14.2 Institutional Review Boards and research ethics committees
4 min read•august 9, 2024
Ethical considerations in nursing research are crucial for protecting participants and maintaining integrity. Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) play a vital role in this process, evaluating research proposals to ensure ethical conduct and participant safety.
These review boards assess potential risks and benefits, procedures, and subject selection. They also monitor ongoing research, investigate adverse events, and provide guidance to researchers on ethical practices. Their oversight helps maintain high ethical standards in nursing research.
IRB and REC Overview
Purpose and Function of Review Boards
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- evaluates research proposals involving human subjects to ensure ethical conduct and participant protection
- assesses ethical implications of research studies, particularly in medical and social science fields
- Both IRB and REC aim to safeguard rights, safety, and well-being of research participants
- Review boards balance potential benefits of research against risks to subjects
- Ensure compliance with federal regulations and institutional policies governing human subject research
IRB Composition and Structure
- IRB consists of at least five members with diverse backgrounds and expertise
- Includes scientists, non-scientists, and community representatives to provide varied perspectives
- At least one member must have no affiliation with the institution conducting the research
- Members possess qualifications through experience and expertise in scientific and non-scientific areas
- IRB may invite individuals with competence in special areas to assist in review of complex issues
- Membership reflects diversity in race, gender, cultural backgrounds, and sensitivity to community attitudes
Key Responsibilities of IRBs and RECs
- Review research protocols for ethical considerations and scientific merit
- Assess informed consent procedures and documentation
- Evaluate potential risks and benefits to research participants
- Ensure equitable selection of research subjects
- Monitor ongoing research for adherence to approved protocols
- Investigate and address any reported adverse events or violations
- Provide guidance and education to researchers on ethical conduct in human subject research
- Maintain records of all review activities and decisions
Types of IRB Review
Full Board Review Process
- Conducted for research involving more than minimal risk to participants
- Requires a quorum of IRB members present at a convened meeting
- Involves thorough discussion and evaluation of all aspects of the research protocol
- May request modifications or clarifications from researchers before approval
- Decisions made by majority vote of present members
- applies to studies involving vulnerable populations (children, prisoners, pregnant women)
Expedited Review Procedures
- Utilized for research posing no more than minimal risk to participants
- Conducted by IRB or designated experienced IRB members
- Applies to specific categories of research defined by federal regulations
- Includes review of minor changes to previously approved research
- Expedited reviewers may exercise all authorities of the IRB except disapproval
- Faster review process compared to full board review (typically 2-4 weeks)
Exempt Research Categories
- Certain types of research may be exempt from IRB review
- Includes educational research, surveys, interviews, and observation of public behavior
- Analysis of existing data, documents, or specimens if publicly available or de-identified
- Taste and food quality evaluation studies
- Exemption determination made by IRB or designated institutional official
- Researchers must still adhere to ethical principles and institutional policies
- Exempt status does not equate to absence of ethical considerations
Ongoing IRB Responsibilities
Continuing Review and Oversight
- IRB conducts periodic review of approved research, typically annually
- Assesses progress of study, any changes in risk-benefit ratio, and adherence to protocol
- Reviews any adverse events or unanticipated problems reported by researchers
- Evaluates adequacy of informed consent process and participant protection measures
- May require more frequent review for high-risk studies or vulnerable populations
- Continuing review ensures ongoing ethical conduct throughout the research lifecycle
Protocol Amendments and Modifications
- Researchers must submit proposed changes to approved protocols for IRB review
- Minor changes may undergo process
- Significant modifications require full board review and approval before implementation
- IRB assesses impact of changes on risk-benefit ratio and participant protection
- Ensures proposed modifications align with original study objectives and ethical standards
- May require re-consent of participants if changes significantly alter study procedures or risks
Addressing Non-Compliance and Adverse Events
- IRB investigates reports of protocol violations or non-compliance with approved procedures
- Reviews and assesses severity of adverse events or unexpected problems involving risks to participants
- May suspend or terminate research activities if necessary to protect participant safety
- Implements corrective actions and additional safeguards as needed
- Reports serious or continuing non-compliance to institutional officials and regulatory agencies
- Provides guidance to researchers on preventing future incidents and improving study conduct
Key Terms to Review (19)
Anonymity: Anonymity refers to the state of being unnamed or unidentified in a given context, allowing individuals to participate without revealing their identity. This concept is crucial in research as it protects participants' privacy and encourages honest responses, especially when sensitive information is involved. Maintaining anonymity can help researchers gather more reliable data while safeguarding the rights and dignity of participants.
Autonomy: Autonomy is the right of individuals to make their own choices and decisions regarding their personal lives and healthcare. It emphasizes respect for a person's ability to govern themselves, which is crucial in ensuring that patients participate actively in their care, including decision-making processes about treatments and interventions.
