Upholding Ethical Research at Our College

The College is committed to fostering research that adheres to the highest ethical standards. Our Institutional Review Board (IRB) plays a vital role in ensuring the safety, well-being, and rights of research participants, as well as considering environmental impacts.

Our Commitment to Ethical Research

For all university and academic staff, ethical practices regarding study participants and environmental considerations are prerequisites for conducting research. All research proposals, including clinical trials involving humans, animals, the environment, new drugs and other new biological products, and vulnerable population groups, must obtain ethical clearance. This is achieved through a critical review of research proposals and ongoing follow-up to ensure proper implementation of research procedures as per ethical clearance.

To uphold this commitment, our College maintains an independent and functional IRB office with responsible and accountable members. Our IRB members rigorously review all research proposals based on national and international research ethics declarations and codes of conduct, such as the Declaration of Helsinki and Ethiopian national research ethics guidelines. Key principles guiding our reviews include informed consent, data privacy, and confidentiality to maximize participant safety.

IRB Structure and Operations

Our IRB is designed to operate effectively and transparently:

Quorum Requirements:

A quorum for an IRB meeting is met when 50% plus one of the members are in attendance. In the absence of the Chairperson, the Secretary will act on their behalf. To ensure a comprehensive review, the quorum must include:

• At least one member whose primary area of expertise is in a non-scientific field.
• One medical scientist.
• At least one member who is independent of the institution/research site.

Membership:

The IRB consists of a minimum of five members, representing diverse disciplines such as Health, Social Science, Science, Law, Agriculture, and Environment. It also includes concerned community representatives and invited experts for specific reviews. To ensure balanced perspectives, the IRB membership will not consist entirely of men or entirely of women.

The IRB members include a Chairperson (assigned by the CED/RCSCD), a Vice-Chairperson, a Secretary (selected by members), and general members. Members serve for three consecutive years, provided they adhere to IRB guidelines, and may be reappointed for one additional term.

Meeting Schedule:

The IRB committee meets once a month. The Chairperson may call an extraordinary meeting at any time deemed necessary. The IRB committee aims to declare project proposals cleared within a one-month period.

Confidentiality:

The IRB process maintains strict confidentiality.

Responsibilities of the Institutional Review Board (IRB)

The Institutional Review Board (IRB) is responsible for a comprehensive range of tasks to ensure ethical research practices:

• Accountability: The IRB is accountable to the Research and Community Service Coordination Directorate (RCSCD).
• Ethical Clearance: Administers and executes the ethical clearance aspects of research projects at the University and requests local clearance for projects funded by other agents.
• Review of External Submissions: Conducts ethical reviews of papers submitted from local institutions and non-governmental organizations.
• Complaint Resolution: Accepts and works to resolve customer complaints concerning the review process.
• Expert Consultation: Consults experts on ethical aspects and updates on national and international standards.
• Guideline Development: Develops ethical guidelines/directives for the IRB office.
• Training and Education: Organizes and delivers research ethics training to IRB members, researchers, academic staff, and relevant stakeholders.
• Procedural Development: Prepares Standard Operational Procedures (SOPs) and forms essential to the ethical review process.
• Reporting: Submits annual progress reports of the IRB’s functions to the national IRB office and quarterly reports to the college.
• Monitoring and Oversight: Monitors each research project for its ethical implementation and provides timely feedback for action, including the termination of a research project if there is a breach of agreement.
• National Collaboration: Works closely with the national IRB office for support and consultations.
• Capacity Building: Solicits funds to build the IRB’s office capacity.
• Data Safety Monitoring: Establishes and/or actively participates as a member of data safety monitoring boards.
• Licensing and Compliance: Registers and renews the IRB license from the national IRB office every two years and complies with the University or Affiliate institution’s conflict of interest policy.
• Fee Estimation: Estimates fees for research proposals submitted to IRB services in consultation with the RCSCD and the college senate.
• Record Keeping: Documents IRB-related records properly and confidentially.
• Enforcement: Addresses researchers who violate ethical clearance agreements or conduct research without obtaining ethical clearance.
• Submission Requirements: Sets requirement checklists for research proposal/project submission for ethical review.
• Office Infrastructure: Arranges a dedicated IRB office and all required inputs, including requirements to obtain and renew the IRB license.
• Member Accountability: Holds IRB members accountable, including disqualifying members from IRB membership for malpractices during the review of research proposals/projects.
• Renewal Tracking: Follows up and orders for renewal of ethical clearance letters based on the expiry date.
• Continuous Training: IRB members are required to undergo training on IRB procedures, review guidelines, SOPs, forms, national guidelines, and international codes of conduct/declarations.
• Meeting Documentation: Prepares and documents minutes of monthly meetings.

Membership Resignation and Disqualification:

IRB member(s) may lose their memberships by submitting a letter of resignation or by being disqualified through a letter from the Chairperson for malpractices. Members who have resigned or have been disqualified may be replaced by the selection and appointment of new members proposed by the ethical committee.