UMCIRB Forms and Documents

ECU’s UMCIRB provides forms and documents to help researchers along their research journey. Please contact the UMCIRB if you have any questions about the following materials.

Consent and Assent Document Templates

• Greater than Minimal Risk Research Consent Template (Word)
  
• Minimal Risk Research Consent Template (Word)
  
• Concise Summary of Consent Examples (PDF)
• Assent Template for Children 12-17 Years of Age (Word)
• Parent Permission Template: Minimal Risk Research (Word)
• Genetic Testing Consent Template (Word)
• Consent Letter Template for Expedited Survey Research (Word)
• Consent Template for Benign Behavioral Interventions (Word) (For use in Exempt Category No. 3)
• Consent Paragraph Template for Exempt Survey Research (Word)
• Short Form Consent for English Speaking Participants (English Version) (Word)
• Short Form Consent for non-English Speaking Participants (Spanish Version) (Word)
• Guidelines to Waive Consent for Emergency Research (Word)
• Language for Use in a Sponsor’s Consent Template (Word)
  
• Local Boilerplate Language for NCI-CIRB Approved Informed Consents Only (Word)
• Local Boilerplate Language for NCI_CIRB Approved Informed Consents Only – Spanish Version (Word)
• Local Boilerplate Language for NCI-CIRB Approved Youth Information Sheets (Assents) (Word)
• Disclosure Statement to Collect, Use, and Disclose Social Security Numbers for Tax Reporting Obligations (Word)
• Compensation for Injury Language for More than Minimal Risk Human Research (Spanish version) (Word)
• NIH supported or conducted studies: Optional sample language for storage and sharing discussions within the informed consent document (PDF)

Biomedical Forms

• Financial Services Summary for Clinical Trials (PDF)
• Service Review Form (Excel)
• Clinical Trial Participant List (Excel)
• Protocol Template (PDF)
• Attending Physician Signature Form (Word)
• ECU Ancillary Approver Contact List (PDF)

HIPAA Forms

• HIPAA Identifiers (PDF)
• HIPAA Authorization Template (Word)
• HIPAA Authorization Template – Spanish Version (Word)
  
• HIPAA Authorization Template – Future Research – English Version (Word)
  
• HIPAA Authorization Template – Future Research – Spanish Version (Word)
• Parent HIPAA Authorization for Minor Participants (Word)
• Application for Waiver or Alteration of HIPAA Authorization (PDF)
• Application for Waiver or Alteration of HIPAA Authorization (Word)
• Research on Decedents Information Form (Word)
• Request for Preparatory Review of PHI (Word)
• ECU Health Care Components (PDF)
• Vidant Health Care Components (PDF)
• Storing Research Data (PDF)

IRB Member Reviewer Tools

• How to Review a New IRB Protocol (PDF)
• Member Education Material (PDF)
• Criteria for Approval (PDF)
• Elements of Consent (PDF)
• Documentation for Children as Research Participant (Word)
• Placebo Documentation (Word)
• Medical Device Documentation (Word)
• Genetic Testing Reviewer Checklist (Word)

General Forms and Worksheets

• Worksheet: Unanticipated Problem Determination (PDF)
• ECU Individual Investigator Agreement (Word)
• Vidant Medical Center Investigator Agreement (Word)
• Individual Investigator Agreement Instructions (PDF)
• Worksheet: Case Reports Using Existing Data (Word)
• Human Research Determination Worksheet (Word)
• Emergency Use of a Test Article Worksheet (Word)
• Site Permission Letter Template (Word)

College of Education Forms

• Pitt County Schools Research Requests Process (PDF)
• Letter to Parents (Word) (for the exempt category of educational research)
• Letter to Teachers (Word)
• Letter to Principals (Word)
• Verbal Assent Script (Word)

Protocol Template