General Discussions

How does your IRB handle "No Human Subjects" determinations? Does the PI complete a form outside of Cayuse Human Ethics or do you use a Cayuse template and process within the Cayuse system? Do you track NHS data? If you are willing to share your form or template, please let me know. Thanks in advance.

------------------------------
Eileen Fry-Bowers
Associate Provost for Research Administration
University of San Diego
------------------------------

This is a good question, Eileen. I'll ping some folks and see if they can jump in here and if they have any form or template they can share!

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

Original Message:
Sent: 06-21-2021 10:58
From: Eileen Fry-Bowers
Subject: No Human Subjects Determination

How does your IRB handle "No Human Subjects" determinations? Does the PI complete a form outside of Cayuse Human Ethics or do you use a Cayuse template and process within the Cayuse system? Do you track NHS data? If you are willing to share your form or template, please let me know. Thanks in advance.

------------------------------
Eileen Fry-Bowers
Associate Provost for Research Administration
University of San Diego
------------------------------

We have built a Determination application into Cayuse. After the Welcome Tab- we ask whether they need the IRB to determine if their study is Human Subjects Research.  If they need us to determine, the determination application is what they complete, if they answer no, they begin the regular application process.

------------------------------
Linda Rupp
Research Compliance Coordinator
University of South Dakota
------------------------------

Original Message:
Sent: 06-21-2021 10:58
From: Eileen Fry-Bowers
Subject: No Human Subjects Determination

How does your IRB handle "No Human Subjects" determinations? Does the PI complete a form outside of Cayuse Human Ethics or do you use a Cayuse template and process within the Cayuse system? Do you track NHS data? If you are willing to share your form or template, please let me know. Thanks in advance.

------------------------------
Eileen Fry-Bowers
Associate Provost for Research Administration
University of San Diego
------------------------------

We handle it inside the initial submission template. After they enter the basic contact information, users are given a choice about what sort of submission they want to make. A NHSR determination is one of the options. We ask them to provide some information about the research they plan to do, and then the IRB staff review it and make the determination.

We're really trying to cut down on the number of systems a researcher has to interact with - to say nothing of our own staff. Having information spread across multiple platforms just makes it harder to keep track of it all - and increases the amount of time it takes to process applications.

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

Original Message:
Sent: 06-21-2021 10:58
From: Eileen Fry-Bowers
Subject: No Human Subjects Determination

How does your IRB handle "No Human Subjects" determinations? Does the PI complete a form outside of Cayuse Human Ethics or do you use a Cayuse template and process within the Cayuse system? Do you track NHS data? If you are willing to share your form or template, please let me know. Thanks in advance.

------------------------------
Eileen Fry-Bowers
Associate Provost for Research Administration
University of San Diego
------------------------------

We don't (yet?) have Cayuse Human Ethics, but we do implement a sort of Cayuse solution.  When it's clear to the Grant Administrator on a proposal that a determination needs to be made (could be as simple as the PI indicates no usage on the IPF yet talks about human tissues or samples or what-have-you in the abstract--which we read--or notices it when skimming the Research Plan), the proposal is flagged for review by the IRB secretary (we manually put them on the routing chain).  We would then send an email to both PI and IRB (with a URL to the IPF and linked or attached proposal) alerting them to the necessity.

Looking forward to SmartForms that will do that for us.  ;-)

Best,
-L-

------------------------------
Lisa Churchill
Grants Administration Manager/Signing Official
The Salk Institute for Biological Studies
------------------------------

Original Message:
Sent: 06-21-2021 10:58
From: Eileen Fry-Bowers
Subject: No Human Subjects Determination

How does your IRB handle "No Human Subjects" determinations? Does the PI complete a form outside of Cayuse Human Ethics or do you use a Cayuse template and process within the Cayuse system? Do you track NHS data? If you are willing to share your form or template, please let me know. Thanks in advance.

------------------------------
Eileen Fry-Bowers
Associate Provost for Research Administration
University of San Diego
------------------------------

We handle it inside the initial submission template. The first section an investigators sees after the introduction statement is called "Getting Started." In that section they can choose the option "I need to know if my activity is considered "Human Subjects Research." which takes them through the determination questions. If their responses indicate HSR, they are "routed" to continue with the remaining Initial Submission sections. If their responses indicate possible NHSR, they are given the option of requesting an official determination. If they want an official determination, they provide a brief description of the HSR activities and complete a few additional Initial Submission sections. Then the ORCA staff review it and make the determination.

