Human Subjects Protection Program (HSPP)

Implementing a New Institutional Review Board (IRB) System

3 years 4 months ago

The Human Subjects Protection Program (HSPP) will launch a new system, eIRB, designed to make submitting human research protocols easier and faster. For more information about the implementation process, please visit RII’s New Systems Information Webpage.

Please note the following important dates in the implementation process:

  • Aug. 13 – Last day to submit to the HSPP for full committee review.
  • Aug. 20 – Last day to submit to the HSPP for non-committee review. Any submissions received by this date but not yet finalized or any submission received after this date may not be reviewed and will be returned to you with further instruction on how to proceed.
  • Aug. 25-Sept. 12 – Blackout period (No IRB system will be available for submissions).
  • Sept. 13 – eIRB is available to submit materials to the IRB.

How will this affect you?

The new system is relevant to all University employees and students who conduct research involving human subjects.

  • Please plan your submission to the HSPP with the above dates in mind.
  • If your existing project(s) is set to expire during the planned blackout period, please submit a renewal or closure paperwork to VPR-IRB@arizona.edu as soon as possible. The HSPP will prioritize renewal submissions to ensure approval does not lapse due to system down time.
  • For urgent matters and Just-in-Time (JIT) requests that arise during the planned blackout period, please contact Christine Melton-Lopez, Director HSPP, directly at melton1@arizona.edu.  

For questions or more information, please contact the HSPP at VPR-IRB@arizona.edu.

Rollout of new Conflict of Interest, Human Subjects Protection Program, and Research administration systems

3 years 7 months ago

Implementing New Systems to Make Your Work Easier

Beginning this summer, the Office of Research, Innovation and Impact will sequentially roll out and upgrade new systems designed to make your work related to Conflict of Interest and Commitment matters, the Human Subjects Protection Program (HSPP), and research proposals much easier. Because these changes are relevant to all of campus, from students to staff to faculty, please check your email inboxes in the coming weeks and months for information about training sessions and transitioning to the new systems.

Conflict of Interest (COI) and Conflict of Commitment (COC)

The COI Program is implementing a new electronic system, called eDisclosure, which will be used by the University community to submit COI disclosure information and COC forms for approval. The emails you will begin receiving will provide information on what you can expect as we transition to the new system. Once the go-live date is finalized, there will be a two-week blackout period during which COI and COC information cannot be submitted. We will update you on specific dates soon. Please work to ensure your COI disclosure, research certifications and COC forms are updated by the end of May. Some of the benefits of eDisclosure include: 

  • A single point of disclosure for COI and COC matters using a progressive smart form that will open and hide pages based on the answers you provide.
  • Ability to view the progress of your disclosure as it makes its way through the COI and COC review processes.

For more information, contact the COI Program at coi@arizona.edu.

New electronic Institutional Review Board (IRB) system

Additionally, HSPP is implementing a new electronic IRB system called eIRB, which is a platform where researchers will submit and manage their human subject protocols. Details regarding the rollout of this new system, which will increase productivity and provide researchers with a greater level of transparency during IRB reviews, include:

  • Going live in August 2021.
  • There will be a planned blackout period where no IRB submissions will be accepted. This will be approximately two weeks before the go-live date. Please check your email inboxes for updates on timing. 
  • IRB Meetings will be held on the first and second Tuesdays of June, July, and August. Ad hoc meetings may be scheduled. 
  • For projects that expire July-August 2021, please get your renewal paperwork in ASAP. If the project expires during the planned blackout period, please submit renewal paperwork at least two weeks before the planned blackout period. Otherwise, reapproval is not guaranteed and the project will expire. The project will also be expired in the new eIRB system after the system goes live. 
  • For projects that expire after the system goes live, please use eIRB to submit Continuing Reviews. User guides will be published when the system is launched. 
  • Submissions to the VPR-IRB@arizona.edu inbox will not be accepted starting approximately one to two weeks before the planned blackout period. Urgent submissions will be handled on a case-by-case basis. IRB inquiries should still be submitted to VPR-IRB@arizona.edu

Those with questions about eIRB are asked to contact Christine Melton-Lopez, HSPP director, at melton1@email.arizona.edu.

Research system upgrade

This fall, following implementation of the COI and HSPP systems, the current UAccess Research (UAR) system will be updated to a newer version called Kuali Research. 

Here are some highlights: 

  • The updated system will go live about a month after eIRB is active.
  • Familiar content will have a more modern look and feel.
  • The system will deliver new features and fixes on a continuous basis.
  • Adjusted proposal routing will shorten approval times.
  • The research system will be unavailable from close of business on a Friday evening and will be live again the next Tuesday morning.
  • To prepare for routing changes, all proposals that start routing in UAR must be fully approved and submitted by Sponsored Projects and Contracting Services (SPCS) before UAR goes down. Any proposals still routing can be canceled, copied and rerouted by the proposal initiator when Kuali Research goes live. Additional details about proposal deadlines will follow.
  • Responses to proposal questions will flow from proposals through awards to facilitate more accurate campus and institutional reporting. 
  • The University VPN will no longer be required to access the research system.

For more information, contact Susan Mundt, SPCS assistant director of operations, at mundts@arizona.edu.
 

Does the HSPP provide any other training for investigators about the IRB?

Yes! The HSPP offers a variety of training opportunities including workshops and Office Hours. For training details, please visit the IRB Training Opportunities webpage. If you are interested in requesting training on a specific topic or having an HSPP member present at a class, lab, or faculty meeting, please contact the general inbox at VPR-IRB@arizona.edu

I'm using Banner Health resources. What do I need to know?

Prior to IRB submission, all projects that will utilize Banner Health resources (i.e., facilities, patients, employees) must be entered into the University of Arizona Health Sciences (UAHS) Research Administration Portal (RAP). Upon submission to the IRB, please upload RAP approval to eIRB. In addition, the IRB also requires that the UA Medical Consent Form be used when Banner Health resources will be utilized.

How do I report an unanticipated complication and/or adverse event?

Investigators are required to report local problems, concerns, serious risks, and failure to follow the protocol to the IRB for all human subjects research. These reports must be submitted to the IRB within ten (10) business days of discovery. Changes made to eliminate risk to subjects must be reported to the IRB within five (5) business days of discovery. Reportable items must be submitted in eIRB as a Reportable New Information (RNI). If the University of Arizona IRB is the IRB of Record for another site, the site must follow the same requirements. For additional information, please see our guidance on Reporting New Information

Does my research require IRB approval?

IRB review and approval is required for research projects involving human subjects.

Human subjects research is a systematic investigation (research question/hypothesis testing), designed to contribute to generalizable knowledge (add to the scientific knowledgebase in the field) done so while intervening or interacting with living individuals or their identifiable data. For additional information, please see our guidance on What is Human Research and watch our pre-recorded training video: Does Your Project Require IRB Review? 

If you are still unsure whether or not your study is human subjects research, complete and submit the IRB Protocol for Determination of Human Research in eIRB.