Before beginning research at Tulane University, all research personnel must complete the CITI Training Program; this can be completed at: www.citiprogram.org
Data Use Agreements
If a Data Use Agreement is required for your research, a centralized process is now in place. Please contact Rusten May, Tulane University Privacy Officer, at dua@wave.Tulane.edu with any questions.
Sponsored Projects Administration Office
If your study will be conducted within Tulane University Medical Center and/or Lakeside Hospital, please contact the SPA Office to obtain approval. Please contact Verna Lee email@example.com with any questions.
Industry Sponsored Research
An Interdepartmental(IT) Form is required to be submitted to the Human Research Protection Office (HRPO) for Industry Sponsored Initial Submissions and Continuing Reviews. Please be sure to view IRB Fees in the Policies link to make sure your IT is completed correctly.
Conflict of Interest
All Conflict Of Interest (COI) matters must be resolved before the IRB can approve a submission. This includes COI issues that relate to PIs, investigators, and key personnel.
The Conflict of Interest Form must be submitted to the General Counsel's Office and investigators should resolve all COI issues before making a submission to the IRB. In addition, researchers are required to comply with the revised Tulane University COI policy to complete and submit COI training via the CITI online training modules.
If you have questions, please contact Genean Mathieu, Administrative Compliance Specialist for the Tulane University Conflict of Interest Committee, at firstname.lastname@example.org or (504) 247-1286 for guidance and/or clarification.
Tips & Templates
Initial Application Checklist (for new research studies)
Secondary Application Checklist (for continuing reviews, amendments, responses, event reports, correspondence and closures)
Biomedical Interventional Consent Form Template
Biomedical Observational Consent Form Template
Social Behavioral OR Other Biomedical Minimal Risk Consent Form Template
Social Behavioral OR Biomedical Consent Script Template (For Use When a Waiver of Documentation of Consent is Granted)
Emergency/Evacuation Card Template
DHHS About Research Participation
Tools for Determining if a Study Requires Registration in CT.gov
Decision Trees for Human Subjects Regulations
Does My Project or Research Need IRB Approval
Types of IRB Review
Criteria for Expedited Determination
Criteria for IRB Approval
IRB Review Timeline
TU-UMC Approval Process
Glossary of Lay Terms for Use in Preparing Consent Forms
Creating a Regulatory Binder
NCCN Informed Consent Language (ICL) Database
Self Audit Tool
Investigator Self Assessment Checklist
Specific Guidance Documents
Guidance on Informed Consent Process
Guidance on Continuing Reviews
Guidance on Study Closures
Is this a Protocol Violation? Diagram
Is this an Unanticipated Problem? Diagram
HIPAA Researcher Certificate
HIPAA Privacy and Research Presentation
Multi-Site and Off-Site Research
Collaborative and Off-Site Research Presentation
Coordination of IRB Research Review
Multi-Site Coordination Guidelines
OHRP Revised Common Rule Resources
OHRP Revised Common Rule Videos
"The Common Rule" (45 CFR 46) - Code of Federal Regulations
The Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research
The Nuremberg Code - Directives for Human Experimentation
Declaration of Helsinki - Recommendations guiding physicians in biomedical research involving human subjects
Office of Human Research Protections
Food and Drug Administration
National Institutes of Health
U.S. Department of Veteran Affairs
Statement of Biomedical IRB Compliance
FDA Investigator Responsibilities
Guidance for the Investigator as a Sponsor
Guidance on Special Considerations and Reporting Requirements for FDA-NIH-DHHS Regulated Items
Comparison of Clinical Trial Phases
Dispensing Investigational Drugs or Drugs Used In Research
Consent for Treatment in Emergencies
Glossary of IRB Terms
Federal: Form OMB 0990-0263 and Instructions
Instructions for Protection of Human Subjects Assurance Identification
What is a Form 310?
Form 310 is the former name for Assurance Identification/IRB Certification/Declaration of Exemption form required for human subject research activities that are conducted or supported by the Departments and Agencies adopting the Common Rule; the revised form is now referred to by the title of the form or by OMB# 0990-0263. It can be downloaded here.
**Join Our Listserv**
If you would like to receive news and updates from the HRPO/IRB from time to time, please e-mail email@example.com with a request to join our lists and you will be added right away!
Tulane University HRPO
1440 Canal Street, Suite 1705, TW-8436
New Orleans, LA 70112