IRB vs. EC for Clinical Trials: Understanding the Differences

For drug development clinical trials, ensuring the ethical conduct and protection of human subjects is of utmost importance. To achieve this, two key entities play pivotal roles: the Institutional Review Board (IRB) and the Ethics Committee (EC). While both are responsible for reviewing and overseeing clinical trials, there are notable differences between them. In this article, I describe some of the dissimilarities between an IRB and an EC, shedding light on their respective functions and responsibilities.

The Institutional Review Board (IRB)

An Institutional Review Board (IRB) is a committee established within an academic, healthcare, or research institution. Its primary function is to safeguard the rights, welfare, and well-being of human subjects involved in clinical trials conducted within that institution. The IRB acts as an independent body, ensuring that the research complies with ethical principles, regulatory requirements, and institutional policies.

Key Responsibilities of an IRB:

1. Ethical Review: The IRB is responsible for reviewing the research protocol and associated documents to assess the study's ethical implications, including potential risks and benefits to participants.

   
   

2. Informed Consent: The IRB ensures that the process of obtaining informed consent from study participants is appropriate and adequately informs them about the study's objectives, procedures, potential risks, and benefits.

   
   

3. Ongoing Oversight: Throughout the course of the trial, the IRB conducts periodic reviews to monitor the study's progress and participant safety, and it has the authority to suspend or terminate the trial if necessary.

   
   

4. Protocol Amendments: Any changes to the research protocol must be submitted to the IRB for approval before implementation.

The Ethics Committee (EC)

The Ethics Committee (EC) is an independent body responsible for reviewing and approving clinical trials' ethical aspects. Unlike the IRB, which is usually institution-specific, the EC often operates at a national or regional level, overseeing multiple institutions or research sites. The EC ensures that research involving human subjects adheres to ethical guidelines and international standards.

Key Responsibilities of an Ethics Committee:

1. Multidisciplinary Review: The EC typically comprises members from various disciplines, including healthcare professionals, researchers, legal experts, and laypersons, to provide a balanced and comprehensive evaluation of the research protocol.

   
   

2. Cross-Institutional Oversight: The EC oversees clinical trials conducted in multiple institutions or research sites, ensuring consistency in ethical review and adherence to ethical principles.

   
   

3. Risk-Benefit Assessment: The EC evaluates the potential risks and benefits of the research to ensure that the well-being of study participants is adequately protected.

   
   

4. Independent Decision-making: EC decisions are independent of any undue influence from the researchers or the institution, promoting unbiased ethical review.

Distinguishing Factors: IRB vs. EC and what is a Central IRB?

1. Scope: The IRB primarily operates within a specific institution, while the EC's purview extends beyond one institution, overseeing multiple research sites. An exception to this is a "Central IRB" A central IRB (or CIRB) is an independent review board that reviews research involving human subjects that is conducted at multiple institutions. A regular IRB, on the other hand, is an independent review board that reviews research involving human subjects that is conducted at a single institution. So a CIRB is more similar to and EC from a multi-institutional oversight perspective.

   CIRBs are typically used for multi-site clinical trials, where the same research protocol is being conducted at multiple institutions. This can help to streamline the review process and ensure that the research is conducted in a consistent and ethical manner.

   There are a few key differences between CIRBs and regular IRBs. First, CIRBs typically have more experience reviewing multi-site clinical trials. Second, CIRBs may have access to more resources, such as specialized expertise and technical support. Third, CIRBs may be able to review research more quickly than regular IRBs.

   Composition: The IRB typically comprises members from the institution where the research is conducted, whereas the EC often includes external experts from various fields.

   
   

2. Level of Review: IRB focuses on the ethical review of individual research projects, whereas the EC may take a broader approach, ensuring compliance with ethical guidelines across multiple studies.

In conclusion, both the Institutional Review Board (IRB) and the Ethics Committee (EC) are crucial components of the ethical framework surrounding clinical trials. While the IRB operates at the institutional level, overseeing the ethical aspects of individual studies, the EC often functions at a broader level, ensuring consistent and comprehensive ethical oversight across multiple institutions or research sites. By understanding the distinct roles and responsibilities of each entity, researchers, institutions, and regulators can collaboratively ensure the ethical conduct of clinical trials and the protection of human subjects involved in medical research.