10.4 Institutional Review Board (IRB) processes

Institutional Review Boards (IRBs) are vital in Communication Research Methods. They ensure ethical standards and participant safety in human subjects research, balancing scientific progress with individual rights protection. IRBs act as gatekeepers, reviewing study designs and methods.

IRBs protect human subjects, uphold ethical research standards, and ensure regulatory compliance. Their diverse composition includes scientific and non-scientific members, bringing varied expertise to evaluate research proposals. Different review types exist based on risk levels, from exempt to full board review.

Purpose of IRB

• Institutional Review Boards (IRBs) play a crucial role in Communication Research Methods by ensuring ethical standards and participant safety in human subjects research
• IRBs serve as gatekeepers for research integrity, balancing scientific advancement with the protection of individual rights and welfare

Protection of human subjects

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• Safeguards participants from physical, psychological, or social harm during research studies
• Ensures vulnerable populations (children, prisoners, mentally impaired) receive additional protections
• Monitors potential risks and benefits to research subjects throughout the study process
• Requires researchers to implement safety protocols and reporting mechanisms for adverse events

Ethical research standards

• Upholds principles of respect for persons, beneficence, and justice in research design and execution
• Evaluates studies for adherence to ethical guidelines (Belmont Report, Declaration of Helsinki)
• Ensures fair selection of research participants and equitable distribution of benefits and risks
• Promotes scientific integrity by reviewing methodologies and data collection procedures

Regulatory compliance

• Enforces federal regulations governing human subjects research (45 CFR 46, 21 CFR 50, 21 CFR 56)
• Ensures institutional policies align with national and international research ethics standards
• Maintains documentation of review processes and decisions for auditing purposes
• Provides guidance to researchers on navigating complex regulatory requirements

IRB composition

• IRB composition directly impacts the quality and breadth of research review in Communication Research Methods
• Diverse IRB membership ensures comprehensive evaluation of ethical considerations across various disciplines and methodologies

Board member roles

• Chair leads meetings, facilitates discussions, and serves as primary point of contact
• Vice Chair assists the Chair and assumes leadership in their absence
• Scientific members evaluate research methodologies and potential risks/benefits
• Non-scientific members represent community interests and assess consent processes
• Unaffiliated members provide external perspectives free from institutional bias
• Prisoner representative (when applicable) advocates for incarcerated research subjects

Expertise requirements

• At least one member with scientific expertise relevant to the research being reviewed
• Inclusion of members with knowledge of applicable laws and regulations
• Representation from various disciplines (psychology, sociology, anthropology) for diverse perspectives
• Expertise in vulnerable populations when reviewing studies involving these groups
• Members trained in ethical principles and regulatory requirements for human subjects research

Diversity considerations

• Gender balance to ensure representation of different viewpoints
• Racial and ethnic diversity to address cultural sensitivities in research
• Age diversity to consider generational perspectives on research ethics
• Inclusion of members with disabilities to advocate for accessibility in research
• Representation from various socioeconomic backgrounds for broader community insight

Types of IRB review

• Understanding different IRB review types is essential for Communication Research Methods to determine appropriate levels of scrutiny for various study designs
• Review categories are based on the level of risk to participants and the nature of the research being conducted

Exempt review

• Applies to minimal risk studies that fall within specific federal exemption categories
• Conducted by IRB staff or designated reviewers rather than full board
• Includes research on normal educational practices or publicly available data
• May involve analysis of existing data sets with de-identified information
• Typically results in faster approval times compared to other review types

Expedited review

• Utilized for minimal risk studies that do not qualify for exemption
• Conducted by IRB Chair or designated experienced reviewers
• Includes research involving collection of data through non-invasive procedures
• May cover studies using surveys, interviews, or focus groups on non-sensitive topics
• Allows for quicker review process while still ensuring ethical standards are met

Full board review

• Required for studies involving greater than minimal risk to participants
• Conducted during convened meetings with quorum of IRB members present
• Includes research on sensitive topics, vulnerable populations, or invasive procedures
• May involve studies using deception or withholding information from participants
• Allows for thorough discussion and deliberation among diverse board members

IRB application process

• The IRB application process is a critical component of Communication Research Methods, ensuring thorough evaluation of proposed studies
• Familiarity with application requirements and timelines helps researchers plan effectively and avoid delays in study initiation

Required documentation

• Completed IRB application form detailing study purpose, methods, and participant safeguards
• Research protocol outlining step-by-step procedures and data analysis plans
• Informed consent documents and recruitment materials for participant enrollment
• Data collection instruments (surveys, interview guides, observation protocols)
• Curriculum vitae of principal investigator and key personnel
• Conflict of interest disclosures for all researchers involved in the study

