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Agenda

  • 1.  Agenda

    Posted 12-08-2023 07:14

    Hello,

    We are new o Cayuse Human Ethics and have learned that only when a study is approved does it get pulled into the agenda. This creates a problem, as some of my reviewers on the committee do not give final approval or conditional approval until the full board meeting is taking place. All studies for a scheduled meeting should be on the agenda whether approved or not along with the reviewer/reviewer's name. 

    I did put in a ticket and there is no work around. This would be a great enhancement. 

    How do other institutions handle this, any feedback would be greatly appreciated.



    ------------------------------
    Jayne Silva
    Manager, Human Research Protections
    St. Luke's University Hospital and Health Network
    ------------------------------


  • 2.  RE: Agenda

    STAR CONTRIBUTOR
    Posted 12-11-2023 06:51

    Jayne,

    This has not been my experience.

    You have to add the submission to the agenda after you add the review type and assign reviewers. https://support.cayuse.com/hc/en-us/articles/360020792393-Creating-Meetings-and-Entering-Decisions-in-Human-Ethics

    Happy to help more if I can.

    Regards,

    Darcy



    ------------------------------
    Darcy Hammar
    Director, HRPP
    Rocky Mountain University of Health Professions
    ------------------------------



  • 3.  RE: Agenda

    Posted 12-11-2023 10:01

    So, you are manually typing into the agenda before a meeting? I looked at the support document previously and actually did not find it very helpful.

    Thank for your feedback.



    ------------------------------
    Jayne Silva
    Manager, Human Research Protections
    St. Luke's University Hospital and Health Network
    ------------------------------



  • 4.  RE: Agenda

    RISING STAR CONTRIBUTOR
    Posted 12-11-2023 10:20

    We ran into this issue when we first started using Cayuse because it wasn't clear to us how expedited actions were being pulled into the meeting details. Someone from another institution walked us through it and we updated our workflow in Cayuse so that things were pulling in automatically.

     

    I'd be happy to show you what we do, if it would be helpful.

     

    -- 

    Jennifer Boe, MA (she/her)

    Sr. IRB Analyst

    Human Research Protections Office (HRPO)

    Hennepin Healthcare Research Institute

     

    Have questions for the HRPO? Join the HRPO Virtual Office Time from 10:30-11:00 AM on the first & third Wednesday of every month!

     

    Provide feedback or comments for HRPO/IRB here!

     






  • 5.  RE: Agenda

    Posted 12-11-2023 11:17

    That would be great if we can connect on Teams. What is your availability?



    ------------------------------
    Jayne Silva
    Manager, Human Research Protections
    St. Luke's University Hospital and Health Network
    ------------------------------



  • 6.  RE: Agenda

    RISING STAR CONTRIBUTOR
    Posted 12-11-2023 08:29

    Are you referring the list of expedited actions that get pulled into each meeting or new items to be reviewed by the convened IRB? For expedited actions, I think you are right – that the item will not appear in the list until final approval but we haven't found this to be an issue, because it will pull into the next meeting after it is approved. But our reviewers aren't typically waiting to complete an expedited review in order to consult with the convened IRB. If that were the case, we would probably assess whether the submission requires full board review.  

     

    I could be misunderstanding something though! I'd be happy to connect and compare how we use meetings in Cayuse (jboe@hhrinstitute.org). I'm always curious to see how different organizations structure things.

     

    -- 

    Jennifer Boe, MA (she/her)

    Sr. IRB Analyst

    Human Research Protections Office (HRPO)

    Hennepin Healthcare Research Institute

     

    Have questions for the HRPO? Join the HRPO Virtual Office Time from 10:30-11:00 AM on the first & third Wednesday of every month!

     

    Provide feedback or comments for HRPO/IRB here!

     






  • 7.  RE: Agenda

    Posted 12-11-2023 09:55

    Our agenda with our previous system pulled in all study types. The exempt and expedited studies are gone over during the full board meeting for committee acknowledgement, even if they are approved. It doesn't' seem like there is a way around this. And this is our SOP.

    Thanks for your feedback.



    ------------------------------
    Jayne Silva
    Manager, Human Research Protections
    St. Luke's University Hospital and Health Network
    ------------------------------



  • 8.  RE: Agenda

    Posted 12-11-2023 22:56

    Hello Dr. Silva,

     

    This is a bit strange. As far as I know, we don't have this problem. We have an IRB meeting this week with several protocols scheduled for review; none of them have had a decision made on them yet. They do end up in the system with a status of "Under Post Review" at times, even if the decisions haven't been made. This occasionally happens after they are assigned to a reviewer, and the first task on the assignment list is "Make Decision". "Assign to Meeting" is also usually on the list, but we've found that they don't have to be done in the order they are listed. So if this is the issue, try assigning it to a meeting by clicking the "Assign to Meeting" link without actually assigning a decision first.

     

    Typically, our routing process is

     

    1. Completion of Study
    2. Certification of Study by PI
    3. Pre-Review by Compliance Administrators
    4. Review by IRB
    5. Post-Review Handling
    6. Review Complete

     

    From assignment to a reviewer at stage 3 to transition to being under review at stage 4, this allows the protocol to be assigned to an IRB meeting. We never have a determination made until after the meeting has occurred; they're on the agenda without a decision, with the reviewer listed. My understanding is that this is the intended route and function.

