563. Continuing Reviews, w88 sports betting app
Updated June 7, 2024
Continuing review of research must occur at intervals appropriate to the degree of risk, but not less than once a year. A qualified IRB member is assigned to complete continuing reviews using w88 sports betting app procedures. Research Integrity & Security staff may assign additional reviewers or a consultant if additional expertise is required (for more information, see reviewer assignment in the online HRPP Policy Manual).
Protocols that require ongoing w88 sports betting app reviews must be approved before the approval expiration date; if not, all research activities (including participant enrollment) must cease unless it is determined that continuation of a research intervention or interaction is in the best interest of enrolled participants.
Studies initially approved by w88 sports betting app or Full Committee Review under the pre-2018 Requirements
Continuing reviews for projects initially approved by w88 sports betting app procedures are also completed by w88 sports betting app Review. Continuing reviews for projects initially approved by Full Committee Review may be completed by w88 sports betting app procedures under specific circumstances (see Categories of Research that May Be Reviewed through an w88 sports betting app Review Procedure, categories 8(a), 8(b), 8(c) or 9).
Studies initially approved by w88 sports betting app Review under the 2018 Requirements
Studies initially approved by w88 sports betting app Review will receive continuing review by w88 sports betting app procedures if
- The project is regulated by the Food & Drug Administration (FDA) or another sponsor that requires w88 sports betting app review; or
- The IRB reviewer requests and justifies a need for ongoing w88 sports betting app review.
Some circumstances that may trigger the w88 sports betting app review requirement include:
- The w88 sports betting app targets vulnerable populations, including those with a mental health diagnosis or self-reported suicidal ideation or past suicide attempts;
- The w88 sports betting app populations are deemed to be at risk of physical or mental harm, or breach of confidentiality;
- The w88 sports betting app involves collection of sensitive information such as substance abuse, criminal behavior, or mental health data;
- The w88 sports betting app involves additional regulatory oversight, such as conflict of interest management;
- The investigator has had w88 sports betting app serious noncompliance or a pattern of non-serious noncompliance.
For studies initially approved by w88 sports betting app Review that do not require continuing review, investigators must submit an annual progress report. The initial IRB protocol approval letter will specify whether the project requires a continuing review by w88 sports betting app procedures or an annual progress report. Progress reports are administratively reviewed by Research Integrity & Security staff to monitor project status.
Studies initially approved by Full Committee w88 sports betting app under the 2018 Requirements
Under specific circumstances, studies initially approved by Full Committee Review may receive continuing review by w88 sports betting app procedures (see Categories of Research that May Be Reviewed through an w88 sports betting app Review Procedure, categories, 8(b) or 9).
When projects initially approved by Full Committee Review reach the stage of data analysis, including analysis of identifiable private information or identifiable biospecimens, or accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care, researchers will submit the continuing review/progress report form with the applicable project status. These projects will no longer receive w88 sports betting app continuing review but will receive administrative review. The IRB will confirm the type of report (continuing review or progress report) and level of review going forward in the outcome letter based upon the research status reported in the continuing review/progress report form.
w88 sports betting app Review Materials
As specified in the IRB policy for submission requirements for continuing review by w88 sports betting app procedures, investigators requesting continuing review must submit a continuing review form and routine (or benign) safety reports not previously reported to the IRB.
The w88 sports betting app review form asks for information about the current status of the project; information about recent literature, interim findings, serious adverse events, problems, complaints, and amendments that occurred during the approval period; participant enrollment and withdrawal numbers; and a current assessment of risks and benefits based on study results.
Considerations for w88 sports betting app Review
In addition to determining whether the research continues to meet the regulatory criteria for approval and additional requirements under Subparts B, C, and D, or from other federal agencies, the w88 sports betting app Reviewer must determine if
- the w88 sports betting app consent document is still accurate and complete;
- information from the w88 sports betting app review suggests there may be changes to participants' willingness to continue participation;
- any significant new findings that arise from the w88 sports betting app process and that might relate to participants' willingness to continue participation will be provided to participants;
- verification is required from sources other than the investigators that no material changes occurred since the previous IRB review (e.g., PI has previous IRB determinations serious or w88 sports betting app noncompliance or information provided suggest unapproved changes may have occurred);
- enrollment numbers are consistent with the expected number of w88 sports betting app as noted in the Part II application or suggest enrollment-related matters may affect participant safety; and
- withdrawal numbers and reasons suggest there may be concerns associated with conduct of the w88 sports betting app or the frequency or severity of risks.
See the online HRPP Policy Manual for w88 sports betting app about reviewer recommendations and documentation.
Possible w88 sports betting app Review Actions for Continuing Reviews
The range of possible actions for w88 sports betting app reviews include Approved, Approved with Conditions, or Deferred (as described in w88 sports betting app policy w88 sports betting app Actions).
When w88 sports betting app reviews culminate in an action other than Approved, the possibility exists for IRB approval to expire before the requested revisions are reviewed and approved. In this case, the investigator would be required to cease all research activities until the IRB reviews and approves the study.
Determining Approval Periods for w88 sports betting app Continuing Reviews
During the continuing review, the w88 sports betting app Reviewer assesses the approved project documents and information in the status report. The reviewer determines the established approval period continues to be reasonable or should be adjusted and documents their decision in IRBNet.
For w88 sports betting app subject to FDA regulations:
- The reviewer must determine which clinical investigations require w88 sports betting app more than annually.
- The reviewer must determine which clinical investigations need verification from sources other than the clinical investigator that no material changes in the w88 sports betting app have occurred since the previous IRB review. The reviewer should consider:
- The nature of and any risks posed by the w88 sports betting app investigation.
- The degree of uncertainty regarding the w88 sports betting app involved.
- The vulnerability of the w88 sports betting app.
- The experience of the clinical investigator in conducting clinical w88 sports betting app.
- The w88 sports betting app’s previous experience with that researcher or sponsor (e.g., compliance history, previous problems with the researcher obtaining informed consent, prior complaints from participants about the researcher).
- The projected rate of w88 sports betting app.
- Whether the w88 sports betting app involves novel therapies.
Actions that Must Occur if w88 sports betting app Approval Expires
w88 sports betting app reviews must be approved before the expiration date; if not, all research activities (including participant enrollment) must cease unless it is determined that continuation of a research intervention or interaction is in the best interest of enrolled participants or the project.
If an investigator does not provide w88 sports betting app review information to the IRB or the IRB has not approved a w88 sports betting app review package by the expiration date, the IRB informs the researcher that all research activities must stop including but not limited to, enrollment of new participants and continuation of research interventions or interactions with currently enrolled participants, and data analysis.
If enrolled w88 sports betting app may be harmed by stopping study procedures, the PI must submit justification and explanation for which study procedures, some, or all, need to continue uninterrupted.