Use the forms, templates, checklists, and guidance below when preparing your IRB submission and supporting study materials. These resources can help you develop study documents, prepare for submission, and ensure your materials are consistent with IRB requirements.
Forms and Templates
ON THIS PAGE
01. Informed Consent & Participant Information
02. Research Involving Children & Assent
03. Recruitment & Screening
04. Collaborative, External & International Research
05. Modifications & Ongoing Review
06. Study Design & Special Research Topics
07. Privacy, Confidentiality & Data Management
08. Participant & Researcher Considerations
09. Checklists
10. Readability Assessment Tools
01. 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
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
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02. Research Involving Children & 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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03. Recruitment & Screening
Templates, examples, and guidance for identifying, screening, and recruiting potential research participants.
Recruitment Materials
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04. Collaborative, External & 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
- Faculty Staff Travel Registration
- Student Travel Registration
Community Partnerships
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05. Modifications & 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
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06. Study Design & 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
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07. Privacy, Confidentiality & 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
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08. Participant & Researcher Considerations
Guidance for research situations involving additional participant, researcher, or institutional considerations.
Participant Considerations
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10. 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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09. 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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