Institutional Review Board (IRB) Protocol Template¶

Important Notice¶

This is a template for informational purposes only. All actual research protocols must be submitted to and approved by an Institutional Review Board (IRB) before any research activities involving human subjects can begin. This template provides guidance on required elements for healthcare data research protocols.

IRB Protocol Placeholder (Template)¶

Protocol Title:
Institution & IRB:
Protocol ID:
PI:
Consent Model:
HIPAA Authorization:
Data Handling: de-identification, U.S.-only storage, access tiers
Risk/Benefit, Contacts

Protocol Header Information¶

Basic Study Information¶

Protocol Title: [Full, descriptive title of the research study]
Institution & IRB: [Name of institution and specific IRB (e.g., "Golden Age Technologies IRB #001")]
Protocol ID: [Unique protocol identification number assigned by IRB]
PI: [Principal Investigator name, credentials, and contact information]
Version Date: [Date of current protocol version]
Version Number: [Sequential version number for protocol amendments]

Study Classification¶

Research Category: [e.g., Biomedical, Behavioral, Social Science]
Study Phase: [e.g., Pilot, Phase I, Phase II, Observational]
Funding Source: [Grant number, sponsor, or internal funding]
Study Duration: [Total anticipated duration of study]
Number of Subjects: [Target enrollment and justification]

Study Objectives and Background¶

Research Objectives¶

Specific, measurable objectives that the study aims to achieve:

Primary Objective: [Main research question or hypothesis]
Secondary Objectives: [Additional research questions or hypotheses]
Exploratory Objectives: [Any exploratory or hypothesis-generating aims]
Clinical Significance: [How findings will advance medical knowledge or practice]

Background and Rationale¶

Scientific justification for conducting the research:

Current Knowledge: Summary of existing research in the field
Knowledge Gaps: What questions remain unanswered
Study Rationale: Why this study is needed to address gaps
Potential Impact: How findings could improve healthcare or patient outcomes
Innovation: Novel aspects of the proposed research approach

Preliminary Studies¶

Prior research by the investigator team supporting the proposed study:

Previous Work: Description of relevant prior studies
Pilot Data: Results from preliminary or pilot studies
Experience: Team's experience with similar research
Feasibility: Evidence supporting the feasibility of the proposed approach

Study Design and Methods¶

Study Design Overview¶

Comprehensive description of the research methodology:

Design Type: [e.g., Randomized controlled trial, cohort study, case-control]
Blinding: [Single-blind, double-blind, open-label]
Control Groups: [Description of control or comparison groups]
Randomization: [Method of randomization, if applicable]
Stratification: [Stratification factors for subgroup analysis]

Subject Selection and Recruitment¶

Inclusion Criteria¶

Specific criteria that subjects must meet to participate:

Demographic Requirements: Age, gender, ethnicity requirements
Clinical Criteria: Specific medical conditions or health status
Diagnostic Criteria: Required diagnoses or test results
Treatment History: Previous treatments or procedures required
Accessibility: Ability to comply with study procedures

Exclusion Criteria¶

Criteria that would exclude potential subjects:

Medical Exclusions: Conditions that would increase risk
Medication Exclusions: Contraindicated medications or treatments
Concomitant Conditions: Other conditions affecting study validity
Participation Restrictions: Recent participation in other research
Vulnerable Populations: Special protections for vulnerable groups

Recruitment Methods¶

How subjects will be identified and recruited:

Recruitment Sources: Where potential subjects will be found
Screening Procedures: How eligibility will be determined
Informed Consent Process: How consent will be obtained
Enrollment Timeline: Schedule for subject recruitment
Retention Strategies: Methods to minimize dropout

Data Collection Procedures¶

Data Types and Sources¶

Specific data to be collected and methods of collection:

Primary Data: Data collected specifically for this study
Secondary Data: Existing data sources (EHR, registries, etc.)
Biospecimens: Collection, processing, and storage of samples
Device Data: Wearables, sensors, or other monitoring devices
Patient-Reported Outcomes: Surveys, questionnaires, or diaries

