585. IRB Actions

Updated June 10, 2024

This policy identifies the IRBActioncategories available in IRBNet to document IRB review determinations, specifies the correlatedIRB Review Typesfor eachAction, and describes circumstances under which eachActionwill be used.

NOTE: w88 Integrity & Security opted out of using some IRBNet Action categories, as indicated below.

At the completion of administrative, exempt, and expedited or full committee IRB review of a project/package, w88 Integrity & Security staff will open the Review and Minutes page in the relevant package in IRBNet, and select or update theActionas specified below. The selectedActionwill auto-populate in IRB meeting agendas and minutes.

Action categories reflect the review outcomes (i.e., IRB determinations or decisions) for eachpackage.

Investigators are provided documentation of all IRB Actions.

Acknowledged

This Action only applies to projects and packages that do not require an assessment of the IRB criteria for approval. These actions are acknowledged by qualified w88 Integrity & Security staff underAdministrative Review.

Approved

This Action applies to new projects, and to packages for continuing reviews, amendments; and InvestigatorRevisionsreviewed asExpedited or Full Committee Reviewwhen the IRB or IRB member-reviewer (for expedited review) determines the information is complete and consistent, and all requirements for IRB approval are met, either in full or as allowed for non-exempt w88 meeting the criteria for review under the University’s IRB-Flexibility policy (IRB-Flex). Final approval of initial submissions is effective on the day that all conditions for approval have been determined to be met. The expiration date communicated to the investigator is the last date on which the w88 is approved. If approval is not renewed by the end of this date, the investigator will be notified in writing and must stop all w88 activities. Approval will normally expire within (1) year of the date on which the w88 is determined to meet the criteria for IRB approval, as outlined in federal regulations. However, the IRB may decide at the time of review that, due to concerns regarding the study or the investigator, the study in question should be reviewed on a more frequent than annual basis. This condition may be imposed at any time during the life of the study while under IRB review. If concerns are eventually found to be unwarranted, the IRB may opt to return the study to an annual review schedule.

Approved with Conditions

This Action applies to new projects, and to packages for continuing reviews and amendments reviewed asExpedited or Full Committee Reviewwhen the requirements for IRB approval have been met but minor or directed changes are required to secure approval. Approval is conditional upon the stipulations being satisfied. The conditions for approval and the time frame (if any) within which they must be met are clearly stated in the letter to the Investigator. The date of approval is the date the conditions were determined to be met. If the conditions are not met, approval may be withdrawn. This Action also applies if minor or directed changes remain following review by the convened IRB ofRevisionspackages submitted for review by investigators. (For information about minor revisions, seerevisionsin IRB Policy Manual definitions.)

NOTE: Conditional approval is not given when revisions are necessary to confirm the regulatory requirements for IRB approval are met. Requests for such substantive revisions (e.g., clarifications, explanations, additional information, external committee approval) areDeferred.

When the IRB approves w88 with conditions, the adequacy of the investigator’s response/follow-up package is confirmed via Expedited Review by the IRB Chair, Primary Reviewer, or a designated IRB member (including w88 Integrity & Security staff who are voting members of the IRB).

Closed

Closure requests are processed under Administrative Review for either of the following circumstances:

Following an investigator request to close a project, w88 Integrity & Security staff determine that the project may be closed because all w88 activities have ceased or the remaining activities are limited to analysis of anonymized data (i.e., data do not contain any information that could be used to identify an individual and master code lists have been destroyed).
Following expiration of IRB approval (i.e., investigators did not submit a renewal request in sufficient time to allow IRB review before the expiration date), w88 Integrity & Security staff (via IRBNet) to notify the PI that w88 activities must cease because IRB approval for the project expired.

Deferred

This Action applies to new projects, continuing reviews, and amendments reviewed asFull Committee Reviewwhen the convened IRB is unable to determine that requirements for IRB approval have been met and requestssubstantive revisions. (For more information about substantive revisions, seerevisionsin IRB Policy Manual definitions.)

