Coeus @ Purdue

• Application to Use Human Research Subjects (FUTUR: Non-Exempt Protocol Application Form)
• Exemption Request – Category 1
• Exemption Request – Category 2 & 3b
• Exemption Request – Category  4
• Exemption Request – Category 6b

• Research Participant Consent Form (Participant & Parental)
• Sample Assent Form
• Assent Scripts
• Authorization for Research or Use of Protected Health Information for Research Purposes
• Information Sheet

• Appendix A – Data Repositories
• Appendix B – Deception Form
• Appendix C – Use of Devices in Research
• Appendix D – Use of Drugs or Biologics in Research
• Appendix E – Storage, Collection, and Use of Biological Materials (Repository)
• Appendix F – Children in Research
• Appendix G – International Research
• Appendix H – Pregnant Women/Fetuses /Neonates
• Appendix I  - Prisoners
• Appendix J1 – Waiver or Alteration of Consent
• Appendix J2 – Waiver of Documentation of Signed Consent
• Appendix K – Request for IRB Waiver of HIPAA Authorization
• Certification of Compliance with HIPAA Privacy Rule for Research Involving Decedent’s Information Only
• Activities Preparatory to Research – Request for Waiver of Authorization

Recruitment Materials

(INVESTIGATOR GENERATED)

•  
  • Advertisements
  • Flyers
  • Letters
  • Scripts
  • Emails

Correspondences

(INVESTIGATOR GENERATED)

• All Email Communications
• All Written Communications

Study Instruments/Surveys/Questionnaires

(INVESTIGATOR GENERATED)

• Study Instruments
• Surveys
• Questionnaires

• Unanticipated Problems Form (INTERIM ONLY)
• Protocol Amendment (INTERIM ONLY)
• Grant Proposal