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IRB Forms and Guidelines

Below you can search for forms and IRB guidelines at Saint ÀË»¨Ö±²¥ University. If you can't find something, please contact the IRB Office at 314-977-7744.

IRB Forms and Guidelines

Document Name
Document Name
Additional Criteria for Department of Defense (DOD) ÀË»¨Ö±²¥
Additional Criteria for Department of Education (EDU) ÀË»¨Ö±²¥
Additional Criteria for Department of Energy (DOE) ÀË»¨Ö±²¥
Additional Criteria for Department of Energy (DOE) ÀË»¨Ö±²¥ - PI Requirements
Additional Criteria for Environmental Protection Agency (EPA) ÀË»¨Ö±²¥
Additional Criteria for Department of Justice (DOJ) ÀË»¨Ö±²¥
Additional Criteria for Investigational Devices
Additional Criteria for Investigational Drugs
Additional Criteria for Sponsor Investigator Responsibilities
Assent - Clinical Studies with Adolescents (Ages 15 – 17)
Assent - Clinical Studies with Children (Ages 7 – 14)
Assent - Non-Clinical Studies with Adolescents (Ages 15 – 17)
Assent - Non-Clinical Studies with Children (Ages 7 – 14)
CCPay Transition Informational Memo
Checklist for Obtaining Consent: 45 CFR 46.406, 21 CFR 50.53
ClinCard - Participant Payment Exception Request Form
Consent - Addendum Informed Consent Template
Consent - Alteration of Consent
Consent - Behavioral & Social Sciences (Non-Clinical) Informed Consent Template
Consent - Biomedical (Clinical) Informed Consent Template
Consent - Ionizing Radiation Risk Template Language
Consent - Human Gene Transfer Informed Consent Guidelines
Consent - Plain Language Thesaurus for Health Communications
Consent - Pregnancy Follow-Up (Pregnant Participant/Pregnant Partner)
Consent - Recruitment Statement Template
Consent - ÀË»¨Ö±²¥ Participant Payments to Saint ÀË»¨Ö±²¥ University Employees
Consent - Short Form (Bosnian)
Consent - Short Form (Chinese)
Consent - Short Form (English)
Consent - Short Form (Spanish)
Consent - Waiver of Consent
Consent - Waiver of Written Consent
Coordinating Center (CC) Application
Department Chair Approval Form
Determining Eligibility for Expedited Continuing Review Worksheet
Emergency Treatment - Consent Template
Emergency Treatment - Application Form
Emergency Treatment - Status/Closure Form
Exempt Categories Worksheet (Revised Common Rule)
External/Central IRB - Submission Authorization Form
External/Central IRB - Site Specific Consent Language
Genomic Data Sharing Form
HIPAA - Authorization Form Template
HIPAA - Authorization Withdrawal Letter
HIPAA - Code Access Agreement
HIPAA - Data Use Agreement (External - SLU Provider)
HIPAA - Data Use Agreement (External - SLU Recipient)
HIPAA - Data Use Agreement (Internal)
HIPAA - De-Identification Certification Form
HIPAA - Disclosure Tracking Log
HIPAA - Notification of Decedent ÀË»¨Ö±²¥
HIPAA - Preparatory to ÀË»¨Ö±²¥ Form
HIPAA - Recruitment Letter
Human Subjects ÀË»¨Ö±²¥ Determination Form
Humanitarian Use Device (HUD) - Application Form
Humanitarian Use Device (HUD) - Consent Template
Humanitarian Use Device (HUD) - Protocol Instructions
IRB Meeting Dates/Deadlines
IRB Reliance Agreement Determination Form
ITS Sensitive Data Guide
National Cancer Institute (NCI) CIRB - Submission Authorization Form
National Cancer Institute (NCI) CIRB - SLU Boilerplate Language for Consent/Assent Forms and HIPAA Authorizations
Paper Submission - Change in Protocol/For Information Only
Paper Submission - Continuing Review/Study Closure
Paper Submission - Notice of Study Completion
Paper Submission - Serious Adverse Event (SAE)
Quality Assurance Review (QAR) Program - Investigator Self-Assessment Checklist
Radiation Risk Calculator
ÀË»¨Ö±²¥ in Concept Only Form
Serious Adverse Event (SAE) Cumulative Table
Serious Adverse Event (SAE) Memo (Jan 2015)
Scientific Review Worksheet
Single Use - Consent Template
SLU/WASHU Umbrella Agreement Determination Form
Unanticipated Problem (UP) Tracking Log
Guidelines for ÀË»¨Ö±²¥ Involving Benign Behavioral Interventions
