10.2 Institutional review boards and research ethics committees

Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) are crucial safeguards in public health research. They review study protocols, ensuring participant safety and ethical standards are met. These committees have the power to approve, modify, or reject research proposals.

IRBs and RECs are made up of diverse experts, including scientists and community members. They carefully assess the risks and benefits of proposed studies, paying special attention to vulnerable populations. Their goal is to balance scientific progress with protecting human subjects in research.

IRB and REC Responsibilities

Ensuring Participant Protection

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  Why Human Subjects Research Protection Is Important | Ochsner Journal View original

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• IRBs and RECs are independent committees established to review and monitor biomedical and behavioral research involving human subjects
• The primary responsibility of IRBs and RECs is to ensure that the rights, safety, and well-being of research participants are protected
• IRBs and RECs review research protocols, informed consent documents, and other study materials to assess the ethical acceptability of the research
• IRBs and RECs conduct continuing review of ongoing research studies to ensure continued adherence to ethical standards and participant protection

Authority and Decision-Making

• IRBs and RECs have the authority to approve, require modifications to, or disapprove research protocols based on their ethical assessment
• IRBs and RECs also have the authority to suspend or terminate research that is not being conducted in accordance with ethical guidelines or that poses unacceptable risks to participants

IRB and REC Composition and Functioning

Member Selection and Diversity

• IRBs and RECs are composed of a diverse group of individuals with varying backgrounds, including scientific, non-scientific, and community members
• IRBs and RECs must have at least five members, with at least one member whose primary concerns are in scientific areas and one member whose primary concerns are in nonscientific areas
• IRBs and RECs must also include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution
• IRB and REC members are selected based on their expertise, experience, and ability to provide unbiased and objective review of research protocols

Training and Decision-Making Processes

• IRB and REC members receive training on the ethical principles and regulations governing human subjects research, as well as the specific policies and procedures of their institution
• IRBs and RECs typically meet regularly to review research protocols and make decisions based on a majority vote of the members present
• IRBs and RECs may also use expedited review procedures for certain types of minimal risk research, where the review is carried out by the IRB or REC chairperson or by one or more experienced reviewers designated by the chairperson

Research Requiring IRB or REC Review

Types of Research Subject to Review

• Research involving human subjects, including studies that collect data through intervention or interaction with individuals or that use identifiable private information, generally requires IRB or REC review and approval
• Clinical trials, which are research studies that test the safety and effectiveness of new medical treatments, drugs, or devices in human participants (vaccine trials, drug efficacy studies), always require IRB or REC review and approval
• Social and behavioral research, such as surveys, interviews, or observations of human behavior, may also require IRB or REC review if the research involves the collection of sensitive or identifiable information

Special Considerations for Vulnerable Populations

• Research involving vulnerable populations, such as children, prisoners, pregnant women, or individuals with mental disabilities, requires special consideration by IRBs and RECs to ensure adequate protections are in place
• Research that is exempt from IRB or REC review includes studies that do not involve human subjects, studies that use only publicly available data (census data, public health statistics), and certain types of educational research

Effectiveness of IRBs and RECs

Consistent Application of Ethical Principles

• IRBs and RECs play a critical role in ensuring that public health research is conducted in an ethical manner and that the rights and welfare of research participants are protected
• The effectiveness of IRBs and RECs can be evaluated based on their ability to consistently apply ethical principles and regulations to the review of research protocols
• IRBs and RECs should have clear policies and procedures in place for reviewing research and should document their decision-making processes to ensure transparency and accountability

Quality of Review and Oversight

• The quality of IRB and REC review can be assessed by examining the thoroughness and consistency of their review of research protocols, informed consent documents, and other study materials
• The effectiveness of IRBs and RECs can also be evaluated based on their ability to identify and address potential ethical issues or concerns in research protocols and to work with researchers to develop appropriate safeguards or modifications
• Regular audits or assessments of IRB and REC performance can help identify areas for improvement and ensure that they are meeting their responsibilities for overseeing the ethical conduct of research

Ongoing Education and Training

• Ongoing education and training for IRB and REC members can help ensure that they have the knowledge and skills necessary to effectively review and oversee public health research