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CITI Training

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 vernalee@tulane.edu 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 coi@tulane.edu or (504) 247-1286 for guidance and/or clarification.

 

General Guidance

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 Exempt Determination

Criteria for Expedited Determination

Criteria for IRB Approval

IRB Review Timeline

TU-UMC Approval Process

Tips & Templates

Initial Application Checklist (for new research studies)

Secondary Application Checklist (for continuing reviews, amendments, responses, event reports, correspondence and closures)

Protocol Template

Biomedical Consent Form Template

Social Behavioral Consent Form Template

Emergency/Evacuation Card Template

HIPAA Template

Assent Template

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

Guidance on Exemptions

Guidance on Oral Histories

Guidance on Retrospective Chart Reviews

Is this a Protocol Violation? Diagram

Is this an Unanticipated Problem? Diagram

HIPAA

HIPAA Researcher Certificate

HIPAA FAQ's

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

External Resources

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

Clinical Trials

Other

Reporting Form for Research Concerns/Complaints

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 irbmain@tulane.edu 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
Tel: 504-988-2665
fax: 504-988-4766
e-mail: irbmain@tulane.edu