Office of the Pro Vice-Chancellor (Research)

University of Tasmania

RESEARCH ACCOUNTABILITY: RECOMMENDATIONS

Increasingly universities are developing research contacts with industry. Such connections are to be welcomed since they:

(1)serve to create improved connections, and hopefully mobility, between the two sectors,

(2)allow researchers to be involved in research of direct applicability,

(3)provide significant opportunities for research higher degree students to gain experience in different environments, and

(4)serve to encourage the notion of developing knowledge industries from the innovation developed within universities.

However, such relationships need to be handled with integrity and the potential risk of the universities being compromised has to be managed appropriately. The Association of American Universities established the Task Force on Research Accountability and in its ‘Report on Individual and Institutional Financial Conflict of Interest’ (2001) it suggested that there are potential concerns at two levels. At the level of the individual researchers there may be concerns about the potential for, or perception of, some compromise in the normal standards of research rigor. For example, if generous research funding is provided by an industry partner there may be real or perceived pressures in relation to the conduct of the research or its reporting.

Similarly there can be institutional conflicts when senior managers or members of the governing body have commercial or financial links with a company that is providing research support to the institution.

The Task Force on Research Accountability recommended a three-fold approach:

(1)“disclose always,

(2)manage the conflict in most cases,

(3)prohibit the activity when necessary to protect the public interest or the interest of the university.”

In relation to the University of Tasmania, there are a number of issues that would need to be addressed in such a policy viz:

(i)direct or indirect financial conflict of interest

(ii)conflicts and contamination in relation to IP both for the University and third parties

(iii)issues in relation to the use of external research funding

(iv)disclosure of interests in publication of research

(v)security of commercially sensitive research data

(vi)conflicts surrounding the involvement of Research Higher Degree students

General Principles

In order for the University of Tasmania to deal with the issues we should adopt a set of general principles.

  1. The University should have a clear procedure for disclosure in relation to industry-sponsored research.
  1. There should be a clear mechanism for reporting of actual or potential, direct or indirect conflicts and a system for ensuring that appropriate bodies within the University are aware of such conflicts.
  1. It is not the role of the University to probe into the private financial dealings of its staff. However, when researchers undertake research projects funded by an entity and they either directly or indirectly have, or undertake,

(i)shares in the entity,

(ii)paid consultancy for the entity,

(iii)act as an advisor to the entity,

(iv)receive financial or other benefits from the entity, or

(v)receive royalty payments or equity shares,

then there is the risk of a ‘perceived conflict of interest.

  1. In some cases such linkages may not present an obvious problem. However, in others it may influence the manner in which the project is undertaken or the results communicated.
  1. When research is published or presented orally, the appropriate financial disclosure should be made either to the journal or to the audience. (see recommendation 1)
  1. There is likely to be enhanced sensitivity surrounding research that involves human subjects. When there is direct financial interest by researchers in research involving human subjects there must be stringent measures in place. In addition to the normal requirement of the Human Research Ethics Committee that the consent to participate form contains an explicit statement that the outcomes of the research may lead to a commercial product, there should also be a mechanism for examining:

(i)if there is a direct financial gain likely to accrue to the researchers personally, or

(ii)if the researchers have equity, financial or other involvements with the company concerned.

It may be necessary to have a process in place for ensuring that such information is presented as part of the ethics approval process. If there are perceived conflicts, appropriate management strategies will need to be developed on a case-by-case basis. (see recommendation 2)

  1. The rationale for developing a policy on this matter is to protect both individual researchers and the University, not to add significant paper work. The policy therefore will require a collaborative approach between researchers, University administration, and external parties.
  1. It is proposed that a sub-committee of the Board of the Research College plus an external person with appropriate commercial/legal skills constitute a Research Accountability Committee that would examine these matters. This sub-committee should report to the Board of the Research College which, in turn, should make an annual report to the University Council via its Audit Committee in relation to these issues. The University’s auditors might be asked to examine this area on a regular basis. (see recommendation 3)
  1. The development of policy in the absence of an education programme is unlikely to bring about the appropriate management of risk. (see recommendation 4)
  1. A simple system of disclosure in such cases is essential - an electronic disclosure form that provides the necessary information would facilitate the process.
  1. The disclosure system should be integrated with:

(i)processing of industrial sponsored research proposals,

(ii)license arrangements, and

(iii)gifts.

