595. Determining w88 online casino betting 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; or would comply with these requirements if specific, minor conditions requested by the IRB are met.

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

Package-level w88 online casino betting

The Effective w88 online casino betting applies at the package level and is documented for each package.

Project-level w88 online casino betting

The Initial Approval w88 online casino betting applies to new projects only. The Initial Approval w88 online casino betting depends on review type (i.e., Expedited versus Full Board) and the IRB Action at the first and subsequent reviews.

The Project Expiration w88 online casino betting designates the due w88 online casino betting for completion of the next IRB review. The Project Expiration w88 online casino betting is calculated by adding the specified approval period to the Initial 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.

The Effective and Project Expiration w88 online casino betting appear in IRB approval letters and minutes.

Regardless of review type, IRB Actions other than Approved require 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).

w88 online casino betting for New Projects: Full Committee Review

w88 online casino betting for Convened IRB Action: Approved

For new projects approved at the first review by the convened IRB, w88 online casino betting are determined and documented as follows.

• The Effective w88 online casino betting for Package-1 is the w88 online casino betting the convened IRB approved the new project
• The Initial Approval w88 online casino betting is documented in Package-1 and is the w88 online casino betting the convened IRB approved the project (the same w88 online casino betting as the Effective w88 online casino betting).
• The Project Expiration w88 online casino betting is documented in Package-1.
• For reporting purposes, the Package-1 Effective w88 online casino betting is considered both the review and the approval w88 online casino betting.

w88 online casino betting 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 w88 online casino betting documented as follows.

w88 online casino betting for New Project (Package-1): Approved with Conditions

• The Effective w88 online casino betting for 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 Approval and Expiration w88 online casino betting remain blank in Package-1.
• For reporting purposes, the Package-1 Effective w88 online casino betting is the first review w88 online casino betting.

w88 online casino betting for Response/Follow-Up (Package-2): Approved

• The Effective w88 online casino betting for Package-2 is the w88 online casino betting a designated IRB member confirmed the conditions for approval were satisfactorily met and is both the effective w88 online casino betting of the initial approval and the w88 online casino betting the IRB determined the research may commence.
• The Initial Approval w88 online casino betting is 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 1 Effective w88 online casino betting ).
• The Project 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 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.

w88 online casino betting 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-2 Effective and Initial Approval w88 online casino betting and whether a third package is needed (e.g., the revisions package is approved with conditions). w88 online casino betting are determined and documented for Package-1, Package-2, and Package-3 (if necessary) as follows.

w88 online casino betting for New Project (Package-1): Deferred

• The Effective w88 online casino betting for Package-1 is the w88 online casino betting the convened IRB deferred approval.
• Initial Approval and Expiration w88 online casino betting remain blank in Package-1.
• For reporting purposes, the Package-1 Effective w88 online casino betting is the first review w88 online casino betting.

w88 online casino betting for Revisions in Response to Deferral (Package-2): Approved

• The Effective w88 online casino betting for Package-2 is the w88 online casino betting the convened IRB approved the revisions package.
• The Initial Approval w88 online casino betting is 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-2 Effective w88 online casino betting).
• The Project 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.

w88 online casino betting for Revisions in Response to Deferral (Package-2): Approved with Conditions

• The Effective w88 online casino betting for Package-2 is the w88 online casino betting the convened IRB determined the research would be approvable and defined the required specific/minor conditions.
• The Initial Approval and Expiration w88 online casino betting remain blank in Package-2.

w88 online casino betting for Response/Follow-up (Package-3): Approved

A third package is required if the revisions package (i.e., Package-2) is approved with conditions. w88 online casino betting for Package-3 follow w88 online casino betting for Response/Follow-Up (Package-2): Approved above.

w88 online casino betting for Convened IRB Action: Disapproved

• The Effective w88 online casino betting for Package-1 is the w88 online casino betting the convened IRB disapproved the project. Package-1 becomes the terminal package for the study.
• Initial Approval and Expiration w88 online casino betting remain blank in Package-1.
• For reporting purposes, the Package-1 Effective w88 online casino betting is the review w88 online casino betting.

