General Guidance and FAQs

• Tools for Determining if a Study Requires Registration in CT.gov
• Instructions for Completing the Protection of Human Subjects Assurance Identification Form (OMB 0990-0263)
• Form OMB 0990-0263
  Federal Form OMB 0990-0263 (formerly Form 310) is the Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption Form.  It is required for Human Subjects Research activities that are conducted or supported by the Departments and Agencies adopting the Common Rule.
• FDA Investigator Responsibilities
• Guidance for the Investigator as a Sponsor
• Guidance on Special Considerations and Reporting Requirements for FDA-NIH-DHHS Regulated Items
• Creating a Regulatory Binder
• Comparison of Clinical Trial Phases
• Dispensing Investigational Drugs or Drugs Used In Research
• Device Accountability Policy
• Device Accountability Log

• Glossary of Lay Terms for Use in Preparing Consent Forms
• NCCN Informed Consent Language (ICL) Database
• Guidance on Informed Consent Process

• About IRB Authorization Agreements
• Collaborative and Off-Site Research Presentation
• Coordination of IRB Research Review
• Multi-Site Coordination Guidelines

• HIPAA Researcher Certificate
• HIPAA FAQ's
• HIPAA Privacy and Research Presentation

For FAQs specific to submitting in IRBManager, please see IRBManager FAQs.

Can a student serve as the Principal Investigator on a study?
Yes, a student can serve as the PI on the study team. In the IRBManager application, when you enter the Principal Investigators information, select “student” for the affiliation type and then you will be prompted to enter in the Faculty Advisor’s information.

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 (GCP) course, the GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)(NIH Requirements) course, or the GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) 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 any of the Good Clinical Practice courses listed above for Social Behavioral studies.

Please ensure that you enter your Tulane email address in TWO places in your CITI account. If you do not use your Tulane email address in both sections, your CITI training information will not automatically populate in IRBManager. In your Member Profile: Enter your Tulane email address as your “Preferred Email”. In your Institutional Profile: Enter your Tulane email address as your “Institutional email address”.

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.

How do I track changes in when I update a Word document?
Open the Word document. Before you begin making your edits, select the “Review” Tab. Click “Track Changes” and select “All Markup”. All of the changes you make will be displayed as tracked.

Video of How to Track Changes in Word

I already updated my document but did not track changes. How can I show the changes that were made?
Open up a Word Document and select the “Review” Tab. Click “Compare” and select “Compare two versions of a document”. Then upload the original document and the updated document and the tracked changes will be displayed.

Video of How to Compare Documents in Word