Institutional Review Board s3

AURORA IRB Request for Use of a Short Form Consent Use when a potential non-English speaking subject is unexpectedly encountered and a translated informed consent form is not available. Research is currently being conducted at:

Aurora Medical Center (list sites): AMG/Aurora Clinic (list sites): VLCC (list sites): Aurora IRB Protocol #: Principal Investigator: Protocol Title: Submitter: Telephone: E-mail: Step 1: Initial Request (Complete this section only. You may either send a hard copy or scan and email to IRB office.) Subject Information Language: Anticipated consent date: (Optional) Provide any additional relevant information:

Signature of Submitter Date

Step 2: Approval to Use Short Form (IRB Use Only) Request for use of Short Form Consent is: Approved Denied (if checked, include rationale)

Signature of IRB Chair or Designee Date

Step 3: Outcome (Complete within 5 business days after use of Short Form and submit to IRB.) Subject declined to participate (no further action required)

Subject agreed to participate. If checked, then: 1.______Attach a copy of the signed short form consent. Redact the subject’s name but leave the date visible. 2.______List date consent was obtained: ______3.______How many more visits will this subject have? ______4.______When will the next scheduled visit(s) occur? (list estimates if exact dates are not known) ______

5. Will the sponsor provide a translation of the informed consent document and any subject materials? Sponsor will provide Sponsor will not provide No sponsor 6. Was there any deviation from the expected informed consent process? (example: interpreter was not available in person as scheduled) Yes - Attach memo to explain No

Signature of Submitter Date

Step 4: Translation Determination (IRB Use Only) After reviewing the information provided above, I have determined that: Full informed consent and any relevant subject materials must be translated and submitted to the IRB as a modification

Translation of documents is not necessary (no further action required)

Form RR 403-C Page 1 of 2 ______Signature of IRB Chair or Designee Date