A Responsible Research Culture at ANU

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A Responsible Research Culture at ANU
Dr Simon Bain Director Office of Research
Integrity Australian National University
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Fundamental Requirement that the ANU provides

• A research environment that promotes
• Rational enquiry
• Respect for the truth
• Scholarly values
• Academic freedom

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Academic freedom
Is there a suggestion of liberty here?
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George Bernard Shaw

• Liberty means responsibility. That is why most
  men dread it
• (Man and Superman 1903)

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So, perhaps slightly manipulating the wisdom of
GBS, it stands to reason

• Along with academic freedom comes
  responsibility..and this what this workshop is
  about
• A responsible research culture at ANU

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Research Integrity

• At first glance this may look somewhat
  forbidding!
• What does research integrity mean to you?

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Integrity means

• (The concept of integrity in research cannot
• be reduced to a one-line definition )
• For a researcher, integrity embodies above all
  the individual's commitment to intellectual
  honesty and personal responsibility. It is an
  aspect of moral character and experience.
• For an institution, it is a commitment to
  creating an environment that promotes responsible
  conduct by embracing standards of excellence,
  trustworthiness, and lawfulness From Integrity
  in Scientific Research Creating an Environment
  That Promotes Responsible Conduct (2002) a Report
  of the US National Academies (p.5)
  (http//www.nap.edu/books/0309084792/html/ )

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The Most Recent Roadmap
Part A advocates and describes best practice for
both institutions and researchers. For example,
how to manage research data and materials, how to
publish and disseminate research findings,
including proper attribution of authorship, how
to conduct effective peer-review and how to
manage conflicts of interest Part B is designed
to ensure there are agreed, fair and effective
processes in place in the event of an allocation
of misconduct
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The Code-Part A

• General principles
• Management of Research data
• Supervision of Research Trainees
• Publication of Research Findings
• Authorship
• Peer review
• Conflicts of Interest
• Collaborative Research Across Institutions

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ANUs Policy Responsible Practice of Research
includes Code Part A and extends to

• Conforming to ethical and safety requirements
• Management of Intellectual Property
• Commercialisation
• http//info.anu.edu.au/Policies/_DRO/Policies/R
  esponsible_Research_Practice.asp?tab1

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ANU Policy 2008 The Responsible Practice of
Research

• Combination of 2003 policy, 2007 Code and input
  from the academic community-circulated to all
  College Research Committees
• 2 areas of greatest controversy in Part A were
• 1) Authorship
• 2) Peer review prior to public comment

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Authorship

• So lets talk about authorship first
• and from the start we need to recognise that
  there are accepted different authorship practice
  between research disciplines

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Authorship order-it can be a weighty issue
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ANU Policy

• 5.1. Attribution of authorship depends to some
  extent on the discipline but in all cases
  authorship reflects substantial participation
  through a substantial contribution to at least
  one of
• conception and design,
• collection of data
• analysis and interpretation of data
• drafting the article or revising it critically so
  as to contribute to the interpretation

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and this doesnt qualify.

• 5.5. The following activities are not of
  themselves criteria for inclusion of authorship
• Participation solely in the acquisition of
  funding
• General supervision of the research group.
• Being head of department, holding other positions
  of authority, or personal friendship with the
  authors
• Providing a technical contribution but no other
  intellectual input to the project or publication
• Providing data that has already been published or
  materials obtained from third parties, but with
  no other intellectual input.

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Please keep in mindand this will help avoid
authorship disputes

• Authorship issues need to be discussed at an
  early stage in a research project, and reviewed
  whenever there are changes in participation.
• Where a work has several authors, one should be
  appointed corresponding author to record
  authorship and to manage communication about the
  work with the publisher. 
• Researchers must offer authorship to all people,
  including research trainees, who meet the
  criteria for authorship.   Those offered
  authorship must accept or decline in writing
  within a reasonable time.
• Use the ANU Authorship Form

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Responsible Authorship

• Publications are about making unique
  contributions to the body of knowledge
• Potential problem areas
• Duplicate publications
• Slicing and dicing data/findings
• Plagiarism

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Publication and Dissemination of Data

• Replies from ANU Colleges indicated differences
  in convention re necessity for peer review
• Medical Sciences/Sciences different to Humanities
  and Social Sciences
• The University encourages the presentation and
  discussion of results via peer reviewed pathways
• As a general principle research findings should
  not be reported in the public media before they
  have been reported to a research audience of
  experts in the field of research - preferably by
  publication or presentation in a peer-reviewed
  outlet.

