This section establishes the foundational identity of your research protocol. Accurate completion ensures proper registration, communication channels, and institutional accountability throughout the review process and study lifecycle.
Principal Investigator Full Name
Principal Investigator Academic Title
Department or Division
Institution or University Name
Principal Investigator Email Address
Principal Investigator Phone Number
Principal Investigator Credentials and Qualifications
Co-Investigators and Research Team Members
Full Name | Role in Study | Institution | Email Address | Relevant Qualifications | |
|---|---|---|---|---|---|
Study Protocol Title
Protocol Version Number
Protocol Date
Anticipated Study Start Date
Anticipated Study Completion Date
Study Type Classification
Observational Study
Interventional Study
Survey or Questionnaire
Secondary Data Analysis
Systematic Review or Meta-Analysis
Qualitative Research
Other
Research Design Methodology
Cross-sectional
Longitudinal or Cohort
Case-control
Randomized Controlled Trial
Quasi-experimental
Descriptive
Mixed-methods
Other
Primary Research Objective
Secondary Research Objectives
Study Hypotheses
Funding Source
Internal Institutional Grant
External Government or Public Agency
External Private Foundation
Industry or Commercial Sponsorship
Unfunded Student or Faculty Project
Other
Grant or Award Number
Is this a multi-site study involving more than one institution or location?
Has this protocol been previously reviewed or approved by any IRB or ethics committee?
Regulatory Classification
Not Regulated
Medical Device Study
Drug or Biologic Trial
Clinical Investigation
Other Regulated Research
Ethical recruitment is fundamental to research integrity. This section evaluates your participant sourcing strategies, eligibility criteria, and special protections for vulnerable populations. Transparent recruitment practices prevent coercion and ensure voluntary participation.
Target Sample Size
Sample Size Justification and Statistical Rationale
Recruitment Strategies and Methods
Institutional email listservs
Social media platforms
Printed posters or flyers
In-person classroom or event recruitment
Clinical database or registry
Community organization partnerships
Snowball or peer referral sampling
Direct mail or postal invitation
Other recruitment method
Recruitment Locations and Settings
Inclusion Criteria
Exclusion Criteria
Age Range of Target Participants
Adults only (18 years and older)
Minors only (under 18 years)
Mixed age groups (including minors and adults)
All ages (including children and elderly)
Will your study involve any vulnerable or special population groups requiring additional protections?
Will participants be recruited from the same institution where the Principal Investigator is employed or holds authority?
Will participants receive compensation, reimbursement, or incentives?
Do you believe the compensation could be considered coercive or undue inducement?
Have all recruitment materials (flyers, emails, scripts) been reviewed for accuracy and non-coercive language?
Informed consent is the cornerstone of ethical research with human participants. This section documents your consent procedures, data handling practices, and privacy protections. Robust anonymization and clear consent processes demonstrate respect for participant autonomy and welfare.
Describe the Informed Consent Process
Consent Form Language
English only
Multiple languages (translated)
Local or indigenous language
Other language arrangement
Will written informed consent be obtained from all participants?
If minors are involved, will assent be obtained from the minor participants?
Will parental permission be obtained for minor participants?
Will any audio, video, or photographic recordings be made of participants?
Data Collection Methods
Online surveys or questionnaires
In-person interviews
Focus group discussions
Physical measurements or examinations
Biological sample collection
Analysis of existing records or data
Photographs or video recordings
Digital or mobile tracking
Other data collection method
Will data be anonymized such that individual participants cannot be identified, directly or through identifiers linked to them?
Data Storage Location and Infrastructure
Institutional secure encrypted server
Commercial encrypted cloud storage
Physical locked storage (paper records)
Hybrid digital and physical storage
Other storage arrangement
Data Security and Protection Measures
Encryption at rest (stored data)
Encryption in transit (transmission)
Password protection and access control
Two-factor authentication
Access logging and audit trails
Physical security for hardware
Regular security audits and updates
Other security measure
Data Retention Period
1 year after study completion
3 years after study completion
5 years after study completion
7 years after study completion
10 or more years
As required by institutional policy
Indefinite retention for future research
Data Destruction or Disposition Method
Secure digital deletion and physical shredding
De-identification and transfer to repository
Return to participants
Transfer to sponsor
Other disposition method
Confidentiality Level of Collected Data
Completely anonymous (no identifiers ever collected)
Confidential (identifiers kept but protected)
Potentially identifiable (risk of indirect identification)
Directly identifiable (clear personal identifiers)
Re-identification Risk Assessment
Have you obtained or will you obtain a Certificate of Confidentiality or equivalent legal protective instrument?
Will data be shared with other researchers or deposited in a repository?
A thorough risk assessment is essential for IRB determination. This section requires you to systematically evaluate all potential harms—physical, psychological, social, and digital—and demonstrate that risks are minimized and reasonable in relation to anticipated benefits. Low-risk studies must still document comprehensive mitigation strategies.
Overall Risk Level Classification
Minimal risk (no greater than everyday life)
Low risk (slightly above minimal, with standard protections)
Moderate risk (requires enhanced monitoring and mitigation)
Greater than moderate risk (may not qualify for fast-track)
Are there any physical risks or discomforts to participants?
Are there any psychological, emotional, or social risks to participants?
Are there any digital, technological, or cybersecurity risks?
Risk-Benefit Analysis and Justification
Adverse Event Reporting Plan
Data Breach Response and Notification Plan
Study Monitoring and Quality Assurance Plan
Emergency Contact Information and Procedures
Will a Data Safety Monitoring Board (DSMB) or independent monitor be used?
Are there clear procedures for participant withdrawal or study termination?
Will participants receive individual or aggregate study results?
This final section ensures regulatory compliance and facilitates IRB review. Accurate declarations and complete documentation accelerate the approval process. The Principal Investigator attests to the truthfulness and completeness of the submission.
IRB Review Category Requested
Exempt from full IRB review (lowest risk)
Expedited review (minor increase over minimal risk)
Full board review (requires convened meeting)
If requesting Exempt status, select applicable category:
Educational research in normal settings
Survey, interview, or observation of adults
Observation of public behavior
Secondary analysis of existing data
Taste and food quality evaluation
Other exempt category
If requesting Expedited status, select applicable category:
Clinical data collection (non-invasive)
Blood samples from healthy adults
Biological specimens (non-invasive)
Voice or video recordings
Research on groups or organizations
Surveys or interviews with sensitive topics
Other expedited category
Do you or any research team member have any potential conflict of interest related to this study?
Are there any financial conflicts of interest (e.g., equity, patents, consulting fees)?
Institutional Approvals Required Beyond IRB
Department Head or Chair approval
Dean or Faculty approval
Hospital or Clinical Director approval
Government or Regulatory Agency approval
Community Gatekeeper permission
No additional approvals required
Other approval
Have all required institutional approvals been obtained?
Additional Documentation Submitted with this Application
Principal Investigator's current CV
All Co-Investigators' CVs
Final recruitment materials
Consent form(s) and assent form(s)
Data collection instruments (surveys, interview guides)
Site permission letters or agreements
Funding proposal or grant application
Data sharing agreements
Other supporting documents
I attest that all information provided in this application is truthful, accurate, and complete to the best of my knowledge. I understand that any misrepresentation may result in protocol suspension or revocation of IRB approval.
I confirm that I will conduct this study in accordance with all applicable ethical principles, institutional policies, and international guidelines for research involving human participants.
I agree to submit continuing review reports as required, report any adverse events or protocol deviations promptly, and obtain IRB approval for any modifications before implementation.
Principal Investigator Signature
Date of Submission
Additional Comments for IRB Chair or Reviewers