Advances in Medical Ethics
Open Access

Role of Institutional Review Boards in Upholding Clinical Trial Ethics

Byung Zhang^{* *}Correspondence: Byung Zhang, Department of Neurosurgery, Catholic University of Korea, Seoul, South Korea, Email:

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Description

Institutional Review Boards (IRBs) are pivotal to the ethical conduct of clinical research, ensuring that studies involving human participants are designed and implemented with the utmost respect for participants' rights, welfare, and dignity. The essential role of IRBs in clinical trials, their functions, the ethical principles they uphold, and the challenges they face.

Institutional review boards

IRBs are independent committees established to review and oversee research involving human subjects. Their primary purpose is to protect the rights and welfare of participants by ensuring that ethical standards are met throughout the research process. IRBs are mandated by regulatory bodies in many countries, including the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), which set forth guidelines for their operation.

Functions

IRBs evaluate research protocols to determine whether the proposed study is ethically sound. This includes assessing the study's design, potential risks, benefits, and the methods used to obtain informed consent from participants. One of the IRB’s important responsibilities is to ensure that researchers provide potential participants with clear, comprehensive information about the study. This includes the purpose, procedures, risks, benefits, and their right to withdraw from the study at any time. mIRBs are responsible for ongoing oversight of approved studies, ensuring that any changes to the research protocol are reviewed and that participant safety is continuously prioritized. This may involve regular progress reports and audits. IRBs assess whether the potential benefits of the research justify any risks to participants. They consider the likelihood and severity of risks in relation to the anticipated benefits, both to participants and to society.

This principle emphasizes the importance of acknowledging the autonomy of individuals and protecting those with diminished autonomy. IRBs evaluate whether studies are designed to achieve this balance effectively. IRBs assess risks associated with the research and ensure that appropriate measures are in place to protect participants. The principle of justice relates to fairness in the selection of research participants and the distribution of research benefits and burdens.

Challenges

As clinical research becomes increasingly complex, IRBs may struggle to thoroughly review and understand intricate study designs, especially those involving advanced technologies or novel interventions. Many IRBs operate with limited staff and funding, which can hinder their ability to conduct thorough reviews and provide timely feedback to researchers. Researchers may seek faster approvals, potentially compromising ethical oversight. IRBs must stay informed about evolving regulations and guidelines, which can be a significant challenge given the dynamic nature of clinical research ethics.

Practices for effective IRB functioning

IRB members should engage in ongoing education regarding ethical principles, regulatory changes, and emerging issues in clinical research to stay current and informed. Implementing efficient review processes, such as expedited reviews for low-risk studies, can help balance the need for timely approvals with ethical oversight. Encouraging open communication and collaboration between IRBs and researchers can lead to better understanding and implementation of ethical guidelines, ultimately enhancing the quality of the research. Adopting electronic submission and review systems can streamline the IRB process, making it more efficient and accessible for researchers while maintaining rigorous oversight.

Conclusion

Institutional Review Boards (IRB) play an important role in upholding the ethical standards of clinical trials, safeguarding the rights and welfare of research participants. By reviewing research proposals, ensuring informed consent, and monitoring ongoing studies, IRBs help navigate the ethical complexities of clinical research. While challenges remain, the commitment to ethical principles such as respect for persons, beneficence, nonmaleficence, and justice remains central to the mission of IRBs.