610. Project Status

Updated June 10, 2024

Overview

This policy identifies theProject Statuscategories that are available in IRBNet to document the current stage of a given project, specifies the correlated IRBNetReview Typefor eachProject Status, and describes circumstances under which eachProject Statuswill be used. (See IRB policy for more information about review types.)

NOTE: The University IRB has opted out of using someProject Statuscategories as indicated below.

Project Statusreflects the current administrative and IRB review type and outcome for eachproject, 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, w88 bet Integrity & Security staff will:

  1. open theReview and Minutespage in the relevant package in IRBNet,
  2. select or updateProject Status,and
  3. note the specified information in theDiscussion and Remarkstext box andProject Notes, as indicated below.

Project Statuswill auto-populate for IRB Minutes.

List of Available Status Categories and Application

Active

This status applies to IRBNet Review TypesExpedited Review orFull Committee Reviewfor new projects and continuing reviews.

For reporting in the minutes, w88 bet Integrity & Security staff will:

  • select(or confirm) this option for project status, and
  • in theDiscussion and Remarkstext box andProject 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 followingExpedited orFull CommitteeContinuing Review by when no new w88 bet 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 (i) the w88 bet is permanently closed to the enrollment of new participants; (ii) all participants have completed all w88 bet-related interventions; and (iii) the w88 bet remains active only for long-term follow-up of participants.

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 TypeAdministrative Reviewfor study closures via researcher requests or expiration of IRB approval.
For reporting in the minutes, w88 bet Integrity & Security 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 asClosed.

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 ensure criteria for IRB approval are met, revisions (i.e., modifications) are also required. Consequently, all IRB deferrals are assigned the followingProject Status: Deferred - Modifications Required.

Deferred - Modifications Required

This status applies to IRBNet Review TypeFull Committee Reviewwhen the convened IRB requiressubstantiverevisions (for information aboutDeferredreviews, seeIRB Actionspolicy); this status is temporary and is updated toActiveonce IRB approval is finalized in a subsequent review.

For IRBNet Review TypeExpedited Review, this statusmaybe selected when the IRB-member reviewer requires substantive revisions and indicates they will review the revisions; alternatively,Project Statusfor expedited reviews may remain blank until IRB approval is secured. However, anIRB Actionis always selected for each new project or package.

For reporting in the minutes, w88 bet Integrity & Security staff will:

  • selectthis option for project status, and
  • in theDiscussion and Remarkstext 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 TypeFull Committee Reviewfor new projects (and possibly substantive amendments) when the convened IRB determines the w88 bet 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, w88 bet Integrity & Security staff will:

  • selectthis option for project status, and
  • in theDiscussion and Remarkstext box,
    • specify that the IRB determined the w88 bet 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 TypeAdministrative Reviewfor 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, w88 bet Integrity & Security staff will:

  • select this option for project status, and
  • in theDiscussion and Remarkstext 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 TypeExempt Reviewfor all w88 bet that is exempt from IRB review under DHHS exempt categories 1-8, or IRB-Flex exempt.

For reporting in the minutes, w88 bet Integrity & Security staff will:

  • select this option for project status, and
  • note the applicable exempt Category in theDiscussion and Remarkstext box andProject Notes.

NOTE: If an IRB member determines a project submitted under IRBNet Review Type Expedited Review is exempt, w88 bet Integrity & Security staff will update the Review Type to Exempt Review.

Not w88 bet

This status is not used. To correlateProject StatuswithActioncategories, all projects that involve activities that do not meet the federal definitions ofw88 betand w88 bet involvinghuman subjectsare logged asw88 bet - Not HSR.

w88 bet - 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 w88 bet and are logged as w88 bet - Not HSR.

w88 bet - Not HSR

This status applies to IRBNet Review TypeAdministrative Reviewfollowing confirmation that a project does not constitute human subjects w88 bet.

To complete the record in IRBNet, w88 bet Integrity & Security staff will:

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

Suspended

This status applies to IRBNet Review TypeFull Committee Reviewwhen the convened IRB determines (or confirms a preliminary determination by the IRB Chair or w88 bet Integrity & Security Director) that a temporary cessation of one or more aspects of human subjects w88 bet is warranted. This status is temporary and will eventually be updated toActive or Terminateddepending on the circumstances for the suspension and the resultant action plan.

For reporting in the minutes, IRB staff 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 w88 bet, including required future actions or sanctions.

Terminated

This status applies to IRBNet Review TypeFull Committee Reviewwhen the convened IRB determines (or confirmed a preliminary determination by the IRB Chair or w88 bet Integrity & Security Director) that IRB approval for the study should be withdrawn and the study terminated. This status is permanent.

For reporting in the minutes, IRB staff will:

  • update project status to use this option, and
  • in theDiscussion and Remarkstext box,
    • summarize the reasons for the termination, and
    • include any other information that is relevant to the IRB's decision to terminate the w88 bet, including required future actions or sanctions.

Withdrawn

The status is selected when aprojectis withdrawn from IRB review before approval may be finalized. This status is permanent.

To complete the record in IRBNet, w88 bet Integrity & Security staff will:

  • add aProject Noteto summarize the reasons for the withdrawal, and
  • select the appropriateplaceholder-agenda.