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  • 1.  Lets talk checklists

    Posted 09-22-2021 06:02
    How do you have your checklists formatted?  I have been re-working our checklists and they are getting kinda messy as I try to add to them.  The submission forms have the ability to break things up into sections but I am not seeing that functionality in the checklists.  How do you guys separate different types of checklists and organize the structure?

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

  • 2.  RE: Lets talk checklists

    Posted 10-05-2021 15:18

    I have to believe someone here has advice for you, Angela! I'm going to tag some folks I believe are using Human Ethics and see who has some wisdom to dispense.

    What say you, @Darcy Hammar @Carey Nadeau @Corey Brooks @Annette King @Amany S. Dahir @Becky Welch @April Gravitt @Sherrie Hixon @Sharla Miles @Nina Yolen (No longer at SHU as of 6.3.22) @Tammy Burgess @Leslie Ingram (moved departments) @Audrey Wineglass Foster @Amy Krenzer @Michael Leary @Maureen Wawsczyk @Beverly Kemp @Kathleen Furr @Kareem Gad @Michael Spires @Dawn Leusner @Marnie Shaffer @Steve Sutcliffe @Kristine Nowak @Wun Chiou @Jennie Kulczyk @Dana Lawrence @Weldon George @Melissa Beck @Rachel Agner @Jenn Dier @Natalie Kolomeitz-Douglas @Jessica Prim


    Simon Helton
    Community Manager

  • 3.  RE: Lets talk checklists

    Posted 10-06-2021 07:01
    Hi Angela,

    I am working on revising my checklists in Human Ethics now. Unless there is another way of formatting the reviewer and analyst checklists, I have built both checklists on the branching logic format: depending on submission type (e.g., initial, mod, renewal, incident, etc.) and review type (e.g., full, expedited, exempt, etc.), I have both lists formatted to only open a certain set of questions based on those 2 variables. I would love to see if anyone else does it differently, so I'll be monitoring the responses you receive. I hope this helped. Thanks for reaching out. Have a great day!

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

  • 4.  RE: Lets talk checklists

    Posted 10-05-2021 16:57
    We are very new to Human Ethics (we went live Sept 24).

    I decided to limit the Reviewer checklist to basics and regulatory items.

    My export is attached.

    Darcy Hammar
    Director, HRPP
    Rocky Mountain University of Health Professions

  • 5.  RE: Lets talk checklists

    Posted 10-06-2021 06:31
    Hi Angela,

    We are currently making revisions to our checklists. We are basically using the submission form as a guide and making sure the questions are answered. (informed consent, human subjects training, etc.)

    Beverly Kemp
    eRA Research Coordinator
    Lamar University
    Beaumont 77710

  • 6.  RE: Lets talk checklists

    CAB Member
    Posted 10-07-2021 05:15
    Good morning, all!  We have 2 Checklists:  one for Analysts and one for Reviewers.

    I tried Exporting both to attach to this response, but no file extension works to open them, so pasted in below:

    Hopefully these can be easily viewed.  While based on the regulations, some checkpoints are for compliance with institutional policies and procedures.

    IRB Analyst Checklist

    Human Subject Training
    Have the investigator(s) completed human subject training?  Please confirm by checking the Prior Review Training YTD file
    Recruitment Letter(s)
    Are all the necessary details of the research included? i.e.,
    - Participant specifications included (e.g., 30 high school students, 2 English Language teachers, 10 scoring raters, etc.)
    - Timeframe of data collection (e.g., This research will begin on October 30, 20xx and end on December 10, 20xx)
    - Location (e.g., This research will be conducted at your school, at ETS, online, etc.)
    - Duration of direct involvement (e.g., You will spend 60 minutes completing an assessment)
    - Eligibility criteria (looking for science teachers with up to x years of experience teaching middle school students)
    - If this research is international AND includes payments, leave a Comment directing the project to start discussion with their Administrative Manager about feasibility
    Consent Process
    Are the procedures adequate to obtain informed consent? i.e.,
    - the consent should mirror the recruitment in regard to the details
    - the consent should be in the appropriate and approved template
    Does the recruitment process involve any possible influence to coerce a subject to participate in the study?
    Determination of Risks to Subjects
    Minimal risk:  The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

    Is any additional paperwork required? e.g.,
     Research Agreement for External Consultants conducting aspects of the project on behalf of ETS
    * an Institutional Authorization Agreement for collaborating institutions who defer to ETS for IRB review
    * a Memorandum of Understanding for schools engaging with ETS - please leave a Comment directing the project to speak with their Administrative Manager
    * a contract for teachers being paid more than $150 - please leave a Comment directing the project to speak with their Administrative Manager
    Analyst Certification
    Please certify the checklist once the pre-review is complete.

