Research Integrity The Australian Code for the Responsible Conduct of Research

Research Integrity

The Australian Codefor the

Responsible Conduct of Research

Dr Peter WigleyManager, Research Ethics and Integrity

Flinders University

Why Am I Here?

• DVCR-initiated training

• All researchers (staff and students), and research support staff, should be familiar with the Code, and understand their responsibilities under the Code

• Condition of our funding from ARC and NHMRC that we comply with the Code

• Seminar in all 14 Schools at Flinders this year

Research Integrity

• The responsible conduct of research

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

– National Statement; SA legislation & national Animal Code; approval• Report research misconduct

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

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)

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

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, falsification (data manipulation)•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

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 2

High 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).

•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."

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 – DVCR (Prof David Day)

• Designated Person – Director, Research Services (Dr Gayle Morris), who receives a written allegation, conducts a preliminary investigation to assess the allegation, and provides advice to the Delegated Officer

• Manager, Research Ethics and Integrity, who assists the Designated Person

• 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

•Research Integrity Advisor (Faculty-based)

  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 Departmental/School level.

If a formal inquiry of misconduct is warranted (decided by DVCR/VC)

•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)

*must be consistent with the current Enterprise 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

Flinders Policies

Currently•Policy on Research Practice + Research Higher Degrees, Intellectual Property, etc

New Policies, under review•Responsible Conduct of Research

•Authorship

•Publication and Peer Review

•Conflict of Interest Policy for Researchers

•Management of Research Data

•OGR updating the Research Higher Degrees Policy

•Research Misconduct Allegations Policy

Researcher Support

SupervisorsDepartment / School Heads

Research Integrity Advisors – Faculties

DVCRResearch Services Office: Director, Research Services Manager, Research Ethics and Integrity

RSO webpages being revamped

Data Management Support – Amanda Nixon, LibraryRSO Data Team: publications, ERA, HERDC

Training: School seminars; considering online training