Forms and Templates

1. Informed Consent & Participant Information

Templates and guidance for developing consent forms, information sheets, and other materials used to inform participants about the research.

Expedited or Full Board Research

• Informed Consent Document Template- Full Board or Expedited
• Informed Consent Document Template - National Institute of Justice
• Short Form Consent
• Verbal Consent Script Template
• Writing Effective Consent Documents

Exempt Research

• Exempt Information Letter Template
• Interview Info Sheet – Exempt
• Focus Group Info Sheet – Exempt
• Verbal Consent Talking Points - Exempt

Survey Research

• Implied Consent for Online Surveys
• Education Survey Info Sheet Template – Exempt

Anonymous Survey Information Sheets

• Email Anonymous Survey Info Sheet – Exempt
• Online Anonymous Survey Info Sheet – Exempt
• Paper Anonymous Survey Info Sheet – Exempt

Confidential Survey Information Sheets

• Email Confidential Survey Info Sheet – Exempt
• Online Confidential Survey Info Sheet – Exempt
• Paper Confidential Survey Info Sheet – Exempt

Additional Consent & Participant Communication

• GDPR Guidance
• FERPA Guidance
• Deception and Incomplete Disclosure Guidance

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2. Research Involving Children and Assent

Templates and guidance for obtaining parental permission and assent when research involves children or participants who may require additional consent considerations.

• Parental Permission Form
• Assent – Ages 7–12 Years
• Assent – Over the Age of 13
• Verbal Assent Script for Children Ages 5–12
• Assent – Cognitively Impaired Individuals
• Guidance & Procedure - Child Assent / Permission by Parents or Guardians

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3. Recruitment and Screening

Templates, examples, and guidance for identifying, screening, and recruiting potential research participants.

Recruitment Materials

• Recruitment Flyer Guidance
• Recruitment Flyer Examples
• Recruitment Email/Letter Template

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4. Collaborative External and International Research

Forms, checklists, and guidance for research involving external organizations, research sites, collaborating institutions, or external investigators.

Reliance & Multi-Site Research

• External Collaborative Research - Guidance & Procedures (Rainbow Chart)
• SMU as IRB of Record - Reliance Process Flowchart
• Relying on an External IRB - Request Checklist
• Checklist for Using a Non-SMU Consent Form

External Sites & Investigators

• Site Authorization Letter Template
• Letter of Support Template
• Unaffiliated Individual Investigator Agreement (IIA)

International Research

• Research in International Setting Guidance
• International Compilation of Human Research Standards
• Faculty Staff Travel Registration
• Student Travel Registration

Community Partnerships

• Community-Engaged Research & Community-Based Participatory Research Guidance

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5. Modifications and Ongoing Review

Resources for making changes to an approved study and maintaining required IRB oversight.

Modifications

• Modifications to Exempt Research
• Modification for Studies Relying on an External IRB
• Modifications to Previously Approved Research Guidance

Continuing & Administrative Review

• Annual Administrative Review
• Continuing Reviews and Revised Common Rule FAQs

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6. Study Design and Special Research Topics

Guidance for common study designs, research methods, and situations that may require additional planning or consideration.

Study Design & Methods

• Inclusion and Exclusion Criteria
• Qualitative & Quantitative Research
• Artificial Intelligence (AI) Tools in HSR
• Generative Artificial Intelligence (AI) Guidance by SMU OIT
• When Your Research Meets the NIH Definition of a Clinical Trial

Common Research Activities

• Course-Based Research Experiences (CBRE)
• Oral History and Ethnography Research
• Quality Improvement and Program Evaluation
• Examples of Activities that May or May Not Require IRB Review

Funding & Research Planning

• Grant Proposals and IRB Review

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7. Privacy Confidentiality and Data Management

Guidance for protecting research information and planning how data will be collected, stored, accessed, shared, and maintained.

Privacy & Confidentiality

• Protecting Privacy and Maintaining Confidentiality
• Anonymous vs Confidential Research · PHI and PII Tip Sheet
• Certificate of Confidentiality - Tip Sheet
• GDPR Guidance
• FERPA Guidance

Data Collection & Security

• Online Survey Protections Considerations
• Data Management Resources

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8. Participant and Researcher Considerations

Guidance for research situations involving additional participant, researcher, or institutional considerations.

Participant Considerations

• Mandatory Reporting
• Research Protocols and Risk of Suicide
• Secondary Subjects
• Student Subject Pools

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9. Readability Assessment Tools

Tools to help evaluate whether consent forms, recruitment materials, and other participant-facing documents are written in clear, understandable language appropriate for your intended participants and their reading comprehension levels.

• Flesch-Kincaid Grade Level – Estimates readability as a U.S. school grade level.
• SMOG Index – Estimates reading level based on the number of polysyllabic words.
• Microsoft Word Readability – Displays readability and reading-level information for a document.
• PRISM Readability Tool Kit – Provides guidance for using plain language, improving document structure, and assessing readability.

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10. Checklists

Quick-reference tools to help you prepare your IRB submission and confirm that required information and study materials are complete.

• IRB Submission Readiness Checklist
• SMU Student Researcher Checklist
• Faculty Advisor Guidance and Checklist

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