Research

Research Governance

Research Governance

Research is an important activity of Austin Health and its partner research institutes and universities. It features prominently in the Health Service's Mission, side-by-side with the provision of health services and health professional education.

Research, especially research that is directly related to patient care, plays a critical role in maintaining and improving the quality of the health services we can provide. It has indirect benefits, too, by acting as a magnet to attract the most highly credentialled clinicians to work in research-active ‘teaching' hospitals.

There are many aspects to the conduct of the best research. Austin Health expects that its researchers (including staff of other organisations working on an Austin Health campus) will carry out their activities to the highest professional standards. Keys to this are close compliance with accepted ethical standards for research, performing research within the researchers' competence and carrying it out in a manner that is likely to maximise its value.

The links from this page give guidance on several requirements for the responsible conduct of research, including specific procedures for responding to allegations of research misconduct. They apply to all individuals paid by, under the control of, or affiliated with Austin Health - such as clinicians, scientists, trainees, technicians, other staff members, students, guest researchers, or collaborators carrying out research in the Austin precinct.

These guidelines comply, and should be read in conjunction, with those of the Australian Code for the Responsible Conduct of Research (2007), available from http://www.nhmrc.gov.au/guidelines/publications/r39

Other relevant national statements and codes for research conduct are:

- NHMRC National Statement on Ethical Conduct in Human Research (2007, updated March 2014), and


- Australian code for the care and use of animals for scientific purposes (8th edition 2013)


Note that all research at Austin Health (with rare exceptions such as a meta-analysis of studies performed elsewhere after ethical review) must have received approval from either the Human Research Ethics Committee or the Austin Health Animal Ethics Committee. The policies and procedures that apply are set out under the Research Ethics tab in the ‘For researchers' group on the Austin Internet site.

 

 

Conflicts of Interest

The Australian Code defines a conflict of interest (COI) as:

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.

Conflicts of interest in research are common. Instances where they may occur and need to be disclosed and dealt with properly include peer reviewing of papers and grant applications submitted by other researchers, as well as conflicts of interest when publishing or presenting their own work or reviewing the work of others in their field.

The perception that a conflict of interest exists raises concerns about the integrity of the institution as a whole as well as the individuals concerned.

Some of the key principles for researchers to properly manage conflicts of interest or perceptions of conflict of interest are:

 

  • Recognising that these occur frequently
  • Making open and full disclosure of actual or apparent conflicts of interest as soon as they are recognised. Details need not be given – there may be for instance personal reasons or a confidentiality agreement in place – but the existence of a conflict needs to be stated
  • Maintaining records of activities that may lead to conflicts, for example: 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
  • Avoiding contributing to decisions where conflict of interest is likely, by absenting themselves from any part of an Ethics Committee or grants advisory meeting where one of their projects is under discussion (unless they are invited to remain to respond to questions)
  • Recording what actions are taken to minimise conflict of interest

 

Section 3 of  the Australian National Ethics Application Form contains questions about possible duality of interest that need to be completed.

In instances where the actual or apparent conflict of interest may be particularly important (e.g. when substantial amounts of money are involved, or the risk of adverse publicity high), researchers are advised to lodge a statement (updated as needed) with the Manager, Austin Health Office for Research, Dr Sianna Panagiotopoulos.

Supervision of Research Students and Trainees

The Australian Code requires that all research trainees receive training on research ethics and the key elements of the Code itself. It states that ‘Researchers and supervisors must ensure that the role model they provide is positive and conducive to a research culture of excellence, integrity, professionalism and mutual respect’.

Austin Health runs a series of seminars each year on successfully negotiating the requirements for ethical approval for research projects. Details are provided here: http://www.austin.org.au/research/training-for-researchers/. In future, Good Clinical Practice (GCP) research credentialing may be required for all principal investigators.

In essence, it is the responsibility of supervisors to provide induction and training for all research trainees. This should cover research ethics, occupational health and safety, environmental protection, as well as technical matters specific to their discipline. The trainees should also be referred to the Research Governance page and its associated tabs on this website.