Data Collection Timeline¶

Schedule for data collection activities:

Baseline Assessment: Pre-intervention data collection
Follow-up Visits: Schedule and frequency of follow-up
Interim Assessments: Any mid-study evaluations
Final Assessment: End-of-study data collection
Long-term Follow-up: Post-study data collection if applicable

Risk/Benefit Assessment¶

Potential Risks¶

Comprehensive evaluation of possible risks to participants:

Physical Risks: Medical procedures, interventions, or treatments
Psychological Risks: Emotional or mental health impacts
Privacy Risks: Data confidentiality and re-identification concerns
Social Risks: Stigma, discrimination, or relationship impacts
Economic Risks: Financial costs or insurance implications

Risk Minimization Strategies¶

Measures to reduce or eliminate identified risks:

Safety Monitoring: Procedures for monitoring participant safety
Risk Assessment: Ongoing evaluation of risk-benefit ratio
Stopping Rules: Criteria for pausing or stopping the study
Emergency Procedures: Response plans for adverse events
Insurance Coverage: Clinical trial insurance or compensation

Anticipated Benefits¶

Expected benefits to participants and society:

Direct Benefits: Immediate benefits to study participants
Indirect Benefits: Benefits to participants' health or well-being
Societal Benefits: Advances in medical knowledge or practice
Knowledge Benefits: Contribution to scientific understanding
Future Benefits: Potential for improved treatments or diagnostics

Privacy and Data Protection¶

PHI and Data Handling¶

Comprehensive plan for protecting sensitive health information:

De-identification: Methods for removing personally identifiable information
Data Security: Encryption, access controls, and secure storage
U.S.-only Storage: Compliance with data residency requirements
Access Tiers: Different levels of data access based on need
Breach Response: Procedures for responding to data breaches

HIPAA Compliance¶

Specific measures to ensure HIPAA Privacy and Security Rule compliance:

Privacy Rule Elements:
Minimum necessary data collection
Individual authorization or waiver documentation
Accounting of disclosures
Individual access to PHI
Amendment and restriction rights
Security Rule Elements:
Administrative safeguards (policies and procedures)
Physical safeguards (facility access controls)
Technical safeguards (access control, audit controls, integrity)
Organizational requirements
Policies and documentation

Plans for sharing research data and results:

Data Sharing: Plans for sharing de-identified data with other researchers
Publication: Timeline and process for publishing study results
Presentation: Conference presentations and abstracts
ClinicalTrials.gov: Registration and results reporting requirements
Data Repository: Plans for archiving data in repositories

Type of consent to be obtained and rationale:

Informed Consent: Traditional written informed consent process
Waiver of Consent: Justification for waiver under regulatory criteria
Assent: Process for obtaining assent from minors or impaired adults
Surrogate Consent: Process for participants unable to consent
Re-Consent: When re-consent will be required for changes

Required consent documents and procedures:

Consent Form: IRB-approved consent form with all required elements
HIPAA Authorization: Separate authorization for PHI use (if applicable)
Information Sheets: Supplemental information provided to participants
Scripts: Scripts for verbal elements of consent process
Documentation: How consent process will be documented

Study Management and Oversight¶

Study Team and Responsibilities¶

Key personnel and their roles in the study:

Principal Investigator: Overall responsibility for study conduct
Co-Investigators: Scientific and clinical expertise
Study Coordinator: Day-to-day study management
Data Manager: Data collection, quality, and analysis
Safety Monitor: Independent safety monitoring (if required)

Quality Assurance and Monitoring¶

Mechanisms for ensuring study quality:

Training: Initial and ongoing training for study personnel
Standardization: Procedures to ensure consistent study conduct
Quality Control: Regular checks of data accuracy and completeness
Monitoring Plan: Internal and external monitoring procedures
Auditing: Plans for independent auditing of study conduct

