Institutional review board

What Is an Institutional Review Board?

An institutional review board (IRB) is a committee formally designated to review, approve, and provide continuing oversight for research involving human subjects research. Its primary purpose within the broader category of regulatory compliance is to protect the rights and welfare of human participants. The IRB ensures that research is conducted ethically and in accordance with federal regulations, institutional policies, and ethical guidelines. This includes evaluating the potential risks and benefits of a study, ensuring adequate informed consent, and safeguarding participant privacy and confidentiality.

History and Origin

The concept of independent review of research involving human subjects gained prominence in the mid-20th century following revelations of unethical experimentation. Landmark events, such as the Nuremberg Trials after World War II and the Tuskegee Syphilis Study in the United States, underscored the critical need for robust protections. The Nuremberg Code of 1947 was an early attempt to establish ethical principles for human experimentation, emphasizing the voluntary consent of participants²², ²³.

In the U.S., the Public Health Service began requiring ethical review of federally funded research in 1966. This policy was expanded over the subsequent years, leading to the formal introduction of the term "institutional review board" in regulations published in 1974²¹. The National Research Act of 1974 further solidified this framework by establishing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research¹⁹, ²⁰. This commission produced the influential Belmont Report in 1979, which outlined three core ethical principles for research involving human subjects: respect for persons, beneficence, and justice. The Belmont Report serves as a foundational document for current IRB practices¹⁶, ¹⁷, ¹⁸. These principles were later integrated into updated U.S. regulations, notably the "Common Rule," which was codified in 1991 and adopted by numerous federal agencies¹⁴, ¹⁵.

Key Takeaways

• An institutional review board (IRB) reviews research involving human subjects to protect their rights and welfare.
• IRBs assess research protocols for ethical soundness, focusing on minimizing risks and maximizing benefits.
• Compliance with IRB requirements is mandated by federal regulations for most human subjects research in the United States.
• The board ensures that participants provide voluntary and adequately informed consent.
• IRBs play a crucial role in maintaining scientific integrity and public trust in research.

Formula and Calculation

The function of an institutional review board does not involve a mathematical formula or calculation. Instead, an IRB employs a qualitative assessment based on established ethical principles and regulatory requirements to evaluate research proposals.

Interpreting the Institutional Review Board

An IRB's interpretation centers on whether a proposed study adequately protects human participants. This involves a thorough examination of several factors. The board evaluates the potential physical, psychological, social, and economic risk management to participants, ensuring these risks are minimized to the greatest extent possible and are reasonable in relation to the anticipated benefits to the individual participants or to society¹², ¹³. The IRB scrutinizes the data collection methods, participant recruitment processes, and the measures for ensuring data security and anonymity. Furthermore, the IRB determines if the informed consent process is comprehensive, understandable, and truly voluntary, allowing potential participants to make autonomous decisions about their involvement.

Hypothetical Example

Consider a university psychology department proposing a study on decision-making under stress. The researchers plan to bring participants into a lab, administer a series of timed cognitive tasks, and monitor physiological responses. Before recruiting any participants, the researchers must submit a detailed research protocol to their institution's IRB.

The IRB would review the protocol to ensure ethical standards are met. They would assess if the stress induction method is minimal risk, whether the debriefing process adequately addresses any psychological discomfort, and if the informed consent document clearly explains all procedures, potential risks, and the right to withdraw without penalty. For instance, if the initial proposal involved deception that could cause significant distress, the IRB might require modifications, such as a different experimental design or a more extensive post-study debriefing, to mitigate potential harm and ensure participant welfare.

Practical Applications

Institutional review boards are integral to the ethical conduct of various types of research involving human subjects. They are prominently featured in:

• Clinical trials: For drug development, medical devices, and other health interventions, IRBs review study designs to ensure patient safety and ethical treatment. The U.S. Food and Drug Administration (FDA) has specific regulations that govern IRBs and their oversight of clinical investigations, emphasizing protections for human subjects and informed consent¹⁰, ¹¹.
• Academic Research: Universities and academic institutions across disciplines, including social sciences, humanities, and biomedical sciences, rely on IRBs to vet studies conducted by faculty and students. This applies to fields ranging from social science research studying human behavior to epidemiological studies in public health.
• Government-funded Research: Any research project receiving federal funding in the U.S. is subject to IRB review under regulations like the Common Rule, ensuring consistent ethical standards across diverse research endeavors⁸, ⁹.

Limitations and Criticisms

While institutional review boards are essential for protecting research participants, they face several criticisms. Some researchers and scholars argue that IRBs can sometimes impose excessive bureaucratic burdens, leading to delays and increased costs for studies without always providing a clear increase in participant protection⁶, ⁷. Concerns have been raised about inconsistencies in IRB review, where similar protocols might receive different decisions from different boards, or even the same board at different times⁵.

Critics also point to a perceived "mission creep," where the responsibilities of IRBs have expanded beyond their initial scope, sometimes leading to an overemphasis on institutional liability rather than solely on human subject welfare³, ⁴. Some academic critiques suggest that the current IRB system, despite conscientious efforts by its members, operates with a flawed approach to risk management, focusing on suppressing all risk rather than distinguishing between pure risks (to be avoided) and opportunity risks (which might be necessary for scientific advancement)². These limitations highlight ongoing discussions about potential reforms to streamline the IRB process while maintaining robust ethical oversight.

Institutional Review Board vs. Informed Consent

An institutional review board (IRB) and informed consent are distinct but interdependent components of ethical research involving human subjects.

The IRB's role is to ensure that the process of obtaining informed consent is ethically sound and compliant with regulations. It reviews the consent forms and procedures to verify that all necessary information is provided to potential participants in an understandable manner, and that participants are free from coercion or undue influence. Without IRB approval, research cannot proceed, meaning the informed consent process cannot legitimately begin.

FAQs

What types of research require IRB review?

Generally, any research involving living individuals as subjects, where the investigator obtains data through intervention or interaction with the individual, or obtains identifiable private information, requires institutional review board (IRB) approval. This includes, but is not limited to, clinical trials, surveys, interviews, and behavioral experiments.

Who typically sits on an institutional review board?

An IRB is usually composed of a diverse group of individuals, including scientists, non-scientists, and community members. This ensures a broad range of perspectives, enabling comprehensive ethical review. Members often have expertise in relevant research areas, ethical considerations, and applicable regulations.

Can an IRB disapprove a study?

Yes, an institutional review board has the authority to approve, require modifications in, or disapprove all research protocols under its jurisdiction. If a study is deemed to pose unacceptable risks to participants, or if it fails to meet ethical and regulatory standards, the IRB will disapprove it until necessary changes are made.

What is the "Common Rule" in relation to IRBs?

The "Common Rule" is the informal name for the Federal Policy for the Protection of Human Subjects. It is a set of regulations adopted by numerous U.S. federal agencies that outlines the basic provisions for institutional review boards, informed consent, and other assurances of compliance for federally funded human subjects research. It provides a standardized framework for ethical oversight across various institutions and disciplines.¹