------------------------------
Jennifer Dier
Assistant Director
University of California, Santa Cruz
jdier@ucsc.edu
------------------------------

Original Message:
Sent: 06-21-2021 10:58
From: Eileen Fry-Bowers
Subject: No Human Subjects Determination

How does your IRB handle "No Human Subjects" determinations? Does the PI complete a form outside of Cayuse Human Ethics or do you use a Cayuse template and process within the Cayuse system? Do you track NHS data? If you are willing to share your form or template, please let me know. Thanks in advance.

------------------------------
Eileen Fry-Bowers
Associate Provost for Research Administration
University of San Diego
------------------------------

We have recently included a form in cayuse for our investigators to either use as a worksheet to help make the determination themselves or submit for an official determination. This is a stand alone type of form the investigator can choose as one of the submission options and also incorporated in the IRB submission form.  We haven't been tracking NHS determinations but it might not be a bad idea to do so in order to gauge whether our education and outreach have any impact on the initial submissions.

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

Original Message:
Sent: 06-21-2021 10:58
From: Eileen Fry-Bowers
Subject: No Human Subjects Determination

How does your IRB handle "No Human Subjects" determinations? Does the PI complete a form outside of Cayuse Human Ethics or do you use a Cayuse template and process within the Cayuse system? Do you track NHS data? If you are willing to share your form or template, please let me know. Thanks in advance.

------------------------------
Eileen Fry-Bowers
Associate Provost for Research Administration
University of San Diego
------------------------------

Angela,

This is part of why we added the process I noted in my prior post. Namely to track NHSR determinations as part of our office workload and to assess the potential need for educational outreach.
Jenn

------------------------------
Jennifer Dier
Assistant Director
University of California, Santa Cruz
jdier@ucsc.edu
------------------------------

Original Message:
Sent: 06-23-2021 07:03
From: Angela Bain
Subject: No Human Subjects Determination

We have recently included a form in cayuse for our investigators to either use as a worksheet to help make the determination themselves or submit for an official determination. This is a stand alone type of form the investigator can choose as one of the submission options and also incorporated in the IRB submission form.  We haven't been tracking NHS determinations but it might not be a bad idea to do so in order to gauge whether our education and outreach have any impact on the initial submissions.

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

Original Message:
Sent: 06-21-2021 10:58
From: Eileen Fry-Bowers
Subject: No Human Subjects Determination

How does your IRB handle "No Human Subjects" determinations? Does the PI complete a form outside of Cayuse Human Ethics or do you use a Cayuse template and process within the Cayuse system? Do you track NHS data? If you are willing to share your form or template, please let me know. Thanks in advance.

------------------------------
Eileen Fry-Bowers
Associate Provost for Research Administration
University of San Diego
------------------------------

We use an off-site google form for a self-determination, but stipulate that it is NOT an official determination.

We chose this after attempting to integrate it into the main form for a few reasons
1) We would be bombarded by student projects, oral histories, and journalistic papers that do not need IRB review, and do not need official determinations.
2) Since there is only one initial submission type, we found many of our users get confused with too many choices at the beginning of the form.  For example, we tried having the smart form check if a reliance agreement is in place, or if the study qualifies for IRB review.  Too many users filled this incorrectly and the submission had to be returned several times with emails outside of the system guiding them correctly.  I suppose for some researchers, trying to find a way out of IRB review was worth more effort than completing the streamlined application?
3) If the work is seeking or has funding, or if an official determination is needed, we would ask for an initial submission with basic descriptions that can lead to NHSR determination. This way the determination is synced with the SP file.  We do have an NHSR determination in our letters template
We generally do not track the determinations as most are unofficial.

If you are interested in the Google form we use, it is here - https://forms.gle/VN6Y5cXP3jcNRfM78

------------------------------
Matt Zembrzuski
Research Compliance Manager
American University
------------------------------

Original Message:
Sent: 06-21-2021 10:58
From: Eileen Fry-Bowers
Subject: No Human Subjects Determination

How does your IRB handle "No Human Subjects" determinations? Does the PI complete a form outside of Cayuse Human Ethics or do you use a Cayuse template and process within the Cayuse system? Do you track NHS data? If you are willing to share your form or template, please let me know. Thanks in advance.

------------------------------
Eileen Fry-Bowers
Associate Provost for Research Administration
University of San Diego
------------------------------