Data and Safety Monitoring¶

Procedures for monitoring participant safety:

Safety Monitoring Plan: How adverse events will be detected and managed
DSMB/DSMC: Data Safety Monitoring Board or Committee (if required)
Interim Analyses: Plans for interim data analysis and stopping rules
Adverse Event Reporting: Timeline and process for reporting adverse events
Unanticipated Problems: Process for handling unexpected issues

Statistical Analysis Plan¶

Analysis Populations¶

Definition of analysis populations:

Intent-to-Treat: All randomized subjects analyzed as assigned
Per-Protocol: Subjects who completed study as planned
Safety Population: All subjects who received intervention
Modified ITT: ITT with minor modifications for practical reasons

Sample Size and Power¶

Statistical justification for sample size:

Primary Endpoint: Main outcome measure for sample size calculation
Effect Size: Expected difference between groups
Statistical Power: Probability of detecting true effect
Significance Level: Alpha level for hypothesis testing
Dropout Rate: Expected attrition and impact on power

Analysis Methods¶

Statistical methods for analyzing study data:

Primary Analysis: Method for analyzing primary endpoint
Secondary Analyses: Methods for secondary endpoints
Subgroup Analyses: Pre-specified subgroup comparisons
Interim Analyses: Methods for interim data review
Missing Data: Approach for handling missing data points

Regulatory and Ethical Considerations¶

Regulatory Compliance¶

Compliance with applicable regulations:

IRB Oversight: Ongoing IRB review and approval
FDA Regulations: If applicable, compliance with FDA requirements
HIPAA: Privacy and security rule compliance
State Laws: Compliance with state-specific research requirements
International Standards: If applicable, Declaration of Helsinki compliance

Ethical Considerations¶

Ethical principles guiding the research:

Respect for Persons: Protection of autonomy and vulnerable populations
Beneficence: Maximizing benefits and minimizing harms
Justice: Fair distribution of research benefits and burdens
Scientific Validity: Ensuring study design supports valid conclusions
Social Value: Ensuring research addresses important health needs

Conflict of Interest¶

Disclosure and management of potential conflicts:

Financial Interests: Funding sources and financial relationships
Intellectual Property: Patents or other intellectual property interests
Institutional Conflicts: Institutional relationships that might influence study
Management Plan: How conflicts will be managed or eliminated
Disclosure: How conflicts will be disclosed to participants and public

Study Timeline and Milestones¶

Study Timeline¶

Major phases and milestones of the study:

Planning Phase: Protocol development, IRB submission, site preparation
Start-up Phase: Staff training, system setup, first subject enrollment
Implementation Phase: Subject recruitment, data collection, follow-up
Analysis Phase: Data cleaning, analysis, interpretation
Dissemination Phase: Publication, presentation, data sharing

Enrollment Projections¶

Anticipated enrollment over time:

Month 1-3: Initial site activation and first subjects
Month 4-6: Steady enrollment ramp-up
Month 7-12: Peak enrollment period
Month 13-18: Enrollment completion and follow-up
Month 19+: Final analysis and reporting

References and Literature Review¶

Key References¶

Literature supporting the study rationale and methods:

Background References: Studies establishing current knowledge
Methodological References: Studies using similar methods
Pilot Studies: Preliminary work supporting the approach
Regulatory References: Guidelines and regulations followed
Statistical References: Methods and software references

Literature Search Strategy¶

How relevant literature was identified:

Databases Searched: PubMed, Embase, Cochrane, etc.
Search Terms: Keywords and MeSH terms used
Inclusion Criteria: Criteria for including studies in review
Exclusion Criteria: Criteria for excluding studies
Search Dates: Date range of literature search

Budget and Resources¶

Study Budget¶

Financial resources required for study conduct:

Personnel Costs: Salary support for study team
Equipment: Devices, software, or other equipment needed
Supplies: Consumables, test kits, or other materials
Facilities: Space, utilities, or facility costs
Participant Costs: Recruitment, compensation, or travel reimbursement

