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  • 1.  Human Ethics - post-approval follow-up documents

    STAR CONTRIBUTOR
    Posted 04-08-2022 06:40
    Colleagues,

    I will do my best to describe this briefly (esp on a Friday).

    We have many PIs who are not co-located with our campus. We require a letter of support indicating permission to conduct the research at their site. Many sites won't sign the letter of support until IRB approval is granted, setting up a bit of a chicken and egg situation where the IRB ends up going first and issuing an approval letter so the letter of support can be obtained.

    We use the Platform version of Human Ethics. We are trying to develop a workflow for submission and documentation of these post-approval letter of support documents. I've chatted with Support and our Success Manager, but wanted to throw it out here too. What we have thought of so far are:

    Options for submission
    1. Modification - hope the PI only changes the question about the letter of support
    2. Renewal - add a choice of "follow up document" to the first question and display an appropriate Section
    3. Email - PI's email the document to staff; staff add the document as an attachment

    Option for processing
    1. Designate Exempt and assign to an analyst. (Staff are not members of the IRB.)

    Options for tracking
    1. Use one of the tags that we wouldn't normally use and agree it means "waiting for follow-up document."
    2. Track outside of Cayuse Human Ethics

    What do your brilliant minds suggest?

    Regards,
    Darcy

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


  • 2.  RE: Human Ethics - post-approval follow-up documents

    Posted 04-13-2022 12:12
    Darcy,

    I don't have that exact scenario at our location, but I have had instances with research coordinators needing to add research personnel to studies with no other changes being done and not wanting to go through a whole modification form.  To do this I created an additional modification form that only contains the necessary question (personnel in my case).  I'll then publish this form on Cayuse when it's a convenient time for them and once they submit the form I'll put our main modification form back up.  This isn't an ideal situation, but it's do-able in our case, especially since we are smaller and I don't have to worry about anyone else submitting a modification while the temp form is published (I'm not sure how big your institution is, so maybe this wouldn't work).

    I have had a couple of situations where I or the research team have a document that is mostly for administration matters and I will just upload it into the attachments section of the study instead of making them fill out a modification form.  Sometimes I'll ask them to also upload it with their next submission, if needed.

    Hopefully this answers your question! Best of luck.

    Rayna Potkonjak
    IRB Coordinator
    Logan Health
    Kalispell, MT

    ------------------------------
    Rayna Potkonjak
    IRB Coordinator
    Logan Health
    ------------------------------



  • 3.  RE: Human Ethics - post-approval follow-up documents

    Posted 04-15-2022 10:44
    We would handle this as a Modification. We have created a non required question in a section of the initial application for the attachment of permission letters, data agreements etc. Our Modification template is short and the PI can easily click to the correct section to attach the letter. By using the "Compare" function, we can ensure that the PI filing the Modification only changes that section. We could designate this as exempt or expedited as staff or the IRB chair could quickly review this and then a letter could be issued.

    We could just receive the letter and attach it to the Study Details page, but of course, cannot issue another letter with that process. Sometimes the PI wants a letter that references the agreement, permission etc so they need to file a Modification for a letter to be issued.

    We track this outside of Cayuse using a 'Task' on our google calendar. We would love the ability to customize the Flags but alas...

    ------------------------------
    Kate Wydeven
    Regulatory Compliance Specialist
    Oakland University
    ------------------------------



  • 4.  RE: Human Ethics - post-approval follow-up documents

    RISING STAR CONTRIBUTOR
    Posted 04-18-2022 07:06
    Hi, Darcy

    Our institution handles Institutional Authorization Agreements outside of Human Ethics (we're in the process of being upgraded to Cayuse's new research platform).  That is, we have a shared mailbox set up for IRB in Outlook, our institution's email system. Some partners have questions during negotiations in determining Single IRBs of Record. This correspondence process, historically, has been quick and easy, especially as our staff continues to get used to using the IRB software. I will confess, staff do not enjoy submitting Modifications - they feel their changes don't warrant another submission. I respond with that Human Ethics is a good tracking and documentation system (which hopefully also improves project planning). Ok, I went a little off topic there, but if there is a workflow capability in the upgrade, I'm all for it so everything in ONE place!

