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Thread: PI Responsibilities & Long term sick leave

  1. #1
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    PI Responsibilities & Long term sick leave

    I was wanting clarification on how long a PI can be off on sick leave before responsibilites should be transferred to another PI? I have read in some documents online 3 months however I could not find any detail in the guide book.

    Thanks

    Cameron

  2. #2
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    Hi Cameron,

    From the REC guidance (which seems to still be applicable) on the HRA website:

    In some cases it may be necessary to appoint an acting or new CI or PI. The following guidance may be given to CIs, PIs and sponsors:
    Where the absence is likely to exceed 3 months or is indefinite, it is recommended that an acting or new CI or PI should be appointed (see
    paragraphs 5.67-5.71, 5.77-5.80 and 5.84-5.85.)
    Where the absence is likely to exceed 4 weeks but will be less than 3 months, the sponsor should ensure that appropriate cover arrangements are made. The main REC should be notified by letter about cover arrangements for absent CIs. R&D offices at NHS sites should be notified about cover arrangements for absent PIs.
    For non-NHS sites in studies requiring SSA, the SSA REC should be notified. If it has any concerns about the suitability of the arrangements, it should notify the main REC. The main REC has the discretion to request formal appointment of an acting CI or PI.
    For absences shorter than 4 weeks, it is not generally necessary to notify the main REC or SSA REC.

  3. #3
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    I would have said that it would be better to take a risk based approach, because 4 weeks is an awful long time if the PI is the only physician (or takes a significant share of the medical doctors role in the trial) and it is a high risk study!
    In contrast, a low risk trial, on a well known marketed product and when sufficient medical back is available, would not be so risky.

  4. #4
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    Although the NRES SOP v5.1 does not specifically mention a "risk based approach", the full text of the NRES SOP does have important clarifications that say that the issue of the absence of the PI must be addressed and various factors affecting the research need to be weighed (i.e. taken into account). A risk based approach would do that.

    What the UK NRES REC SOP v5.1 actually says:-
    Absence of Chief or Principal Investigator
    5.86 From time to time, Chief Investigators or local Principal Investigators may be absent due to annual leave, sick leave, maternity leave, sabbatical or for other reasons. For short absences, the CI or PI is responsible for arranging adequate cover. Where this has not been possible, for example because the absence was unforeseen, the research sponsor will be responsible for ensuring that appropriate arrangements are made for the continued conduct of the study. The care organisation hosting the research is normally responsible for monitoring the conduct of the study.
    5.87 In some cases it may be necessary to appoint an acting or new CI or PI. The following guidance may be given to CIs, PIs and sponsors:
    Where the absence is likely to exceed 3 months or is indefinite, it is recommended that an acting or new CI or PI should be appointed (see paragraphs 5.67-5.71, 5.77-5.80 and 5.84-5.85.)
    Where the absence is likely to exceed 4 weeks but will be less than 3 months, the sponsor should ensure that appropriate cover arrangements are made. The main REC should be notified by letter about cover arrangements for absent CIs. R&D offices at NHS sites should be notified about cover arrangements for absent PIs. For non-NHS sites in studies requiring SSA, the SSA REC should be notified. If it has any concerns about the suitability of the arrangements, it should notify the main REC. The main REC has the discretion to request formal appointment of an acting CI or PI.
    For absences shorter than 4 weeks, it is not generally necessary to notify the main REC or SSA REC.

    5.88 The above guidance is not prescriptive. Other factors may need to be weighed, such as the nature, duration and progress of the research, the rate of recruitment and the structure of the research team.


    I have added underlining for emphasis.

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