595. Determining Dates for Full Committee and Expedited Reviews

Updated July 19, 2021

The IRB approves new projects, continuing reviews, and project amendments only after determining the research complies with the DHHS criteria for IRB approval at 45 CFR 46.111 and when applicable, the additional requirements of Subparts B, C, and D; and of other federal agencies; orwouldcomply with these requirements if specific, minor conditions requested by the IRB are met.

The IRB documents all approval dates in IRBNet as outlined below. The w88 online casino betting of approval is calculated, consistent with applicable law, regulations, and guidance.

Package-level Dates

TheEffective w88 online casino bettingapplies at the package level and is documented for each package.

Project-level Dates

TheInitial Approval w88 online casino bettingapplies to new projects only. TheInitial Approval w88 online casino bettingdepends on review type (i.e., Expedited versus Full Board) and theIRB Action at the first and subsequent reviews.

TheProject Expiration w88 online casino bettingdesignates the due w88 online casino betting for completion of the next IRB review. TheProject Expiration w88 online casino bettingis calculated by adding the specified approval period to theInitial Approval w88 online casino betting. The expiration w88 online casino betting is updated following each continuing review. It is the last day the project is approved.

TheEffectiveandProject Expiration Datesappear in IRB approval letters and minutes.

Regardless of review type,IRB Actionsother thanApprovedrequire at least two packages in IRBNet. The following sections for new projects refer to the new project package as Package-1 and the second package submitted and reviewed as Package-2, containing the investigator's response to the revisions requested by the IRB (i.e., response/follow-up package).

Dates for New Projects: Full Committee Review

Dates for Convened IRB Action: Approved

For new projects approved at the first review by the convened IRB, dates are determined and documented as follows.

• TheEffective w88 online casino bettingfor Package-1 is the w88 online casino betting the convened IRB approved the new project
• TheInitial Approval w88 online casino bettingis documented in Package-1 and is the w88 online casino betting the convened IRB approved the project (the same w88 online casino betting as theEffective w88 online casino betting).
• TheProject Expiration w88 online casino bettingis documented in Package-1.
• For reporting purposes, the Package-1Effective w88 online casino bettingis considered both the review and the approval dates.

Dates for Convened IRB Action: Approved with Conditions

New projects approved with conditions at the first review by the convened IRB will have at least two packages, a new project and response/follow-up package, with dates documented as follows.

Dates for New Project (Package-1): Approved with Conditions

• TheEffective w88 online casino bettingfor Package-1 is the w88 online casino betting the convened IRB determined the research would be approvable and defined the required specific/minor conditions.
• Initial ApprovalandExpiration Datesremain blank in Package-1.
• For reporting purposes, the Package-1Effective w88 online casino bettingis the first review w88 online casino betting.

Dates for Response/Follow-Up (Package-2): Approved

• TheEffective w88 online casino bettingfor Package-2 is the w88 online casino betting a designated IRB member confirmed the conditions for approval were satisfactorily met and is both theeffective w88 online casino betting of the initial approvaland the w88 online casino betting the IRB determined the research may commence.
• TheInitial Approval w88 online casino bettingis documented in Package-2 and is the w88 online casino betting the convened IRB determined the research would be approvable and defined the required specific/minor conditions (the same w88 online casino betting as the Package 1Effective w88 online casino betting).
• TheProject Expiration w88 online casino bettingis calculated from theInitial Approval w88 online casino bettingand is documented in Package-2.

NOTE: The Package-2 Effective w88 online casino betting auto-generates in IRB approval letters and as a notification in IRB minutes as the Effective w88 online casino betting for the Expedited Review of the Response/Follow-Up package (or other subsequent packages). No expedited review category is noted.

Dates for Convened IRB Action: Deferred

New projects deferred at the first review by the convened IRB will have at least two packages, new project and revisions package. The outcome of the Package-2 review dictates the Package-2EffectiveandInitial Approval Datesand whether a third package is needed (e.g., the revisions package is approved with conditions). Dates are determined and documented for Package-1, Package-2, and Package-3 (if necessary) as follows.

Dates for New Project (Package-1): Deferred

• TheEffective w88 online casino bettingfor Package-1 is the w88 online casino betting the convened IRB deferred approval.
• Initial ApprovalandExpiration Datesremain blank in Package-1.
• For reporting purposes, the Package-1Effective w88 online casino bettingis thefirst revieww88 online casino betting.