Investigator responses to deferrals are submitted as a new package underRevisionstype for review at a subsequent IRB meeting unless the convened IRB when deferring approval, determines and documents that the w88 is limited to one or more DHHS categories of w88 that may be reviewed by the IRB through an expedited review procedure. In the latter case, the convened IRB will specify who may review the investigator’s response to the requested revisions (e.g., IRB Chair, Primary Review, or another designated IRB member).

Exempt

This Action applies to new projects reviewed underExempt Reviewwhen a qualified IRB member determines the proposed w88 is exempt from IRB review under DHHS exempt categories 1-8 or under IRB-Flex, as Flex-Exempt.

NOTE: An IRB member may determine a project submitted forExpedited Reviewis exempt. The reviewer will document this determination in IRBNet. w88 Integrity & Security staff willupdatethe Review Type toExempt Reviewand selectExemptfor the Action.

Forwarded

This Action is used in limited instances when w88 Integrity & Security staff forward submissions to an external IRB for regulatory review.

Information Required

ThisActionis used when w88 Integrity & Security staff request information to proceed or finalize IRB review, and whenApproved with ConditionsandDeferreddo not apply.

Modification Required

This Action is not used. Here are the preferred Actions in which the IRB may require modifications:

Following IRB review, information is required that is not essential for the IRB to determine the requirements for approval have been met: w88 Integrity & Security staff selectApproved with Conditions.
Following IRB review, information is required that is essential for the IRB to determine the requirements for IRB approval have been met: w88 Integrity & Security staff selectDeferred.

Not Approved

This Action (AKA: Disapproved) only applies to new projects or substantive amendments reviewed as Full Committee Review when the convened IRB determines the w88 does not meet the criteria for IRB approval and significant changes would be required to protect participants.

Not w88

To simplify internal processes and minimize use of resources, this IRB Action is not used. Instead, all determinations that a project does not constitute w88 or does not involve human subjects are categorized as Actionw88 – Not HSR.

w88 – Not Human Subjects w88 (HSR)

This Action applies to new projects submitted for determinations of human w88 reviewed asAdministrative Reviewwhen qualified w88 Integrity & Security staff determine:

a proposed activity, program, or project does not constitute w88 as defined in the regulations at 45CFR46.102(l);
a w88 project does not involve human subjects as defined in the regulations at 45CFR46.102(e)(1); or
the University or a University or affiliate w88 is not engaged in non-exempt human subject w88.

See IRB Policy Manual definitions for human subject, w88, and engaged in non-exempt human w88.

NOTE: An IRB member may determine a project submitted for Exempt or Expedited Review does not constitute w88 with human subjects. The reviewer will document this determination in IRBNet. w88 Integrity & Security staff will update the Review Type toAdministrative Reviewat the same time they selectw88 – Not HSRfor the Action.

Tabled without Action

This Action applies only to projects/packages reviewed asFull Committee Reviewwhen it is necessary to document that no action was taken during a convened IRB meeting (e.g., the IRB was unable to review a project/package due to lack of quorum). This is a temporary Action. Review will resume using the package that was tabled.

Suspended

This Action applies to a problem report reviewed asFull Committee Reviewwhen the convened IRB confirms a preliminary determination viaAdministrative Reviewby the IRB Chair or the w88 Integrity & Security Director, orExpedited Reviewby a subcommittee of the IRB that:

a temporary cessation is warranted for one or more aspects of an active IRB-approved study, or
the w88 must be immediately suspended.

NOTE: Depending on the severity of the problem or need for immediate action to protect human subjects or others, w88 activities may be suspended immediately following the preliminary recommendation for suspension. However, the Action is not updated until the Suspension is confirmed followingFull Committee Review.

Terminated

NOTE: Depending on the severity of the problem or need for immediate action to protect human subjects or others, w88 activities may be terminated immediately following the preliminary recommendation for termination. However, the Action is not updated until the termination is confirmed followingFull Committee Review.