Welcome to our comprehensive guide on Institutional Review Board (IRB) governance! In this article, we will provide you with an overview of IRB definition, functions, regulations, goals, and ethical principles. We’ll also discuss different IRB governance models, including centralized, local, regional, and hybrid IRBs. Further, we’ll go in-depth about the composition of IRB committees, covering membership requirements, diversity, expertise, role of alternates, and the IRB chair.
We won’t stop there! Our guide dives into IRB subcommittees, detailing specific committees tasked with privacy, data security, conflict of interest, protocol review, and protection of vulnerable populations. You’ll also learn about the IRB decision-making process, exploring review criteria, levels of review, quorum, voting requirements, and communication with researchers. Lastly, we’ll examine oversight and accountability mechanisms, such as institutional officials’ responsibilities, ongoing education, performance evaluation, external audits, and how IRBs handle noncompliance and adverse events. So, sit back and get ready to become an expert on IRB governance!
IRB Governance Structure Overview
The Institutional Review Board (IRB) is a committee established to protect the rights, welfare, and safety of human subjects involved in research. It ensures that research is conducted ethically, and is in compliance with applicable federal and institutional regulations and guidelines. This article provides an overview of the IRB’s governance structure, examining its definition, function, regulating guidelines, goals, and ethical principles.
IRB Definition and Function
An Institutional Review Board (IRB) is an independent, multidisciplinary committee tasked with the review, approval, and monitoring of research projects that involve human subjects. Its primary function is to protect research subjects’ rights, safety, and welfare, ensuring that all human subjects research conforms to ethical standards and applicable regulations.
To achieve this, the IRB evaluates research proposals to determine if they meet defined criteria, such as respect for persons, beneficence, and justice. Researchers must submit their proposed studies for IRB review and approval before initiating any work involving human subjects. The IRB also closely monitors ongoing research projects, ensuring they remain compliant during their duration.
The IRB is composed of members with diverse backgrounds, allowing for a comprehensive review of proposed research projects. This diversity allows the board to consider the cultural, social, and economic implications of research protocols. Members often include professionals from various fields, such as medicine, ethics, law, social sciences, and education, as well as community representatives who provide a lay perspective on the research proposed.
Regulations and Guidelines Governing IRB
Several regulations and guidelines govern the operation of IRBs. In the United States, the primary federal regulation is the Department of Health and Human Services (HHS) “Common Rule” (45 CFR part 46), which outlines the basic policies for the protection of human subjects in research. Additional institutional policies, state laws, and other federal regulations, such as the Food and Drug Administration (FDA) regulations for investigational drugs and devices (21 CFR parts 50 and 56), may also apply to specific research projects.
IRBs are also guided by international ethics guidelines, such as the Declaration of Helsinki, which sets forth ethical principles for research involving human subjects, and the International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines, which provide standards for designing, conducting, recording, and reporting clinical trials involving human subjects.
To ensure compliance with these regulations and guidelines, IRBs conduct initial and ongoing reviews of research projects, requiring researchers to submit detailed information about their proposed studies, including study design, recruitment methods, informed consent processes, confidentiality measures, and any risks or benefits to research subjects.
IRB Goals and Ethical Principles
The primary goal of the IRB is to protect the rights, safety, and welfare of human subjects who participate in research. This protection is achieved by ensuring that research projects adhere to three fundamental ethical principles, as outlined in the Belmont Report: respect for persons, beneficence, and justice.
Respect for persons: This principle acknowledges the autonomy of research subjects and seeks to ensure that their rights, dignity, and privacy are protected. Researchers are required to provide informed consent, allowing subjects to make a voluntary choice about their participation in the research project. Vulnerable populations, such as children, prisoners, and individuals with cognitive impairments, may require additional protections.
Beneficence: This principle involves the moral obligation to do good and minimize harm, including physical, psychological, and social risks. IRBs weigh the potential risks to research subjects against the potential benefits of the research. Researchers must design their studies so that any risks are justified by the potential benefits to society or the advancement of knowledge.