Protocol submission

• Electronic submission through institutional IRB management system
• Initial screening by IRB staff for completeness and assignment to appropriate review type
• Preliminary review by IRB Chair or designated reviewer for potential issues
• Distribution of materials to full board members for studies requiring convened review
• Opportunity for researchers to respond to initial queries or concerns before formal review

Review timelines

• Exempt review typically completed within 1-2 weeks of submission
• Expedited review generally takes 2-4 weeks for initial determination
• Full board review may require 4-8 weeks due to meeting schedules and potential revisions
• Conditional approvals may extend timelines pending researcher responses to IRB concerns
• Researchers should factor in review timelines when planning study start dates and grant deadlines

Informed consent

• Informed consent is a cornerstone of ethical research in Communication Research Methods, ensuring participants understand study procedures and potential risks
• Proper consent processes protect both participants and researchers by establishing clear expectations and agreements

Elements of consent forms

• Clear explanation of study purpose, duration, and procedures
• Description of potential risks, benefits, and alternatives to participation
• Statement of voluntary participation and right to withdraw at any time
• Information on confidentiality measures and limits to confidentiality
• Contact details for researchers and IRB for questions or concerns
• Language appropriate to the target population's reading level and cultural background

Waiver of consent

• Granted when research involves no more than minimal risk to participants
• Applicable when study could not practicably be carried out without the waiver
• Used in studies involving deception where full disclosure would compromise research validity
• May be appropriate for secondary data analysis of existing records or specimens
• Requires strong justification and alternative participant protection measures

Assent for minors

• Required in addition to parental consent for research involving children
• Tailored to the child's age and cognitive abilities to ensure comprehension
• May involve simplified language, pictures, or interactive explanations
• Respects the child's right to refuse participation even with parental consent
• Ongoing process throughout the study to ensure continued willingness to participate

Risk assessment

• Risk assessment is integral to Communication Research Methods for evaluating potential harm to participants and determining appropriate review levels
• Careful consideration of risks and benefits helps researchers design studies that maximize scientific value while minimizing participant exposure to harm

Minimal risk vs greater risk

• Minimal risk defined as probability and magnitude of harm not greater than everyday life
• Greater risk involves potential for physical, psychological, or social harm beyond normal experience
• Consideration of both short-term and long-term risks to participants
• Evaluation of risk level impacts IRB review type and required safeguards
• Examples of minimal risk (online surveys on non-sensitive topics) vs greater risk (interviews about traumatic experiences)

Risk-benefit analysis

• Weighing potential benefits to participants, science, and society against risks to subjects
• Consideration of direct benefits to participants vs broader societal or scientific gains
• Evaluation of whether risks are reasonable in relation to anticipated benefits
• Assessment of whether risks have been minimized through study design and procedures
• Determination if alternative procedures could achieve similar results with less risk

Vulnerable populations

• Identification of groups requiring additional protections (children, prisoners, pregnant women)
• Consideration of cognitive, physical, or situational factors affecting vulnerability
• Evaluation of capacity to provide informed consent or need for surrogate decision-makers
• Implementation of extra safeguards to prevent coercion or undue influence
• Justification for inclusion of vulnerable populations if they are the focus of the research

Confidentiality and privacy

• Protecting participant confidentiality and privacy is crucial in Communication Research Methods to maintain trust and ethical standards
• Robust data protection measures safeguard sensitive information and prevent potential harm from breaches

Data protection measures

• Use of secure, password-protected databases for electronic data storage
• Encryption of files containing identifiable participant information
• Physical security measures for paper records (locked cabinets, restricted access areas)
• De-identification or coding of data to separate identifying information from research data
• Secure data transfer protocols when sharing information between researchers or institutions

Anonymity vs confidentiality

• Anonymity involves collecting no identifying information from participants
• Confidentiality requires protecting identifiable information from unauthorized access
• Consideration of whether true anonymity is achievable in qualitative research designs
• Implementation of pseudonyms or aggregate reporting to maintain confidentiality
• Clear communication to participants about limits of confidentiality (mandatory reporting)

HIPAA compliance

• Adherence to Health Insurance Portability and Accountability Act for health-related research
• Implementation of physical, technical, and administrative safeguards for protected health information
• Use of HIPAA-compliant tools and platforms for data collection and storage
• Obtaining authorization for use of protected health information or meeting waiver criteria
• Training of research staff on HIPAA requirements and breach reporting procedures

Ongoing IRB oversight

• Continuous IRB oversight ensures ethical conduct throughout the research process in Communication Research Methods
• Regular monitoring and reporting mechanisms help identify and address emerging ethical issues or protocol deviations

