Guidance for Responsible Health and Medical Research in Australia

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Guidance for Responsible Health and Medical
Research in Australia
Professor Warwick Anderson
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About NHMRC

• NHMRC was established in 1936 within the
  Department of Health.
• 1 July 2006 became an independent statutory
  agency with a New Act and changed
  accountabilities for the CEO.
• April 2007 Incorporation of NICS.

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The Objectives of NHMRC
The objectives of NHMRC are to

• raise the standard of individual and public
  health throughout Australia
• foster the development of consistent health
  standards between the various States and
  Territories
• foster medical research and training and public
  health research and training throughout
  Australia and
• foster consideration of ethical issues relating
  to health

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Structure of the NHMRC
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NHMRC Strategic Plan (2006-2009)

• Three year strategic plan that complements
• Ministers annual Statements of Expectations and
• CEOs annual Statements of Intent.
• Sets Strategic Objectives and key strategies and
  performance indicators.

• Identifies
• major health issues
• national strategy for health and medical
  research
• a longer-term vision for NHMRC

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Five Strategic Objectives
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Australian Code for the Responsible Conduct of
Research
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Australian Code for the Responsible Conduct of
Research

• Jointly developed by
• National Health and Medical Research Council
• Australian Research Council
• Universities Australia (formerly AVCC)
• Replaces the Joint NHMRC/AVCC Statement and
  Guidelines on Research Practice (1997)
• Promotes integrity in all Australian research
• Provides guidance on how to manage departures
  from best practice.

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Australian Code for the Responsible Conduct of
Research

• The Code covers
• All research disciplines
• Institutions, researchers and publicly funded
  research bodies
• All research institutions are encouraged to adopt
  the Code as standard practice
• The Code will provide the general public
  reassurance of good practice in Australian
  research

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Structure of the Code

• Part A Principles and practices to encourage
  responsible research conduct
• Best practice institutions and researchers
• How to manage research data and materials
• How to publish and disseminate findings
• Effective peer review
• Conflicts of interest
• Part B Breaches of the Code, research
  misconduct, framework for resolving allegations
• How to handle allegations of research misconduct
• How to handle breaches of the Code
• Roles and responsibilities of all parties
• Clear, effective and fair processes

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Changes to the Code Part A
Part A Principles and practices to encourage
responsible research conduct

• Definition of research
• Managing collaborative research with other
  organisations
• Reporting research misconduct
• Research with Aboriginal and Torres Strait
  Islander peoples
• Value of consumer involvement in research
• Communicating research findings to the public
• Appropriate attribution of authorship
• Importance and value of peer review
• Identification and management of conflicts of
  interest

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General Principles

• Responsibility of Institutions
• Promote the responsible conduct of research
• Establish good governance and management
  practices
• Staff training
• Promote Mentoring
• Ensure a safe research environment
• Responsibility of Researchers
• Maintain high standards of responsible research
• Report research responsibly
• Respect research participants
• Respect animals used in research
• Respect the environment
• Report research misconduct

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Management of data and materials

• Responsibility of Institutions
• Retain research data and primary materials
• Provide secure research data storage and
  record-keeping
• Identify ownership of data and materials
• Ensure security and confidentiality of research
  data
• Responsibility of Researchers
• Retain research data and materials
• Manage storage of research data and materials
• Maintain confidentiality of research data and
  materials

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Supervision

• Responsibility of Institutions
• Set Standards for supervision and mentorship
• Induct research trainees
• Responsibility of Researchers
• Ensure training
• Mentor and provide support
• Ensure valid and accurate research
• Ensure appropriate attribution
• Responsibility of Trainees
• Seek guidance
• Undertake induction and training

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Publication and dissemination

• Responsibility of Institutions
• Promote responsible publication and dissemination
• Protect confidentiality and manage intellectual
  property
• Support communication of research findings to
  wider public
• Responsibility of Researchers
• Disseminate all research findings
• Ensure accuracy of publication and dissemination
• Cite the work of other accurately and fully
• Multiple submission of research
• Obtain permission for republishing and disclose
  support
• Register clinical trials
• Manage confidentiality
• Responsibly communicate research findings in the
  public arena

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Authorship

• Responsibility of Institutions
• Have criteria for authorship
• Responsibility of Researchers
• Follow policies on authorship
• Agree on authorship
• Include all authors
• Do not allow unacceptable inclusion of authorship
• Acknowledge other contributions fairly
• Extend the authorship policy to web-based
  publications
• Maintain signed acknowledgements of authorship
  for all publications