In most cases there will be no conflict of interest. (see recommendation 5)

  1. Such a disclosure mechanism would combine the current approach to the involvement of Research Higher Degree students. (see recommendation 6)
  1. In respect to publication the University should adopt a policy of disclosing the sources of funding that supported the research.
  1. If there are breaches in the disclosure mechanism the University should be clear about the sanctions it might impose if, after appropriate scrutiny, the breach is seen as deliberate and willful. (see recommendation 7)
  1. There may be situations in which senior university managers acting on behalf of the University in a research matter may have a conflict of interest. Such conflicts must be disclosed. An annual declaration of holdings to the Vice-Chancellor may address this issue. (see recommendation 8)
  1. Conflict of interest may also occur in relation to ownership of IP. Researchers frequently have several different sources of research funding that may involve similar projects. The ownership of any resultant IP can then be problematic. It may become contentious if the IP has significant commercial value and more than one external funding source believes they have either sole rights or shared rights with the University. In these matters researchers will need to exercise significant care in defining the scope of the projects for particular funding agencies. The University should also ensure that researchers sign a declaration that these matters have been considered and the IP arrangements have been clarified before the research commences or the monies are accepted by the University. (see recommendation 9)
  1. Research Higher Degree students can benefit significantly from carrying out their studies in association with an industry partner. However, there must be clear expectations about the resultant thesis and its examination and regarding any delays in relation to publication. Similarly if the research is commercial (or potentially commercial) the student must be invited to sign a Deed of Assignment at the start of candidature. If they are unwilling to do this, for whatever reason, they may be offered another project that does not have commercial requirements.
  1. Research that has commercial value to a particular sponsor may lose that value if it is disclosed. A departmental seminar, a conference poster or paper, a journal article or a web site can all disclose IP. Part of the research accountability in relation to undertaking research with industry, which may have commercial value is that there must be an awareness of the importance of disclosure. In view of this, the University might consider requiring that where there is clear commercial interest in the research there should be written clearance from the industrial sponsor and the Head of School or Institute in relation to all seminars/ presentations/ publications arising from the sponsored research.
  1. The appropriate management and security of data is also important. Both individual researchers and the institution must ensure that appropriate mechanisms are in place to secure commercially sensitive data and that there is a process for changing the security system from time to time. Some best practice examples of appropriate management and security of data should be identified and made available for researchers. (see recommendation 10)
  1. External research funding is almost invariably awarded for researchers to undertake a specific programme of research. In ‘blue sky’ research it is recognised that new and unexpected paths open up as the research proceeds. New techniques become available and collaborations are forged with other researchers that accelerate progress and allow new possibilities to be explored. This is to be encouraged, as it is the lifeblood of curiosity driven research. However, industry sponsored research is more focused and, in many cases, seeks a particular end point. It is inappropriate for funds awarded for such purposes to be employed in other ways. In most cases there is an external reporting requirement that enables this concern to be satisfied. Where there is no such requirement the University may consider an annual declaration that industry sponsored funding has been used for the purposes for which it was awarded. (see recommendation 11)
  1. It may be possible to file a single annual report (perhaps mid year). This would be electronic and available to appropriate groups within the University e.g. Ethics Committees, Research College Board, Research Higher Degrees Unit, Finance Committee. The Pro-Vice-Chancellor (Research) would have responsibility for reading and following up on any specific issues and for making an annual report to University Council via Finance Committee in relation to all these matters.

Recommendations

  1. That research publications or oral presentations by University employees acknowledge the sources of financial support for the research
  1. That the RDO Clearance Form, the Statewide Human Research Ethics or Animal Ethics forms contain explicit statements about whether:

(i)it is envisaged that the research has a commercial outcome, and

(ii)the researchers have equity, financial or other involvements with a commercial company funding their research

  1. That a Research Accountability Committee be established as a sub-committee of the Research College Board to monitor issues of research accountability on a on- going basis; this group to report to University Council via the Audit Committee
  1. That the University develop a simple education procedure to raise the awareness of staff about accountability in research
  1. That the Research and Development Office modify the Ethics approval process to include consideration of disclosure of conflict of interest
  1. That this disclosure mechanism apply to RHD project work within the University
  1. That the University have a clear policy on the action it will take in the event of deliberate and wilful breaches
  1. That University senior managers make an annual declaration of conflicts of interest to the Vice-Chancellor
  1. That where there is clear commercial interest in particular research, there should be written clearance from an industrial sponsor and the Head of School/Institute in relation to publications/seminars/conference presentations arising from the sponsored research to be kept on the project file
  1. That the University audit process include investigation of the security of commercially sensitive data and appropriate changes to security over time
  1. That as part of the annual reporting on industry sponsored research, there is provision for a declaration that the funding has been used for the purposes for which it was awarded

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19/09/18