610. w88 mobile Status

Updated June 10, 2024

Overview

This policy identifies the w88 mobile Status categories that are available in IRBNet to document the current stage of a given w88 mobile, specifies the correlated IRBNet w88 mobile Type for each w88 mobile Status, and describes circumstances under which each w88 mobile Status will be used. (See IRB policy for more information about w88 mobile types.)

NOTE: The University w88 mobile has opted out of using some w88 mobile Status categories as indicated below.

w88 mobile Status reflects the current administrative and IRB w88 mobile type and outcome for each w88 mobile, 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 w88 mobile/package, Research Integrity & Security staff will:

  1. open the w88 mobile and Minutes page in the relevant package in IRBNet,
  2. select or update w88 mobile Status, and
  3. note the specified information in the Discussion and Remarks text box and w88 mobile Notes, as indicated below.

w88 mobile w88 mobile will auto-populate for w88 mobile Minutes.

List of Available w88 mobile Categories and Application

Active

This w88 mobile applies to IRBNet Review Types Expedited w88 mobile or Full Committee w88 mobile for new projects and continuing reviews.

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

  • select (or confirm) this option for w88 mobile status, and
  • in the Discussion and Remarks text box and w88 mobile Notes, note the expedited w88 mobile category, for projects reviewed by expedited procedures.

Active - Open to Enrollment

This w88 mobile is not used.

Active - Closed to Enrollment

This w88 mobile is updated following Expedited or Full Committee Continuing Review by when no new research participants will be enrolled in an approved w88 mobile. This status also applies following IRB approval of a w88 mobile 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 mobile is permanently closed to the enrollment of new participants; (ii) all participants have completed all w88 mobile-related interventions; and (iii) the w88 mobile remains active only for long-term follow-up of participants.

Active - Data Analysis Only

This w88 mobile is not used.

Active - Long-Term Follow-Up Only

This w88 mobile is not used.

Closed

This w88 mobile applies to IRBNet Review Type Administrative w88 mobile for study closures via researcher requests or expiration of w88 mobile approval.
For reporting in the minutes, Research Integrity & Security staff will update w88 mobile 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 w88 mobile is not used. Expirations are treated as Closed.

Closed - w88 mobile Complete

This w88 mobile is not used. The University IRB does not specify why a study closed.

Deferred - Information Required

This w88 mobile 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 following w88 mobile w88 mobile: Deferred - Modifications Required.

Deferred - Modifications Required

This w88 mobile applies to IRBNet Review Type Full Committee w88 mobile when the convened w88 mobile requires substantive revisions (for information about Deferred reviews, see w88 mobile Actions policy); this w88 mobile is temporary and is updated to Active once IRB approval is finalized in a subsequent w88 mobile.

For IRBNet w88 mobile Type Expedited w88 mobile, this w88 mobile may be selected when the IRB-member reviewer requires substantive revisions and indicates they will w88 mobile the revisions; alternatively, w88 mobile Status for expedited reviews may remain blank until w88 mobile approval is secured. However, an w88 mobile Action is always selected for each new w88 mobile or package.

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

  • select this option for w88 mobile status, and
  • in the Discussion and Remarks text box,
    • specify the w88 mobile was unable to determine that requirements for w88 mobile 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 w88 mobile applies to IRBNet Review Type Full Committee w88 mobile 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 w88 mobile.

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

  • select this option for w88 mobile status, and
  • in the Discussion and Remarks text box,
    • specify that the IRB determined the w88 mobile 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 w88 mobile applies to IRBNet Review Type Administrative w88 mobile 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 w88 mobile and approval by the IRB.

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

  • select this option for w88 mobile 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 w88 mobile applies to IRBNet Review Type Exempt w88 mobile for all w88 mobile that is exempt from IRB review under DHHS exempt categories 1-8, or IRB-Flex exempt.

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

  • select this option for w88 mobile status, and
  • note the applicable exempt Category in the Discussion and Remarks text box and w88 mobile Notes.

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

Not w88 mobile

This w88 mobile is not used. To correlate w88 mobile Status with Action categories, all projects that involve activities that do not meet the federal definitions of w88 mobile and w88 mobile involving human subjects are logged as w88 mobile - Not HSR.

w88 mobile - Not Engaged

This status is not used. To correlate w88 mobile Status with Action categories, projects in which the University is not engaged are not considered research and are logged as Research - Not HSR.

w88 mobile - Not HSR

This w88 mobile applies to IRBNet Review Type Administrative w88 mobile following confirmation that a w88 mobile does not constitute human subjects research.

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

  • select this option for w88 mobile status, and
  • in the Discussion and Remarks text box, summarize the w88 mobile activity. This information will in the IRB decision letter.

Suspended

This w88 mobile applies to IRBNet Review Type Full Committee w88 mobile when the convened IRB determines (or confirms a preliminary determination by the IRB Chair or Research Integrity & Security Director) that a temporary cessation of one or more aspects of human subjects research is warranted. This w88 mobile 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, w88 mobile staff will:

  • update w88 mobile 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 mobile, including required future actions or sanctions.

Terminated

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

For reporting in the minutes, w88 mobile staff will:

  • update w88 mobile 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 w88 mobile, including required future actions or sanctions.

Withdrawn

The w88 mobile is selected when a w88 mobile is withdrawn from IRB review before approval may be finalized. This w88 mobile is permanent.

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

  • add a w88 mobile Note to summarize the reasons for the withdrawal, and
  • select the appropriate placeholder-agenda.