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A slight variation to publish or perish..
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Peer Review Prior to Public Comment

• Code 4.12.1 Discussing research findings in the
  public arena should not occur until the findings
  have been tested through peer review.
• ( Peer review described in Code as impartial and
  independent assessment or research by others
  working in the same or related fields)
• In discussing outcomes of a research project,
  special care should be taken to explain the
  status of the project-for example whether still
  in progress or has been finalised

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Management of Research Data
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ANU Future Research Leaders identified as the
single most critical RI factor to enforce at ANU

• Good record keeping!
• Also note Inadequate record keeping related to
  research projects admitted by 27.5 anonymous
  participants (Martinson, Anderson de Vries
  Nature 2005 435737-738) Scientists Behaving
  Badly

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Ownership of Data

• Concerning ownership of data, as a general rule
  the materials and data retained at the end of a
  research project carried out under the auspices
  of ANU are the property of ANU
• By general agreement this may extend to another
  institution with an interest in the research, or
  a central repository.
• The ownership may also be influenced by the
  funding conditions of the project

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IP Created by a Student

• Within the terms of the ANU Policy Intellectual
  Property - Ownership, Protection and
  Commercialisation, the University does not own IP
  created by a student, unless prescribed otherwise
  by law, the student assigns that IP, or its
  development to the University, or the student had
  developed the IP directly in the course of
  working as a staff member.

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Confidentiality Agreements

• Confidentiality agreements to protect
  intellectual property rights may be agreed
  between the University, the researcher and a
  sponsor of the research. Where such agreements
  limit free publication and discussion,
  limitations and restrictions must be explicitly
  agreed (see the ANU policy, Intellectual
  Property Ownership, Protection and
  Commercialisation). In general researchers should
  not unnecessarily enter agreements which limit or
  prevent open access to information of potential
  public interest, especially for periods of time
  longer than 1-2 years.

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Data Management (Cont)

• Data management should comply with relevant
  privacy protocols. As the University is
  constituted under federal legislation it must
  conform to the Commonwealth Privacy Act 1988 and
  other State and Territory privacy laws (where
  applicable).
• Storage of data is a departmental or research
  unit responsibility
• If research results are challenged, data must be
  held until resolution of the issue

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Data (including electronic data) must be recorded
in a durable and appropriately referenced form.

• Duration is important
• For short-term research projects that are for
  assessment purposes only, retaining research data
  for 12 months after the completion of the project
  usually sufficient.
• Published data Minimum period of retention 5
  years from date of publication Clinical trials 15
  years
• Clinical trials 15 years
• Areas like gene therapy patient records retained
  permanently
• Community or heritage value Kept permanently at
  this stage

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Supervision of Students/Research
TraineesResponsibilities of Supervisors

• Provision of guidance in all matters relating to
  research conduct
• Oversight of all stages of the research project
  including identifying research objectives and
  approach, conducting the research, and reporting
  the research outcomes in appropriate forums and
  media
• Obtaining ethics and other approvals
• Obtaining funding

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Mentors

• Guide a protégé to learn attitudes and difficult
  skills
• Characteristics Experience, empathy, honesty,
  selflessness, moral/ethical rectitude
• Can good mentors be made, or are they born?

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Peer Review

• Impartial assessment of research by others
  working in the same or a similar field
• Principles
• Fair and timely in review
• Review done in confidence
• Declare all conflicts of interest
• Do not take advantage of knowledge obtained
• Ensure you are informed about, and comply with
  relevant criteria
• Give proper consideration to research that
  challenges accepted way of thinking
• Do not agree if outside your area of expertise

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Conflicts of Interest

•  A conflict of interest exists where there is a
  divergence between the individual interests of a
  person and their professional responsibilities
  such that an independent observer might
  reasonably conclude that the professional actions
  of that person are unduly influenced by their own
  interests.
• Disclosure, disclosure, disclosure!
• Individuals and committees dedicated to this now
  at many US institutions

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Ethics Committees

• Human Research Ethics Committee (HREC) and DERCs
• Animal Experimentation Ethics Committee (AEEC)
• Recombinant DNA Ethics Committee (IBC)

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Ethics Approval

• Enquire widely if you feel there is a chance you
  may need ethics clearance
• Investigators, including post-graduate students,
  can get into serious strife if found to be
  carrying out research without necessary approval
• If so discovered, then data accumulated without
  approval will not be able to be used

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A message from the sponsor

• The ORI is constantly endeavouring to make ethics
  approval easier and quicker eg
• E1 and E2 Human Research Ethics approvals
• Weekly training ARIES human ethics submissions
• Proposal and amendment approval animal ethics
  within 21 days

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So you have got the Code and relevant ANU
Responsible Research Policy

• So what are some of the other things that you
  need to engage with re governance and
  compliance?

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Accountability for Research Funding

• Increased emphasis on accountability for Govt
  grant funds
• Governments are more mission oriented
• Increased pressure to seek research funding from
  non-traditional sources
• Increased involvement of universities in ventures
  such as CRCs

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And, relative to governance and compliance there
is more .

