Promoting research ethics and integrity - an international perspective

1. Promoting research ethics and integrity - an international perspective Dr Paul Taylor Manager, Research Ethics and Integrity Melbourne Research Office pmt@unimelb.edu.au, 42047

2. Overview • About the University • Guidelines and Regulations Downunder • Our approach • Challenges

3. About the University of Melbourne

4. The University of Melbourne • Established 1853 • 11 Faculties/Graduate Schools • 45,569 Students (Aug 2009) • 37.9% Postgraduate Students • 26.4% International Students • 10.2% RHD Students • 7,326 Staff

5. Academic Structure Faculties and Graduate Schools  Architecture, Building and Planning  Arts  Economics and Commerce  Education  Engineering  Land and Environment  Law  Medicine, Dentistry and Health Sciences • Science • VCA and Music  Veterinary Science • Melbourne Business School • Melbourne School of Graduate Research

6. Research income and rankings • In 2008, research income $382.5M and expenditure of $653.7M (total budget approaching $1.5B) • Second largest R&D organisation in Australia, behind CSIRO • Ranked 73 in SJTI 2008; 36 in THES 2009 • second in Australia • Ambition to be top 50 • Member of Go8

7. Breadth • One of 16 Universities to be ranked in top 30 across all disciplines (THES) • One of 2 in the Asia-Pacific (University of Tokyo)

8. Melbourne Research Office - Supporting Research Excellence

9. Research Office • operational and strategic support to researchers and University management • close working relationship Melbourne Ventures, Legal Services, Melbourne School of Graduate Research • four groups • Grants and Contracts • Research Performance and Analysis (ERA) • Research Systems • Research Ethics and Integrity

10. Research ethics and integrity group • responsibilities across • Codes of Conduct for Research/research integrity (up to 1.0 FTE) • research disputes and misconduct • human research ethics (3.8 EFT) • animal ethics and welfare (3 +1 EFT) • gene technology and biosafety (1.0 - 2.0 EFT) • directly involved in providing advice to applicants, departments, senior University officers • strategic and operational - how do I dispose of an unidentified pathogen? how should the EA be changed to accommodate funding requirements? should the University still work with non-human primates?

11. Scale • Research disputes/misconduct ? • Human research ethics 1800 • Animal ethics 700 • Gene tech and biosafety 350+150 • kind of busy…

12. Cultural exchange #1 • someone: “y’orright?” • me: “do I look unwell?”, or “am I bleeding from somewhere?”, or “yep” • advice welcome…

13. Rules and regulations Downunder

14. The ACRCR Part A advocates and describes best practice for both institutions and researchers. Part B is designed to ensure there are agreed, fair and effective processes in place in the event of an allegation of misconduct

15. Research misconduct 10.1 “Research misconduct includes fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting the results of research , and failure to declare or manage a serious conflict of interest. It includes avoidable failure to follow research proposals as approved by a research ethics committee, particularly where this failure may result in unreasonable risk or harm to humans, animals or the environment. It also includes the willful concealment or facilitation of research misconduct by others”

16. Research misconduct 10.1 “……….relates to misconduct if it involves all of the following: • an alleged breach of the Code • 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” Repeated or continuing breaches of the Code may also constitute misconduct Honest differences in judgment or errors made unintentionally do not

17. Authorship • critical - majority of complaints • must have made significant contribution by • conception and design of the project • analysis and interpretation of the data • drafting substantial parts of the publication or critically revising it so as to change the interpretation • not for providing materials, collecting data, or by virtue of relationship or position (ghost or honorary authorships) • discuss authorship and acknowledgments prior to starting research

18. Research Data and Records Management • critical • challenging - range of materials, sheer volume • research data vs research records • ACRCR and University policy says • at least 5 years from date of last publication • data register required • data management plan recommended • schedule and authorisation for disposal

19. Other areas covered • Supervision of research trainees • Conflict of interest • Peer review • Collaborations • Publications and dissemination of results

20. Cultural exchange #2 • someone: “give us a squiz” • you: “no, thanks”, or “call the police!!” • really being asked ‘may I please have a look?’ • no need for concern • similar to “howya goin’”…this is not an enquiry about a mode of transportation

21. Our approach

22. YOU ARE HERE Expectations of the General Public Publications, posters and conferences Actually doing research! Life Knowledge transfer, IP and commercialisation Rules and Regulations Expectations of the Research Community Teaching and supervision Departmental repsonsibilities

