IRB Forms, Guidance, and Instructions

1) New Submission Information and Forms

   a) Instructions For New Submissions (doc)

   b) Application For Use Of Human Subjects (Form) (doc)

   c) Guidance: "Elements of a Protocol" (doc)

   d) Signature Assurance (Form) (doc)

   e) Contact Information (Form) (doc)


2) Informed Consent Requirements and Forms

   f) Instructions: Consent Form Formatting & Other Requirements (doc)

   g) Guidance: "Elements of Disclosure for Informed Consent" (doc)

   h) Informed Consent (Template) (doc)

   i) Spanish Informed Consent (doc)

   j) Minor Assent (Template) (doc)

   k) Parent Permission/Child Assent (doc)

   l) Statement of Witness for Consent of Subjects Unable to Read (doc)

   m) Waiver of Documentation of Informed Consent (Form) (doc)

   n) Waiver of Informed Consent (Form) (doc)


3) Forms and Guidance Used During the Life of a Study

   o) Amendment Request (Form) (doc)

   p) Guidance: Reporting Unanticipated Problems (doc)

   q) Report of Unanticipated Problem (Including Serious Adverse Events) (Form) (doc)

   r) Report of Protocol Violation (Form) (doc)

   s) Continuing Review Progress Report (Form) (doc)

   t) Exempt Research Status Report (Form) (doc)

   u) Final Protocol Closure Report (Form) (doc)


4) Additional Forms

   v) Translation Verification (Form) (doc)

   w) Guidance: De-Identified Data (or Specimens) in Research (doc)

   x) Request for Use of De-Identified Data (or Specimens) in Research (doc)