The research supervisor should guide the professional development of research trainees. This involves overseeing all stages of their research, including the reporting of the research outcomes in appropriate fora and media. A supervisor must be satisfied that the research methods and outcomes of those under their supervision are appropriate and valid.

Research trainees have the responsibility to demonstrate a professional approach to their research and to seek help when it is needed. They also have the responsibility to promptly complete induction and training courses to which they are directed.

Management of Research Data

It is the responsibility of researchers to manage and retain data they collect during their research, in accord with national and international conventions. Specific requirements are set out in Section 2 of the Australian Code:http://www.nhmrc.gov.au/guidelines/publications/r39

Further useful guidance is given at The University of Melbourne’s website:

Management of Research Data and Records Policy (November 20, 2013).

The principles will be summarised here, but researchers are advised to also consult the two source documents above.

  • Data acquired during research must be recorded or preserved in a form that is accurate, complete, authentic and reliable. The Code defines ‘data’ as:

sufficient information from the work to enable the published results to be defended, enable other researchers to follow what was done, and ascertain whether the findings were genuine, analysed appropriately, and not fabricated. Research methods also need to be described in sufficient detail to enable independent replication of findings.

  • The data must be identifiable, and stored in such a way that they can be retrieved when needed.
  • Data should be secure.
  • They should be freely available to all the researchers working on the project (except when the requirements for blinding may require some of the team to have access only to blinded data).
  • Records should be maintained of any necessary approvals (such as Ethics Committee) obtained for the research.
  • Confidentiality should be preserved whenever the ethical framework under which the research was conducted requires it. This particularly applies to research involving human subjects.
  • Overall, the recording and maintenance of records of data must be compliant with legal obligations (including relevant privacy legislation), and rules of funding bodies.

Requirements for the length of time data are to be retained:

  • As a minimum, for five years from the time of publication or other public release of the research.
  • If the subject of a patent, the source data should be retained for the life of the patent.
  • If from a Clinical Trial, they should be kept for at least 15 years, and preferably the lifetime of the product.
  • In the case of sponsored research, researchers should be aware of any specific requirements of the funding body.
  • More generally, data should be retained not only for the minima set out above, but for as long as they are of continuing value to the researcher, and/or to resolve scientific queries and challenges that may arise after completion of the study.

 

When a researcher leaves Austin Health, issues of data ownership and retention need to be addressed. The following general principles should be followed:

 

1. New responsible investigator: An early decision must be made as to future supervision of the study. This should be determined principally by the responsible investigator who will determine whether they are able to retain supervision of the study from their new position. In cases where most of the data have already been collected, this may be appropriate. When the study is at an earlier stage, and particularly when the study requires the enlistment of hospital patients or studies conducted on-site at the hospital, a replacement responsible investigator should be sought by discussion between the responsible investigator, the other investigators and the head of department.

All changes in study personnel must be reported in writing to the Ethics Committee at the earliest opportunity.

 

2. Study records: When a study involves patients of Austin Health or volunteers studied on site, the original copies of all study documentation must be retained at Austin Health. On completion of the study it is the responsibility of the responsible investigator and the head of department to ensure that all documentation is archived in keeping with hospital policy. Only copies of documentation may be removed by departing investigators.

When copies of records are removed by departing investigators, a record of exactly what has been copied, by whom, for what reason and where it will subsequently be stored must be kept, especially if the data copied include patient identification. When such copies of records include identifiable patient information, approval must be requested from the Ethics Committee.

 

3. Equipment: All equipment purchased using funds administered by the Health Service is the property of the Health Service. A departing responsible investigator may request permission in writing to take with them items of equipment purchased with funds gained from outside granting bodies. The head of department and/or the Chief Medical Officer should generally approve such requests where the departing responsible investigator bore the sole or major responsibility for securing the funds to purchase the equipment and if the equipment is not needed for the continuation of this project.

