Institutional Review Board (IRB) at the University of Ghana Medical Centre (UGMC)

The Institutional Review Board (IRB) at the University of Ghana Medical Centre (UGMC) operates under the Medical and Scientific Research Directorate (MSRD) and plays a crucial role in the oversight of research involving human subjects. As a core component of UGMC’s mission to uphold ethical standards, the IRB ensures that all research involving human participants complies with both national regulations and international best practices. Through rigorous review, the IRB protects the rights, safety, and welfare of individuals participating in research.

Our IRB is guided by the Standard Operating Procedures and Policy for IRB Activities and Jurisdiction, which mandates that all human research conducted at UGMC, or by its affiliates, be reviewed and approved before initiation. Whether engaging in independent research or collaborating with external institutions, researchers are required to comply with UGMC's policies to promote transparency, accountability, and ethical integrity.

Mission and Purpose

The primary mission of the UGMC-IRB is to safeguard the dignity, welfare, and rights of individuals participating in research. In alignment with international guidelines such as the International Conference on Harmonization (ICH) and national laws, the IRB aims to foster an ethical research environment by ensuring that research activities respect participants and maintain scientific excellence. The IRB ensures:

• Informed consent is obtained from participants.
• Vulnerable populations are protected from undue influence or coercion.
• Compliance with all ethical, regulatory, and institutional guidelines.

Scope of Activities and Responsibilities

1. Research Jurisdiction

   
   All human research conducted at UGMC, including collaborative, multi-site, or subcontracted research involving human participants, must obtain written IRB approval. The IRB ensures:
   • Prior review and approval of all research proposals involving human subjects.
   • Oversight of multi-site research, whether UGMC is the primary or secondary IRB.
   • Establishment of reliance agreements when UGMC defers oversight to other IRBs.
   • Verification that external performance sites provide permission to engage in research activities.

2. Research Disseminations

   
   Researchers unsure whether their work qualifies as human research may submit a written request for IRB determination. Determinations are reviewed following the Expedited Review Procedures outlined in our policies. Changes to previously approved research must be resubmitted for re-evaluation. Any failure to obtain IRB approval before data collection can lead to serious compliance violations.

IRB Membership and Structure

UGMC-IRB is composed of individuals with diverse expertise, including physicians, scientists, community members, and non-scientific representatives. This diversity ensures a thorough review of research from multiple perspectives. Key features include:

• Membership Diversity: The IRB is committed to gender, cultural, and professional diversity.
• Vulnerable Populations: For research involving vulnerable groups (e.g., children, prisoners, pregnant women), the IRB engages experts familiar with those populations.
• Conflict of Interest Management: IRB members and consultants must disclose potential conflicts of interest and recuse themselves from reviews where conflicts exist.
• Consultants and Expertise: When specialized knowledge is required, the IRB invites subject-matter experts as consultants to assist with the review process.

Ethics, Compliance, and Community Engagement

The UGMC-IRB upholds the principles of openness, transparency, and ethical conduct in all its operations. It prohibits classified or restricted research and promotes the free dissemination of knowledge through open research initiatives. Additionally, it encourages researchers to submit proposals early to avoid retroactive review issues that could lead to non-compliance.

UGMC is committed to nurturing ethical research practices within the institution. IRB members attend regular training sessions to remain informed about emerging regulations and ethical challenges. This ongoing education ensures that UGMC’s research activities adhere to both national and international standards.

Commitment to Continuous Improvement

The IRB conducts regular evaluations of its members and structure to align with evolving research needs. Feedback mechanisms such as surveys and performance reviews help maintain the effectiveness and integrity of the review process. IRB members are appointed for an initial two-year term, with the possibility of reappointment based on performance and mutual agreement.

Multi-Site and Collaborative Research

The IRB actively supports collaborative research by ensuring proper coordination between multiple institutions. When UGMC is the coordinating center, the Principal Investigator (PI) must ensure that each site involved in the study has IRB approval before the research begins. For external performance sites, written permission must be obtained and provided to the IRB.

Researcher Support and Community Involvement

In addition to its regulatory role, the UGMC-IRB serves as a resource for researchers and participants. Investigators are encouraged to engage with the IRB early in their project planning to ensure smooth reviews and adherence to ethical standards. Community members also play a vital role in the IRB by offering diverse perspectives on research proposals, particularly those that may impact public welfare.

Our Commitment

Our IRB reflects the institution’s commitment to scientific excellence while upholding the highest standards of human subject protections. As an academic health center, UGMC is proud to facilitate research that not only advances knowledge but also respects the rights and well-being of participants. Our IRB strives to foster an ethical research environment that benefits both the scientific community and society at large.

For more information or to submit research proposals, please visit the UGMC IRB Office or contact us at msrc@ugmc.ug.edu.gh