Continuing review requirements

• Annual (or more frequent) review of ongoing studies to assess continued ethical acceptability
• Submission of progress reports detailing participant enrollment, withdrawals, and adverse events
• Review of any new findings that might affect participants' willingness to continue
• Evaluation of whether risks/benefits have changed since initial approval
• Determination if study still meets criteria for current review category (exempt, expedited, full board)

Reporting adverse events

• Prompt notification to IRB of any unanticipated problems involving risks to subjects
• Documentation of adverse events, including severity, relatedness to research, and outcomes
• Implementation of corrective actions to prevent recurrence of similar incidents
• Assessment of whether adverse events necessitate changes to protocol or consent forms
• Communication of significant new findings to current and past participants when appropriate

Protocol amendments

• Submission of proposed changes to research procedures for IRB review before implementation
• Evaluation of whether amendments alter the risk-benefit profile of the study
• Determination if changes require re-consent from current participants
• Assessment of impact on data already collected and analysis plans
• Review of revised recruitment materials or consent forms for accuracy and completeness

International research considerations

• International research in Communication Research Methods introduces unique ethical challenges and regulatory complexities
• Understanding cultural differences and local requirements is essential for conducting ethical and compliant global studies

Cultural sensitivity

• Adaptation of research methods and materials to respect local customs and values
• Consideration of cultural taboos or sensitive topics that may require special handling
• Collaboration with local researchers or community leaders to ensure cultural appropriateness
• Translation and back-translation of study materials to ensure accuracy and cultural relevance
• Recognition of power dynamics between Western researchers and local participants

Local ethics committees

• Identification of appropriate local ethics review boards or committees
• Navigation of dual review processes (home institution IRB and local ethics committee)
• Adherence to both U.S. and host country regulations for human subjects protection
• Reconciliation of potential conflicts between different ethical standards or requirements
• Establishment of communication channels between home IRB and local ethics committees

Regulatory differences

• Familiarization with host country laws governing research conduct and data protection
• Compliance with varying definitions of "minimal risk" or vulnerable populations across countries
• Navigation of different consent requirements (verbal vs written) in diverse cultural contexts
• Adherence to international guidelines (Declaration of Helsinki, CIOMS) for ethical research
• Consideration of data ownership and sharing restrictions in international collaborations

Common IRB challenges

• Awareness of common IRB challenges helps Communication Research Methods practitioners anticipate and address potential ethical issues
• Proactive consideration of these challenges can streamline the review process and improve study designs

Recruitment issues

• Balancing scientific needs with ethical concerns in targeted recruitment strategies
• Addressing potential coercion or undue influence in participant compensation
• Ensuring equitable selection of participants across diverse populations
• Navigating recruitment in closed systems (schools, prisons) without compromising voluntariness
• Developing culturally appropriate recruitment materials for diverse communities

Deception in research

• Justification for use of deception when no alternative methods are feasible
• Development of debriefing procedures to mitigate potential harm from deception
• Consideration of staged consent processes for studies involving temporary concealment
• Balancing scientific validity with respect for participant autonomy in deceptive designs
• Addressing potential distress or loss of trust resulting from use of deception

Secondary data use

• Determining whether secondary analysis requires new IRB review or falls under existing approvals
• Ensuring proper consent was obtained for future use of data in original studies
• Addressing privacy concerns when linking multiple data sets
• Navigating restrictions on data sharing or use imposed by original researchers or institutions
• Considering potential for re-identification of participants in large data sets

IRB decision outcomes

• Understanding potential IRB decision outcomes is crucial for Communication Research Methods practitioners to navigate the review process effectively
• Familiarity with decision types helps researchers prepare for possible revisions or appeals

Approval vs rejection

• Approval granted when study meets all ethical and regulatory requirements
• Rejection occurs if risks outweigh benefits or ethical concerns cannot be adequately addressed
• Consideration of approval with conditions requiring minor revisions before study initiation
• Differentiation between outright rejection and requests for major revisions and resubmission
• Impact of approval or rejection on research timelines and funding considerations

Conditional approval

• Granted when minor changes or clarifications are needed before full approval
• May involve revisions to consent forms, recruitment materials, or data collection procedures
• Typically allows researchers to begin some study activities while addressing IRB concerns
• Requires timely response to IRB stipulations to maintain approval status
• Conversion to full approval upon satisfactory completion of required changes

Appeal process

• Available for researchers who disagree with IRB decisions or believe review was flawed
• Involves submission of written appeal detailing reasons for disagreement with IRB determination
• May require presentation of additional evidence or expert opinions to support appeal
• Consideration by IRB leadership or designated appeal committee for final decision
• Potential outcomes include upholding original decision, modifying requirements, or granting approval