General Discussions

Hi all,

I'm wondering what you do when you'd really like a member of the IRB to review the closure and provide feedback on a response to the PI.

An example of this is when the PI has over-enrolled or notes there were Adverse Events that were not reported. We most often see these issues with graduating students and an Incident Report is not timely or useful in what is essentially is now an educational moment.

Since you can't route a Closure Report, what do you do?  Are there any "in Cayuse" solutions we haven't thought of?

Regards,
Darcy

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

Hi, Darcy!

This is an interesting question.  I appreciate the example too, which really helped to contextualize the issue in practice. My institution has not run into this problem before, so I don't have any "in Cayuse" solutions to offer. We are still relatively new users of Human Ethics, and are not yet on the new research platform. I'm going to Follow this discussion should others weigh in.

I do agree it is important to talk with the PI and project about the Adverse Events that were not reported, including timely submissions of Incident Reports for prompt and appropriate resolution. So while there may not be a capability for this action right now in Human Ethics, still do it, and submit it as a possible new feature for Cayuse consideration.

Best,

Dawn  

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

Original Message:
Sent: 08-03-2022 08:49
From: Darcy Hammar
Subject: Human Ethics - Closures with issues/share with IRB member

Hi all,

I'm wondering what you do when you'd really like a member of the IRB to review the closure and provide feedback on a response to the PI.

An example of this is when the PI has over-enrolled or notes there were Adverse Events that were not reported. We most often see these issues with graduating students and an Incident Report is not timely or useful in what is essentially is now an educational moment.

Since you can't route a Closure Report, what do you do?  Are there any "in Cayuse" solutions we haven't thought of?

Regards,
Darcy

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

I do not have a solution that incorporates cayuse but it sounds like something a post approval monitor would handle.  Perhaps your coordinator who handles closures could also hold the title of post approval monitor. This was something that I did at my former institution.  I took over all of the closures, continuing reviews, and modifications as post approval monitor and would handle all of the situations like this with educational moments and even bring to the attention of the committee if necessary as part of the process.

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

Original Message:
Sent: 08-03-2022 08:49
From: Darcy Hammar
Subject: Human Ethics - Closures with issues/share with IRB member

Hi all,

I'm wondering what you do when you'd really like a member of the IRB to review the closure and provide feedback on a response to the PI.

An example of this is when the PI has over-enrolled or notes there were Adverse Events that were not reported. We most often see these issues with graduating students and an Incident Report is not timely or useful in what is essentially is now an educational moment.

Since you can't route a Closure Report, what do you do?  Are there any "in Cayuse" solutions we haven't thought of?

Regards,
Darcy

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

Angela,

I appreciate your response.

We are an office of 2. The IRB analyst essentially was doing the normal post-approval monitoring in flagging the closure report for an IRB member.  We needed "scientific" eyes on it and guidance on whether to request the Data Safety Monitoring file, etc.

It's rare that we need IRB member eyes on a Closure, but when we do, we wanted to see if we hadn't thought of something we could do/route in Cayuse.

Regards,
Darcy

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

Original Message:
Sent: 08-09-2022 10:42
From: Angela Bain
Subject: Human Ethics - Closures with issues/share with IRB member

I do not have a solution that incorporates cayuse but it sounds like something a post approval monitor would handle.  Perhaps your coordinator who handles closures could also hold the title of post approval monitor. This was something that I did at my former institution.  I took over all of the closures, continuing reviews, and modifications as post approval monitor and would handle all of the situations like this with educational moments and even bring to the attention of the committee if necessary as part of the process.

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

Original Message:
Sent: 08-03-2022 08:49
From: Darcy Hammar
Subject: Human Ethics - Closures with issues/share with IRB member

Hi all,

I'm wondering what you do when you'd really like a member of the IRB to review the closure and provide feedback on a response to the PI.

An example of this is when the PI has over-enrolled or notes there were Adverse Events that were not reported. We most often see these issues with graduating students and an Incident Report is not timely or useful in what is essentially is now an educational moment.

Since you can't route a Closure Report, what do you do?  Are there any "in Cayuse" solutions we haven't thought of?

Regards,
Darcy

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

I have not run into this situation myself, but the only quick alternative that I could think of would be to assign one of the IRB members or chair to the analyst role, then you could assign to them as analyst during prereview.  The problem with this is that  the member might need some training navigating the new role, and would then have to see everything on the analyst dashboard.  I am not sure how your notifications are set up, but I am also a very small office and I turned off email notifications of analyst assignments.   So that would be another area that would need to be adjusted for this case.     My recommendation would be to go out of Cayuse and add any documentation as either a restricted comment or in the decision panel under internal notes.