Justice: This principle mandates fair and equal distribution of benefits and burdens in research. Researchers should not unfairly target or exploit any particular population to participate in their research or be excluded from the potential benefits of research findings.
In conclusion, the IRB is a vital component of the research process, ensuring that research involving human subjects is conducted ethically and adheres to applicable regulations and principles. By carefully reviewing and monitoring research projects, IRBs play a crucial role in maintaining public trust in the research enterprise and promoting the responsible conduct of research.
IRB Governance Models
Institutional Review Boards (IRBs) are essential for ensuring ethical and regulatory compliance in conducting research involving human subjects. In the United States, Federal regulations require IRBs to monitor and approve research activities involving vulnerable populations such as children, prisoners, and pregnant women, among others. Different governance models exist for IRBs across different research institutions. This article will discuss four key models: Centralized, Local, Regional, and Hybrid IRB models.
Centralized IRB Model
The Centralized IRB model is characterized by the use of a single IRB across multiple research sites or institutions within the same organization. This centralized authority helps streamline the review process, reduces duplicative efforts, and ensures consistency in ethical oversight of research activities. In this model, one IRB acts as the primary ethical review board and other sites defer to its decisions and documentation when initiating new research projects.
Benefits of a Centralized IRB Model include increased efficiency and uniformity in the review process due to the use of standardized procedures and a centralized repository of relevant policies and guidelines. Streamlined communication can improve the resulting approval rates and reduce misunderstandings or errors resulting from inconsistent feedback. Additionally, centralized IRBs can allocate resources more effectively for the organization.
However, there are challenges inherent in the Centralized IRB Model as well. One primary concern is that a single IRB may not be sufficient to address the diverse ethical considerations that may arise from multi-site studies or research involving specialized knowledge. Further, local IRBs might still be required to provide their knowledge and expertise on local laws, regulations, customs, and research settings.
Local IRB Model
The Local IRB model involves separate IRBs functioning independently at each research institution or site. Each IRB is responsible for the ethical review and oversight of research studies within its specific organization or facility. Local IRBs provide a more tailored approach for regulatory approval and monitoring, as they are intimately familiar with the institution, its research activities, and applicable local laws.
Although the Local IRB Model allows for a more customized approach to the ethical review process, it can face challenges including fragmented and misaligned policies, lengthy decision timelines, and resource inefficiencies due to duplication of efforts among multiple IRBs. This can lead to variations in the interpretation and application of ethical principles and regulations, which may cause confusion and inefficiencies across multi-site studies.
Regional IRB Model
The Regional IRB model involves multiple institutions located within a specific geographic region joining together to create a single IRB for greater collaboration and shared resources. This model encourages the sharing of expertise, technology, and funding in order to improve overall impact and efficiency in ethical oversight.
By pooling resources and standardizing policies and procedures, the Regional IRB model offers a balance between local and centralized governance models. However, despite the potential for increased efficiency and cost-effectiveness, a challenge with this model is the need for effective coordination and communication among different organizations.
Hybrid IRB Model
The Hybrid IRB model combines elements from both Centralized and Local IRB Models. In this approach, an organization may have one central IRB providing overall guidance, standardized policies, and consistent management, while each research site retains its local IRB to handle specific ethical issues and concerns unique to the institution or research.
This model helps in maintaining consistent ethical standards, while still allowing for local IRBs to provide valuable input. The Hybrid IRB Model, however, may require significant coordination and communication among the central and local IRBs.
When determining the most appropriate IRB governance model, research institutions and organizations need to weigh the benefits and challenges of each model, considering factors such as the size of the institution, its research portfolio, geographic distribution, and available resources. Choosing the best-suited model can aid in providing a more effective and efficient ethical review process, ultimately protecting the rights and welfare of human subjects involved in research.