     

    If I had to guess, I would suspect that this issue lay with the backend workflow, which is not something that general administrators typically have access to. Do you have an organizational superuser? Someone with backend access? Maybe they can check the workflow steps to see if there is a flag that has been enabled or a workflow error somewhere that is requiring approval prior to the ability to assign the protocol to a meeting? If not, it might be worth checking your process back with Cayuse HE and make sure that the stepwise process is set right, because that is definitely not what our process looks like, and it is certainly not what is going to be intended by OHRP or the FDA.

     

    Speaking on behalf of myself (not my institution), I would be concerned that any approval outside of a convened meeting (even if pro forma and merely for the purpose of getting it on the agenda and then making a final determination) may be viewed inappropriately, so it is definitely something that I would want figured out and fixed.

     

    Hope that this helps,

     

    Daniel R. Kirienko, Ph.D.

    Preferred pronouns: he, him, his

    IRB Compliance Administrator

    Office of Research Integrity

    Rice University

    dk32@rice.edu

     

     






  • 9.  RE: Agenda

    STAR CONTRIBUTOR
    Posted 12-12-2023 07:51

    Hi Jayne,

    Any studies that are conducted via an Expedited review by one member of the IRB Committee, once approved, will get put on to the next Meeting's agenda so that all members are aware and can see what studies have recently been approved since the last meeting.  Any submissions that require a Full Board Review get assigned to the Full Board and then you need to add it to an IRB Meeting.  The meeting needs to be on the calendar first in order to add the submission or assign the meeting to the submission.

    Are you conducting Expedited Reviews where either the IRB Chair or a designated reviewer can review/approve submissions? Or are you requiring a review by the IRB Committee for every submission?  If you are wanting the Full Board to make the ultimate decision on every submission, then they have to be assigned to the Full Board for review and assigned a meeting date.



    ------------------------------
    Leigh Schectman, MPH
    Research Protections Coordinator
    California Lutheran University
    Thousand Oaks, CA
    lschectman@callutheran.edu
    ------------------------------



  • 10.  RE: Agenda

    RISING STAR CONTRIBUTOR
    Posted 12-13-2023 07:14

    While Leigh describes this perfectly, I have always wondered if anyone in this community wanted to see more information in the agenda regarding studies that were approved outside of a meeting. Before we launched Human Ethics in 2018, I prepared minutes and agendas manually. The following is a template of information that I included for each study:

    Protocol Number

    Protocol Title

    PI

    Reviewers (members' initials only)

    Review Type

    Approval/Decision Date

    Expiration Date (before 2018 CR was implemented)

    Justification (i.e., category under which study was reviewed)

    I wish the Human Ethics agendas would include additional information. I would think if the approval letter could pull in these variables, the agenda/minutes would be able to do this as well. Thoughts anyone?

    Sharla



    ------------------------------
    Sharla Miles, M.Ed., CIP
    Director, Research Compliance
    Sam Houston State University
    Huntsville, TX
    (936) 294-4875
    sharla_miles@shsu.edu
    ------------------------------



  • 11.  RE: Agenda

    STAR CONTRIBUTOR
    Posted 12-13-2023 07:20

    Sharla,

    You are not alone.  We too, would like more detail in the Agenda/Minutes for Exempt and Expedited.  We'd like NHSR to be reported as well.

    Regards,

    Darcy



    ------------------------------
    Darcy Hammar
    Director, HRPP
    Rocky Mountain University of Health Professions
    ------------------------------



  • 12.  RE: Agenda

    Posted 12-14-2023 06:34

    I must admit I am a bit disappointed in the agenda/minutes, as this wasn't my understanding during the demo. I have been through an FDA audit and the really scrutinize the agenda an especially the minutes. Below are screenshots of what my previous system generated.

    Agenda

     

     

    SLUHN IRB #

    Protocol Title/Investigator/Items

    Assigned Reviewers

    III. Committee Business

    A. General

    B. New Studies - Full Board

    IRB-FY

    Protocol Title: title
    PI: name
    Study Status: IRB PENDING


    Submission Documents and Details:



    Primary:

    Secondary:

    Minutes

    I. CALL TO ORDER: 7:30 am

    II. APPROVAL OF MEETING MINUTES: TIME am

     

    SLUHN IRB #

    Protocol Title/Investigator/Items

    Assigned Reviewers

    III. Committee Business

    A. General

    B. New Studies - Full Board

    IRB-FY

    Protocol Title: title
    PI: name
    Study Status: IRB PENDING


    Submission Documents and Details:
    Please find initial application and supporting documents for review and approval.
    -


    Reviewer Decision and Comments:
    name
    [ ] Approved
    [ ] Not Approved
    [ ] Acknowledged
    [ ] Conditionally Approved with the following changes:

    Comments:  

    name
    [ ] Approved
    [ ] Not Approved
    [ ] Acknowledged
    [ ] Conditionally Approved with the following changes:

    Comments:


    TIME am- By proper motion duly passed, the IRB Committee voted: 0 For; 0 Against; 0 Recused; 0 Abstained to (conditionally) approve this study for a 12- month period (with the following changes: )

    ·        (If conditional comments)

    The IRB deemed this study MORE than minimal risk. This study will comply under the new final rule effective DATE. No other concerns raised by the reviewers and no further discussion by the board.

    Primary:

    Secondary:

    Regards

    Jayne



    ------------------------------
    Jayne Silva
    Manager, Human Research Protections
    St. Luke's University Hospital and Health Network
    ------------------------------