent forms signed and dated by participants !

"  Copy / original given to participant !

"  Copy in medical record / study listed on alert sheet !

"  Number of withdrawals, reasons !

What is monitored? eg!

#  Privacy and confidentiality: !"  Hard copies of data containing identifying information

stored securely to maintain confidentiality of participants !

"  Electronic files with identifying information stored securely to maintain confidentiality of participants !

"  Biological samples / specimens stored securely to maintain confidentiality of participants !

"  Who has access to study data, identifiable, re-identifiable !

What is monitored? eg!

#  Serious Adverse Events (SAEs): !"  Is there a Monitoring body such as a Data Safety

Monitoring Board (DSMB) (if yes ask to see reports) !

"  Have Local SAEs occurred and been reported Austin Health HREC !

Take home messages!#  Download Code, Nat Statement, DOH Guide

#  If it doesn’t feel right, it probably isn’t

#  Don’t assume

Session 4

Tools to run a research project

25th June, 5pm

Austin LifeSciences

Introduction to research methods 2014