What's New

New Forms!!!

• New Study Application Form

• Continuing Review Application Form
• Determination of Human Research Worksheet
• Assent Template

Notice: Previous versions of these forms will be accepted until July 16, 2007. On and after that date please use only the revised versions.

Application Forms

NOTE: Because changes will be made on a routine basis, forms must be downloaded prior to each use.  Hand-written copies of applications will not be accepted. Original signatures must be on at least one copy of paperwork submitted to the IRB office. 

INITIAL APPLICATION FORMS

(Effective May 26, 2005, there is no longer a Claim of Exemption Application.  All Exempt, Expedited and Full Board Studies should be submitted on the IRB Application Form below.)

• Form Instructions - Please read first.

              Set of instructions for all interactive IRB forms

• IRB Application Form

              Please use this application for Full Board, Expedited and Exempt Studies.

• Checklist for IRB Application Submission

Required elements to be submitted with the application form to OU-NC IRB.

• Appendix A -- Protocol Description
• Appendix B -- Student as Principal Investigator
• Appendix C -- International Research Review Form

CONSENT FORM DOCUMENTS

• Informed Consent Template
• Informed Consent Form - Required Elements
  Information required by Federal Law to be provided in the Informed Consent Form.
• Information Sheet for Consent to Participate in a Research Study
• Assent Template
• Debriefing Template

ANNUAL REVIEW FORM/PROGRESS REPORT

• Continuing Review Form

  This form is for annual continuing review purposes.

MODIFICATION FORM

• Modification Form
  Form for all amendments and revisions.

PROTOCOL DEVIATION FORM

• Protocol Deviation Form

CONFLICT OF INTEREST

• Conflict of Interest Disclosure Form

UNANTICIPATED PROBLEM

• Unanticipated Problem
  Form for reporting all unanticipated problems (ex: subject recruitment issues, compensation to participants, inclusion/exclusion criteria, costs to participants, informed consent issues, documentation of informed consent, privacy or confidentiality protections, vulnerable subject protections, etc.).

HIPAA FORMS

• Authorization to Use or Disclose Protected Health Information for Research