610. Project Status

Updated July 1, 2019

Overview

This policy identifies the Project Status categories that are available in IRBNet to document the current stage of a given project, specifies the correlated IRBNet Review Type for each Project Status, and describes circumstances under which each Project Status will be used. (See IRB policy for more information about review types.)

NOTE: The University IRB has opted out of using some Project Status categories as indicated below.

Project Status reflects the current administrative and IRB review type and outcome for each project, and will be updated one or more times over the life projects as reflected below.

At the completion of administrative, exempt, or expedited or full committee IRB review of a project/package, RI staff will

  1. open the Review and Minutes page in the relevant package in IRBNet,
  2. select or update Project Status, and
  3. note the specified information in the Discussion and Remarks text box and Project Notes, as indicated below.

Project Status will auto-populate for IRB Minutes.

List of Available Status Categories and Application

Active

This status applies to IRBNet Review Types Expedited Review or Full Committee Review for new projects and continuing reviews.
For reporting in the minutes, RI staff will

  • select (or confirm) this option for project status, and
  • in the Discussion and Remarks text box and Project Notes, note the expedited review category, for projects reviewed by expedited procedures.

Active - Open to Enrollment

This status is not used.

Active - Closed to Enrollment

This status is updated following Expedited or Full Committee Continuing Review by when no new research participants will be enrolled in an approved project. This status also applies following IRB approval of a project amendment notifying the IRB that enrollment has closed. 

Note: Full Committee Reviews may be completed as Expedited Reviews under Category 8(a) when the research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects.

Active - Data Analysis Only

This status is not used.

Active - Long-Term Follow-Up Only

This status is not used.

Closed

This status applies to IRBNet Review Type Administrative Review for study closures via researcher requests or expiration of IRB approval.
For reporting in the minutes, RI staff will update project status to use this option and record the date the closure is effective. Effective Date for the closure event will reflect the protocol closure date.

Closed - Expired

This status is not used. Expirations are treated as Closed.

Closed - Project Complete

This status is not used. The University IRB does not specify why a study closed.

Deferred - Information Required

This status is not used. Generally, when information is required to insure criteria for IRB approval are met, revisions (i.e., modifications) are also required. Consequently, all IRB deferrals are assigned the following Project Status: Deferred - Modifications Required.

Deferred - Modifications Required

This status applies to IRBNet Review Type Full Committee Review when the convened IRB requires substantive revisions (for information about Deferred reviews, see IRB Actions policy); this status is temporary and is updated to Active once IRB approval is finalized in a subsequent review.

For IRBNet Review Type Expedited Review, this status may be selected when the IRB-member reviewer requires substantive revisions and indicates she/he will review the revisions; alternatively, Project Status for expedited reviews may remain blank until IRB approval is secured. However, an IRB Action is always selected for each new project or package.
For reporting in the minutes, RI staff will

  • select this option for project status, and
  • in the Discussion and Remarks text box,
    • specify the IRB was unable to determine that requirements for IRB approval have been met,
    • describe any controverted issues that arose during the meeting and resolution, and
    • note the requested revisions including justifications for same.

Disapproved

This status applies to IRBNet Review Type Full Committee Review for new projects (and possibly substantive amendments) when the convened IRB determines the research does not meet the requirements for IRB approval and significant changes would be required to protect participants. This is a permanent status.
For reporting in the minutes, RIO staff will

  • select this option for project status, and
  • in the Discussion and Remarks text box,
    • specify that the IRB determined the research did not meet the requirements for IRB approval,
    • describe any controverted issues that arose during the meeting and resolution, and
    • note the reasons for the decision.

Emergency Use

This status applies to IRBNet Review Type Administrative Review for IRB notification and assessment of emergency use of a test article according to the provision in the FDA regulations [21 CFR 56.104(c)] for emergency-use to be exempt from requirements for prior review and approval by the IRB.
For reporting in the minutes, RI staff will

  • select this option for project status, and
  • in the Discussion and Remarks text box,
    • specify that the Emergency Use was adequately described and met FDA criteria, and
    •  indicate if informed consent was obtained from the patient; or note that the clinician was unable to obtain consent from the patient and specify if the clinician appropriately sought and documented counsel of an independent physician.

Exempt

This status applies to IRBNet Review Type Exempt Review for all research that is exempt from IRB review under DHHS exempt categories 1-6, or IRB-Flex exempt.

For reporting in the minutes, RI staff will

  • select this option for project status, and
  • note the applicable exempt Category in the Discussion and Remarks text box and Project Notes.

NOTE: If an IRB member determines a project submitted under IRBNet Review Type Expedited Review is exempt, RI staff will update the Review Type to Exempt Review.

Not Research

This status is not used. To correlate Project Status with Action categories, all projects that involve activities that do not meet the federal definitions of research and research involving human subjects are logged as Research - Not HSR.
Research - Not Engaged

This status is not used. To correlate Project Status with Action categories, projects in which the University is not engaged are not considered research and are logged as Research - Not HSR.

Research - Not HSR

This status applies to IRBNet Review Type Administrative Review following confirmation that a project does not constitute human subject research.

To complete the record in IRBNet, RI staff will

  • select this option for project status, and
  • in the Discussion and Remarks text box, summarize the project activity. This information will in the IRB decision letter.

Suspended

This status applies to IRBNet Review Type Full Committee Review when the convened IRB determines (or confirms a preliminary determination by the IRB Chair or RI Director) that a temporary cessation of one or more aspects of human subject research is warranted. This status is temporary and will eventually be updated to Active or Terminated depending on the circumstances for the suspension and the resultant action plan.
For reporting in the minutes, IRB Program Managers will

  • update project status to use this option,
  • in the Discussion and Remarks text box,
    • summarize the reasons for the suspension, and
    • include any other information that is relevant to the IRB's decision to suspend the research, including required future actions or sanctions.

Terminated

This status applies to IRBNet Review Type Full Committee Review when the convened IRB determines (or confirmed a preliminary determination by the IRB Chair or RI Director) that IRB approval for the study should be withdrawn and the study terminated. This status is permanent.
For reporting in the minutes, IRB Program Managers will

  • update project status to use this option, and
  • in the Discussion and Remarks text box, 
    • summarize the reasons for the termination, and
    • include any other information that is relevant to the IRB's decision to terminate the research, including required future actions or sanctions.

Withdrawn

The status is selected when a project is withdrawn from IRB review before approval may be finalized.  This status is permanent.
To complete the record in IRBNet, RI staff will

  • add a Project Note to summarize the reasons for the withdrawal, and
  • select the appropriate placeholder-agenda.