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General FAQs

The HRPO is working to create a comprehensive list of FAQs.  Please check back as we will be adding more questions to this list soon.

1. My Initial submission was returned for Conditions Required for Approval, when do I need to submit the requested modifications?

2. My Initial submission was Deferred, when do I need to submit the Deferral response?

3. Which CITI Training course do I need?

4. Do I have to use the Consent Form Template and/or the Consent Script Templates to compose my Consent Document?


 

My Initial submission was returned for Conditions Required for Approval, when do I need to submit the requested modifications?

Please submit your Conditions Required for Approval Response within 30 days of the IRB determination. Please keep in mind that the failure to submit a response to IRB requirements for conditionally approved submissions within 30 days of the IRB date of determination may result in Administrative Closure of the IRB study.

 

My Initial submission was Deferred, when do I need to submit the Deferral response?

Please submit your Deferral Response within 90 days of the IRB determination. Please keep in mind that the failure to submit a response to IRB requirements for deferred submissions within 90 days of the IRB date of determination may result in Administrative Withdrawal of the IRB study.

 

Which CITI Training course do I need?

Biomedical Studies - All study team members should complete the Group 1. Biomedical Research Investigators and Key Personnel course. We also accept the CITI Good Clinical Practice course.

Social Behavioral Studies - All study team members should complete the Group 2. Social and Behavioral Research Investigators and Key Personnel course.  Please note that we will accept a Group 1. Biomedical Research Investigators and Key Personnel course or Good Clinical Practice course for Social Behavioral studies.

CITI Training certificates expire four years from the completion date and the completion date is listed on the certificate. Please make sure all CITI Training is current.

 

Do I have to use the Consent Form Template and/or the Consent Script Templates to compose my Consent Document?

For Full Board (Greater than Minimal Risk) and Expedited (Minimal Risk) Research, you are required to use one of the IRB-approved Consent Form Templates.

For Expedited (Minimal Risk) Research when a Waiver of Documentation of Consent is being requested, you may use the Consent Script Template.

For Exempt Research, the HRPO strongly advises investigators to use the IRB-approved Consent Script Template, although it is not required. For Exempt studies only, you may use your own consent language as long as it contains the necessary elements of consent.

 

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