Guidelines for ÀË»¨Ö±²¥ Involving Adults Unable to Provide Consent
Guidelines for Case Reports
Guidelines for Confidentiality of Human Subjects ÀË»¨Ö±²¥
Guidelines for Obtaining Informed Consent from ÀË»¨Ö±²¥ Volunteers
Guidelines for Data Safety Monitoring of Human Subjects ÀË»¨Ö±²¥
Guidelines for ÀË»¨Ö±²¥ Involving Deception
Guidelines for Department/Division Specific Pre-Review Requirements
Guidelines for Emergency Use of Test Articles (Investigational Drugs, Biologics, or Devices)
Guidelines for HIPAA in ÀË»¨Ö±²¥
Guidelines for ÀË»¨Ö±²¥ Involving HIV Testing and Reporting
Guidelines for Humanitarian Use Device (HUD) Submissions
Guidelines for IND/IDE Submissions
Guidelines for Use of Legally Authorized Representatives (LAR)
Guidelines for ÀË»¨Ö±²¥ Involving Minors
Guidelines for ÀË»¨Ö±²¥ Involving Neonates
Guidelines for New Faculty
Guidelines for ÀË»¨Ö±²¥ Involving Non-English Speaking Subjects
Guidelines for ÀË»¨Ö±²¥ Involving Non-SLU ÀË»¨Ö±²¥ers or Non-SLU Sites
Guidelines for ÀË»¨Ö±²¥ Involving Pregnant Women and Fetuses
Guidelines for ÀË»¨Ö±²¥ Involving Prisoners
Guidelines for Quality Assurance/Quality Improvement ÀË»¨Ö±²¥
Guidelines for ÀË»¨Ö±²¥ Involving Radioactive Materials or Radiological Procedures
Guidelines for Providing ÀË»¨Ö±²¥ Subjects Information of Significant New Findings and Consent Form Revisions
Guidelines for Regulatory Binders
Guidelines for Reporting Events Relating to Subjects/Subject Safety
Guidelines for Scientific Pre-Review
Guidelines for ÀË»¨Ö±²¥ Involving Students and Employees
Guidelines for Closure of Human Subjects ÀË»¨Ö±²¥ Studies
Guidelines for Subject Accrual
Guidelines for Recruitment of Subjects for ÀË»¨Ö±²¥
CITI Training Instructions - Adding a Course to Your CITI Account
CITI Training Instructions - Connecting (affiliating) an Existing CITI Account to SLU
CITI Training Instructions - Registering a New Account
ClinCard - Procedures for Processing and Distributing Participant Payments within ÀË»¨Ö±²¥ and/or Sponsored Activities
ClinCard - ÀË»¨Ö±²¥ Participant Payment Quick Reference
Consent Process: Do’s and Don’ts
Common Consent Process Errors and Corrective Actions
Decision Tree - HIPAA
Decision Tree - Protocol Violation (PV)
Decision Tree - Serious Adverse Event (SAE)
Decision Tree - Unanticipated Problem (UP)
eIRB - Investigator Submitter Guide
eIRB - Pre-Reviewer Guide
eIRB - Investigator Submitter QuickSheet
eIRB - Pre-Reviewer QuickSheet
eIRB Tip - How to Create a New Application
eIRB Tip - How to Delete a Form/Protocol
eIRB Tip - How to Disable Pop-Up Blocker
eIRB Tip - How to Provide Documentation of Human Subjects Training
Emergency Treatment - Previous Emergency Uses of Test Articles at SLU
Exempt Categories Summary Chart
External/Central IRB - Post Approval Requirements
HIPAA - Examples of Protected Health Information (PHI)
HIPAA - Limited Data Set
HIPAA - Waiver or Alteration of HIPAA Authorization
IRB Analyst - Department Assignments
Is Your Project Human Subjects ÀË»¨Ö±²¥?
National Cancer Institute (NCI) CIRB - Guidelines for Use of NCI Central IRB (CIRB)
National Cancer Institute (NCI) CIRB - Submission QuickSheet
National Center for Advancing Translational Sciences (NCATS) GCP Training Registration Instructions
National Institute of Allergy and Infectious Diseases (NIAID) GCP Training Registration Instructions
National Institutes of Health (NIH) Clinical Trial Definition
National Institutes of Health (NIH) Single IRB Use Policy Guidance
Post Approval Submission Requirements
Quality Assurance Review (QAR) Program
Quality Assurance Review (QAR) Program - FAQS
Quality Assurance Review (QAR) Program - Review Types
SLU Clinical Trial Process Map Summary
SLU IRB Fees
SLUCare Clinical Workflow: Documenting ÀË»¨Ö±²¥ Encounters in Epic
SLUCare Epic ÀË»¨Ö±²¥ Charting Policy
Standard Operating Policies and Procedures (SOPP) for the Protection of Human ÀË»¨Ö±²¥ Subjects
Tips for Choosing the Appropriate IRB Application/Form