216. Unexpected Incarceration of a Research w88 sports betting

Updated June 7, 2024

It may happen that an individual becomes incarcerated while enrolled in a University w88 sports betting study that was not designed to include prisoners.

Reporting Requirements for Unexpected Incarceration of a Research w88 sports betting

Upon discovery of a w88 sports betting's incarceration, the principal investigator (PI) will notify the IRB in writing of the incarceration and effects of discontinuation of research intervention or treatment. If the w88 sports betting were enrolled in a clinical trial involving therapeutic treatment, or investigational drugs or devices, and immediate cessation of the research intervention could imperil the imprisoned w88 sports betting's health, the PI must also promptly notify the Nevada Department of Corrections.

The report/notification should include a written assessment of whether it is in the best interest of the prisoner-w88 sports betting to continue in the study, and the PI's plans for continuation or cessation of the intervention during the w88 sports betting's incarceration.

Considerations for Temporary w88 sports betting

If a w88 sports betting is incarcerated temporarily while enrolled in a study and the temporary incarceration has no effect on the study, the PI may keep the w88 sports betting enrolled if research activities, including the collection of identifiable information from the incarcerated w88 sports betting, are curtailed during the w88 sports betting's incarceration.

If a w88 sports betting is incarcerated temporarily while enrolled in a study and the temporary incarceration may affect the prisoner-w88 sports betting's health or safety, the PI must assess risks to the prisoner-w88 sports betting resulting from cessation of the research intervention during the temporary incarceration. The PI may consider requesting temporary continuation of the intervention.

Immediate Cessation w88 sports betting Intervention

Where a prisoner-w88 sports betting may be safely withdrawn from research interventions, or for research that does not involve interventions, the PI must immediately cease all research activities involving the prisoner-w88 sports betting under one of the two conditions listed below.

Condition 1: The PI does not request IRB approval for continuation of the prisoner's participation in the w88 sports betting.

The prisoner-w88 sports betting will be immediately withdrawn from the study.
The PI may retain and use data collected from or about the w88 sports betting up to the point of incarceration.

Condition 2: The PI requests IRB approval for an amendment to allow continuation w88 sports betting prisoner's participation in the study.

All research interactions and interventions involving the prisoner-w88 sports betting, including the collection of identifiable information from or about them, will w88 sports bettingw88 sports betting.
Research activities involving the prisoner-w88 sports betting will resume following IRB review and approval of a project amendment to allow the research to involve prisoners.

Temporary Continuation w88 sports betting Intervention

If the PI determines that immediate cessation of a study intervention may harm a prisoner-w88 sports betting such that continuation of the intervention is advisable, the PI must provide the following information to the IRB:

Determination of the minimum intervention necessary to protect the prisoner-w88 sports betting;
Plan for monitoring the prisoner-w88 sports betting's health and safety during discontinuation of the medication (including tapering if warranted) or removal of the device; or for continued dosing or placement of the device;
Description of standard care the w88 sports betting was receiving while in the research study (if applicable);
Timeline for safely withdrawing the prisoner-w88 sports betting from the intervention;
Specification of w88 sports betting three outcomes for the situation:
- following safe cessation of the intervention, the prisoner-w88 sports betting will be permanently withdrawn from the study;
- via an IRB-approved project amendment, the prisoner-w88 sports betting will be kept on the study intervention under an alternate mechanism such as emergency or compassionate (devices only) use;
- following IRB approval of a project amendment to allow the involvement of prisoners in the research, the prisoner-w88 sports betting will continue participation in the research.

In preparing the request for temporary continuation, the PI may wish to consult with the IRB, a qualified representative w88 sports betting Nevada Department of Corrections Medical Division, or both to confirm the plan for continuation is compliant and feasible.

NOTE: The IRB must inform DHHS OHRP of the decision to allow the temporary continuation of an intervention for the health and safety of an individual prisoner-w88 sports betting.

Continued Participation of Prisoners in the w88 sports betting

In cases of unexpected incarceration of a w88 sports betting where the PI wishes to amend the study to allow the continued involvement of the prisoner-w88 sports betting and may wish to enroll other prisoners in the research, the PI must complete the following:

confirm that the incarcerated w88 sports betting meets the definition of a prisoner;
submit a project amendment to allow the involvement of the individual prisoner-w88 sports betting and/or other prisoners in the research;
confirm the w88 sports betting meets the requirements for w88 sports betting involving prisoners
revise the application to include prisoners among the w88 sports betting populations and modify the procedures to accommodate incarcerated persons;
w88 sports betting and submit the researcher form Population: w88 sports betting; and
provide documentation of permission from the penal institutions where the prisoner-w88 sports betting is incarcerated and where other prisoners may be recruited.