Human Subjects Protection Program (HSPP)

Do I need to submit a continuing review for my research study?

Annual continuing review is generally required for protocols approved by the fully convened IRB committee. An annual continuing review may also be necessary for the following types of protocols:

  • Projects involving Native American or Indigenous Populations;
  • Principal Investigator has received serious or continuing non-compliance determinations in the past two years;
  • Projects that involve deception but do not receive the subject’s prior authorization to be deceived before engaging in the deception;
  • A Conflict of Interest Management Plan exists;
  • FDA-regulated research eligible for Expedited review under Expedite Category 1 on approved drugs or devices;
  • Projects deemed Expedited Category 9; or
  • As determined by the IRB on a project basis depending on the risks in the research project.

As a courtesy, eIRB notifications are sent to investigators several weeks before the approval end date for protocols needing a continuing review. A continuing review submission must be submitted in eIRB at least 4-6 weeks before the approval end date. If the protocol is not granted continuing approval before expiration, all research activities must pause until reapproval.

Please review HSPP Guidance, Continuing Review of Human Research for more information.

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I will be collaborating with another institution. What do I need to know?

Typically, U of A researchers must receive U of A IRB approval to conduct research with human subjects, regardless of where the research takes place. When collaborative projects are expected to involve researchers from multiple institutions, contact the HSPP to determine next steps.  While in some cases each investigator should work with their own institution’s IRB, in other cases, it might be advisable (or required by a funder) to arrange an IRB reliance/institutional agreement (IAA) to designate one IRB to review and approve the research as a whole. Visit the Single IRB Research webpage for details.

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I received a determination of "Not Human Research" and need to modify my project. Do these changes require IRB review and approval?

The HSPP does not accept modifications to determinations of human research as these projects are not overseen by an IRB. Investigators may proceed as long as the intent behind the project remains unchanged. If changes are made affecting whether the activities are human research, a new determination request must be submitted for review in eIRB.

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What IRB training do I need to take?

Human subjects training is required for all investigators, faculty, staff, and students conducting research with human subjects at the University of Arizona. There are two CITI training options for investigators to choose from, depending on the type of research:

  1. IRB: Biomedical Research Investigators (required for FDA-regulated research or projects involving accessing medical records); OR
  2. IRB: Social & Behavioral Research Investigators

Visit our Training Requirements webpage for more information.

Human Subjects Training Handout

 

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Do I need to submit a modification to my approved research study?

Full Committee or Expedite Research

The IRB must review and approve all changes to previously approved Full Committee or Expedite research prior to implementing the changes. For additional information, see our guidance on Modifying Approved Research.

More information on how to submit a Modification can be found on our eIRB Information webpage.

Exempt and Minimal Risk Research

Studies that are Exempt or Minimal Risk (MR) do not need to submit modifications to the IRB for review and approval unless the modifications change the nature of the project from being Exempt/MR. See the Exempt Minimal Risk Research guidance, which outlines when modifications are required.

If a modification is not required, the IRB recommends downloading the relevant approved documents within eIRB, making the necessary changes, and saving them separately in your research files. All modifications not reviewed by the IRB should be documented systematically to maintain an accurate record of all study activities to date.

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What does "Exempt" mean? Does this mean I don't have to submit an application for review?

Projects that meet the definition of regulated human research under the Common Rule may fit within one or more categories of “Exempt” research. This does not mean that these studies do not need IRB review. For a research study to be deemed "Exempt", investigators need to submit an application to the IRB. Please note that an "Exempt" determination must be made by the IRB.

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eIRB and eDisclosure Unavailable April 21-23

2 years 1 month ago

The Research, Innovation & Impact Human Subjects Protection Program (HSPP) will implement upgrades to the electronic Institutional Review Board (eIRB) system to provide the latest features and maintain quality performance.

This upgrade will cause the eIRB and eDisclosure systems to be unavailable beginning 8 a.m., Friday, April 21 through 8 a.m., Monday, April 24.

eIRB

  • During the upgrade period, eIRB review and approval will be unavailable.
  • Submissions to the eIRB should be processed before 8 a.m., Friday, April 21, or after 8 a.m., Monday, April 24.
  •  
  • For urgent eIRB matters and just-in-time (JIT) requests that arise during this window: email Christine Melton-Lopez, director HSPP. 
  • For questions or more information: email the HSPP team.

eDisclosure

  • During the upgrade period, individuals will be unable to disclose Outside Interests, Outside Activity and Substantial Interests. Individuals will not be able to submit Research Certifications and Outside Activity approval will not be available.
  • Conflict of Interest (COI) at Proposal Submission: for federal and sub-federal proposals due on or before Wednesday, April 26, investigators are encouraged to complete annual disclosures before 6 p.m., Thursday, April 20.
  • For routing proposals received during the upgrade period, the Office for Responsible Outside Interests (OROI) will rely on data from Thursday, April 20. Beginning 8 a.m., Monday, April 24, OROI will return to using live data.
  • UAccess Analytics dashboards: the eDisclosure Conflict of Interest dashboards will reflect data from Thursday, April 20 until Tuesday, April 25.

 

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New eIRB System Now Available

3 years 8 months ago

The new eIRB is now available for human subjects research submissions.

For information on using eIRB, please consult the following resources:

Video demos and instructional material: eIRB Information (NetID is required)

Zoom drop-in training sessions: eIRB Drop-In Office Hours (no registration required)

  • Weeks of Sept. 13 and Sept. 24: Mondays, Wednesdays, Fridays: 10-11 a.m. and 1-2 p.m.
  • Weeks of Sept. 27 and Oct. 8: Tuesdays, Thursdays: 10-11 a.m. and 1-2 p.m.
  • Weeks of Oct. 13 and Oct. 18: Wednesdays: 10-11 a.m. and 1-2 p.m. 

How will the move to eIRB affect you?

The new eIRB system is now being used for all human subjects research submissions, including determination of human research and external IRB requests. Submissions are no longer accepted via our general departmental email inbox.

For questions or more information, contact the Human Subjects Protection Program at vpr-irb@arizona.edu. 

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

4 years 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.
 

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