ETSU-TTU Doctorate of Nursing Practice IRB Process

Overview

The contents of this page apply only to students and faculty in the ETSU-TTU joint Doctorate of Nursing Practice (DNP) program.

An agreement has been formally established between ETSU and TTU regarding the review of human subject research proposed by students currently in the DNP program and faculty advisors to these students. The process involves a pre-review process at TTU and an IRB review at ETSU. Students and faculty in this program do not follow the standard IRB process at TTU. For DNP students and Faculty Advisors, please follow all instructions on this page very carefully.

Training Requirements

DNP students and Faculty Advisors must complete the following training:

1. Human Subjects Training (CITI; "Human Subjects Research (including privacy)| All students & faculty researchers & Fac. Supervisor")

2. Responsible Conduct of Research Training (CITI; "Social and Behavioral Responsible Conduct of Research Course")

3. HIPAA Training (CITI; "IPS for Researchers including all student investigators and faculty acting as an investigator (PI/Co-PI")

4. IRBManager Training (ETSU)

Training for #1-#3 are conducted through the CITI Program website CITI Program website.

Training #4 requires training through ETSU. Instructions for the training are available here on the ETSU IRB website. Specifically,  follow all instructions under "Accessing/Using the IRBManager system." Those instructions are as follows:

"New Users:  Before you can begin using IRBManager, you will need to get a login and go through a brief training session.  Here's how to get started:

1. Complete, sign, and submit a Request for Log-in Form to April Cheyne (cheyne@etsu.edu).
2. When the IRB office receives your completed form, they will contact you via email to schedule a brief (30 minute) individual phone training. Your username and password will be provided at that time.
3. Upon completion of the training, you will be ready to use the IRBManager system." 

It is recommended that you complete the IRBManager training once you are ready to the process of submitting a proposal. 

Contacts

TTU Point Person: Dr. Sue Piras, Associate Professor of Nursing, Whitson-Hester School of Nursing, Tennessee Tech (spiras@tntech.edu)

ETSU Point Person: Theresia Cannon, Medical IRB Coordinator, Office for the Protection of Human Research Subjects, East Tennessee State University (cannontl@etsu.edu)

TTU HIPAA Compliance Officer: Greg Holt, Compliance Officer, Compliance Office, Tennessee Tech (gholt@tntech.edu)

Submission Process

Step #1: The student and Faculty Advisor must complete the CITI Training and IRBManager Training with ETSU.

Step #2: The student completes and submits an IRB application in IRBManager. Note: During the process, the student will need to provide their Faculty Advisor's name and contact information at three places. 

Step #3: The Faculty Advisor carefully reviews the application in IRBManager for content and completeness.

Step #4a: TTU Point Person, Dr. Sue Piras, reviews the application for completeness. If the application is incomplete, Dr. Piras will send the application back to the PI for revisions.

Step #4b: If HIPAA applies, the application would be reviewed by TTU Compliance Officer, Greg Holt, for HIPAA compliance. If revisions or additional documents are necessary, Mr. Holt will send the application back to the PI for revisions. 

* Note: Please allow ten (10) business days for initial review by Dr. Piras. Please allow an additional ten (10) business days for review by Mr. Holt, if HIPAA applies to the application. 

Step #5: Once Dr. Piras and, if applicable, Mr. Holt approve the application, the application is sent to the ETSU Medical IRB for review. 

Step #6: The ETSU will render a decision and notify the PI directly of the decision. If the study is approved, then the PI can begin data collection. 

Step #7: If the study is approved by the ETSU IRB, notification of the approval will be sent from ETSU to the TTU IRB Chairperson. The PI will receive a confirmation email that the approved application has been received by TTU. (Note: The study can begin immediately once ETSU notifies the PI the study is approved; the PI does not need to wait to receive confirmation from TTU. TTU generates an email just so the PI has record that the approval is on file in the Office of Research at TTU.)

Helpful ETSU Links

ETSU IRB

ETSU Student Checklist

ETSU Faculty Advisor Checklist

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