University Research Ethics Committee

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

2. 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

3. 2.1 Some principles • This policy will apply to all research, as defined in this policy, • that is conductedby • University personnel, • undergraduate and postgraduate students, • whichinvolves human subjects.

4. 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.

5. 2.3 Vulnerables • The University recognizes the need for appropriate additional safeguards inresearch involving subjects who are likely to be vulnerable to coercion or undueinfluence, such as • children (under the age of 18), • prisoners, • mentally disabled personsor • economically or educationallydisadvantaged persons.

6. 3.1 Some definitions: Research • A systematic investigation, including research development, testing andevaluation, designed to develop or contribute to generalizable knowledge.

7. 3.2 Human Subject • A human being and/or human tissue about whom an investigator(whether professional or student) conducting research obtains (1) data throughintervention or interaction with the individual or (2) identifiable private information.

8. 3.3Minimal Risk • The probability and magnitude of harm or discomfort anticipatedin the research are intrinsically not greaterthan those ordinarily encountered in dailylife or during the performance of routine physical or psychological examinations ortests.

9. 3.4Data Protection • The Data Protection Act provides for the protection ofindividuals against the violation of their privacy, by regulating the processing ofpersonal data. The University shall give proper consideration to the principles ofproper handling of information

10. 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 theresearch and the expected duration of the subject's participation, a description of theprocedures to be followed and identification of any procedures which areexperimental. • Any reasonably foreseeable risks or discomforts to the subject. • Any benefits to the subject or to others.

11. 4. Informed consent (2) • The extent to which confidentiality of records identifyingthe subject will be maintained • An explanation of whom to contact for answers to pertinent questions about theresearch and research subject's rights • A statement that participation is voluntary, refusal to participate will involve nopenalty or loss of benefits to which the subject is otherwise entitled, and that thesubject may discontinue participation at any time without penalty or loss of benefits towhich the subject is otherwise entitled.

12. 4. Informed consent (1) • A consent form • Signed by • Subject • researcher and • supervisor • In English and Maltese

13. 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

14. 5. Other documentation • Institutional approval, from eg: • Education/health division • Hospital • School, parish, office, consultant, nursing officer • Data steward (eg Registrar...)

15. 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

16. 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

17. 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

18. 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?

19. 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

20. 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