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

Original Message:
Sent: 08-09-2022 10:57
From: Darcy Hammar
Subject: Human Ethics - Closures with issues/share with IRB member

Angela,

I appreciate your response.

We are an office of 2. The IRB analyst essentially was doing the normal post-approval monitoring in flagging the closure report for an IRB member.  We needed "scientific" eyes on it and guidance on whether to request the Data Safety Monitoring file, etc.

It's rare that we need IRB member eyes on a Closure, but when we do, we wanted to see if we hadn't thought of something we could do/route in Cayuse.

Regards,
Darcy

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

Original Message:
Sent: 08-09-2022 10:42
From: Angela Bain
Subject: Human Ethics - Closures with issues/share with IRB member

I do not have a solution that incorporates cayuse but it sounds like something a post approval monitor would handle.  Perhaps your coordinator who handles closures could also hold the title of post approval monitor. This was something that I did at my former institution.  I took over all of the closures, continuing reviews, and modifications as post approval monitor and would handle all of the situations like this with educational moments and even bring to the attention of the committee if necessary as part of the process.

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

Original Message:
Sent: 08-03-2022 08:49
From: Darcy Hammar
Subject: Human Ethics - Closures with issues/share with IRB member

Hi all,

I'm wondering what you do when you'd really like a member of the IRB to review the closure and provide feedback on a response to the PI.

An example of this is when the PI has over-enrolled or notes there were Adverse Events that were not reported. We most often see these issues with graduating students and an Incident Report is not timely or useful in what is essentially is now an educational moment.

Since you can't route a Closure Report, what do you do?  Are there any "in Cayuse" solutions we haven't thought of?

Regards,
Darcy

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

Matt,

This is something I had not thought of, so thank you.

The Chair could be trained, but I'm not sure I want to turn analyst notifications off.  (I use emails to create tasks for myself.)

For now, I think we will stick to our out-of-Cayuse approach as "problematic" closures are few and far between.

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

Original Message:
Sent: 08-10-2022 05:54
From: Matt Zembrzuski
Subject: Human Ethics - Closures with issues/share with IRB member

I have not run into this situation myself, but the only quick alternative that I could think of would be to assign one of the IRB members or chair to the analyst role, then you could assign to them as analyst during prereview.  The problem with this is that  the member might need some training navigating the new role, and would then have to see everything on the analyst dashboard.  I am not sure how your notifications are set up, but I am also a very small office and I turned off email notifications of analyst assignments.   So that would be another area that would need to be adjusted for this case.     My recommendation would be to go out of Cayuse and add any documentation as either a restricted comment or in the decision panel under internal notes.

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

Original Message:
Sent: 08-09-2022 10:57
From: Darcy Hammar
Subject: Human Ethics - Closures with issues/share with IRB member

Angela,

I appreciate your response.

We are an office of 2. The IRB analyst essentially was doing the normal post-approval monitoring in flagging the closure report for an IRB member.  We needed "scientific" eyes on it and guidance on whether to request the Data Safety Monitoring file, etc.

It's rare that we need IRB member eyes on a Closure, but when we do, we wanted to see if we hadn't thought of something we could do/route in Cayuse.

Regards,
Darcy

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

Original Message:
Sent: 08-09-2022 10:42
From: Angela Bain
Subject: Human Ethics - Closures with issues/share with IRB member

I do not have a solution that incorporates cayuse but it sounds like something a post approval monitor would handle.  Perhaps your coordinator who handles closures could also hold the title of post approval monitor. This was something that I did at my former institution.  I took over all of the closures, continuing reviews, and modifications as post approval monitor and would handle all of the situations like this with educational moments and even bring to the attention of the committee if necessary as part of the process.

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

Original Message:
Sent: 08-03-2022 08:49
From: Darcy Hammar
Subject: Human Ethics - Closures with issues/share with IRB member

Hi all,

I'm wondering what you do when you'd really like a member of the IRB to review the closure and provide feedback on a response to the PI.

An example of this is when the PI has over-enrolled or notes there were Adverse Events that were not reported. We most often see these issues with graduating students and an Incident Report is not timely or useful in what is essentially is now an educational moment.

Since you can't route a Closure Report, what do you do?  Are there any "in Cayuse" solutions we haven't thought of?

Regards,
Darcy

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