Oromia Regional Research Ethics Review Guidelines

Contents

Preface                                                                                                                                                 5

Acknowledgement                                                                                                                             6

1.      Constitutive Terms. 9

2.      The Role of RRERC. 11

3.      The General Attitude of RRERC. 12

4.      Research Evaluation Policy. 12

5.      Independence of RRERC. 12

6.      Membership. 13

6.1.       Co‐option. 13

6.2.       Appointments. 13

6.3.       Tenure and conditions of appointment13

6.4.       Resignation, disqualification, and replacement of members. 14

6.5.       Allowances. 14

6.6.       Review fees. 15

6.7.       Contact Information for RRERC. 15

7.      Terms of Reference (TOR)15

7.1.       Review and Approvals of Research Proposals. 15

7.2.       Continuous professional development in research ethics. 17

7.3.       Provide Leadership in Research Ethics  19

8.      The Secretariat19

9.      Functions and Responsibilities. 19

9.1.       Chair:19

9.2.       Vice‐Chair. 19

9.3.       Committee Secretary. 20

9.4.       Administrator. 20

9.5.       Committee Members. 21

10.        Regular RRERC Meetings. 21

10.1.         Frequency. 21

10.2.         Quorum.. 21

11.        Conduct of RRERC Meetings. 22

11.1.         RRERC Meeting Schedule and Distribution of Agenda. 22

11.2.         Meeting Procedure. 22

11.3.         Minutes of meetings. 22

12.        Special Meetings. 23

13.        The Participant Informed Consent Document and The Consent Process. 23

13.1.         Language of Informed Consent Documents:23

13.2.         General requirements. 24

13.3.         The Elements of Informed Consent25

13.3.1.      Basic Elements of Informed Consent  25

14.        Submission of a Research Protocol / Proposal26

15.        Types of Review.. 26

15.1.         Expedited Review.. 26

15.2.         Full Review.. 27

15.3.         Continuing Review.. 27

15.4.         Exempt review.. 28

15.5.         Review of Undergraduate Research Proposals. 29

16.        Post Approval Protocol / Proposal Amendments and Continued Review.. 30

16.1.         Proposal/protocol Amendments. 30

16.2.         Adverse and Serious Adverse Events (SAE) and Suspected Unexpected Serious adverse reactions (SUSAR Reports)31

17.        Communication of Review Decisions. 32

18.        Follow‐Up. 32

18.1.         Progress Reports. 32

18.2.         Protocol deviations and protocol violations  32

18.3.         Premature Suspension/Termination of a research study. 32

18.4.         Completion of the study. 33

18.5.         Dissemination of Research Results. 33

19.        Monitoring of Research. 33

20.        Appeal Against Committee Decision. 34

21.        Responsibility of the Principal Investigator in the Review Process. 34

22.        Documentation and Archiving. 35

23.        References

Bibliography

Appendix I.  Abbreviations. 44

Appendix II. Glossary of Terms. 45

Appendix III. RRERC Term of Reference. 48

Appendix IV. RRER Application Form.. 50

Appendix V. Research Ethics Review Form.. 51

Appendix VI. Material Transfer Agreement Form.. 52

Appendix VII. List of RREC Membership