IRB Notes

From the Chairs' Desk

Dr. Susan Hickman will be leaving OHSU and sadly leaving her post as IRB Co-Chair.  She has been an invaluable resource with respect to the review of social and behavioral research and serving as a liaison with the School of Nursing.  She will certainly be missed and we wish her luck in her new endeavors.  

 

 

In May we launched the new Research Integrity Website.  At that time, we made some minor improvements to our policy pages, however finding a specific policy can still be cumbersome.  Our web editors are working on a easy-to-use browse or search option for our policies that will be deployed in the next couple of months.  Please feel free to call an ORIO analyst if you have specific policy questions.

Analyst Notes

eIRB users may have noticed a new look to the Initial Review (IR), Continuing Review (CR), and Modification Request (MR) questionnaires. There is a new function that came out with the last eIRB development cycle that allows the IRB analyst to enter notes, requested changes, or queries directly on the pages of the questionnaires. This new function is called Reviewer Note and is visible at the top of all questionnaires.

 

 

Listed are some things to note about the reviewer note function:

• All notes require a response prior to resubmission.
• If you disagree with a change that is requested, indicate this and provide justification when you respond to the note.
• The hide/show errors option within the questionnaire will indicate whether you have not responded to a note.
  
• Clicking on the “Analyst Requested Changes” from the project log will display all notes made using this function.

Reviewer Note is an exciting new function that will allow a query or requested change, together with the response, to be noted directly on the applicable page of the questionnaires.  This should help to track IRB queries as well as make resubmission easier.

Research Administration:

The OHSU Integrity Office has announced a new required course in Big Brain:  The Integrity Education Booster.  All employees, faculty, staff, students, and volunteers are required to complete this course, which covers institutional, clinical, and research topics.  This course includes NEW information as well as a refresher of many integrity topics. 
Those involved in Human Subjects research have a choice about how to fulfill the Human Subjects Research part of this course; complete the online Human Subjects module or attend a live IRB session:

1. Online module.  After completing the Integrity Booster Course General module, indicate that you are involved in Human Subjects Research and follow the instructions to enter the Human Research module.  This module contains 8 different topics.  Select and review 2 topics to complete this module.  Your course status in Big Brain will change to “complete.”
   
   
2. Live IRB educational session.  The IRB tracks attendance at IRB educational events.  Your attendance at such an event is sufficient substitution for the Human Subjects module.  After completing the Integrity Education Booster Course General module (and indicating “yes” for Human Subjects Research), log out of the course.  If you have attended past events (for example, the Integrity Week PI Town Hall in May, 2008) contact the IRB at irb@ohsu.edu or 503-494-7887.  Future events will be announced soon, stay tuned!  Please note that this credit can only be granted after you have completed the General module of the course and your overall course status will remain incomplete until the IRB grants credit.

“Am I speaking with the eIRB Helpdesk,” asked the flustered voice on the other end of the line.

“Yes, ma’am, you are.  How may I help you?” I greeted.

“Well, I didn’t know if this number was still for the eIRB Helpdesk, and someone said that it went away, “Is that true?”

“No, you’ve reached the eIRB Helpdesk and we’re still around to help you with your needs.”

The conversation started a little rocky, but as I assured that the helpdesk was still there to serve her needs, we moved on to solving her issue. So what has happened to the eIRB Helpdesk, anyway?
It’s true that lately there’s been some confusion regarding the eIRB Helpdesk’s recent changeover. When the eIRB first deployed, Research Information Services (RIS) took charge of assisting clientele whenever technical problems arose, answering specific content-related questions, troubleshooting system problems, and resetting the occasional password. RIS has since joined forces with the OHSU ITG, passing their helpdesk responsibilities onto some familiar faces: The Research Integrity Office. 

Here are some common eIRB Helpdesk questions and answers: 

17. Where do I call for questions? 
1. The number to call for eIRB technical-related questions is 503–494–7887.
   
   
17. We have a new collaborator we need to add to our project.  How do they register?
1. To register for the eIRB as a non-OHSU employee (or anyone at OHSU who does not have an EID such as a student), the researcher needs to request an external OHSU Employee ID number (EID) at https://www.ohsu.edu/research/rda/eid_request.php.  The EID acts as a unique identifier, assisting with the synchronization of compliance status data between various electronic systems such as, but not limited to, the eIRB, CoIR Management System, and the OHSU Big Brain. After completing and submitting this form, the researcher will receive the EID in an email from the OHSU Human Resources Office.  Then they will be able to register for their eIRB account by following the “register here” link from the eIRB home page and using their EID.