University Research Ethics Committee Workshop on procedure and data protection issues 30th May 2008

1.Some history 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 This policy will apply to all research, as defined in this policy, that is conducted by University personnel, undergraduate and postgraduate students, which involves human subjects.

2.2 What considerations? 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 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 A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

3.2 Human Subject 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 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 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) 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)  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) A consent form Signed by Subject researcher and supervisor In English and Maltese

4. Informed consent (2) 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 Institutional approval, from eg: Education/health division Hospital School, parish, office, consultant, nursing officer Data steward (eg Registrar...)

6. Procedures (1) 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) 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) 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) 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) 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 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