Institutional Review Board (IRB)

National University of Sudan

The Institutional Review Board (IRB) of the National University of Sudan protects the rights, safety, dignity, and well-being of all individuals participating in human research. It fosters a research culture grounded in the highest standards of ethics, scientific integrity, and regulatory compliance, ensuring that every study serves the public good while minimising potential harm.

It aspires to cultivate a vibrant, ethically rigorous research ecosystem at the National University of Sudan that is globally recognised and locally responsive. By advancing responsible research conduct, the IRB aims to position the university as a leading center of excellence in ethical governance, driving meaningful progress in science, health, and society across local, regional, and international communities.

Governance and Responsibilities

• The IRB operates as an independent, multidisciplinary committee dedicated to participant protection and objective review. Its composition reflects diverse expertise and perspectives to ensure a comprehensive assessment of research protocols.
• All research conducted under the university’s auspices is evaluated against the highest ethical and scientific criteria, aligning with international norms and national regulations.
• Through rigorous proposal evaluation, the IRB safeguards participants by upholding informed consent, confidentiality, risk-benefit assessment, and methodological validity, in accordance with guidelines such as the Declaration of Helsinki, CIOMS, and national regulatory frameworks. The IRB also attends to vulnerable populations and equity considerations in participant selection.
• The IRB provides continuous oversight of approved studies, including post-approval monitoring, amendments, and adverse event reporting, to ensure sustained ethical compliance and participant safety.
• The IRB commits to education and professional development for investigators, research staff, and students in ethics, governance, data privacy, and risk assessment, thereby strengthening the university’s overall research governance capacity.
• The IRB engages with local communities, stakeholders, and international partners to ensure research relevance, cultural sensitivity, transparency, and adherence to globally recognised ethical standards.

Core Principles in Practice

• Prioritise informed consent, autonomy, and the inherent dignity of all research participants.
• Strive to maximise potential benefits while minimising risks to participants.
• Ensure fair participant selection and the equitable distribution of research burdens and benefits.
• Safeguard privacy and ensure secure handling, storage, and disposal of data.
• Promote research questions that are meaningful and methods that are rigorous and appropriate.
• Maintain open communication about study aims, risks, and findings; uphold accountability to participants, the university, and oversight bodies.

Implementation and Impact

• The IRB ensures that all university-affiliated research complies with applicable ethical, legal, and regulatory requirements at national and international levels.
• The IRB provides clear guidance and timely feedback to researchers to facilitate compliant study design, robust informed consent processes, and effective risk mitigation.
• By upholding rigorous ethical review and ongoing oversight, the IRB enhances the integrity of the university’s research portfolio, fostering public trust and international credibility.

The IRB is comprised of 15 voting members drawn from a broad mix of disciplines and professional backgrounds, ensuring a holistic and well-rounded review process. Members bring deep expertise in ethics, research methodology, clinical practice, public health, statistics, law, data protection, and academic leadership. This diverse composition is designed to reflect the range of research conducted at the university and to provide robust protection for participants across study types.

Leadership and governance

• The Board is led by a Chair and a Co-chair, who provide strategic direction, ensure continuity of oversight, and represent the IRB in internal governance and external engagements.
• The Chair and Co-chair are supported by standing staff liaisons and subcommittees as needed to address specific topics or review needs.

Ad hoc expertise

• Additional subject-matter experts may be invited on an ad hoc basis to contribute specialised knowledge relevant to particular proposals, such as genetics, pediatric research, vulnerable populations, biosafety, or international collaborations.
• Ad hoc members participate as non-voting or voting members depending on the nature of the review and the committee’s deliberations, and their involvement is governed by defined terms and conflict-of-interest policies.

Terms, rotation, and continuity

• Members serve defined terms with opportunities for renewal, enabling both continuity and fresh expertise over time.
• A structured rotation and staggered terms help preserve institutional memory while incorporating new perspectives.
• All members complete initial and ongoing ethics, regulatory, and compliance training as a condition of service.