IRB Committee Composition
Institutional Review Boards (IRBs) play a critical role in the protection of human subjects involved in research projects. Comprised of diverse and experienced members, an IRB reviews research proposals to ensure they adhere to ethical standards and protect the rights, safety, and welfare of human subjects. In order to maintain a high level of integrity, it is essential that an IRB is composed of a diverse and knowledgeable membership.
IRB membership requirements are mandated by federal regulations. Generally, an IRB committee must have a minimum of five members, including both scientists and non-scientists. Members should be qualified to review the specific research in question, possessing knowledge of relevant fields such as medical, psychological, social, or legal aspects of the research. Additionally, the committee must include at least one individual with scientific expertise and one without, to ensure fair and unbiased reviews.
The membership should represent a variety of backgrounds and perspectives, ensuring diversity in cultural, social, and professional backgrounds, race, gender, and age. This ensures that the IRB has a diversity of ideas and experiences to draw upon when making decisions about a particular research proposal. Furthermore, at least one member of the IRB should have no direct affiliation with the institution under which the IRB operates, to ensure impartiality.
Diversity and Expertise Considerations
To ensure that an IRB committee is capable of effectively reviewing research proposals involving human subjects, it is important to consider both diversity and expertise within its membership. Diversity in terms of gender, race, age, socioeconomic background, and professional experience is crucial to ensure that a variety of perspectives are taken into account when reviewing research proposals. Diverse backgrounds can also enhance the understanding of the IRB committee about different cultural or social groups that may be affected by the research under review.
Expertise is another key consideration when selecting members of an IRB committee. Members should possess knowledge and experience across a broad range of disciplines, including the sciences, engineering, social and behavioral sciences, ethics, law, and medicine. This variety of expertise is necessary to ensure that the committee can adequately assess the ethical, scientific, and practical aspects of proposed research. Additionally, having a mix of scientific and non-scientific members help to ensure that reviews are both thorough and unbiased.
Role of Alternates
IRB committees often identify alternate members to serve on the board in the absence or unavailability of a primary member. Alternates should possess similar qualifications and expertise as their corresponding primary members and are expected to review the materials and participate in discussions and voting on issues in the same manner as primary members. The role of alternates is crucial in maintaining the continuity and efficiency of the IRB and helps ensure that there are no delays in the review and approval process due to the unavailability of primary members.
Role of IRB Chair
The IRB chair plays a critical role in guiding and overseeing the activities of the IRB committee. Typically, the chair is an experienced member of the IRB, possessing significant knowledge and understanding of research ethics and regulations. The primary responsibilities of the chair include:
- Leading and facilitating committee meetings, ensuring adherence to the agenda and fostering open and productive discussions of the research proposals under review.
- Coordinating with the IRB administrative staff to ensure timely distribution of meeting materials and overseeing the documentation of committee activities, including minutes and correspondence.
- Serving as a liaison between the IRB committee and institutional officials, communicating decisions and recommendations regarding the approval, modification, or disapproval of research proposals.
- Providing guidance and mentorship to new or less experienced members of the IRB committee, helping them develop proficiency in reviewing research proposals and understanding applicable regulations and ethical guidelines.
- Ensuring that the composition of the IRB committee meets federal regulations, and maintaining a diversity of expertise, backgrounds, and perspectives among members.
In conclusion, the composition of an IRB committee is vital to ensuring the protection of human subjects involved in research. The combination of diversity and expertise among its membership, as well as the roles of alternates and the IRB chair, ensure a sound, ethical, and unbiased review process.
IRB Subcommittees and Specializations
Institutional Review Boards (IRBs) are responsible for the oversight and conduct of human subject research. To ensure the proper functioning and expertise necessary for the diverse range of research conducted, there are several subcommittees and specialized groups within the board. Some of these subcommittees include the Privacy and Data Security Subcommittee, Conflict of Interest Subcommittee, Protocol Review Subcommittee, and Vulnerable Population Subcommittee. Each of these subcommittees has a specific area of focus and is composed of experts in that respective field.