 

4. Biological specimens: These may include various tissue or blood samples collected as part of a research program. When a departing chief investigator has particular expertise in the analysis and/or processing of such specimens it may be appropriate for them to be taken by this individual. However, such removal must be undertaken in a systematic and ordered fashion. This is to be contingent on all of the following: (i) documenting the exact nature and origin of the specimens and whether the specimens are marked with identifiable patient information; (ii) securing approval in writing from co-investigators and the head of department; (iii) providing such documentation to the Ethics Committee which will include details of the proposed new site where the specimens will be housed; (iv) if the Ethics Committee approves the request there should be a formal written handover from one Ethics Committee to the other, noting that the specimens can only be used for the purpose for which the patient has given informed consent and not for other future unspecified studies unless further ethics approval is obtained from the new institution.

 

5. Legal and contractual responsibilities: A proportion of the research undertaken at Austin Health is conducted under contractual agreements with industry. This often requires strict adherence to timelines and may place additional requirements (eg. attendance at meetings, financial reporting) on the responsible investigator. When an investigator departs from the hospital there must be a detailed review of relevant projects to determine the responsibility of the institution in relation to the project. If this is substantial, a meeting involving the outgoing responsible investigator, the other investigators and the head of department must be held to clarify the nature of the continuing responsibility and to select a new responsible investigator who can ensure that these responsibilities are met. Following this meeting the sponsoring company should be contacted and a meeting arranged to discuss proposals for the continuation of the study. These should also be communicated to the Chief Medical Officer, appropriate hospital director and the Ethics Committee.

Publication and Authorship

Research findings are of very little use unless they are made widely available to others, via presentations at meetings and publication in print or digitally in books, journals and/or websites. Researchers are encouraged to disseminate negative as well as positive findings whenever possible.

The Australian Code sets out detailed and very helpful advice about publication of research findings and also principles that should govern authorship of publications. Researchers are advised to consult Sections 4 and 5 of the Code athttp://www.nhmrc.gov.au/guidelines/publications/r39

Publication

  • Strenuously attempt to disseminate all research findings (although confidentiality agreements to protect intellectual property may require delays in publication).
  • Ensure accuracy of findings and that they are properly reported. If researchers become aware of mistakes in publications they must be corrected as soon as possible.
  • Cite work of other authors appropriately and accurately.
  • Multiple publication of the same data is strongly discouraged, except when included in review articles or when additive studies are performed. In the latter cases, the original publication(s) must be cited.
  • Material should not be republished without all reasonable steps to obtain permission from the original publisher.
  • All sources of financial support for the research, and any potential conflicts of interest, must be specified in written reports and summarised for verbal presentations.
  • Researchers must register clinical trials with a recognised registry, e.g. www.clinicaltrials.gov  and/or the local registry at Australian New Zealand Clinical Trials Registry (ANZCTR)
  • Presentation of research in the public arena (as distinct from scientific meetings) requires additional care. Researchers should carefully read the relevant section (4.12) of the Australian Code before proceeding.

Authorship

Authorship:

  • Authorship of research publications should be based on substantial contributions to the work. It is not enough to have provided materials of routine technical support, or to have made the measurements on which publication is based. Substantial intellectual involvement is required.
  • A person who qualifies as an author should not be included or excluded without their permission. The Code suggests that this should be in writing and include a brief description of their contribution to the work.
  • Collaborating researchers should agree on authorship of a publication at an early stage in the project, and review their decisions periodically.
  • Authorship should be offered to all, including research trainees, who meet the criteria above. Authorship should NOT be offered to those who do not meet the criteria above.
    • Researchers must ensure that all who have contributed to the research or materials, such as research assistants and technical writers, are properly acknowledged. Where individuals are named, their consent must be obtained (the Code specifies in writing).

