Frequently Asked Questions about Human Subjects Protection

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

Approval timelines are contingent upon the complexity of a study, the investigator's responsiveness, and whether applicable approvals have been obtained. Average approval timelines are broken down by level of review:

• Non-Committee Review (Minimal Risk/Exempt/Expedite): 14 business days
• Committee Review: 30 business days

The IRB evaluates every research protocol according to the ethical principles described in the Belmont Report and according to the specific regulatory criteria outlined in the Common Rule (45 CFR 46) and, when applicable, FDA regulations (21 CFR 50 and 56). The IRB considers whether the risks and benefits of a study are acceptable and managed appropriately, and whether individuals being asked to participate are adequately informed about the research.

Investigators should look at their research from the point of view of a participant or an observer concerned about responsible research. For example:

• Who are the participants, and how are they recruited?
• Could they be unduly influenced or coerced to participate?
• Do they understand, in advance, what they are agreeing to participate in and give their consent willingly?
• What will they do, and what will be done to them, during the study?
• Is it possible that the experience might be injurious, painful, uncomfortable, needlessly boring, embarrassing, offensive, or otherwise stressful?
• Might there be long-term consequences?
• Could the participant be endangered, compromised, or embarrassed if information collected leaked out?  

The IRB's role is to look at the study from this perspective and to ensure that proper precautions are in place to protect research participants.

We encourage investigators to review the Guidance for Researchers webpage, which includes essential information on many different research topics to learn more about what ethical standards and regulatory requirements the IRB assesses during their 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.

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.

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.

You can find more information on how to submit a Modification 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. Refer to 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.

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.

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.

Only the Principal Investigator (PI) and designated PI Proxies can submit to the IRB. A PI Proxy is someone designated by the PI who can submit on the PI’s behalf in eIRB. PIs can assign any individual listed as a study team member in eIRB as a PI Proxy. Refer to the How to Add and Remove a PI Proxy handout for step-by-step instructions.

All investigators and research personnel must complete a Research Certification for each study they are involved with before IRB approval is granted. Note: these study-specific Research Certifications are in addition to the annual conflict of interest (COI) Disclosure Certification.

Research Certifications are integrated with eIRB in two ways: 

1. When a funding source is selected, eIRB displays the COI review status for individuals who are listed on the UA Institutional Proposal and/or Award.
2. When there is no funding source for the protocol, Research Certifications are created. 

When there are research personnel who are not listed on the non-sponsored protocol, Institutional Proposal, and/or Award, HSPP requests that the Office of Responsible Outside Interests (OROI) manually create Research Certifications for these individuals.

Study-specific Research Certifications are generated on a project-by-project basis. To complete them, investigators need to:

1. Log into eDisclosure.
2. From the Dashboard, locate the “My Inbox” tab to locate a list of outstanding Research Certifications. Locate the project title by clicking the Research Certification.

COI Resources

• For assistance navigating eDisclosure, refer to the information on the OROI webpage.
• Instructions for completing research-related COI certifications
• Email coi@arizona.edu with questions about the COI process.

The “Response Time Exceeded’ notification is an auto-generated weekly reminder when a Clarification Request response is pending in eIRB. The notification serves to alert the Principal Investigator and study team that a reply is needed. It does not mean that the response time has expired. The notifications will continue every 7 days until a response is submitted to the IRB.

The “Continuing Review Not Required” notification is generated by eIRB when a Minimum Risk, Exempt, or Expedited study that previously had an expiration date in the old IRB system is migrated, and no longer has an IRB approval end date in the new eIRB system. The notification is automated, and you might receive it multiple times; however, no action is required from the Principal Investigator or the study team.