Dates for Revisions in Response to Deferral (Package-2): Approved

• TheEffective w88 online casino bettingfor Package-2 is the w88 online casino betting the convened IRB approved the revisions package.
• TheInitial Approval w88 online casino bettingis documented in Package-2 and is the w88 online casino betting the convened IRB approved the project (the same w88 online casino betting as the Package-2Effective w88 online casino betting).
• TheProject Expiration w88 online casino betting is calculated from the Initial Approval w88 online casino betting and is documented in Package-2

NOTE: The Package-2 Effective w88 online casino betting (i.e., effective w88 online casino betting for initial approval) auto-generates in IRB approval letters and as a notification in IRB minutes as the Effective w88 online casino betting for the revisions package.

Dates for Revisions in Response to Deferral (Package-2): Approved with Conditions

• TheEffective w88 online casino bettingfor Package-2 is the w88 online casino betting the convened IRB determined the research would be approvable and defined the required specific/minor conditions.
• TheInitial ApprovalandExpiration Datesremain blank in Package-2.

Dates for Response/Follow-up (Package-3): Approved

A third package is required if the revisions package (i.e., Package-2) is approved with conditions. Dates for Package-3 follow Dates for Response/Follow-Up (Package-2): Approved above.

Dates for Convened IRB Action: Disapproved

• TheEffective w88 online casino bettingfor Package-1 is the w88 online casino betting the convened IRB disapproved the project. Package-1 becomes the terminal package for the study.
• Initial ApprovalandExpiration Datesremain blank in Package-1.
• For reporting purposes, the Package-1Effective w88 online casino bettingis therevieww88 online casino betting.

Dates for New Projects: Expedited Review

Dates for Expedited Review Action: Approved

• TheEffective w88 online casino bettingfor Package-1 is the w88 online casino betting the expedited reviewer approved the new project.
• TheInitial Approval w88 online casino bettingis documented in Package-1 and is the w88 online casino betting the expedited reviewer approved the project (the same w88 online casino betting as theEffective w88 online casino betting).
• TheProject Expiration w88 online casino bettingis documented in Package-1.
• For reporting purposes, the Package-1Effective w88 online casino bettingis the review and the approval w88 online casino betting.

Dates for Expedited Review Action: Approved with Conditions or Deferred

New projects approved with conditions (or deferred) at the first expedited review will have at least two packages, a new project and response/follow-up package, with dates documented as follows.

Dates for New Project (Package-1): Approved with Conditions/Deferred

• TheEffective w88 online casino bettingfor Package-1 is the w88 online casino betting the expedited reviewer determined the research would be approvable and defined the specific/minor conditions required to finalize IRB approval, or deferred IRB approval pending receipt and review of the researcher's response to requested substantive revisions.
• Initial ApprovalandExpiration Datesremain blank in Package-1.
• For reporting purposes, the Package-1Effective w88 online casino bettingis the first review w88 online casino betting.

Dates for Response/Follow-Up (Package-2): Approved

• TheEffective w88 online casino bettingfor Package-2 is the w88 online casino betting a designated IRB member confirmed the conditions for approval were satisfactorily met or the requested revisions rendered the research approvable and is both theeffective w88 online casino betting of the initial approvaland the w88 online casino betting the IRB determined the research may commence.
• TheInitial Approval w88 online casino bettingis documented in Package-2 and is the same w88 online casino betting as the Package -2Effective w88 online casino betting (i.e., the w88 online casino betting a designated IRB member determined the conditions for approval were satisfactorily met).
• TheProject Expiration w88 online casino bettingis documented in Package-2.

NOTE: The Package-2Effective w88 online casino bettingauto-generates in IRB approval letters and as a notification in IRB minutes as theEffective w88 online casino bettingfor theExpedited Reviewof theResponse/Follow-Uppackage (or other subsequent packages).

Dates for Expedited Review Action: Disapproved

Projects cannot be disapproved by Expedited Review. If the expedited reviewer determines disapproval may be warranted, the project is referred for review by the convened IRB. The dates are determined and documentedafterthe subsequent IRB review and action.

Dates for Continuing Reviews

TheEffective w88 online casino bettingfor continuing review packages is the w88 online casino betting the convened IRB or expedited reviewer reviews and approves the continuing review package. If the review is approved with conditions, the response/follow-up package will result in a newEffective w88 online casino betting.