w88 online casino betting for New Projects: Expedited Review

w88 online casino betting for Expedited Review Action: Approved

• The Effective w88 online casino betting for Package-1 is the w88 online casino betting the expedited reviewer approved the new project.
• The Initial Approval w88 online casino betting is documented in Package-1 and is the w88 online casino betting the expedited reviewer approved the project (the same w88 online casino betting as the Effective w88 online casino betting).
• The Project Expiration w88 online casino betting is documented in Package-1.
• For reporting purposes, the Package-1 Effective w88 online casino betting is the review and the approval w88 online casino betting.

w88 online casino betting 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 w88 online casino betting documented as follows.

w88 online casino betting for New Project (Package-1): Approved with Conditions/Deferred

• The Effective w88 online casino betting for 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 Approval and Expiration w88 online casino betting remain blank in Package-1.
• For reporting purposes, the Package-1 Effective w88 online casino betting is the first review w88 online casino betting.

w88 online casino betting for Response/Follow-Up (Package-2): Approved

• The Effective w88 online casino betting for 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 the effective w88 online casino betting of the initial approval and the w88 online casino betting the IRB determined the research may commence.
• The Initial Approval w88 online casino betting is documented in Package-2 and is the same w88 online casino betting as the Package -2 Effective w88 online casino betting (i.e., the w88 online casino betting a designated IRB member determined the conditions for approval were satisfactorily met).
• The Project Expiration w88 online casino betting 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).

w88 online casino betting 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 w88 online casino betting are determined and documented after the subsequent IRB review and action.

w88 online casino betting for Continuing Reviews

The Effective w88 online casino betting for 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 new Effective w88 online casino betting.

The University IRB maintains fixed annual renewal w88 online casino betting by basing Project Expiration w88 online casino betting on the Initial Approval w88 online casino betting. Exceptions to fixed annual renewal w88 online casino betting occur when the continuing review is completed more than 30 days before the expiration date, or the continuing review is not approved by the expiration date.

Fixed Annual Renewal w88 online casino betting

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

w88 online casino betting for Early Reviews

For continuing reviews completed more than 30 days before the expiration w88 online casino betting: The new Project Expiration w88 online casino betting is calculated by adding the specified approval period to the Effective w88 online casino betting of the early continuing review.

w88 online casino betting 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.

• The Effective w88 online casino betting for 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 new Project Expiration w88 online casino betting is calculated by adding the specified approval period to the continuing review package Effective w88 online casino betting.

w88 online casino betting 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.

• The Effective w88 online casino betting following 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 new Project Expiration w88 online casino betting is calculated by adding the specified approval period to the new Effective w88 online casino betting.
• The Initial Approval w88 online casino betting remains unchanged but is no longer used to calculate the Expiration w88 online casino betting in subsequent continuing reviews.

w88 online casino betting for Amendments

Reviews of amendment packages do not affect Initial Approval or Project Expiration w88 online casino betting.

Amendment Package: Approved

For amendment packages approved as submitted, the Effective w88 online casino betting is 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 by Expedited or Full Committee Review will take at least two packages, amendment and response/follow-up, with w88 online casino betting documented as follows.

w88 online casino betting for Amendment Package: Approved with Conditions

• The Effective w88 online casino betting for 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-1 Effective w88 online casino betting is the amendment package review w88 online casino betting.

w88 online casino betting for Amendment Response/Follow-Up Package: Approved

• The Effective w88 online casino betting for 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 package Effective w88 online casino betting is 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.

w88 online casino betting for Amendment Package: Deferred by Convened IRB

• The Effective w88 online casino betting is 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.

w88 online casino betting for Amendment Revisions in Response to Deferral (Revisions Package): Approved by Convened IRB

• The Effective w88 online casino betting for the amendment revisions package is the w88 online casino betting the convened IRB approved the amendment revisions package.
• For reporting purposes, the Effective w88 online casino betting for the amendment revisions package is the amendment package approval w88 online casino betting.