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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 irbmain@tulane.edu.
 

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

Criteria for IRB Approval

CITI Training Guidance

IRB Review Timeline

Frequently Asked Questions (FAQ) 

 

Checklists

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

2 Ledger IT Template

5 Ledger IT Template

 

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

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

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

 

 

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: http://www.hhs.gov/ohrp/assurances/forms/of310.pdf

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

 

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!

Institutional Review Board, New Orleans, LA 70112 504-988-2665 irbmain@tulane.edu