Belmont Report: The Belmont Report is a foundational document that outlines ethical principles and guidelines for research involving human subjects. It emphasizes the importance of respect for persons, beneficence, and justice, which guide the conduct of research and protect participants. This report plays a critical role in shaping the practices of Institutional Review Boards and ensuring informed consent is obtained while addressing ethical issues in research involving vulnerable populations.
Beneficence: Beneficence is the ethical principle that emphasizes the moral obligation to act for the benefit of others, promoting good and preventing harm. In healthcare, it guides professionals to prioritize patient welfare, fostering an environment where patient needs and well-being take precedence over other interests.
Chairperson: A chairperson is an individual appointed to preside over a meeting, committee, or organization, responsible for ensuring that discussions are orderly and productive. In the context of Institutional Review Boards and research ethics committees, the chairperson plays a vital role in guiding ethical oversight and decision-making regarding research proposals involving human subjects.
Clinical trials: Clinical trials are research studies that involve people and are designed to test new medical interventions, such as drugs, treatments, or devices, to determine their safety and effectiveness. They play a crucial role in advancing medical knowledge and practice, providing evidence-based data that informs patient care and healthcare policies.
Common rule: The common rule refers to a set of federal regulations that govern the ethical conduct of research involving human subjects in the United States. It establishes fundamental principles for the protection of participants, including requirements for Institutional Review Boards (IRBs), informed consent, and safeguards for vulnerable populations. This rule is essential in ensuring that research is conducted ethically and responsibly, fostering trust between researchers and the communities they study.
Confidentiality: Confidentiality refers to the ethical and legal obligation to protect the privacy of patients by ensuring that their personal health information is kept secure and shared only with authorized individuals. This principle is crucial in fostering trust between healthcare providers and patients, which ultimately supports effective treatment and care.
Data fabrication: Data fabrication refers to the unethical practice of inventing, altering, or falsifying data in research. This misconduct undermines the integrity of research findings and can lead to harmful consequences in various fields, especially in healthcare where evidence-based practices rely on accurate data. Data fabrication not only discredits the work of the researcher but also poses significant risks to public trust and safety.
Expedited review: Expedited review is a process used by Institutional Review Boards (IRBs) to evaluate research proposals that involve minimal risk to participants, allowing for a faster approval timeline than standard reviews. This approach is essential for facilitating timely research while still ensuring the protection of human subjects, particularly in situations where delays might hinder important advancements or timely interventions.
Full Board Review: A full board review refers to the comprehensive examination and evaluation of research proposals involving human subjects by an Institutional Review Board (IRB) during a convened meeting where a quorum of members is present. This type of review is required for studies that present greater than minimal risk to participants, ensuring thorough scrutiny and adherence to ethical standards before research can proceed. It is essential in maintaining the integrity of the research process and protecting the rights and welfare of participants.
Informed Consent: Informed consent is the process by which a patient voluntarily agrees to a proposed medical treatment or intervention after being fully informed of its risks, benefits, and alternatives. This concept is crucial in promoting patient autonomy and ensuring that individuals have the right to make educated decisions regarding their healthcare.
Institutional Review Board (IRB): An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects, ensuring that the rights and welfare of participants are protected. The IRB plays a critical role in maintaining ethical standards in research by reviewing study proposals, assessing risks and benefits, and ensuring informed consent is obtained from participants, thereby safeguarding patient rights and promoting the integrity of nursing research.
Justice: Justice in healthcare refers to the ethical principle that emphasizes fairness and equity in the distribution of benefits and burdens among individuals and communities. It highlights the importance of treating individuals impartially and ensuring that everyone has access to necessary resources and opportunities, particularly in nursing and research contexts.
Protocol: A protocol is a formal set of rules and guidelines that dictate how research should be conducted, ensuring consistency, safety, and ethical standards. These guidelines are crucial for researchers to follow when designing studies, particularly those involving human participants, as they help protect the rights and welfare of subjects while also maintaining scientific integrity.
Qualitative research: Qualitative research is a method of inquiry that seeks to understand human behavior, experiences, and social phenomena through non-numerical data, such as interviews, focus groups, and observations. This approach emphasizes the meanings individuals assign to their experiences, allowing for deeper insights into complex issues.
Research coordinator: A research coordinator is a professional responsible for overseeing and managing the day-to-day operations of clinical trials or research studies. This role involves ensuring compliance with regulatory requirements, coordinating communication between various stakeholders, and maintaining accurate documentation throughout the research process, all while prioritizing participant safety and ethical standards.
Research ethics committee (rec): A research ethics committee (REC) is a group that reviews research proposals to ensure that ethical standards are met, protecting the rights and welfare of research participants. RECs play a critical role in overseeing the ethical aspects of research, ensuring compliance with regulations and guidelines, and providing an essential safeguard for participants by evaluating the potential risks and benefits of studies.
Research misconduct: Research misconduct refers to unethical behavior in the conduct of research, including fabrication, falsification, and plagiarism. This serious issue undermines the integrity of scientific inquiry and can lead to significant consequences for researchers, institutions, and the public's trust in research outcomes.