Resource Requirements¶

Non-financial resources needed:

Personnel: Number and types of staff required
Facilities: Clinical space, laboratory space, or office space
Equipment: Computers, devices, or specialized equipment
Software: Statistical software, database systems, or other tools
Support Services: IT support, statistical consultation, or other services

Protocol Amendments and Modifications¶

Amendment Procedures¶

Process for making protocol changes:

Minor Amendments: Changes that don't affect risk-benefit ratio
Major Amendments: Changes requiring full IRB re-review
Administrative Changes: Updates to contact information or formatting
Safety Amendments: Changes required for participant safety
Regulatory Amendments: Changes required by new regulations

Amendment Documentation¶

How amendments will be documented and communicated:

Version Control: Sequential numbering of protocol versions
Change Summary: Description of what changed and why
Impact Assessment: Evaluation of amendment impact on study
Participant Notification: When participants need to be informed
IRB Notification: Timeline for notifying IRB of changes

Protocol Template Sections¶

Required Protocol Elements (per 45 CFR 46.111)¶

Risks to subjects are minimized
Risks are reasonable in relation to benefits
Subject selection is equitable
Informed consent is adequate
Informed consent is documented
Data monitoring for safety
Privacy and confidentiality protections
Additional safeguards for vulnerable subjects

Additional Recommended Elements¶

Data sharing and dissemination plans
Plans for data analysis and interpretation
Quality assurance and monitoring procedures
Study timeline and milestones
Budget and resource requirements
Protocol amendment procedures

IRB Submission Requirements¶

Required Documents¶

Documents that must be submitted with protocol:

Protocol Document: Complete study protocol
Consent Forms: All consent and HIPAA authorization forms
Recruitment Materials: Advertisements, flyers, or other materials
Data Collection Forms: Case report forms or data collection tools
Investigator Qualifications: CVs and training documentation
Site Information: Information about study sites
Budget: Detailed study budget
Conflict of Interest: Disclosure forms for all investigators

Submission Process¶

Steps for IRB submission and review:

Pre-Submission: Complete all required documents and forms
Administrative Review: Initial review for completeness
Full Board Review: Presentation to convened IRB
Expedited Review: If qualifies for expedited review process
Continuing Review: Annual or periodic review requirements
Amendments: Process for submitting protocol changes

Special Considerations for Healthcare Data Research¶

Electronic Health Records (EHR) Research¶

For studies using EHR data:

EHR Access: Process for accessing and extracting EHR data
Data Quality: Assessment of EHR data quality and completeness
Patient Identification: Methods for identifying eligible patients
Data Linkage: If linking multiple data sources
Query Development: Development of EHR queries for data extraction

Multi-Site Studies¶

For research involving multiple institutions:

Central IRB: Use of central or single IRB for multi-site studies
Site-Specific Requirements: Additional requirements for each site
Coordination: Process for coordinating across sites
Data Aggregation: Methods for combining data from multiple sites
Site Monitoring: Oversight of individual site performance

Longitudinal Studies¶

For studies collecting data over extended periods:

Follow-up Methods: How participants will be contacted over time
Retention Strategies: Methods to minimize participant dropout
Data Management: Handling of data collected over long periods
Interim Analyses: Plans for analyzing data during study conduct
Adaptation: How study might be modified based on interim findings

Protocol Development Resources¶

Regulatory Guidance¶

Internal Resources¶

Golden Age Technologies IRB Policies and Procedures
Research Ethics and Compliance Office
Clinical Research Coordinator Training Materials
Data Governance and Security Guidelines

Professional Organizations¶

This IRB protocol template provides comprehensive guidance for developing research protocols involving human subjects and healthcare data. All protocols must be reviewed and approved by an Institutional Review Board before implementation.

Last Updated: 9/28/2025 Version: 1.0.0