Privacy and Data Security Subcommittee
The Privacy and Data Security Subcommittee is responsible for ensuring that research involving human subjects adheres to data privacy and confidentiality regulations, guidelines, and best practices. This includes evaluating the data collection, storage, and sharing procedures put in place by researchers and identifying potential risks or breaches of privacy.
Members of this subcommittee include individuals with expertise in areas such as data protection regulations, information technology, cybersecurity, and confidentiality laws. They work together to review and approve research protocols that involve the collection and use of sensitive or protected information and make recommendations for minimizing privacy risks to participants.
Some of the key responsibilities of this subcommittee include:
- Reviewing research protocols to ensure the privacy and confidentiality of participant data.
- Ensuring that proper informed consent includes provisions for data protection and confidentiality.
- Evaluating proposed data storage, sharing, and management practices.
- Recommending strategies to mitigate privacy risks and comply with relevant privacy regulations.
Conflict of Interest Subcommittee
The Conflict of Interest (COI) Subcommittee is tasked with identifying, managing, and mitigating any potential conflicts of interest that may arise in the conduct of human subject research. Conflicts of interest can occur when individuals involved in the research, including investigators, IRB members, or consultants, have personal or financial ties that could affect their impartiality or the integrity of the research.
Members of the COI Subcommittee possess expertise in areas such as research ethics, policy development, and financial management. They work together to review disclosures of potential conflicts of interest and recommend measures to ensure the integrity of the research process.
Some of the key responsibilities of the COI Subcommittee include:
- Assessing potential conflicts of interest reported by researchers, IRB members, and consultants.
- Developing and implementing policies to prevent, identify, and manage conflicts of interest.
- Recommending appropriate measures to mitigate or manage identified conflicts of interest.
- Providing guidance on best practices for disclosing and managing conflicts of interest in research.
Protocol Review Subcommittee
The Protocol Review Subcommittee is responsible for the preliminary review and assessment of research protocols submitted for IRB approval. The primary goal of this subcommittee is to ensure that proposed research involving human subjects meets ethical principles and regulatory guidelines.
Members of the Protocol Review Subcommittee generally have expertise in research design, methodology, and data analysis. They collaborate to evaluate research protocols, provide feedback on the design and implementation of the study, and make recommendations for improvements or revisions before the full IRB review.
Some of the key responsibilities of the Protocol Review Subcommittee include:
- Reviewing and evaluating research protocols for ethical and regulatory compliance.
- Identifying areas for improvement or revision in research design, methodology, and data analysis.
- Providing feedback and guidance to researchers on the development of research protocols.
- Recommending research protocols for approval, conditional approval, or disapproval by the full IRB.
Vulnerable Population Subcommittee
The Vulnerable Population Subcommittee is responsible for ensuring that research involving vulnerable populations, such as children, pregnant women, prisoners, or individuals with cognitive impairments, is conducted ethically and in accordance with all applicable regulations. This subcommittee focuses on ensuring that appropriate protections are in place for these populations and that the benefits of the research outweigh the potential risks.
Members of the Vulnerable Population Subcommittee typically have backgrounds in ethics, research involving vulnerable populations, and specific regulatory guidelines related to these populations. They work together to review research protocols involving vulnerable participants and recommend safeguards to protect these individuals from potential harm.
Some of the key responsibilities of the Vulnerable Population Subcommittee include:
- Reviewing research protocols involving vulnerable populations for ethical and regulatory compliance.
- Ensuring that appropriate safeguards and protections are in place for vulnerable participants.
- Assisting in the development of consent procedures and documentation for vulnerable populations.
- Recommending approval, conditional approval, or disapproval of research protocols involving vulnerable populations by the full IRB.
IRB Decision-Making Process
The Institutional Review Board (IRB) plays a pivotal role in ensuring that human subjects research is conducted ethically and in compliance with federal regulations, institutional policies, and ethical principles. The decision-making process in the IRB follows certain guidelines, principles, and structures to evaluate proposed research and make informed decisions.
