564. w88 sports betting app Reviews, Full Committee
w88 sports betting app July 13, 2021
The University w88 sports betting app uses a primary reviewer system for Full Committee w88 sports betting app (for more information, see reviewer assignment in the online Human w88 sports betting app Protection Program (HRPP) Policy Manual).
Amendments to projects initially approved by Full Committee w88 sports betting app continue to be reviewed at convened meetings unless changes are limited to addition or removal of study personnel or performance sites, or are minor or editorial. Minor changes are those that do not materially increase the risks or decrease the benefits of the study, nor materially decrease scientific merit.
w88 sports betting app Review Materials
As specified in the online HRPP Policy Manual for overview of requirements for amendments and submitting amendments, investigators requesting IRB approval for an w88 sports betting app must submit an w88 sports betting app request form and updated versions of all amended documents. The w88 sports betting app request form asks for information about and justification for the amendments being requested, including the specific documents that are being changed.
The Primary Reviewer comprehensively reviews the materials submitted in the w88 sports betting app package, previous versions of any newly amended documents if necessary, and other relevant approved project documents in IRBNet (or those flagged by Research Integrity & Security staff); and completes the relevant review worksheets. IRB members (including alternate members) voting during the meeting are expected to review the same materials as the Primary Reviewer.
See the online HRPP Policy Manual for more information about w88 sports betting app materials and worksheets.
Considerations for w88 sports betting app Review
The w88 sports betting app review focuses on the following:
- effect of the amendments on the DHHS criteria for w88 sports betting app approval (at 45 CFR 46.111);
- effect of any significant new findings that arise from the w88 sports betting app review that might relate to participants’ willingness to continue participation and when warranted, processes to inform participants of these findings;
- consistency of requested changes with ensuring w88 sports betting app’ continued welfare;
Changes in approved w88 sports betting app that are initiated without prior IRB to eliminate apparent immediate hazards to a participant are promptly reported to the IRB as problems, assessed according to IRB policy, and if warranted, reviewed as possible noncompliance, Unanticipated Problem, or for suspension or termination of IRB approval.
Primary w88 sports betting app Presentation
During the convened meeting, the Primary Reviewer summarizes the w88 sports betting app as needed to provide context for the requested amendments. The Primary Reviewer describes the amendments and presents their questions or concerns about the effects of the amendments on the continuation of the w88 sports betting app and participants’ continued welfare.
If the assigned Primary Reviewer is unexpectedly absent from the meeting, at the discretion of the Chair a written commentary from the Primary Reviewer may be submitted and presented for discussion, or another w88 sports betting app member who is present at the meeting may assume the responsibilities of the Primary Reviewer if the Chair determines the member has the requisite knowledge and expertise and is sufficiently familiar with the materials submitted for review.
See the online w88 sports betting app for information about reviewer recommendations and documentation.
Possible w88 sports betting app Actions
The range of possible actions for w88 sports betting app include w88 sports betting app, w88 sports betting app with Conditions, Deferred, or Not w88 sports betting app (of Disapproved) (as described in w88 sports betting app policy regarding w88 sports betting app Actions).
A decision to not approve an w88 sports betting app request would apply only to the proposed amendments, not to the project as previously approved. Investigators would be notified that the proposed changes are unacceptable and may not be initiated.
w88 sports betting app Periods and Expiration Dates
Approval dates for amendments do not affect approval periods, or expiration dates unless the IRB determines the w88 sports betting app increases risks such that the approval period should be reduced. In this case, the expiration date would be adjusted to reflect the new approval period.