IRB Templates and Sample Documents

Template Letters

Letter to Investigator with Prisoner Participants
Training Compliance Statement - Medical Center (submit to NIH when appropriate)
Training Compliance Statement - University (submit to NIH when appropriate)

Sample Protocols and Guidelines

Behavioral and Social Sciences Sample Protocol
Biomedical/Health Sciences Sample Protocol
FDA Protocol Development Guidelines
NCI/CTEP Protocol Templates and Guidelines
NINDS Protocol Template for Definitive/Efficacy (Phase III) Trials

Template Language

  Adverse Event/Immediate Necesssary Care Language
  Adverse Event/Immediate Necessary Care Langugage - DoD
  Albumin Language
  Allergic Reaction Language (optional)
  Anti-Nausea Medication for Chemotherapy
  Blood Collection Language
  Bronchoscopy Language
  Chemotherapy Language
  Conflict of Interest Disclosure Language
  Conscious Sedation Language
  Continuing Review with Summary of Outside Safety Reports (OSR)
  Dissent Procedure Language
  Dose Escalation Language
  Drug Interaction Language
  Expected Costs (Cancer Trials) Language
  fMRI Procedure Language
  Genetic Screening "Rider" Language
  High Risk Language
  HIV Language
  Lidocaine Use Language
  Monoclonal Humanized Antibody Language
  MRI Procedure Language
  Non-Paternity DNA Testing Language
  Potential Research Cost Language
  Pregnancy Language - Adults (Female/Male)
  Pregnancy Language - Minors 12-17 (Female/Male)
  Privacy Language for Adults, Parents, and Legal Guardians
  Privacy and Confidentiality Language for Minors
  Reimbursement for Research Participation Language (including compensation greater than $600)
  Risks of Radiological Procedures Language
  Withdrawal Language



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Contact the IRB | Last modified: February 08, 2008