Directorate Overview
The IRERC ensures that all research activities comply with national regulatory requirements and international ethical guidelines, including the Declaration of Helsinki. We review collaborative and joint proposals, staff research, and student projects to ensure every study is ethically sound, scientifically valid, and socially responsible.
Key Services & Responsibilities
Primary functions and strategic operations
Ethical Review of Proposals
Comprehensive review of all research protocols involving human participants to ensure ethical justification.
Protection of Participants
Ensuring respect for autonomy, voluntary participation, and protection of vulnerable groups above all interests.
Continuous Monitoring
Ongoing oversight of approved research, including progress reports, deviations, and serious adverse event reports.
Ethical Guidance & Training
Providing mentorship and guidance to researchers on national and international ethical standards.
Protocol Review Procedures
Standardized review cycles including expedited reviews for low-risk studies and full board reviews for higher-risk research.
Ethical Clearance Issuance
Issuing official ethical clearance letters with defined validity periods and reporting requirements.
Conflict of Interest Management
Rigorous processes to identify and manage potential conflicts of interest among investigators and committee members.
Data Protection Oversight
Examining data protection and confidentiality safeguards to protect medical and personal information.
Complaint Handling
Receiving and evaluating complaints related to research conduct and investigating allegations of misconduct.
Recruitment Evaluation
Reviewing recruitment methods and inclusion/exclusion criteria to ensure fair and equitable participant selection.
Core Functions and Responsibilities
The IRERC operates as a cornerstone of research governance through the following domains:
- Ethical Review: Evaluating scientific validity, risk-benefit balance, and informed consent procedures.
- Participant Protection: Prioritizing safety, confidentiality, and prevention of exploitation.
- Continuing Review: Periodic monitoring of protocol deviations and study amendments.
- Capacity Building: Promoting ethical awareness and training initiatives within the College.
- Documentation: Maintaining confidential archives of all protocols, decisions, and meeting minutes.
Protocol Review Procedures
Researchers must follow the standardized submission and review cycle:
- Submit protocols via department (students) or institutional email: irerc@mmhsc.edu.et.
- Protocols must follow College guidelines (Introduction, Methodology, Consent forms, etc.).
- Quorum of at least 50% required for valid committee decisions.
- Conflict of interest policy strictly enforced (investigators excluded from their own reviews).
- Formal notification of decisions (Approval, Conditional, Deferral, or Rejection) within one month.
Institutional Commitments
The College affirms its commitment to ethical research excellence through:
- Protecting Human Rights: Treating all participants with dignity, fairness, and respect.
- Promoting Ethical Excellence: Fostering transparency and accountability in all research.
- Ensuring Scientific Integrity: Supporting methodologically sound and ethically justified research.
- Strengthening Public Trust: Enhancing community confidence through rigorous oversight.
- Responsible Innovation: Safeguarding welfare while advancing critical health knowledge.