Diversity and inclusion

• The IRB seeks broad representation across disciplines, genders, career stages, research domains, and community perspectives to enhance decision-making and cultural sensitivity.
• Mechanisms are in place to identify and address potential conflicts of interest and to ensure decisions are made in the participants’ best interests.

Roles and responsibilities

• Each member contributes to protocol review, risk-benefit assessment, informed consent evaluation, privacy protection, and data integrity considerations.
• Subcommittees (e.g., expedited review, biosafety, data protection, vulnerable populations) may be formed to handle specific review needs and to streamline processes while maintaining rigorous standards.
• All members participate in ongoing education and capacity-building activities to stay aligned with evolving ethical, regulatory, and methodological best practices.

Operationalising governance

• Clear appointment processes, performance evaluations, and accountability mechanisms ensure the IRB operates with transparency, efficiency, and integrity.
• A centralised record-keeping and documentation system tracks decisions, rationale, and post-approval monitoring activities to support audit readiness and public trust.

Foundational Documents and Frameworks

• The IRB operates in accordance with a defined set of governance documents, including:
  • Terms of Reference (ToR)
  • Institutional Bylaws
  • Standard Operating Procedures (SOPs)
• These documents establish the authority, scope, roles, and procedures guiding the Board’s work and ensure consistent, transparent oversight.

Review Process and Proposal Evaluation

• The IRB meets on a regular basis to evaluate research proposals submitted by faculty, students, and external collaborators.
• Each submission undergoes rigorous review focused on:
  • Ethical soundness: ensuring respect for participants, autonomy, and dignity.
  • Scientific merit: assessing the validity and potential contribution of the research.
  • Risk–benefit assessment: weighing potential harms against anticipated benefits to participants and society.
  • Regulatory and guideline compliance: alignment with international standards (e.g., the Declaration of Helsinki, CIOMS Guidelines) and national requirements.
  • Legal and regulatory adherence: conformity with Sudanese national regulations and institutional policies.

Process Enhancements

• Documentation and transparency: standardised submission checklists, traceable decision rationales, and archiving of all review outcomes.
• Stakeholder engagement: mechanisms for stakeholder input, community consultation, and respondent protection in research planning.
• Oversight and monitoring: post-approval monitoring, amendments review, and adverse event reporting protocols.
• Continuous improvement: periodic SOP reviews, internal audits, and ongoing training for IRB members and researchers to reflect evolving ethical, methodological, and regulatory standards.

IRB Board Members

 

Name	Title / Role	Affiliation / Expertise
Prof. Ahmed Awad Elgamel	Chair	Professor of Pharmacognosy
Dr. Ali Awadallah Saeed	Co-chair	Consultant in Pharmacology
Prof. Amin Osman Sidahmed	Member	Professor of Paediatrics
Ms. Sumia Yousif	Member	Researcher, National University Biomedical Research Institute (NUBRI)
Dr. Mohamed Mustafa Eldaw	Member	Faculty of International Relations and Diplomatic Studies
Dr. Sawsan Mohamed Makkawi	Member	Faculty of Engineering and Architecture
Prof. Amnai Abdelrazik Elfaki	Member	Professor of Anatomy
Dr. Sumia Ibrahim Abdelaziz	Member	Faculty of Nursing and Midwifery Sciences
Dr. Sababil Salih	Member	Faculty of Medical Laboratory Sciences
Dr. Lana Satti	Member	Faculty of Physiotherapy
Prof. Maha Esmaeil	Member	Faculty of Radiography and Medical Imaging
Dr. Mubarak Dalil	Member	Faculty of Computer Science and Information Technology
Dr. Hidayh Elyas	Member	Faculty of Dental Medicine and Surgery
Dr. Myson Elgusi	Member	Faculty of Administrative Sciences
Dr. Hiba Mohamed Elhassan	Member	Head, Quality Department