IV. IMPLEMENTATION 19. Responsibilities of Deans and Heads of Department 1. Deans of Faculties and Directors of Institutes, Centres and School shall ensure that applicable University regulations and policies regarding the use of human subjects in research are followed. 2. Deans of Faculties and Directors of Institutes, Centres and School shall ensure that the research activities covered by this policy are related to the academic programmes of the faculty and department. 20. Responsibilities of the Researcher 1. Researchers shall prepare a protocol giving a complete description of the proposed research. In the protocol, researchers shall make provisions for the adequate protection of the rights and welfare of prospective research subjects and ensure that pertinent laws and regulations are observed. 2. Researchers are responsible for preparing and submitting a protocol to the Faculty Research Ethics Committee and for including a sample of proposed informed consent forms in English and Maltese - with the protocol when appropriate. – 3. Researchers shall submit a supplement to an original protocol to the Faculty Research Ethics Committee when: (a) it is proposed to involve human subjects, and the activity previously had only indefinite plans for the involvement of human subjects; or (b) it is proposed to involve human subjects, and the activity previously had no plans for the involvement of human subjects; or (c) it is proposed to change the involvement of human subjects and that involvement is significantly different from that which was initially approved by UREC. 4. Researchers shall be responsible for complying with all Faculty Research Ethics and decisions, conditions and requirements. Committee’s UREC’s 5. Researchers are responsible for reporting promptly to UREC any injuries to human subjects, any anticipated problems which involve risks to the human subjects or others and any serious or continuing non-compliance with the requirements of this policy or the determinations of UREC. Prior to initiation, researchers shall obtain the review and approval of the Faculty Research Ethics Committee and UREC for any proposed changes in the research activity.
IV. IMPLEMENTATION 19. Responsibilities of Deans and Heads of Department 1. Deans of Faculties and Directors of Institutes, Centres and School shall ensure that applicable University regulations and policies regarding the use of human subjects in research are followed. 2. Deans of Faculties and Directors of Institutes, Centres and School shall ensure that the research activities covered by this policy are related to the academic programmes of the faculty and department. 20. Responsibilities of the Researcher 1. Researchers shall prepare a protocol giving a complete description of the proposed research. In the protocol, researchers shall make provisions for the adequate protection of the rights and welfare of prospective research subjects and ensure that pertinent laws and regulations are observed. 2. Researchers are responsible for preparing and submitting a protocol to the Faculty Research Ethics Committee and for including a sample of proposed informed consent forms – in English and Maltese - with the protocol when appropriate. 3. Researchers shall submit a supplement to an original protocol to the Faculty Research Ethics Committee when: (a) it is proposed to involve human subjects, and the activity previously had only indefinite plans for the involvement of human subjects; or (b) it is proposed to involve human subjects, and the activity previously had no plans for the involvement of human subjects; or (c) it is proposed to change the involvement of human subjects and that involvement is significantly different from that which was initially approved by UREC. 4. Researchers shall be responsible for complying with all Faculty Research Ethics Committee’s and UREC’s decisions, conditions and requirements. 5. Researchers are responsible for reporting promptly to UREC any injuries to human subjects, any anticipated problems which involve risks to the human subjects or others and any serious or continuing non-compliance with the requirements of this policy or the determinations of UREC. Prior to initiation, researchers shall obtain the review and approval of the Faculty Research Ethics Committee and UREC for any proposed changes in the research activity.
a.Guidelines_for_UoM_Research_Ethics_Committee1.docx