Nova Southeastern University

• Home
• Introduction & History
• Research Responsibilities
• IRB Process
• Schedule of Meetings
• Membership
• Forms & Policies and Procedures
• Adverse Events / Unanticipated Problems
• Research with Human Subject Links
• CITI Training
• Online Center/College Protocol Log
• Sponsored Programs

"The IRB works with investigators from across the university to protect the individuals who participate in research conducted by members of the NSU community."

Note: Forms are available in Microsoft Word format, so they can be downloaded, completed, saved and printed as necessary.

• Preparing and Submitting Proposals to the IRB
• Tips for Completing the Submission Form for Initial Review

Submission Forms

Initial Review

• New Protocol Form (Submission Form for Initial Review)
• New Protocol Form (Submission Form for Initial Review)

Amendment

• Submission Form for Amendment of IRB Approved Studies
• Submission Form for Amendment of IRB Approved Studies

Continuing Review

• Submission Form for Continuing Review of IRB Approved Studies
• Submission Form for Continuing Review of IRB Approved Studies

Closing Report

• Closing Report Form
• Closing Report Form

Informed Consent

• Consent Form Checklist
• Consent Form Checklist
• Consent Instructions
• Consent Instructions
• Assent Instructions
• Assent Instructions
• Readability Instructions
• Readability Instructions

Consent and Assent Forms

Note: For adult and parent consent forms the IRB is providing two versions for each form. You may select which version you would like to use. The bold title containing a version number at the top of each model and template is intended to provide information as to the nature of the form. The actual form you create should NOT contain the bolded title and should begin with either “Consent Form for Participation. . .” or “Assent Form for Participation. . ” Letterhead: Principal investigators should contact their center/college representative to receive letterhead for the consent and assent forms. A list of center/college representatives is available here (http://www.nova.edu/irb/membership.html).

• Document Template for Adult/General Consent Form
• Document Model for Adult/General Consent Form (Readability Score: Grade 6)
  
  
• Document Template for Child Assent Form
• Document Model for Child Assent Form (Readability Score: Grade 3)
  
  
• Document Template for Adolescent Assent Form
• Document Model for Adolescent Assent Form (Readability Score: Grade 5)
  
  
• Document Template for Parent or Guardian Consent Form
• Document Model for Parent or Guardian Consent Form (Readability Score: Grade 7)
  
  
• Document Template for Adult/General Consent Form
• Document Model for Adult/General Consent Form (Readability Score: Grade 6)
  
  
• Document Template for Child Assent Form
• Document Model for Child Assent Form (Readability Score: Grade 3)
  
  
• Document Template for Adolescent Assent Form
• Document Model for Adolescent Assent Form (Readability Score: Grade 5)
  
  
• Document Template for Parent or Guardian Consent Form
• Document Model for Parent or Guardian Consent Form (Readability Score: Grade 7)

Translation Services

• Translation Services Information

Unanticipated Problem and Adverse Event Reporting

• Adverse Event Reporting Flowchart
• Unanticipated Problem Reporting Flowchart
• Unanticipated Problem and Adverse Event Reporting

HIPAA

• Authorization Form
  • Exhibit 1 - NSU Authorization for Use and Disclosure of Protected Health Information in Research
  • Exhibit 1 - NSU Authorization for Use and Disclosure of Protected Health Information in Research
  • Exhibit 1 - NSU Authorization for Use and Disclosure of Protected Health Information in Research (Spanish)
  • Exhibit 1 - NSU Authorization for Use and Disclosure of Protected Health Information in Research (Spanish)
  • Exhibit 1 - NSU Authorization for Use and Disclosure of Protected Health Information in Research (Creole)
  • Exhibit 1 - NSU Authorization for Use and Disclosure of Protected Health Information in Research (Creole)
  • Exhibit 2 - Instructions for Preparing the Authorization For Use and Disclosure of Protected Health Information in Research Form
• Exhibit 3a - Notice of Privacy Practices
• Exhibit 3b - Acknowledgement of Receipt of Notice of Privacy Practices
• Exhibit 4 - Documentation of Good Faith Efforts
• Exhibit 5 - IRB Guidance on Research versus Educational Activity
• Exhibit 6 - NSU HIPAA Authorization for Educational and Related Purposes
• Exhibit 7 - Accounting of Disclosures for Research
• Exhibit 8 - IRB Waiver of Authorization Form
• Exhibit 8 - IRB Waiver of Authorization Form
• Exhibit 9 - IRB Research on Decedent’s Information Without Authorization Form
• Exhibit 9 - IRB Research on Decedent’s Information Without Authorization Form
• Exhibit 10 - IRB Review Preparatory to Research Form (Clinic Workforce Version)
• Exhibit 10 - IRB Review Preparatory to Research Form (Clinic Workforce Version)
• Exhibit 11 - IRB Review Preparatory to Research Form (NSU Affiliate-Outside Researcher Version)
• Exhibit 11 - IRB Review Preparatory to Research Form (NSU Affiliate-Outside Researcher Version)
• Exhibit 12 - IRB Review Preparatory to Research Form (Non-NSU Researcher-Outside Researcher Version) -Request for IRB to Waive Patient Authorization
• Exhibit 12 - IRB Review Preparatory to Research Form (Non-NSU Researcher-Outside Researcher Version) -Request for IRB to Waive Patient Authorization
• Exhibit 13 - 42 CFR Part 2 Addendum Form
• Exhibit 13 - 42 CFR Part 2 Addendum Form
• Exhibit 14 - HIV Records Addendum Form
• Exhibit 14 - HIV Records Addendum Form
• Exhibit 15 - Mental Health Records Addendum Form
• Exhibit 15 - Mental Health Records Addendum Form