General Discussions

 View Only
  • 1.  Human Ethics studies and record retention

    TEAM CAYUSE
    Posted 11-16-2021 10:12

    Hi everyone,

    A Human Ethics user shared a question with me that I wanted to put out there to see what other folks are doing.

    "Since we are unable to delete studies from Cayuse, how do institutions with record retention requirements handle this situation? Our record retention period is 3 years, and we submit a request for approval to delete all study materials 3 years after closure. We are still trying to figure out how to proceed with this process since we are not able to delete studies from Cayuse."

    Thanks to everyone for sharing their wisdom!

    Simon



    ------------------------------
    Simon Helton
    He/him
    Community Manager
    Cayuse
    ------------------------------


  • 2.  RE: Human Ethics studies and record retention

    CAB Member
    Posted 11-17-2021 04:38
    Great question and will be following for best practices...

    ------------------------------
    Dawn Leusner
    IRB Manager
    Educational Testing Service
    Princeton, NJ 08541
    irb@ets.org
    ------------------------------



  • 3.  RE: Human Ethics studies and record retention

    CAYUSE CHAMPION
    Posted 12-02-2021 06:15
    This is a good question and a discussion on this would be very helpful as my institution is doing some work on our record retention policy.  I guess to begin, we all would need a good understanding of how Cayuse treats closed studies.  What happens on the Cayuse end when a study is closed?  Are there dedicated servers to hold archived data?  Where are these things stored? (These technical things are a bit out of my realm so if anyone has a kindergarten way to explain to me, I appreciate it) It seems that at some point Cayuse would need to get rid of some data because storage isn't really infinite and these studies are going to start piling up eventually.  Maybe this is something that Cayuse can map out with us and together we can establish our policies and processes.

    ------------------------------
    Angela Bain, CIP, CIM
    Director, IRB Office
    Kennesaw State University
    ------------------------------



  • 4.  RE: Human Ethics studies and record retention

    CAYUSE CHAMPION
    Posted 12-03-2021 07:04
    We've wrestled with the question of record retention for SP and 424 records, and one of the ideas we've batted around there might be applicable in this instance.

    Our dilemma comes to this: We want to be able to preserve a history of proposal and award activity, as we think this is likely to be useful down the road when we want to look at trends, success rates, and so forth. So we don't want to lose the record of all that activity - who submitted what proposals to which sponsors, which sponsors made awards to us on what projects, with what frequency, and so forth.

    On the other hand, we don't need or want to keep complete records once the retention requirements have lapsed - because anything we still have in the system is subject to audit, and we'd just as soon not have to dig back into projects that were closed long since just because we left files there for someone to peek into.

    Our workaround is to maintain the SP records - the IPF, basically, so we'll know the PI and the research team, the sponsor, the deadlines, whether or not an award was made, and so forth - and then delete the attachments. That way we can maintain historical data, but we won't have all the files sitting there in the system of record. Would that work in the Human Ethics context as well?

    ------------------------------
    Michael Spires
    Research Development Officer
    Oakland University
    Rochester, MI
    (he/him)
    mspires@oakland.edu
    ------------------------------



  • 5.  RE: Human Ethics studies and record retention

    TEAM CAYUSE
    Posted 12-03-2021 14:32

    I just want to thank everyone for weighing in on this question. This has raised some good questions so I wanted to mention that this topic has been added to the agenda for a January Customer Advisory Board meeting. If you have anything else you want to add on the topic in anticipation of that meeting, please feel free!

    Simon



    ------------------------------
    Simon Helton
    He/him
    Community Manager
    Cayuse
    ------------------------------



  • 6.  RE: Human Ethics studies and record retention

    TEAM CAYUSE
    Posted 12-15-2021 13:01
    Hello!  The Human Ethics Customer Advisory Board was so inspired by this topic that they introduced it at our December meeting just last week.  Here is a summary of the CAB's conversation:

    "At their December meeting, the Human Ethics CAB discussed the topic of record retention motivated by the ongoing conversation in the Connect Community.  CAB members noted that their institutional retention requirements can vary between federal (3 year), at a minimum, and longer, as a result of organizational or state policies/regulations (5 years and 7 years were noted) from date of study closure.  There was strong support for being able to set an archiving standard organizationally in Cayuse and also per study if needed at the time of study closure.

    CAB members noted that they review studies annually for archiving purposes and would want to be able to archive studies as needed in the Human Ethics module.  To assist that effort, it was note that it would be very helpful to have retention auditing reports that could help identify records to clean up or expunge and that included insight to admin check-in dates to assist with timely study closure.  Recurring reminder notifications to researchers would help too especially if they provided a confirmation of study continuation to the Office.  The CAB agreed that continuing discussion is needed to define requirements regarding handling information on and off the Internet Cloud."

    The CAB would love to continue the conversation here to expand and refine requirements and common understanding.  Looking forward to the discussion!

    ------------------------------
    Jenny Walsh
    Product Manager
    Cayuse
    ------------------------------



  • 7.  RE: Human Ethics studies and record retention

    CAYUSE CHAMPION
    Posted 12-16-2021 06:38
    CAB clearly had a very thoughtful discussion on this topic. And I like Michael's idea of maintaining a skeleton record.  Before, when I was only dealing with paper files, we put all closed files in a closed cabinet grouped by month and year and once a year would pull the files that reached the end of retention period, make a spreadsheet to record the study ID, title, PI, funding source, etc and then sent them off to the people who have the fun job of throwing the boxes into the incinerator. I haven't been using an online system long enough to have reached the time that we would normally destroy a paper file. I don't want to completely wipe its memory from existence because, institutionally, there is good reason to maintain a history of an investigator's research. So what Michael suggests is a good way to do that electronically.  We could maybe maintain the Study info and delete the Submissions.

    Since I am still fairly new to Cayuse, I don't really know how the administrative check in works in real time as we have not yet reached our first administrative check in date.  I plan to do some exploring of that soon when I get to working on that policy for our HRPP. The reporting and notifications that were mentioned from the CAB discussion are definitely something that I personally would like to have a better understanding of.  I don't know if I could offer much in the way of suggestions for the process since I don't have working knowledge of it.

    Anyway, those are some of my thoughts on the subject.  Probably not much help defining solutions but hopefully helpful for the Cayuse team in some way.

    ------------------------------
    Angela Bain, CIP, CIM
    Director, IRB Office
    Kennesaw State University
    ------------------------------