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For Investigators

Before beginning research at Tulane University, all research personnel must complete the CITI Training Program; this can be completed at:

www.citiprogram.org

 

Important Notes to All Investigators

AAHRPP Announcement

Tulane University is currently seeking re-accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Our AAHRPP site visit is scheduled for June 7, 2018 through June 8, 2018. The site visit will include interviews with researchers, research staff, IRB members and IRB staff, as well as various administrators and program directors that have been chosen by the agency. AAHRPP will provide a list of individuals that have been selected for interviews in advance, but reserves the right to contact other persons associated with the human subjects protection program during the site visit. Once we are provided with the list, we will contact the selected individuals to schedule interview preparations.

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.
 

**IMPORTANT INFORMATION AFFECTING IRB APPROVALS**

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.

If you are interested in becoming a member of the Biomedical IRB or Social/Behavioral IRB and want to contribute to research, please e-mail us at irbmain@tulane.edu or call us at 988-2665.

The guidance documents listed below were designed to assist you in your research. If any investigator or their research staff would like to schedule a meeting with the Human Research Protection Office (HRPO) staff to answer questions about prospective or ongoing human subjects research projects, IRBManager electronic submissions, or questions on IRB review requirements,  please send an e-mail request to irbmain@tulane.edu.

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

Cover Letter 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

Other

Copy Request Form

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