The University IRB maintains fixed annual renewal dates by basingProject Expiration Dateson theInitial Approval w88 online casino betting. Exceptions to fixed annual renewal dates occur when the continuing review is completed more than 30 days before the expiration w88 online casino betting, or the continuing review is not approved by the expiration w88 online casino betting.

Fixed Annual Renewal Dates

For continuing reviews completed less than 30 days before the expiration w88 online casino betting: The newProject Expiration w88 online casino bettingis calculated by adding the specified approval period to the existingProject Expiration w88 online casino betting, thereby maintaining a fixed annual renewal w88 online casino betting.

Dates for Early Reviews

For continuing reviews completed more than 30 days before the expiration w88 online casino betting: The newProject Expiration w88 online casino bettingis calculated by adding the specified approval period to theEffective w88 online casino bettingof the early continuing review.

Dates Following Lapse of IRB Approval

When continuing reviews are not approved by the expiration w88 online casino betting, IRB approval expires.

When IRB approval expires, the IRB informs the researchers in writing that all research activities must cease (including enrollment of new participants) until the research is approved by Full Committee or Expedited Review, as applicable. If due to an over-riding safety concern or ethical issue it is in the best interests of individual participants for interactions or interventions to continue, the IRB may allow conditional continuation. The PI must submit a report explaining why the research should be continued to avoid harm to current participants that would result from stopping study procedures and a plan for continuation pending re-approval.

• TheEffective w88 online casino bettingfor continuing review following lapse of IRB approval is the w88 online casino betting the convened IRB or expedited reviewer reviews and re-approves the research.
• A newProject Expiration w88 online casino bettingis calculated by adding the specified approval period to the continuing review packageEffective w88 online casino betting.

Dates Following Suspension of IRB Approval or Research Activities

When IRB approval is suspended or the sponsor suspends research activities, the IRB informs the researchers in writing that the research activities must temporarily cease until the research is re-approved by the IRB. Re-approval generally requires Full Committee Review of amendments to minimize risks that prompted the suspension.

• TheEffective w88 online casino bettingfollowing suspension of IRB approval or research activities, is the w88 online casino betting the convened IRB reviews and re-approves the research (or subsequent amendment).
• A newProject Expiration w88 online casino bettingis calculated by adding the specified approval period to the newEffective w88 online casino betting.
• TheInitial Approval w88 online casino bettingremains unchanged but is no longer used to calculate theExpiration w88 online casino bettingin subsequent continuing reviews.

Dates for Amendments

Reviews of amendment packages do not affectInitial Approval or Project Expiration Dates.

Amendment Package: Approved

For amendment packages approved as submitted, theEffective w88 online casino bettingis the w88 online casino betting the convened IRB or expedited reviewer approved the amendment package.

Amendment Package: Approved with Conditions

Amendment packages approved with conditions whether byExpedited or Full Committee Reviewwill take at least two packages, amendment and response/follow-up, with dates documented as follows.

Dates for Amendment Package: Approved with Conditions

• TheEffective w88 online casino bettingfor an amendment package approved with conditions is the w88 online casino betting the convened IRB or expedited reviewer determined the amendments would be approvable and defined the required specific/minor conditions.
• For reporting purposes, the Package-1Effective w88 online casino bettingis the amendment package review w88 online casino betting.

Dates for Amendment Response/Follow-Up Package: Approved

• TheEffective w88 online casino bettingfor the amendment response/follow-up package is the w88 online casino betting a designated IRB member confirmed the conditions for approval were satisfactorily met.
• For reporting purposes, the amendment response/follow-up packageEffective w88 online casino bettingis the amendment package approval w88 online casino betting.

Amendment Package: Deferred by Convened IRB

For amendment packages deferred by the convened IRB, approval is not finalized until the convened IRB approves the revisions package.

Dates for Amendment Package: Deferred by Convened IRB

• TheEffective w88 online casino bettingis the w88 online casino betting the convened IRB deferred approval of the amendment package.
• For reporting purposes, the Package-1 Effective w88 online casino betting is the amendment package review w88 online casino betting.

Dates for Amendment Revisions in Response to Deferral (Revisions Package): Approved by Convened IRB

• TheEffective w88 online casino bettingfor the amendment revisions package is the w88 online casino betting the convened IRB approved the amendment revisions package.
• For reporting purposes, theEffective w88 online casino bettingfor the amendment revisions package is the amendment package approval w88 online casino betting.