Overview
The IRERC ensures that all research activities comply with national regulatory requirements and internationally accepted ethical guidelines, including the Declaration of Helsinki of the World Medical Association and guidelines developed by the Council for International Organizations of Medical Sciences. Moreover, the Committee operates in accordance with national and international ethical guidelines and the College’s approved Standard Operating Procedures (SOPs). The Committee ensures that all research involving human participants are ethically sound, scientifically valid, and socially responsible before implementation.
The Committee serves as a cornerstone of the College’s research governance framework, promoting ethical research culture, academic integrity, and public trust. The IRERC reviews collaborative and joint proposals, funded projects, small-scale staff proposals, and undergraduate and postgraduate student proposals to ensure that risks to participants are minimized and justified by the anticipated benefits. Through rigorous ethical review and continuous oversight, IRERC ensures that research conducted at the College meets accepted ethical principles including:
- Respect for people
- Beneficence and non-maleficence
- Justice
- Scientific integrity
- Confidentiality and privacy protection
Core Functions
Ethical Review of Research Proposals
Reviews of all research protocols involving human participants. Evaluates scientific validity, assesses risk-benefit balance, and ensures protection of vulnerable populations. Ensures voluntary informed consent procedures are appropriate. Reviews recruitment methods and inclusion/exclusion criteria. Examine data protection and confidentiality safeguards. Reviews compensation and reimbursement arrangements.
Protection of Research Participants
Ensures respect for autonomy and voluntary participation. Proper documentation of informed consent. Additional protection for vulnerable groups. Confidential handling of personal and medical information. Fair and equitable selection of research participants. Prevention of exploitation or undue influence.
Continuing Review and Monitoring
Responsible for ongoing oversight of approved research, including periodic progress report review, monitoring protocol deviations, reviewing amendments and modifications, evaluating serious adverse event reports, and suspending or terminating studies if ethical violations occur.
Ethical Guidance and Capacity Building
Provides guidance to researchers on ethical standards, offers clarification on ethical requirements during proposal development, promotes awareness of research ethics within the College, and supports ethical research training initiatives.
Documentation and Record Management
Maintains records of submitted protocols, minutes of meetings and review decisions, letters, conditional approvals, and rejections, reports on adverse events and monitoring findings, and confidential archives of all reviewed research.
Key Activities
Regular Committee Meetings
Regular meetings conducted monthly for ethical review. Urgent meetings held as needed based on emerging conditions. Reviews of new submissions, revisions, and continuing applications. Documents decisions and recommendations.
Protocol Review Procedures
Researchers submit protocols through their department or using institutional email: irerc@mmhsc.edu.et. A quorum of at least 50% of committee members is required to approve the protocol. The protocol is available on the institutional website. Administrative screening for completeness is considered. Full board review for higher-risk studies.
Monitoring and Compliance
Reviews periodic progress reports, monitors compliance with approved protocols, reviews safety and adverse event reports, and conducts follow-up actions when necessary.
Ethical Clearance Issuance
Issues ethical clearance letters, specifies validity period of approval, outlines reporting requirements, and provides guidance on renewal procedures.
Complaint and Ethical Concern Handling
Receives and evaluates complaints related to research conduct, investigates allegations of ethical misconduct, and recommends corrective actions when necessary.
Institutional Commitments
Protecting Human Rights
We ensure that all research participants are treated with dignity, fairness, and respect.
Promoting Ethical Excellence
We foster a culture of ethical responsibility, transparency, and accountability in all research activities.
Ensuring Scientific Integrity
We support research that is methodologically sound, socially valuable, and ethically justified.
Strengthening Public Trust
We recognize that ethical oversight enhances community confidence in research conducted by the College.
Supporting Responsible Innovation
We encourage research that advances health knowledge while safeguarding participant welfare.