The IRB reviews the research proposals based on several criteria to ensure the adequate protection of human subjects. These criteria include:
Risk-Benefit Assessment: IRB evaluates the risks to human subjects and determines whether they are minimized and reasonable in relation to anticipated benefits to the subjects and the knowledge that may reasonably be expected to result from the research. Steps should be taken to mitigate potential risks to subjects, such as implementing proper confidentiality measures for data storage and using informed consent procedures that transparently disclose risks and benefits.
Equitable Selection of Subjects: The IRB ensures that the selection process of subjects is fair and justifiable, avoiding any potential for unfair treatment or exploitation and considering the research’s purposes, target population, and recruitment methods.
Informed Consent: The IRB evaluates whether informed consent will be obtained from all subjects or their legally authorized representative before their participation in the research. The informed consent process should include adequate information about the research, possible risks and benefits, the voluntary nature of participation, and the right to withdraw at any time without penalty.
Monitoring of Data: The IRB assesses the proposed plan for monitoring data collection to ensure subjects’ safety and protection. This may involve data safety monitoring boards, interim analyses, or regular communication with research teams.
Confidentiality and Privacy: The IRB considers whether appropriate procedures are in place to protect the confidentiality and privacy of information obtained from subjects. This includes secure storage of data, anonymizing subject identifiers, and limiting access to sensitive information.
Levels of Review
Depending on the risk and complexity associated with the proposed research, the IRB may follow different levels of review:
Exempt Review: Research with minimal risks to subjects and belonging to specific categories defined by the federal regulations may be exempt from a full board review. However, some institutions may still require researchers to submit an exemption request to the IRB for confirmation.
Expedited Review: A single IRB member or designated subcommittee may review research projects that involve only minimal risks and are suitable for expedited review under federal regulations. These reviews often represent a quicker review process compared to the Full Board Review.
Full Board Review: Research that involves more than minimal risk to the subjects or does not meet the criteria for an exempt or expedited review is subjected to a full board review. It entails a thorough assessment of the research proposal by the entire IRB committee during a convened meeting.
Quorum and Voting Requirements
Quorum is defined as the minimum number of IRB members required to be present during a full board review meeting. Generally, the quorum consists of a majority of members (at least 50% of the members), as well as a non-scientific member. If a quorum is not met, decisions cannot be made on the research proposals.
Voting requirements vary across IRBs; nevertheless, most require a majority vote for the approval of a research project. Abstentions, recusals due to conflict of interest, and opposition votes may be recorded during these processes.
Communicating Decisions to Researchers
After the IRB review is completed and a decision has been made, the IRB must promptly communicate the result to the researchers. The possible decisions are:
Approval: The research has been approved, and the researcher can proceed with the study as per the proposal.
Approve with Modifications: The research can proceed only after specific modifications have been made to the proposal and resubmitted to the IRB for review and final approval.
Deferral: The research requires major modifications or additional information; the investigator should resubmit a revised proposal to the IRB.
Disapproval: The research has been rejected due to significant ethical concerns or protections; in this case, researchers may opt to appeal the decision or revise the proposal and resubmit.
Researchers are required to comply with IRB decisions, address any concerns raised, and ensure that they adhere to the approved protocol during the study.
IRB Oversight and Accountability
Institutional Review Boards (IRBs) play a crucial role in ensuring the ethical protection of human subjects and overseeing the proper conduct of research. Establishing oversight and accountability for such boards is an essential practice that aims to guarantee the quality and fidelity of research studies. This article covers institutional officials’ responsibilities, ongoing education and performance evaluation, external audits and inspections, and handling noncompliance and adverse events.
Institutional Officials’ Responsibilities
Institutional officials bear primary responsibility for determining and fostering a strong ethical environment and ensuring strict adherence to federal regulations and guidelines related to human subjects research. Specific responsibilities include, but are not limited to:
Appointing qualified members to the IRB: Institutional officials should carefully select competent and diverse members who bring varied areas of expertise, backgrounds, and perspectives to the board. This selection is essential for ensuring that the IRB’s decisions represent a diverse pool of perspectives on culturally, ethically, and scientifically valid research practices.
