The University of Global Health Equity (UGHE) Institutional Review Board (IRB) was established to ensure compliance with the highest legal and ethical standards for the conduct of Human Research. The UGHE IRB was created under the umbrella of the Rwandan National Ethics Committee (RNEC) and complies with its procedures, norms and guidance. The UGHE Institutional Official (IO) designates IRB members, and the Board’s operations are supported and managed by the UGHE Office of Human Research Administration (OHRA).

UGHE IRB shares the commitment of RNEC to safeguard the dignity, rights, health and wellbeing of research participants and the wider community. It also follows the ethical principles outlined in the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects, and the World Health Organization (WHO) and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice.

In accordance with directives from RNEC, the scope of inclusion of projects to be reviewed by the UGHE IRB is protocols for the research projects from:

• Students enrolled at UGHE
• Interns carrying out research projects at UGHE
• Students attached to UGHE staff by formal institutional agreement (i.e. fellows or exchange students)
• Staff in any UGHE academic department, on which staff serve as Principal Investigators (PI), co-investigators, or collaborators.

All protocols for professors involving partners and funding from outside Rwanda are reviewed by RNEC.

Responsibilities of the UGHE IRB

In accordance with RNEC guidelines, and for research projects included in RNEC’s scope of review, the UGHE-IRB has the authority to:

• Determine whether an activity is Human Research.
• Determine whether Human Research is exempt from IRB approval.
• Approve, require modifications to secure approval, and disapprove all Human Research overseen and conducted by UGHE agents.
• Ensure that there is regular evaluation of the ethics of ongoing studies that have received approval
• Suspend or terminate approval of Human Research not being conducted in accordance with the UGHE-IRB requirements or that has been associated with unexpected serious harm to participants.
• Observe the consent process and the conduct of the Human Research, such as in cases where study participants are minors.
• Evaluate the financial interests of investigators and research staff, determine whether possible conflict of financial interest exists, evaluate the conflict management plan (if any exists), and determine whether the research meets criteria for approval.
• Make a final determination as to whether a particular event constitutes an unanticipated problem involving risks to participants or others.
• Make a final determination as to whether a particular protocol violation constitutes serious or continuing non-compliance.
• Has a direct legal responsibility to research subjects.

UGHE IRB members

1. Dr. Patrick Orikiriza (Ph.D, Assistant Professor, Chairperson)- porikiriza@ughe.org

2. Dr. Deogratias Ruhangaza (M.D, Assistant Professor, Member)- druhangaza@ughe.org

3. Ms. Sandra Insano (M.A, Lecturer, Member)- sisano@ughe.org

4. Dr. Anselme Shyaka (Assistant Professor, Member)- ashyaka@ughe.org

5. Dr. Augustine Ndaimani (Assistant Professor, Member)- andaimani@ughe.org

6. Ms. Alice Muhoza Mutoni (M.A, Legal Issues Expert at PIH, Secretariate)- amutoni@ughe.org

7. Dr. Vincent K Cubaka (M.D, Director of Research and Training at PIH/IMB, Member)- vcubaka@pih.org

8. Dr. Tayechalem Moges Girma (Assistant Professor, Member)- tmoges@ughe.org

9. Mr. Don King Agaba (PIH Attorney, Member)- adonking@ughe.org

10. Ms.Patience Odour (Lecturer, Head of Clinical Trial, Member)- podour@ughe.org

11. Dr. Julien Nyombayire Mutagisha (Community Expert, Member)- jnyombayire@rzhrg-mail.com

12. Dr. Alemayehu Amberbir (PHD, Assistant Professor, Member)- aamberbir@ughe.org

 

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UGHE IRB Review Application Template

Template UGHE-IRB Application

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UGHE Standard Operating Procedures

UGHE SOP-manual_Draft_18Nov2019update (2) (1)

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IRB Standard Operating Procedures

standard_Operating_procedures_SOPs (1)

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View the template here

Please Submit ALL the Required Documents HERE