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.”
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Office of the Pro Vice-Chancellor (Research)
University of Tasmania
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.
2. 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.
3. 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.
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Office of the Pro Vice-Chancellor (Research)
University of Tasmania
4. 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.
5. 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)
6. 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)
7. 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.
8. 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
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Office of the Pro Vice-Chancellor (Research)
University of Tasmania
issues. The University’s auditors might be asked to examine this area on a regular
basis. (see recommendation 3)
9. The development of policy in the absence of an education programme is unlikely
to bring about the appropriate management of risk. (see recommendation 4)
10. A simple system of disclosure in such cases is essential - an electronic disclosure
form that provides the necessary information would facilitate the process.
11. 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)
12. Such a disclosure mechanism would combine the current approach to the
involvement of Research Higher Degree students. (see recommendation 6)
13. In respect to publication the University should adopt a policy of disclosing the
sources of funding that supported the research.
14. 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)
15. 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)
16. 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
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Office of the Pro Vice-Chancellor (Research)
University of Tasmania
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)
17. 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.
18. 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.
19. 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)
20. External research funding is almost invariably awarded for researchers to
undertake a specific programme of research. In ‘blue sky’ research it is recognised
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Office of the Pro Vice-Chancellor (Research)
University of Tasmania
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)
21. 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.
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Office of the Pro Vice-Chancellor (Research)
University of Tasmania
Recommendations
1. That research publications or oral presentations by University employees
acknowledge the sources of financial support for the research
2. 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
3. That a Research Accountability Committee be established as a sub-committee of
the Research College Board to monitor issues of research accountability on a ongoing basis; this group to report to University Council via the Audit Committee
4. That the University develop a simple education procedure to raise the awareness
of staff about accountability in research
5. That the Research and Development Office modify the Ethics approval process to
include consideration of disclosure of conflict of interest
6. That this disclosure mechanism apply to RHD project work within the University
7. That the University have a clear policy on the action it will take in the event of
deliberate and wilful breaches
8. That University senior managers make an annual declaration of conflicts of
interest to the Vice-Chancellor
9. 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
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Office of the Pro Vice-Chancellor (Research)
University of Tasmania
10. That the University audit process include investigation of the security of
commercially sensitive data and appropriate changes to security over time
11. 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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