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

1 year 7 months 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 2 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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Reminder: Implementing a New IRB System

3 years 3 months ago

Implementing a New Institutional Review Board (IRB) System

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.

August 13th is the last day to submit to the HSPP for full committee review. August 20th is the last day to submit to the HSPP for non-committee review. 

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.  

Please forward this notice to any undergraduate students that may find this information useful.

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

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