• Import approval for material-AQIS
• Licences to access certain areas
• Licences to use certain materials
• Permissions from government agencies or
  communities
• OHS considerations
• Native flora and fauna
• Historical or cultural artefacts
• Travel permits
• Scheduled poisons
• Scheduled carcinogens
• Radiation sources

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Code Part B

• Discusses what constitutes breaches of the Code,
  research misconduct, and the framework for
  resolving allegations
• We should initially look at a couple of
  definitions in Part B

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Code Definition of Research Misconduct

• 10.1
• A complaint or allegation 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

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Code Misconduct (Cont)

• 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

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Does a problem exist?

• Martinson, Anderson de Vries Nature 2005
  435737-738
• Our finding suggest that US scientists engage
  in a range of behaviours extending far beyond
  falsification, fabrication or plagiarism

The next three slides are interesting
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Scientists Behaving Badly Martinson,Anderson de
Vries Nature 435,737-738 (2005)
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Nature paper (cont)
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Nature paper (cont)
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Questionable Research Practices (QRPs)

• Bias in selecting methods that favour the outcome
  in research
• Failing to disclose all conflicts of interest
• Supplying over-optimistic interpretations to
  review committees
• Supervising inadequately
• Using inappropriate statistical research methods
• Inadequate record keeping

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What can we learn from high-profile cases?

• Jon Sudbø
• Many collaborators - Created 900 fictitious
  patients
• Geoffrey Chang
• Incredible drive and work ethic faulty
  software threw everything off
• Woo Suk HwangEthical misrepresentation and fraud
  
• Eric Poehlman
• Fabrication of results-sentenced to gaol

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Jon Sudbo-2006

• Falsified data in 3 seminal papers published by
  top medical journals, with questions against a
  4th
• Revelations put on hold a multimillion dollar
  oral cancer prevention trial
• Raised questions about whether researchers in
  multi-institutional collaborations should do more
  than double-check the validity of data collected
  by others

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Geoffrey Chang-Science Dec 2006

• In 1999 this protein crystallographer landed a
  position at Scripps Research Institute
• 2000 Received Presidential Early Career Award
• September 2006 Swiss researchers published Nature
  paper that cast serious doubts on a protein
  structure described in Changs 2001 Science paper
• When he investigated, Chang found that a homemade
  data analysis program flipped two columns of data
• Chang and colleagues retracted 3 Science papers
  and 2 papers in other journals also with
  erroneous data
• Praised although cost other researchers time and
  effort

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Hwang Woo-Suk

• Professor of Thereniology at Seoul National
  University
• Stem cell research-reported in 2 Science papers
  the creation of human embryonic stem cells by
  cloning
• A collaborator raised the question of human egg
  donation-subsequently found to have coerced
  fellow researcher into donating human ova
• Both papers later found to have a large amount of
  fabricated data
• Scientific misconduct confirmed by the university
• Subsequently found to have mis-approriated
  research funds

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Eric Poehlman-University of Vermont 2006First US
academic researcher to be sentenced to gaol

• Research into the effects of aging on the human
  body. Grants worth 2.9 million
• Admitted fabricating results in a decade
  beginning 1992
• The Judge ordered him to spend a year and a day
  in custody. Judges summary is interesting ..

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Judge William Sessions 111 said to Poehlman

• When you commit this kind of misconduct, you put
  at risk a communities acceptance of all
  scientific and medical research. You put at risk
  fully the work of other scientists. When
  scientists use their skill, their intelligence,
  their sophistication, their position of trust to
  do something that puts people at risk, that is
  extraordinarily serious.

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What can we learn from high-profile cases?

• What went wrong?
• Why?
• Who gets hurt?
• Ways forward?

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The Barriers
Funding Pressure

Publishing Pressures
Feeling under-the-hammer
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Advisers on Research integrity

• A senior staff member who advises and guides
  staff on matters of research integrity. Has
  research experience, knowledge of procedures and
  management structures, and accepted practices in
  research

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Designated Person

• A senior person within the institutions
  management structure, experienced in research and
  research management. Receive written allegations,
  conducts a preliminary investigation and provides
  advice to the CEO

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Specialist external resources
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http//ori.dhhs.gov
Part I Shared Values Chapter 1. Rules of the
RoadChapter 2. Research MisconductPart II
Planning Research Chapter 3. The Protection of
Human SubjectsChapter 4. The Welfare of
Laboratory AnimalsChapter 5. Conflicts of
Interest Part III Conducting Research Chapter 6.
Data Management Practices Chapter 7. Mentor and
Trainee ResponsibilitiesChapter 8. Collaborative
Research Part IV Reporting and Reviewing
Research Chapter 9. Authorship and
PublicationChapter 10. Peer Review Part V Safe
Driving and Responsible Research
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