Faculty of Medicine – Al-Subtain University for Medical Sciences

1. Definition and General Objective

The Research Ethics Committee (REC / Institutional Review Board - IRB) at the Faculty of Medicine is an independent body responsible for reviewing and evaluating research proposals before execution. Its primary objective is to balance scientific advancement with the protection of human rights, ensuring that researchers fully comply with international medical ethics standards (e.g., the Declaration of Helsinki) and the regulations of the Iraqi Ministry of Higher Education and Scientific Research.

2. Key Responsibilities

• Participant Protection: Ensuring the safety of patients and volunteers, preventing any physical, psychological, or social harm.
• Informed Consent: Verifying that participants are fully informed about the study's nature, benefits, and risks, and that they participate voluntarily with the right to withdraw at any time.
• Data Confidentiality: Guaranteeing strict protection and encryption of patients' medical records and personal information.
• International Accreditation: Providing researchers with an official Ethical Approval Number, which is a mandatory prerequisite for publishing in global indexed journals (e.g., Scopus and Clarivate).

3. Scope of Covered Research

All research projects within the Faculty of Medicine involving the following must undergo review:

1. Clinical Trials: Direct medical, therapeutic, or diagnostic interventions on patients.
2. Biological Samples: Research utilizing human blood, tissues, or bio-fluids.
3. Retrospective Studies: Analyzing archived medical records and patient histories within teaching hospitals.
4. Surveys and Questionnaires: Behavioral and social studies targeting patients, students, or healthcare professionals via digital or paper forms.

4. Operational Workflow & Submission Process

• Step 1 (Submission): The researcher submits a complete portfolio including the Research Proposal, Informed Consent Form (in both Arabic and English), and Data Collection Tools.
• Step 2 (Evaluation): The committee reviews the file to assess the risk-to-benefit ratio and ensure ethical compliance.
• Step 3 (Decision): The committee either issues a formal Ethical Approval with an official license number or requests specific modifications to align the study with ethical guidelines.

5. Conclusion

The Research Ethics Committee acts as the academic safety valve at Al-Sabtain University. It serves as an essential guarantee for producing credible, high-quality medical research that respects professional ethics and safely serves the community.