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
  Dissent Procedure Language
NEW
11/4/2009
Dose Escalation Language
  Drug Interaction 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
  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
  "Sticky" Pads Used During ECG/EEG
  Suicidal Ideation Language
  Synthetic Derivative Language
  Withdrawal Language



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Contact the IRB | Last modified: November 04, 2009