Exempt Submission Checklist

advertisement
Human Research Forms – Exempt
Application Checklist
Submission Instructions
 Always download the forms from the IRB website to ensure you are using the most current
versions.
 All submissions to the IRB should be sent via the IRBmail@uthscsa.edu mailbox.
 Original Signed documents are to be scanned and attached to the email.
 Label the subject of the email with: NS, PI name (Exempt).
 Hard copy submissions are not accepted.
 Items in the blue section are required.
 Items in the orange sections should be submitted if applicable to your research. Depending on
the nature of your research, some sections of the application will apply to your research, some will
not. Please review each section to determine applicability to your research, and include the forms
appropriate for your study in your IRB application submission.
 This checklist document should not be submitted to the IRB. It is intended to assist the study team
in preparing the submission packet.
Mark the boxes to designate forms applicable to your study.
X
Required Forms for Initial Submission
X
Research Common Application Step 1 Form
*Required
X
Research Common Application Step 2 Institutional Form
*Required
X
Inst-M – Personnel Form
*Required
X
Form B-3 - Exempt Research Request - General
Information Sheet
*Required
X
Form A - Signature Assurance Sheet
*Required
Billing / Payment Forms - Submit as applicable
Billing Grid
Submit if applicable
Participant Payment Form
Submit if applicable
Study Budget
Submit if applicable
Clinical Trial Agreement
Submit if applicable
Consent Forms - Submit as applicable
Form D-IS (Information Sheet)
Submit if applicable
Telephone Script
Submit if applicable
HIPAA (Health Insurance Portability and Accountability) - Submit as applicable
Form J - HIPAA Waiver of Authorization
Submit if applicable
Collaboration - Submit as applicable
Form K-1 - UT System Centralized IRB Review
Submit if applicable
Form K-2 - Intent to Rely on UTHSCSA for IRB Review
Submit if applicable
Advertisements & Data Collection Instruments - Submit as applicable
Form L - Proposed advertisement(s) of any type for
recruiting
Submit if applicable
Form L-1 - Find a Study Recruitment Website
Submit if applicable
Page 1 of 2
Form M - Proposed data collection instrument(s) (i.e.,
survey(s), questionnaire(s))
Submit if applicable
Schedule of Events
Submit if applicable
Other Materials - Submit as applicable
Form AA - Grant Application
Submit if applicable
Form BB - Sponsor's protocol
Submit if applicable
Form BC – Protocol Template Form
Submit if applicable
Form HH - CTRC Review Committee
Submit if applicable
Form X - Protocol Related Conflict of Interest (COI) Report
Submit if applicable
Letters of Support or Memorandum of Understanding for
Off-site Research
Submit if applicable
Page 2 of 2
Download