Overseeing and evaluating the IRB’s performance: Institutional officials must maintain rigorous oversight of the IRB’s operations, ensuring compliance with federal and institutional policies. Regular evaluation of the IRB’s performance is essential for maintaining the highest ethical standards and improving research practices over time.
Ensuring adequate resources and support: Institutional officials must provide adequate financial, administrative, and informational resources to the IRB. This support is crucial for maintaining a highly functioning board capable of effectively overseeing research involving human subjects.
Establishing written policies and procedures: Institutional officials should develop clear, written policies and procedures governing the IRB’s operations and decision-making processes. Well-defined procedures help guarantee accountability, transparency, and consistency.
Ongoing Education and Performance Evaluation
Continuous training and performance evaluation of IRB members and staff are vital for maintaining the highest research standards and ensuring compliance with federal regulations. Ongoing education should address relevant topics, such as emerging ethical dilemmas, advancements in research methods or technology, and changes to federal regulations. Performance evaluations should involve assessing board members and staff based on established criteria and performance metrics. These evaluations may lead to recommendations for improvement or the identification of areas in need of additional training.
External Audits and Inspections
External audits and inspections can play a vital role in fostering accountability and ensuring rigorous IRB oversight. Government agencies, independent organizations, or outside consultants may conduct these evaluations. External auditors may examine the IRB’s adherence to regulations, the adequacy of its policies and procedures, and the overall integrity of its review process. The findings of external audits may serve as a basis for making changes or improvements to the IRB’s policies, training, or overall operations.
Handling Noncompliance and Adverse Events
Proper handling of noncompliance and adverse events is critical to preserving the integrity of the research process and safeguarding the welfare of research participants. IRBs must establish mechanisms for reporting and addressing instances of noncompliance with approved study procedures and institutional or federal regulations. Similarly, IRBs must have processes in place for monitoring, managing, and reporting adverse events experienced by research participants, such as unforeseen complications, injuries, or misconduct.
Institutional officials, researchers, and IRB members and staff should work together to identify contributing factors to noncompliance or adverse events and to develop corrective and preventative actions. When necessary, disciplinary measures may be imposed to enforce compliance with ethical guidelines. Ultimately, the goal of handling noncompliance and adverse events should be to enhance the ethical and scientific quality of research, protect the welfare of research participants, and preserve public trust in the research enterprise.
What is the function of an Institutional Review Board (IRB) governance structure?
The IRB governance structure ensures ethical research conduct by reviewing, approving, and overseeing research involving human subjects to protect their rights, welfare, and confidentiality per regulations and guidelines.
How is an IRB structured and constituted?
An IRB typically has at least five members with diverse backgrounds, including different professions, research experience, and expertise in human subject protection, along with one member who is not affiliated with the institution (U.S. Department of Health and Human Services, 2020).
How do IRB committees ensure ethical research conduct?
IRB committees review study protocols, informed consent documents, and other materials to evaluate risks and benefits, participant selection, and confidentiality measures. They can approve, require modifications, or disapprove a proposed research study.
What types of projects are subject to IRB review?
Projects involving human subjects, including biomedical, social, and behavioral research, are subject to IRB review. This includes funded and non-funded research conducted within or outside the institution, if it falls under the institution’s purview.
How often do IRB committees meet, and what happens during a meeting?
IRB committees generally meet once a month (varies by institution), where they discuss submitted research protocols, review required documents, and take approval decisions. Some applications may undergo expedited review outside of scheduled meetings.
Can researchers appeal decisions made by their IRB committee?
Yes, researchers can request reconsideration or appeal an IRB decision, providing additional information or modifications addressing the committee’s concerns. However, the ultimate authority to approve or disapprove a study lies with the IRB.
U.S. Department of Health and Human Services. (2020). Institutional Review Board Guidebook. Retrieved from https://www.hhs.gov/ohrp/sites/default/files/ohrp-archive-IRB_guidebook.pdf