| Additional Criteria for Department of Defense (DOD) Research |
| Additional Criteria for Department of Education (EDU) Research |
| Additional Criteria for Department of Energy (DOE) Research |
| Additional Criteria for Department of Energy (DOE) Research - PI Requirements |
| Additional Criteria for Environmental Protection Agency (EPA) Research |
| Additional Criteria for Department of Justice (DOJ) Research |
| 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 - Research Participant Payments to Saint Louis 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 Research |
| HIPAA - Preparatory to Research Form |
| HIPAA - Recruitment Letter |
| Human Subjects Research 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 |
| Research 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 Research Involving Benign Behavioral Interventions |
| Guidelines for Research Involving Adults Unable to Provide Consent |
| Guidelines for Case Reports |
| Guidelines for Confidentiality of Human Subjects Research |
| Guidelines for Obtaining Informed Consent from Research Volunteers |
| Guidelines for Data Safety Monitoring of Human Subjects Research |
| Guidelines for Research 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 Research |
| Guidelines for Research 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 Research Involving Minors |
| Guidelines for Research Involving Neonates |
| Guidelines for New Faculty |
| Guidelines for Research Involving Non-English Speaking Subjects |
| Guidelines for Research Involving Non-SLU Researchers or Non-SLU Sites |
| Guidelines for Research Involving Pregnant Women and Fetuses |
| Guidelines for Research Involving Prisoners |
| Guidelines for Quality Assurance/Quality Improvement Research |
| Guidelines for Research Involving Radioactive Materials or Radiological Procedures |
| Guidelines for Providing Research 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 Research Involving Students and Employees |
| Guidelines for Closure of Human Subjects Research Studies |
| Guidelines for Subject Accrual |
| Guidelines for Recruitment of Subjects for Research |
| 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
Research and/or Sponsored Activities |
| ClinCard - Research 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 |
| External Researcher Request Form |
| 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 Research? |
| 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 Research Encounters in Epic |
| SLUCare Epic Research Charting Policy |
| Standard Operating Policies and Procedures (SOPP) for the Protection of Human Research
Subjects |
| Tips for Choosing the Appropriate IRB Application/Form |