More detailed guidance about authorship is provided by the International Committee of Medical Journal Editors (ICMJE), and this is broadly in line with the statements in the Australian Code. The ICMJE sets out the following criteria for authorship of a paper:

  • Authorship credit should be based on:
    • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
    • Drafting the work or revising it critically for important intellectual content; AND
    • Final approval of the version to be published; AND
    • Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
    •  When a large, multicenter group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript. These individuals should fully meet the criteria for authorship/contributorship defined above, and editors will ask these individuals to complete journal-specific author and conflict-of-interest disclosure forms. When submitting a manuscript authored by a group, the corresponding author should clearly indicate the preferred citation and identify all individual authors as well as the group name. Journals generally list other members of the group in the Acknowledgments. The NLM indexes the group name and the names of individuals the group has identified as being directly responsible for the manuscript; it also lists the names of collaborators if they are listed in Acknowledgments.
    • Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship. All persons designated as authors should qualify for authorship, and all those who qualify should be listed.
    • Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section. Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chairperson who provided only general support. Editors should ask corresponding authors to declare whether they had assistance with study design, data collection, data analysis, or manuscript preparation. If such assistance was available, the authors should disclose the identity of the individuals who provided this assistance and the entity that supported it in the published article. Financial and material support should also be acknowledged.

The ICMJE website (2015) can be accessed at: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

Intellectual Property

Policy relating to the management of research intellectual property within the Health Service is under development.

Collaboration across Institutions

Collaborative research, involving multiple partners who bring complementary expertise to solving a research question, is valuable and becoming increasingly frequent. It does raise specific issues, though, which need to be addressed. These include sharing intellectual property, managing the research findings and conflict of interest, and commercialising research outcomes.

The Code specifies that organisations should ensure that agreement on these points is reached and put in writing. It may take the form of a legal contract, an exchange of letters, a research management plan signed by all parties or appropriate representatives of all parties.

The collaborating parties should each identify a person to be involved in the management of the research data, and which items are to be retained (and where) at the end of the project.

Templates to be used for collaborative agreements across institutions are available at http://www.austin.org.au/RE/NewProjects/#Section15

Research Misconduct

Research Misconduct

A fundamental tenet of all research is that it is performed and reported honestly, as well as in an ethical fashion. Section 9 of the Australian Code provides detailed guidance about how institutions and their staff should respond to allegations that research has not been conducted responsibly, and the link to the Code is provided again here: http://www.nhmrc.gov.au/guidelines/publications/r39

Should any concern arise about the conduct of research on an Austin Health campus, the Administrative Procedure ‘MANAGEMENT OF COMPLAINTS RELATED TO CONDUCT OF RESEARCH’, which is lodged in the electronic Policies, Procedures and Guidelines section of the Austin Health intranet, must be consulted (in addition to the guidelines summarised here).

This section of the Austin Guidelines reproduces key aspects of the Australian Code and some definitions. The Code distinguishes between more minor issues (breaches of the Code), which can be suitably managed within Austin Health, and more serious or deliberate deviations (Research Misconduct), which it recommends be dealt with by involving people independent of Austin Health. It is recognised that the boundary between more minor and more serious issues is not sharp. One factor that may help in deciding the seriousness of an allegation is how it might affect public confidence in research and in Austin Health were it true.

In any consideration of allegations of Research Misconduct and/or more minor breaches of the Code, the principles of procedural fairness must be observed.

 

Definition of Research Misconduct

The Code provides detailed advice about this. It is reproduced here verbatim:

A complaint or allegation relates to Research Misconduct if it involves all of the following (our emphasis):

  • an alleged breach of the Australian Code for the Responsible Conduct of Research
  • 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.

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 wilful concealment or facilitation of Research Misconduct by others.

Repeated or continuing breaches of the Code may also constitute Research Misconduct, and do so where these have been the subject of previous counselling or specific direction.

Research Misconduct does not include honest differences in judgment about management of the research project, and may not include honest errors that are minor or unintentional. However, alleged breaches of the Code that do not meet the other criteria required in the definition of Research Misconduct will still require investigation and, if found to be substantiated, will require specific action by supervisors and/or other responsible officers of the health service.

Depending on the nature and seriousness of the breach, Research Misconduct might also constitute serious Research Misconduct warranting termination of employment.

While Austin Health will use the above definition (and its explanatory notes) in the Australian Code, when considering allegations of possible misconduct, some further guidance can also be obtained from the US government’s slightly more restricted definition of Research Misconduct, as:

 ‘Fabrication, falsification, or plagiarism (FFP). Misconduct does not include honest error or differences of scientific opinion.’

