UREC Workshop
8th May 2006
Ladies and Gentlemen:
It is my pleasure to welcome you to this workshop on Research
Ethics organised by the University Research Ethics Committee for
the members of the faculty research ethics committees and their
administrative staff. A special word of welcome goes to Mr Paul
Mifsud Cremona, Data Protection Commissioner, and his staff, and
to Dr Calleja and Mr Ellul from the Health Ethics Committee.
1. The University Senate set up a Research Ethics Committee some
years ago, and the committee appointed in June 2002 set itself the
task of drawing up a set of guidelines. These were approved at the
July 2004 Senate meeting and became effective on 1 October,
2004.
I will now try to give an overview of the procedure and activity of
UREC since then, and outline some of the main issues we have
encountered in these eighteen months of experience.
2. The Committee is made up of myself from the Faculty of
Theology as Chairman, Mr Paul Attard, member of the University
Council, Prof Marie-Therese Camilleri Podesta’ from the Faculty of
Medicine and Surgery, Dr David Fabri from the Faculty of Law, Dr
Grace Grima from the Faculty of Education, and Prof Angela Xuereb
from the Institute of Health Care, as members. Ms Gillian Cachia is
our very efficient and helpful secretary.
The Committee normally meets once a month, except during
August, although there have been some months when we met more
than once. Thus we have had 10 meetings in the academic year
2004-2005 and 8 meetings in the present academic year.
3. The Guidelines approved by Senate envisage a simple structure
that can safeguard both ethical standards and efficiency while
ensuring proper accountability.
As you know, the present set-up requires that each university
member, whether student or member of staff, undertaking research
involving human subjects, submits his or her proposal for approval
to the respective faculty research ethics committee. The proposal
form clearly identifies the person taking responsibility for the
research and for compliance with the guidelines and Data Protection
legislation.
The faculty committee will discuss the research proposals according
to the criteria set out in the guidelines, and will give its advice
whether the research is to be approved or not, and for what
reasons. This advice is passed on to the University committee,
which will give the final approval.
The dates of the University committee meetings are advertised in
good time on our website, so that faculty committees can plan their
work in a way that does not cause unnecessary delays. We are
bound to process those projects that are sent to us at least two
weeks before our meeting; we have managed to follow this
guideline almost to perfection.
4. Let it be said at the outset that this set-up is not of our own
choice, and that it places a considerable burden on us. However, we
are happy to say that after some initial difficulties, we established a
rhythm and method of work that, while involving some hard work
on the part of us all, is balanced and, in our opinion, quite efficient
and effective.
This is mostly due to the atmosphere of openness and trust we have
succeeded to create among ourselves, with the members of the
respective faculty committees, and with the Office of the Data
Protection Commissioner. We believe that our role is to facilitate
research and not to create obstacles, to look for solutions to
problems and not merely point them out, to establish good
communication channels and personal contact with faculty
committees and researchers. That seems the most effective way to
improve and maintain high standards of ethics in research.
We seem to be one of the very few EU countries, if not the only
one, where the same committee is responsible both for ethical
approval and data protection issues in research. This places a
considerable burden on us, but it is of practical benefit to the
researcher, for it obviously means one step less in the approval
process. More importantly, through the agreement we have
established with the Data Protection Commissioner, our approval is
equivalent to approval by the Data Commissioner, so that once the
research project is approved by UREC it can start immediately,
without needing the explicit approval by the Data Protection. UREC
regularly provides the Office of the Data Commissioner with a list of
the approved projects, and supplies any clarifications or
explanations which may be necessary. This is a very efficient and
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practical system, and the only snag seems to be that not all
government departments and data controllers are aware of it.
Moreover, whenever serious data protection problems have arisen,
or researchers faced difficulties with access to data, we have offered
our help to researchers to trash out their problems and find
solutions with the Data Protection Office.
5. In the months since its setting up, UREC has approved 358
research proposals, subdivided as follows:
Arts
Education
Engineering
Health care
Laws
Linguistics
Med & Surg
Science
Undergraduate
Postgraduate
Diploma,Masters
16
23
1
219
2
2
12
40
1
1
10
1
Doctorate
Staff
projects
1
2
2
3
1
4
17
TOTAL
18
26
1
264
4
1
43
1
358
6. We are therefore very pleased to be able to welcome such a
good number of faculty research ethics committee members this
morning. It will be an opportunity to share our experience as we
raise questions and issues and learn from one another.
Today’s programme has been drawn up with this end in view. We
will now listen to three short presentations on topics we believe are
of central importance in research ethics:
Research with vulnerable persons, presented by Dr Joe
Fenech, chairman of the research ethics committee of the
faculty of education;
Informed consent, by Dr Mario Vassallo, consultant physician
and chairman of the research ethics committee of the faculty
of medicine and surgery; and
Issues of conflict of interest, by Dr David Fabri, from the
faculty of law, and UREC member
After that there will be time for discussion, not only on the
presentations but on the whole area of research ethics at the
university. For instance, How do we ensure that bureaucracy is kept
to a minimum, how can we raise awareness of research ethics
among both students and members of staff? Can we improve
communication? Can the guidelines be improved? And what about
animal research?
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7. After our coffee break we move to another area of interest to us
all, data protection, still an obscure area for most and perhaps of
frustration and irritation for some. Yet, issues of access to all kinds
of data, confidentiality, use and misuse of information, are all both
ethical and data protection issues, so that we are very happy to
have the opportunity to listen to the data protection office staff and
be able to put questions and clarify issues.
With that, I will not take more of your time, and pass the floor to Dr
Fenech. Thank you.
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