IRB Toolkit

Request for IRB Determination of Non-human Research

IRB Application Package

Checklist

• Applicant Checklist
• IRB Naming Convention for Full Board Electronic Submissions

Application Forms

• Clinical Trial (See Application Guidelines)
• Archival/Retrospective Data (See Application Guidelines)
• Minimal Risk Studies
• Humanitarian Use Device
• Emergency Use of an Investigational Drug or Device 
• Anonymous Surveys

Abstract Templates

• Template for Convened (Full) Board Protocols
• Template for Expedited or Exempt Protocols 

Recruitment & Consent Forms

• Telephone Recruitment Script
• California Experimental Subject Bill of Rights (Required if study meets the state definition of "medical experiment.")
  • English
  • Spanish
  • Other Translations
• Consent Templates
  • (See Guidance for developing the Informed Consent Document)
  • (See Lay Terms for Preparing Consent Documents)
  • Clinical Trials
  • Minimal Risk Studies
  • Anonymous Survey
  • Genetic Research
• Assent Templates (for minors)
  • Blood Draw
  • Bone Marrow
  • Oncology Treatment
• Authorization for Use of Protected Health Information (HIPAA)
  • Adult [Standard][Dependency Treatment]
  • Minors [Standard][Dependency Treatment]
• Authorization for Case Studies
• Waiver of Consent

Protocol

• Sample Protocol Outline
• NIH-FDA Clinical Trial Protocol (See Guidelines)
  • NIH-FDA Clinical Trial Protocol (Word)
  • Electronic Protocol Writing Tool (Web-based)

Maintaining Your IRB Record (Requires use of a log-in name and password. For assistance, call x44531.)

• View Status of Your Research Projects
  Change Request Forms
  • Protocol/Consent Changes (Needs log-in name/password)
  • Protocol/Consent Changes (Word)
  • Study Personnel Changes (Word) (To be printed for submission)
• Adverse Event/Unanticipated Problem Reporting
• Protocol Violation Report Form (To be printed for submission)
  • Examples of Serious or Minor Protocol Violations
  • Minor Protocol Violation Log
• Renewals/Closures (To be printed for submission)

Topical Toolkits

Behavioral/Social Research

• IRB Application for Social/Behavioral Research
• Consent Template for Minimal Risk Studies

Retrospective/Archival Data

• IRB Application Form for Archival/Retrospective Data
• Application Guidelines

Related tips:

• Deception (Research involving)
• Observational Studies
• Public Officials (Involvement of) as Subjects In Research
• Questionnaires, Surveys, Interviews (Research involving)
• School Permission (Research involving)
• Social & Behavioral Research (Program Director's Role)
• Subject Inclusion Risk & Suicidal Ideation Language
• Doctorate in Nursing Practice