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  • 1.  Human Ethics: Process Management

    Posted 14 days ago

    Hi Cayuse Community,


    Our institution is one of the first to implement Cayuse in Canada. We are running into some process related challenges and are hoping to hear how other institutions are managing. I have questions about SP4 and Human Ethics; I shared the SP questions in a different thread let week and have posted here some of our HE questions.

    For context, Queen's University is a research-intensive institutions (medical school, all levels of post-graduate training) in Canada, but we have a relatively smaller faculty cohort of about 850.

    1. Does your institution have more than one IRB using Human Ethics? E.g. a health sciences review board and a separate general/social sciences review board? If so, how do you meet reporting requirements per board? We are learning that while we can create one smart form that immediate branches based on an answer to the question of which board a new ethics protocol is being submitted to that field is not reportable and therefore we are struggling to figure out how we can pull reports for each board easily.

    2. If you have researchers on your IRB, how do you prevent them from seeing comments made by other reviewers on their own submissions? We see this as a serious issue in confidentiality, but this should not be a Canadian specific problem. Wondering how other institutions have found a way around this.

    3. What is the process used by your institution for reviewing student-led ethics applications? Our current system allows us to send these applications directly and automatically to unit (departmental) level review boards as a first step, who then forward the file to the IRB (typically our General Research Ethics Board) if evaluated review is required. The Cayuse system doesn't support this so we are considering alternative approaches. 

    4. Do you create reports that distinguish between incident types that occurred within a given reporting cycle, e.g. adverse events vs. protocol deviations? If so, what is your process?

    Happy to hear how your institution used HE. We likely have many more questions and will share those as they come up.

    Best
    Karen



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    Karen Samis
    Director, Grants and Research Operations
    Queen's University,
    Kingston, Ontario, Canada
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  • 2.  RE: Human Ethics: Process Management

    This message was posted by a user wishing to remain anonymous
    Posted 13 days ago
    This message was posted by a user wishing to remain anonymous

    Hi Karen,

    1. We only have one IRB but have added a second which provides access to the protocols to our prisoner advocates.  From what I can tell, they can only view studies and submissions which are assigned to that IRB.   Reporting is difficult in Human Ethics - you can try to creatively use flags which might have no other use.   My institution is not on the platform yet, but my understanding is that the platform gives additional reporting flexibility.   I do not believe it is flexible enough to search or index results within individual form fields, only overall fields such as PI, department, submission dat, approval date....
    2. I have not thouroughly tested this, but I believe they will only see what any other researchers would if there is a conflict.  If the comments are restricted only those with reviewer access who are not conflicted would be able to see the comments.  Human Ethics will NOT allow a review conflict - it is impossible to assign a reviewer if they are the PI or PC.
    3. We have our IRB review student protocols if they meet the definition of Human Subjects Research.   The student acts as the Primary Contact and fills out the application and provides supporting documents.  They then list their faculty supervisor/ course instructor as the Principal Investigator.  When they submit, it goes first to the PI who can return it or certify it, which will send it to the IRB.  I am ont sure how many departments you have, but you could conceivably set up each department's review unit as their own IRB and assign student protocols to those as they are submitted, but an analyst would need to manage that prereview process.
    4.  At this time, we do not.  Our research is usually shorter-lived social/behavioral studies and we only collect a narrative description of the incident and follow-up steps. Cayuse probably does not have a built-in reporting mechanism to distinguish between different types.

    I hope this helps.   Often, thoughtful adjustment of the Smartforms has solved most of our process issues.  Reporting has always been a little more difficult.


  • 3.  RE: Human Ethics: Process Management

    CAB Member
    Posted 12 days ago
    Anonymous beat me to it, and agree with the points mentioned.

    2. At our small, SBER-only institution the use of Restricted for Comments should suffice (although I have worked hard to make our review process transparent and collegial i.e., Comments should not be taken defensively by projects, but rather "ok, they are helping us and making everything better for participants" (e.g., whether making recruitment and eligibility terms more explicit, to providing details of payments (when and how will they receive it), to informing participants where and for how long their data will be kept, our charge to follow the regulations, and at the the same time reduce liability to our institution and protect project teams and PIs for smooth research.

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