Transcript University Research Ethics Committee

University Research Ethics
Committee
Workshop on procedure and data
protection issues
30th May 2008
1. Some history
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UREC set up in 2002
First version of Guidelines in July 2004
First meeting in September 2004
Second version of Guidelines in
September 2007
Committee reappointed for 3 years
2.1 Some principles
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This policy will apply to all research, as
defined in this policy,
that is conducted by
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University personnel,
undergraduate and postgraduate students,
which involves human subjects.
2.2 What considerations?
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The University ensures that before human subjects
are involved in research, proper consideration will be
given to:
the risks to the subjects;
the anticipated benefits to the subjects and others;
the importance of knowledge that may reasonably be
expected to result;
the informed consent process to be employed;
the additional safeguards for vulnerable subjects; and
the data protection provisions.
2.3 Vulnerables
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The University recognizes the need for appropriate
additional safeguards in research involving subjects
who are likely to be vulnerable to coercion or undue
influence, such as
 children (under the age of 18),
 prisoners,
 mentally disabled persons or
 economically or educationally disadvantaged
persons.
3.1 Some definitions: Research
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A systematic investigation, including
research development, testing and
evaluation, designed to develop or
contribute to generalizable knowledge.
3.2 Human Subject
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A human being and/or human tissue
about whom an investigator (whether
professional or student) conducting
research obtains
(1) data through intervention or
interaction with the individual or
(2) identifiable private information.
3.3 Minimal Risk
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The probability and magnitude of harm
or discomfort anticipated in the
research are intrinsically not greater
than those ordinarily encountered in
daily life or during the performance of
routine physical or psychological
examinations or tests.
3.4 Data Protection
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The Data Protection Act provides for the
protection of individuals against the
violation of their privacy, by regulating
the processing of personal data. The
University shall give proper consideration
to the principles of proper handling of
information
4. Informed consent (1)
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The research subject has a right to adequate
information about his/her involvement and
risks; viz:
An explanation of the purpose of the research
and the expected duration of the subject's
participation, a description of the procedures
to be followed and identification of any
procedures which are experimental.
Any reasonably foreseeable risks or
discomforts to the subject.
Any benefits to the subject or to others.
4. Informed consent (2)
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The extent to which confidentiality of records
identifying the subject will be maintained
An explanation of whom to contact for answers to
pertinent questions about the research and
research subject's rights
A statement that participation is voluntary, refusal
to participate will involve no penalty or loss of
benefits to which the subject is otherwise entitled,
and that the subject may discontinue participation
at any time without penalty or loss of benefits to
which the subject is otherwise entitled.
4. Informed consent (1)
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A consent form
Signed by
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Subject
researcher and
supervisor
In English and Maltese
4. Informed consent (2)
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In the case of children or other
vulnerables consent from parents/legal
guardian
In the case of children over 12 years,
the child’s consent too
5. Other documentation
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Institutional approval, from eg:
 Education/health division
 Hospital
 School, parish, office, consultant,
nursing officer
 Data steward (eg Registrar...)
6. Procedures (1)
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Researcher fills in proposal form and
prepares other documentation
This is presented to Faculty Research
Ethics committee
which in turn passes it on to UREC for
final approval
6. Procedures (2)
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UREC meets once a month, according
to dates on website
It examines all proposals that reach it
two weeks before meeting
Sends form back to faculty with
approval, conditional approval, rejection
within two weeks
6. Procedures (3)
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UREC approval is equivalent to approval
by Data Protection Commissioner
required by Data Protection law
At regular intervals, UREC informs DPO
of research proposals approved
Constant contact to ensure standards
and to solve difficulties
7. What to look out for... (1)
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Awareness raising at all levels
Keeping records at UREC and Faculty levels
Conflict is excluded by Guidelines: one cannot
be both supervisor and involved in U/REC
screening of proposal
What do we tell student after REC approval?
What do we return to student, the completed
proposal form or something else?
7. What to look out for... (2)
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UREC will not accept proposals that do not
include all necessary documentation: we will
soon have a checklist
Access to (sensitive personal) data is often an
issue
Declaration that applicant will not start
research on human subjects before UREC
approval
8. And finally
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This is an interesting and valuable
educational exercise
In this area, consistency produces quick
results
Awareness raising at all levels is essential
Thank you for your attention and
participation