    Reviewer Checklist
    IRBs are to evaluate the probability, magnitude and duration of risks involved with participants in research.

    This Reviewer Checklist will be used to document review assignments, and will also serve as a quality-control mechanism to ensure Board members complete this process consistently. 
    Type of Review
    Select one
    Please communicate any issues or concerns
    Reviewer Certification

    Dawn Leusner
    IRB Manager
    Educational Testing Service

  • 7.  RE: Lets talk checklists

    Posted 10-06-2021 07:35
    Hi Angela,
    We developed checklists when we first started with Cayuse IRB, and just tried to follow the flow of the application with questions. Formatting wise we ran into issues being able to actually view the checklist while reviewing the app at the same time, so reviewers do not really use them. We've not updated them for some time either. We created two different ones, one for analyst and one for reviewers, but as I said we do really utilize them due to formatting issues.

    Maureen Wawsczyk
    Research Integrity & Compliance Officer
    Ferris State University

  • 8.  RE: Lets talk checklists

    Posted 10-08-2021 11:27

    Dear Angela and Cayuse colleagues, from the discussion thread I conclude that you probably have a different built and approach to your ethics management than we do. As a University in the UK, we have joined the Cayuse community as the result of our developers integrating with Cayuse. I was interested in reading the exchange on this, so thought I would add some info on ours.

    We use the ethics and governance workflow as a management tool for ethics applications, as a  repository for projects which have undergone ethics approval, as a tracking system for projects which have applied for approval and as a reporting facility. Our workflow uses a combination of system fields (mandatory), plus uploads requirements.

    We designed our ethics application workflow (applicable to staff and PG students) in relation to our Ethics and Governance Policy. The principle we applied is that we collect as little information in the form fields as possible with a firm focus on the ethics aspects of the project, amplified by requiring uploads of other existing documentation as appropriate; while providing decision makers with as comprehensive information as needed to assess the ethics application. It works well and is liked by those applying (PG students and staff).    

    Initially the registration of a project is triaged to identify whether ethics is required.  There are then various questions (routing) that will identify the project specific requirements for ethics permission, with advice on what to submit additionally. This is overseen by the  'back office' of the system. On submission, the requisite information (application form and uploaded supporting material) lands with the appropriate disciplinary ethics chair and the application either goes to committee or is processed through chair's action. Outcome and recommendations are recorded in the system and applicant is notified. Projects in some subject areas require an external governance and ethics application (example: health care research) – the policy makes provision for devolving approval (in order to avoid duplication and inconsistencies in outcome).  With some basic information on the project, only the outcome and permissions received have to be uploaded. Predesigned uploads include

    • A Research Health & Safety Risk Assessment Form (required for all applications)
    • Copies of any research materials/tools e.g. questionnaires, interview schedules or other materials to be used in the collection of data
    • Participant information materials
    • Participant consent form
    • An Independent/Peer Review Form
    • Any advertisements used to attract participants

    Other forms may need to be resourced from other places (system does not aim to be comprehensive). 

    I am not quite sure whether this is particularly useful to your inquiry – of course  happy to share details of the system questions.


    Annette King
    Director of Research Development
    Canterbury Christ Church University
    United Kingdom

  • 9.  RE: Lets talk checklists

    Posted 10-11-2021 05:39
    Thank you for your response, Annette.  It is definitely interesting to have a glimpse of how human research protections work in the UK.  I do something similar with our projects that have been reviewed by another IRB and are seeking our reliance.  I only have our investigators upload the approved materials rather than answering the questions in our regular initial submission form.  I try to reduce burden on our investigators as much as I can.

    You mention that you provide decision makers with comprehensive information needed to assess the initial application.  Do you use the checklists for that?  If so, Is there significant branching in the checklist?  How do you have it structured? Also, do you have different committees for different disciplines?  Do they have each their own set of requirements or is it a matter of subject matter expertise? My main struggle is with the structure of my checklists.  I am trying to have separate ones for initial submission, modifications, continuing reviews, etc. The submission form itself allows different sections / pages but the checklists do not and I am finding it difficult to get my branching logic to function the way I want it to.

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