23. Personal Integrity • personal integrity • honesty • trustworthiness • lawfulness • respect

24. Research Integrity • like any community, there are generally accepted standards of practice  the right way to do research, or Research Integrity • like any community, there are consequences if these standards are not met

25. Research compliance, ethics and shades of grey • research compliance vs research ethics • compliance is the indicator of your intent to do things the right way • research integrity is not just about avoiding bad, but doing good - compliance is the wrong model • there are some common principles across the disciplines…these are encapsulated in the ACRCR and the University Code of Conduct of Research

26. Turning principles into practice • at first glance, some of the concepts covered in ACRCR are abstract • challenge is to make them real to researchers • fabrication, falsification and plagiarism = lying, cheating and stealing • best achieved through discussion/education rather than ticking a box - “I have read the Code of Conduct” doesn’t work very well…

27. Trickle down and build up • high-level principles locked into policy at institutional level • expect (require?) that Faculties elaborate on these policies so that they make sense for their researchers • also, expect then that Departments will do the same thing • aim is to have localised versions of the policies that offer practical, relevant, discipline-specific advice (difficult/unwise to try this centrally) • close the gap between principle and practice • requires that support for (and engagement with) local-level developments/projects is available

28. Cultures of research ethics and integrity • a microbiological perspective? • used to managing cultures ‘food’ health stationary (death) growth lag time

29. FRLP • Future Research Leaders Program (research.unimelb.edu.au/frlp) • Go8 initiative, Commonwealth funded • 8 modules that cover the research lifecycle; case study across all 8 • Module 3 Governance and Compliance • data security, authorship, ethics, biological safety • participants enjoy discussing the principles and practicality of research integrity • case study frees up discussion (but does not hinder personal statements)

30. ECR Workshops • ‘laying the foundations’ • research ethics and integrity included for the first time this year • ‘build your own code’ activity • e.g. all involved in the project should be listed as an author (!) • initial hesitation (‘boring!’), discussion went into overtime • most found it valuable - first time some of the issues had been raised • very helpful for explaining how these principles do impact on the day-to-day operation of research • ‘getting in early’

31. GREIM • Global Research Ethics and Integrity Module • http://www.gradresearch.unimelb.edu.au/programs/GREIM/ • Universitas 21 initiative, UoM as lead institution (MSGR) • targetted at research higher degree students • 8 chapters that cover basic principles of research ethics and integrity • reflection tasks, f2f workshops and online discussions (with ‘expert’ moderators chipping in where appropriate)

32. Ethical risk management • based on findings of ARC funded ‘Investigating Human Research Ethics in Practice’ project (http://www.chs.unimelb.edu.au/programs/investigating_human_research_ethics_in_practice) • better training to improve understanding of basis of human research ethics and committee operations, and consideration of ‘ethical risk’ • participants observed a real committee meeting and held a moot meeting • all reported having a much better understanding of the process and why they were asked particular questions • ‘a grant proposal is conceptual, but the ethics process makes it real’

33. Research Integrity Toolkit (2010) • material to encourage discussion at a group/department level • one a month for 8-10 months • guided discussion • copies of institutional and local policies (where available) • research integrity climate survey as a way of measuring the ‘health’ of the culture?

34. Challenges

35. Status of ACRCR • not a legislative/regulatory document - guidelines only… • …except for NHMRC funded research where compliance with it is part of the funding agreement • some clashes with internal University policies, EA • will be resolved over time • problems with Part B: Process for handling allegations of research misconduct • e.g. the full legislative protection offered to whistleblowers must be extended to complainants, but this means that we then can’t tell anyone about the complaint…natural justice/procedural fairness?

36. Two definitions for research misconduct… • UoM • deviation from accepted practice/breach of the Code • intentional, deliberate or reckless and negligent • ACRCR adds • serious consequence (e.g. false information on public record) • so our first decision when faced with an allegation has to be which definition are we using…not ideal • definition also problematic, but perhaps this is less important than we think it is

37. Authorship • clash with UoM policy, ICMJE guidance (Vancouver Protocol) and ACRCR • is giving final approval for publication really worth an authorship credit? how will the Director of a medical research institute react to this no longer being enough? • covered in review of UoM Code for 2010

38. Finally… • there are institutional responsibilities in ensuring that research is conducted responsibly • training and education - ‘the discussion’ - in the principles of responsible research, research ethics and research integrity is important • clear statements from the institution about the way research that is carried out in it’s name is to be conducted are important • long term project with intangible (or at least difficult to measure) benefits, but this should not mean that it is not paid attention to

39. Thanks