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 ÀÏ˾»ú¸£ÀûÍø 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 |
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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 |