[Office of Science and Technology Policy (2000) Federal Research Misconduct Policy. Federal Register, 6 December 2000; 65(235): 76260–76264.]

The European Union has a broader definition, with extends beyond FFP to include poor data handling, COI, authorship issues etc.

Procedures in cases of allegations of breaches of the Code or of Research Misconduct

(1)  Research Integrity Advisors

 

It is recognised that a staff member or student who is unsure about a research conduct issue, and who may be considering whether to make an allegation, may find it helpful to first discuss the matter in confidence with someone who has considerable experience and wisdom in research. For this purpose, three senior staff members have made themselves available as Research Integrity Advisors. They are:

 

Professor George Jerums AM, Endocrinology Centre For Excellence, Repatriation campus

   Extension 3580, g.jerums@unimelb.edu.au

Dr Jennifer Johns, Senior Cardiologist, Department of Cardiology, Austin campus

   Extension 5283, jennifer.johns@austin.org.au

Professor Albert Frauman, Director, Clinical Pharmacology & Therapeutics, Austin campus

   Extension 5486, albertf@unimelb.edu.au

The research integrity advisor’s role is solely to assist with advice. They must not contact the person who is the subject of the possible allegation but should explain the options to the person considering making an allegation. These options include:

  • The person who has raised the concern referring them directly to the person against whom the allegation is being made
  • Not proceeding, or withdrawing the allegation if discussion resolves the concerns
  • Referring the allegation to a person in a supervisory capacity for resolution at the local or departmental level
  • Making an allegation of Research Misconduct in writing to the designated person (see below)

After providing such advice, the research inegrity advisor will play no further part in proceedings if a decision to formalise an allegation is made.

 

(2)   Lodging a complaint

 

With the proviso that the first step may have been to obtain clarification about the Code from a Research Integrity Advisor, which might have allayed any concerns, all employees or students associated with Austin Health who still have concerns should report suspected or apparent Code breaches or alleged Research Misconduct.

In the case of suspected minor breaches, the initial step may be to raise the concern with the immediate supervisor of the staff member or student, who could then take the responsibility to decide whether to proceed with a formal allegation. In the situation where the concern of the staff member or student was about  the research conduct of their supervisor, this step would clearly be inappropriate.

A formal allegation of a breach of the Code or of Research Misconduct must be referred in writing to the person designated to receive allegations, as detailed in the next section.

A person who is the subject of an allegation must be treated fairly and provided with opportunities to respond to allegations in writing. A person who makes an allegation must also be treated fairly, and according to any legislative provisions for whistleblowers during and following investigation of the allegations.

Adequate protection of the complainant and the accused person requires absolute confidentiality in the early stages of the investigation.

 

(3)   Designated person to receive allegations

 

The designated person to receive allegations of Research Misconduct or of noncompliance with the Code at Austin Health is the Manager, Office for Research. The Designated Person will conduct a preliminary investigation and provide advice to the Director of Research about whether the allegations appear to be justified and a prima facie case exists.

 

When undertaking a preliminary investigation, the Designated Person will take into account the requirements of theAustralian Code for the Responsible Conduct of Research. The Designated Person has the authority to secure all relevant documents and evidence so that they are available if it is decided that the allegations are to be investigated. Where necessary, the Designated Person must ensure that arrangements in the local workplace are fair to all parties until the allegations have been dealt with.

 

After completing the preliminary investigation, the designated person will advise the Director of Research whether the allegation should be:

 

  • Dismissed
  • Dealt with under other misconduct provisions unrelated to Research Misconduct
  • Referred back to the departmental level with advice about how it should be handled
  • Investigated further through a Research Misconduct enquiry

 

(4)    Procedures to be followed when the allegations appear to be justified and a prima facie case exists

 

If the allegations do appear to be justified and a prima facie case exists, the procedures which must be followed subsequently are set out in the Austin Health Administrative Procedure entitled Management of Complaints Related to Conduct of Research, lodged in the Policies and Procedures section of the Austin Health intranet.