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, informed consent 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

• Institutional Review Board (IRB) evaluates research proposals involving human subjects to ensure ethical conduct and participant protection
• Research Ethics Committee (REC) 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 protocol 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
• Full board review 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 chairperson 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 expedited review 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