The Human Research Protection Office (HRPO) offers hour-long presentations on a variety of topics related to human subjects research. These presentations are designed to provide information on topics of interest to Principal Investigators, Study Coordinators, research team members, and members of the Tulane University research community.
HRPO Educational Presentations will be held over Zoom. See the full schedule of HRPO presentations.
Please register to attend. You will receive an email confirmation message with the Zoom link.
In the Single IRB model, one IRB oversees research at multiple study sites. The TU IRB could serve as the Lead IRB or rely on another IRB to oversee TU research activities. TU researchers must still submit an Initial Application for Human Subjects Research even when the study is overseen by another IRB. This presentation provides an orientation to the application and the TU Review Process for studies that use the single IRB model.
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When the TU IRB is the Lead IRB, the TU IRB collects information about research activities at all study sites that are relying on the TU IRB; a full application is required, and a regulatory review is conducted.
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When the TU IRB relies on an external IRB, the TU IRB collects basic information to ensure compliance with institutional policies and procedures and state regulations; an abbreviated application is required, and a facilitated review is conducted.
TU is an academic institution that still allows student researchers to serve as the Principal Investigator (PI) of their own project involving human subjects research. But this is only possible if the student has adequate training and expertise to serve as the PI AND has an engaged Faculty Advisor who agrees to oversee the project, from study design and IRB submission through to completion of the project.
This presentation will provide an overview of the expectations for students who plan to conduct research and the responsibilities of Faculty Advisors of student research projects. You must know the responsibilities for whichever position you hold to ensure the ethical conduct of research and the protection of human research subjects.
What happens after the Human Research Protection Office (HRPO) receives an application? This presentation covers how to achieve the most efficient review of the application to the IRB.
Complete Submission Materials:
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How researchers can ensure complete submission materials have been provided.
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What “starts the clock” for IRB review.
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How human subjects research application reviews can occur in parallel to COI review.
You answered every question in the xForm. You put a lot of time into editing the TU Informed Consent Document template to describe your study. You checked your attachments page--twice. You crossed every T and dotted every I. Yet, the application was returned to your Inbox for you to address questions and provide clarification. The truth is, this is a very common scenario for many researchers, and the Human Research Protection Office (HRPO) wants to help.
In this presentation, we will show you the IRB-side of the application review process.
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We will look at the most common Workflow questions and requests and provide strategies for addressing them to keep the IRB review process moving along. Ideally, we want you to know how to anticipate and avoid having these application issues altogether.
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We will review common Informed Consent Document challenges.
- Finally, we will share insights about the review process from HRPO staff reviewers/Analysts.
This presentation will be beneficial to anyone who works with TU Human Subjects Research applications.
Protecting subject safety is one of the most important responsibilities of an investigator. This presentation will:
- Define and explain protocol deviations, adverse events, and unanticipated problems;
- Explain the relationships between them;
- Clarify when to report Unanticipated Problems to the TU IRB; and
- Review real world scenarios.
Tulane University HRPO
1440 Canal Street, Suite 1705, TW-8436
New Orleans, LA 70112
Tel: 504-988-2665
fax: 504-988-4766
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