    Thanks for thinking this through, Darcy, do let us know how it works out!
    Dawn

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



  • 5.  RE: Human Ethics - post-approval follow-up documents

    RISING STAR CONTRIBUTOR
    Posted 04-18-2022 07:23
    I should clarify, our Initial Submission Form Template asks submitters if the research is "multi-institutional," flagging required paperwork; the dual signing is contingent on the project receiving IRB approval. So yes, this executed agreement would be added to the submission form by way of the Modification process OR the Attachment section of the form since these do not warrant a review by anyone other than the IRB Analyst. The same holds true for subcontractor and external consultant paperwork i.e., if our institution is the IRB of Record, we issue Human Subject Research Agreements for signature; again, projects use the Attachment capability to upload these forms.

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



  • 6.  RE: Human Ethics - post-approval follow-up documents

    RISING STAR CONTRIBUTOR
    Posted 04-18-2022 07:11
    Good morning Darcy,

    We tackle this very issue constantly at my institution. How we have worked it out is once the IRB verifies that all criteria for IRB approval are satisfied aside from the submission of the site permission letter, my IRB grants a conditional approval so the PI can get the requested documentation from the site in which they will be conducting their study. Our conditional approval essentially informs the PI that they still cannot begin any human subject activities (recruitment, consent, data collection, etc.) until they have attached their site permission to the application. The decision in Human Ethics reopens their application so they can add the requested documentation once they get it.

    If they have multiple site permissions that require our conditional approval first, we require the PI to use that conditional approval to obtain at least one of the permission letters. Additionally, we ask our PIs to only list that one site in their Initial submission and include a statement that there are more site permissions to come at a later date, and then we process the others as a Modification. I have had PIs submit a plethora of Modifications for one study in compliance with this requirement. It seems to work for us. I hope this helps. Take care.

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



  • 7.  RE: Human Ethics - post-approval follow-up documents

    STAR CONTRIBUTOR
    Posted 04-21-2022 08:01
    Sharla,

    Thank you for your reply.  It all makes sense to me to track the letter of support as a Modification.

    I have two follow-up questions.

    Who approves the Modification?  IRB Member or staff.  (Keep in my our staff are not members of the IRB)

    And do you wait to issue the final recruitment and consent documents until you have the letter?

    Regards,
    Darcy

    Darcy L. Hammar, CIM
    Director, Human Research Protection Program (HRPP) & 
    Senior Instructor, PhD in Health Sciences

    ––––––––––––––––––––––––––––––––––––––
    Rocky Mountain University of Health Professions
    122 East 1700 South, Building 3, Provo, Utah 84606
    Direct: 801.734.6770 | Campus: 801.375.5125
    Cell: 443.926.6243
    ––––––––––––––––––––––––––––––––––––––
    Stay connected, learn more!
    Rocky Mountain University of Health Professions is accredited by the Northwest Commission on Colleges and Universities (8060 165th Avenue NE Ste 100, Redmond, WA 98052-3981), an institutional accrediting body recognized by the Secretary of the US Department of Education.






  • 8.  RE: Human Ethics - post-approval follow-up documents

    RISING STAR CONTRIBUTOR
    Posted 04-21-2022 08:32
    Hi Darcy,

    Not a problem. Happy to help. Regarding your first question, it depends on review type. Although I am not a member of the IRB, by policy, I am the designated reviewer for all exemptions other than the Limited IRB reviews. If the study is exempt, either I or the IRB Chair will approve the Modification. If expedited or full review, the IRB Chair or other designated IRB reviewer will approve the Modification. As for the final recruitment and consent documentation, yes, that is correct. Those are not released for use until we receive the site permission and issue the final approval. Let me know if you have other questions. Thank you.

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



  • 9.  RE: Human Ethics - post-approval follow-up documents

    STAR CONTRIBUTOR
    Posted 05-06-2022 06:41
    Thanks to everyone who replied to my initial post.  Based on your feedback, for now we have

    Added a question to our Modification Submission "are you providing a post-approval document that couldn't be provided until RMU approved the project?" (our most common scenario)

    We are processing these as exempt so staff can approve them.

    We created a new letter template that states it was an "admin" review and the action was "acknowledged."

    We have not yet worked out whether we will tag these studies, track them outside of Cayuse, or issue conditional approval/hold back stamped documents until we receive the document.  Sometimes our PIs have multiple sites and only one letter of support is not available at submission.

    Regards,
    Darcy

    It's not perfect or elegant, but will work for us for now.

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