Office of Human Research Protection

Investigator Guidance

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, IRBNet electronic submissions, or questions on IRB review requirements,  please send an e-mail request to

General Guidance

Tulane University Investigator's Manual 

Investigator Responsibilities

10 Steps to IRB Approval

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

Human Subjects Research Determination

Criteria for IRB Approval

CITI Training Guidance

IRB Review Timeline

Frequently Asked Questions (FAQ) 



Initial and Secondary Exempt Submission Checklist

Initial Expedited and Full Board Submission Checklist

Secondary Submission Checklist

Informed Consent Checklist



Tips & Templates

Protocol Template

Cover Letter 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



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 International Research

Guidance on Retrospective Chart Reviews

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 



Cover Letter-Lead

Cover Letter-Collaborator



Copy Request Form

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




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 from the OHRP web site:

A cover letter (as per the HRPO submission checklists) must be submitted along with Form 0990-0263 prior to review and signature.


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Institutional Review Board, New Orleans, LA 70112 504-988-2665