Full Board Submission Checklist

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Human Research Forms – Full Board Review
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 [email protected] mailbox.
 Original Signed documents are to be scanned and attached to the email.
 Label the subject of the email with: NS, PI name (Full Board).
 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 that are 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
Research Common Application Step 2 Continuation UTHSCSA
IRB Application
*Required
X
Form BB - Sponsor's protocol OR Form BC – Protocol Template
*Required
Form
X
Form A - Signature Assurance Sheet
*Required
Form C-1 - Local Repository Description
*Required for repository
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 - Research Consent
Submit if applicable
Form D-1 - VA Research Consent
Submit if applicable
Form D-2 - Spanish Research Consent
Submit if applicable
Form D-PP – Pregnant Consent and Authorization
Submit if applicable
Form D Withdrawal
Submit if applicable
Page 1 of 3
Form D-IS (Information Sheet)
Submit if applicable
Telephone Script
Submit if applicable
Form E - Repository Consent
Submit if applicable
Form E-1 - VA Repository Consent
Submit if applicable
Form E-2 -Spanish Repository Consent
Submit if applicable
Form F - BLANK Template
Submit if applicable
Form F - SAMPLE waiver of consent for Chart Review study
Submit if applicable
Form F - SAMPLE waiver of consent for Recruitment
Submit if applicable
Form F - SAMPLE Alteration and waiver of documentation of
consent for research procedures prior to full consent
Submit if applicable
Form G - Model Consent Form
Submit if applicable
Form H-1 - Translation Certification Form
Submit if applicable
HIPAA (Health Insurance Portability and Accountability) - Submit as applicable
Form I - HIPAA De-identification Agreement Form
Submit if applicable
Form J - HIPAA Waiver of Authorization
Submit if applicable
Form J-1 - Assurance for Research on Decedent's Information
Submit if applicable
Form H-UT - UT HIPAA Authorization
[Use with Form D-1 for non-VA sites.]
Submit if applicable
Form H-VA - VA HIPAA Authorization
[Use with Form D-1 for VA sites.]
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
Form M - Proposed data collection instrument(s) (i.e., survey(s),
questionnaire(s))
Submit if applicable
Schedule of Events
Submit if applicable
Use of Drugs and/or Devices - Submit as applicable
Form O - Use of a Drug in Research
Submit if applicable
Form O-2 - Use of a Placebo in Place of Standard Therapy
Submit if applicable
Form P - Use of Investigational Device Form (May be Exempt
from IDE)
Submit if applicable
Form Inst-H - Local Sponsor-Investigator Monitoring Plan
Submit if applicable
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Form Inst-F - Investigational Drug Information Record Form
Submit if applicable
Form Inst-G - Pharmacy LOU
Submit if applicable
Form S - Copy of package insert or FDA approved label (PDR
reference)
Submit if applicable
Use of Radiation / Use of Gene Transfer - Submit as applicable
Form Q - Use of Radiation in Human Research (Radiation
Exposure Worksheet)
Submit if applicable
Form GG - Radiation Safety Committee
Submit if applicable
Form II - Radioactive Drug Research Committee
Submit if applicable
Form Q-1 - Gene Transfer Therapy in Human Research Studies
Submit if applicable
Form EE - Institutional Biosafety Committee
Submit if applicable
Vulnerable Populations - Submit as applicable
Form T - Research Involving the Decisionally Impaired
Submit if applicable
Form U - Research Involving Pregnant Women, Fetuses, &/or
Neonates
Submit if applicable
Form U - Prefilled for Pregnant Partners
Form D-PP Pregnant Partner Consent and Authorization
Form V - Research Involving Prisoners
Submit if applicable
Submit if applicable
Submit if applicable
Form W - Research Involving Children, Healthy Neonates, and/or Submit if applicable
Neonates (Viability not in question)
Form Inst-J - Texas Department of Family and Protective
Services Request for Approval
Submit if applicable
Other Materials - Submit as applicable
Form AA - Grant Application
Submit if applicable
Form CC - Investigator Brochure
Submit if applicable
Form HH - CTRC Review Committee
Submit if applicable
Form R - Monitoring Participant Safety and Data Integrity
Submit if applicable
Form X - Protocol Related Conflict of Interest (COI) Report
Submit if applicable
Form Y - Monitoring Plan - Coordinating Center and/or Lead PI
Letters of Support or Memorandum of Understanding for Off-site
Research
Page 3 of 3
Submit if applicable
Submit if applicable
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