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Peer Review

• Responsibility of Institutions
• Encourage participation in peer review
• Responsibility of Peer Reviewers
• Conduct peer review responsibly
• Responsibility of Researchers
• Do not interfere during peer review process
• Participate in peer review
• Mentor trainees in peer review
• Declare conflicts of interest

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Conflicts of Interest

• Responsibility of Institutions
• Maintain a policy
• Responsibility of Researchers
• Disclose conflicts of interest

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Collaborative research

• Responsibility of Institutions
• Establish agreements for each collaboration
• Manage conflicts of interest
• Manage access to research materials
• Responsibility of Researchers
• Comply with multi-institutional agreements
• Declare conflicts of interest

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Changes to the Code Part B
Part B Breaches of the Code, research
misconduct, Framework for resolving allegations

• Definition of research misconduct
• Specific examples of research misconduct
• Relationship of research misconduct to other
  forms of misconduct
• Roles and responsibility (e.g Advisor in research
  integrity, Institutional and departmental)
• Relationship between the Code and Workplace
  agreements
• Resolving complaints/allegations of research
  misconduct inquiry
• Establishment of independent research misconduct
  inquiry
• Internal versus external research misconduct
  inquiry
• What to do when the inquiry has been complete

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Examples of research misconduct

• Ways that researchers deviate from the Code can
  include
• Fabrication of results
• Falsification or misrepresentation of results
• Plagiarism
• Misleading ascription of authorship
• Failure to declare and manage serious conflicts
  of interest
• Falsification or misrepresentation to obtain
  funding
• Conducting research without ethics approval
• Risking the safety of human participants, animals
  or the environment
• Deviations from the Code through gross or
  persistent negligence
• Wilful concealment or facilitation of research
  misconduct by others

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Framework for Resolving Allegations

• Anyone concerned that a researcher has not acted
  responsibly must take action in accordance with
  The Code.
• In the first instance, complaints and allegations
  are dealt with at departmental level.
• If not resolved, a formal complaint or allegation
  must be made, in writing, to the designated
  person.

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Framework for Resolving Allegations

• The designated person must advise the CEO whether
  there is a prima facie case, and how to proceed.
  Options include
• Dismissing the allegations
• Instructing department on how to deal with
  allegations
• Dealing with the complaint under provisions
  unrelated to research misconduct
• Investigating the matter further through a
  research misconduct inquiry

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Framework for Resolving Allegations

• If a research misconduct inquiry is needed, the
  designated person must decide whether to proceed
  to an
• Internal institutional research misconduct
  inquiry or
• Independent external research misconduct inquiry
• The inquiry must report findings to the CEO
• The CEO determines that actions to be followed,
  in accordance to institutional policy
• Subsequent action may include correcting the
  public record of the research.

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Management of Research Misconduct
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National Statement on Ethical Conduct of Human
Research
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National Statement on Ethical Conduct of Human
Research

• Jointly developed by
• National Health and Medical Research Council
• Australian Research Council
• Universities Australia (formerly AVCC)
• Replaces the National Statement on Ethical
  Conduct in Research Involving Humans (1999)
• First consultation (Dec 2004) resulted in 178
  submissions
• Second consultation (Jan 2006) resulted in 186
  submissions

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National Statement on Ethical Conduct of Human
Research

• Tabled in both houses of Parliament 28 March 2007
• Institutions to report against it from 1 January
  2008
• Transition period for information, promotion and
  preparation for institutional compliance
• National roll-out information sessions began in
  August 2007

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• Towards a streamlined approach to scientific and
  ethical review of Multi Centre research

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Background

• In Australia, research that is conducted in
  multiple sites and jurisdictions, undergoes
  separate ethical review.
• This process is
• - time consuming
• - an inefficient use of resources, and
• - costly for researchers

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The NHMRCs role

• In 2006, Australian Health Ministers Advisory
  Council (AHMAC) tasked NHMRC with developing an
  approach to streamlining ethical review of
  multi-centre research.
• NHMRC is investigating the best way in which to
  approach this initiative.
• 5.6 million provided over three financial years
  to implement the initiative.

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National Health and Medical Research
Council Professor Warwick Anderson www.nhmrc.gov.
au