516. Continuing Review or w88 online sports betting Report: Submission Requirements for Expedited Studies
Updated August 23, 2021
The Revised Common Rule (2018 w88 online sports betting) authorizes a burden reducing provision for discontinuing continuing review for some categories of research. The IRB must maintain oversight over the research initially reviewed using the expedited procedure, as long as the research is ongoing. Continuing reviews are not required for protocols that were approved by Expedited Review (unless the IRB determines otherwise), or if the current status of participant enrollment is determined to be:
- Active, Closed to w88 online sports betting;
- Active, Data analysis Only; or
- Active, w88 online sports betting Term Follow-Up only
The types of research studies required to undergo w88 online sports betting Continuing Review include:
- Studies initially approved by Expedited Review under the pre-2018 w88 online sports betting
- Studies initially approved by Full Committee Review under the pre-2018 w88 online sports betting that meet the criteria for expedited categories 8(a), 8(b), 8(c) or 9;
- Studies initially approved by Expedited Review under the 2018 w88 online sports betting that are required to undergo continuing review;
- Studies initially approved by Full Committee Review under the 2018 w88 online sports betting that meet the criteria for expedited categories 8(b) or 9.
Investigators must submit a Continuing Review or w88 online sports betting Report Request marking the current status of the project on or before 12 months from the initial or last annual review date. Notification from IRBNet is sent to the investigator as a reminder to submit Continuing Review – w88 online sports betting Report Request form 45-15 days prior to the last review date. For studies initially approved by Expedited Review or Full Committee Review under the 2018 Requirements that are not required to undergo continuing review, investigators must provide an annual status update by submitting a w88 online sports betting Report Request. To determine if a research project is required to undergo continuing review or a status update, the Reviewer should document:
- The rationale for conducting w88 online sports betting review of research that otherwise would not require w88 online sports betting review.
- The rationale for a determination that research appearing on the list of eligible w88 online sports betting review categories is greater than minimal risk.
Principal Investigators (PIs) should view the w88 online sports betting approval letter for the new project for information regarding the annual submission requirement and due date. The information is also in IRBNet dashboard for each IRBNet project.
NOTE: Project amendments may NOT be submitted at the time of continuing review/w88 online sports betting report.
New Materials for Expedited Continuing Review or w88 online sports betting Report
PIs must add the following new document to a w88 online sports betting Review package for the existing project:
- Continuing Review/w88 online sports betting Report Form
The form elicits w88 online sports betting about:
- Number of w88 online sports betting accrued.
- A summary since the last IRB w88 online sports betting of: Adverse events, untoward events, and adverse outcomes experienced by participants; Unanticipated problems involving risks to participants or others; Participant withdrawals; The reasons for withdrawals; Complaints about the research; Amendments or modifications; Any relevant recent literature.
- Any interim findings.
- Any w88 online sports betting multi-center trial reports.
- The researcher’s w88 online sports betting risk-potential benefit assessment based on study results.
Signature Requirements for Expedited Continuing Review or w88 online sports betting Report
- PI signature for the Continuing Review or w88 online sports betting Report package, obtained electronically through IRBNet
w88 online sports betting Originally Reviewed via Full Board Meeting
For renewals or modifications, the IRB reviewer determines if research that was initially approved by the full-board IRB may now qualify for w88 online sports betting review. This determination is made based on the risk level or status of the research, specifically involves no greater than minimal risk and no additional risks have been identified.
Materials Available for IRB w88 online sports betting
Researchers do not need to resubmit project documents because all the documents attached to the project in IRBNet are available for IRB review. The attachments vary for each project (for a comprehensive list, see IRB policy for submission w88 online sports betting for Expedited continuing review) and include the following as applicable:
- Part I, Protocol, and applicable supplemental applications such as for vulnerable populations; federal agency w88 online sports betting; and research involving blood or other biospecimens;
- w88 online sports betting;
- consent and HIPAA w88 online sports betting, or waiver requests;
- w88 online sports betting instruments;
- previously w88 online sports betting amendment packages with related amended materials;
- problem reports previously submitted for assessment/w88 online sports betting;
- documentation of external approvals; and
- w88 online sports betting correspondence.