Human Ethics | ROAMWyo

The Human Ethics module of ROAMWyo will streamline all aspects of human subjects research: protocol submission, review, and approval, as well as provide a dashboard where researchers can view the status of all of their proposed, approved, and past protocols.

 

Announcements:

Human Ethics to launch January 8th, 2024

In light of the upcoming launch of the ROAMWyo HE Module on January 8th, 2024, we will be implementing a temporary pause for human subject research protocol submissions and approvals beginning at 3 pm on December 15th, 2023.  We will be unable to accept any submissions or approve any protocols during this short period.  Following this period, all new HE submission will be submitted through the ROAMWyo system beginning on January 8th.  Thank you for your support, patience, and understanding.

UW will soon begin the transition to ROAMWyo Human Ethics (HE) for all IRB protocol submissions, review processes, and approval notifications for research involving human subjects. ROAMWyo Human Ethics will be launched January 8th, 2024.

After January 8th, 2024, all NEW protocols, updates/modifications, and annual renewals MUST be submitted through ROAMWyo. Protocols currently under review in the old paper system will be completed via the paper system but must be entered into ROAMWyo (instructions to follow).

Currently approved IRB protocols will be in the new system on January 8th, 2024 as Legacy protocols (aka Shell protocols). Legacy protocols are transitional protocols that house only the most basic information: PI, faculty advisor, title, and approval date. Researchers will be required to update their Legacy protocols with their approved study information by August 1, 2024 in order to complete the transition into the new system. This conversion will be required before the IRB Office will accept any project modifications or renewals. Information on Legacy protocol conversion will be given in the training materials.

Written Step-by-Step Guidance for IRB Reviewers

ROAMWyo Human Ethics Access

ROAMWyo will be accessible here as of 1/8/2024.

 

ROAMWyo Instructions & Training

Instructions from Cayuse: https://support.cayuse.com/hc/en-us/sections/360002794613-Researchers-Creating-and-Managing-Studies-and-Submissions

Self-guided ROAMWyo Training:

ROAMWyo Human Ethics (IRB) - Video 1 - Submitting a New Study

ROAMWyo Human Ethics (IRB) - Video 2 - Additional Submissions

ROAMWyo Human Ethics (IRB) - Video 3 - Legacy Study/Submission

Written Step-by-Step Guidance for Researchers is available here

 

Live ROAMWyo Training:

Live Virtual HE Training Session:

A live training for the ROAMWyo HE module will be conducted via Zoom on January 9th, 2024 from 10 am-12 pm

Zoom link:

Virtual Office Hours:

Wednesdays and Thursdays beginning after 1/8/2024, 10 – 11 am

The live virtual training seminars and the live virtual office hours can be accessed here.

 

ROAMWyo Support

Email Support ·

 

Reporting Issues

ROAMWyo Human Ethics FAQ

A. The ROAMWyo HE module is an electronic IRB protocol management and submission system that manages all human subjects research protocols from initial submission to closure. It is cloud-based, user-friendly, and secure. It can be accessed from anywhere as long as an internet connection is available.
A. The ROAMWyo HE dashboard is the homepage for your human subjects research. You can use the dashboard to access your studies, submissions, and tasks.
A. ROAMWyo Human Ethics will officially launch January 8th, 2024
A. Once ROAMWyo Human Ethics goes live (January 8th, 2024), all new IRB submissions, updates, and annual reviews will take place entirely in ROAMWyo. Paper submissions will not be accepted after this date
A. No.
A. Every investigator with an active IRB protocol will have that protocol’s basic information pre-populated into ROAMWyo for convenience. However, it will be the investigator’s responsibility to enter the remaining information upon time of renewal or prior to submitting a protocol amendment. The basic information of your existing IRB protocol is called the “Legacy” protocol.

A. All of your currently active & approved studies have been carried over from the old system into ROAMWyo as “Legacy” protocols. Legacy Protocols contain the basic information of your project: PI name, faculty advisor, project title, and approval date. PIs will be required to update their Legacy Protocols via protocol updates to add in all their originally approved study information (this is not an opportunity for amendments). This will be required prior to a study update/modification or renewal. Legacies not updated by August 1, 2024, may be administratively closed out by the IRB Office. Researchers who do not see their active and approved study listed as a Legacy Protocol must contact the IRB Office immediately.

Guidance on the Legacy Protocol conversion process will be shared in the written and video training opportunities.

A. Shell Protocols are Legacy Protocols. Please see the Legacy Protocol question above
A. Researchers will be required to update their Legacy Protocol to a full version prior to: proposing any project updates, amendments, or alterations; an annual renewal; or by August 1st, 2024. Studies that are no longer active may be closed out in lieu of completing the Legacy conversion.

A. Yes. After your Legacy protocol has been updated to contain all original language and has been approved, you will select “Modification” under the “New Submission” button on your study page. Amendments may include (but are not limited to): changes in research personnel, changes in study design or execution, or altering of any surveys, recruiting materials, and/or consent forms.

A. Each approved protocol has a “Study Details” page and a “Submissions Details” page. The “Study Details” page is the page for the overall protocol/study and includes the approval/expiration dates and all submissions related to the study. The “Submission Details” page outlines each individual submission (initial submission, updates, renewal, etc.) and includes the status of the submission and all approved study materials for the submission.

A. No. ROAMWyo HE will warn you with a red lock icon if another user is currently editing a section. You won't be able to edit that section until they're done with their edits.

A. You will be able to access your approved documents by viewing your submission in ROAMWyo HE. Your approval letter will be sent to you via email.

A. During the submission process, the IRB office may send communication to the PI in the form letters notifying the PI of status changes, approvals, and other needed information. Those letters are sent via email and are available to download directly from “Submission Details” in ROAMWyo HE.

A. CITI integrates with ROAMWyo HE and training certificates will be stored in your user account.

A. Any research personnel who are employed by UW (including paid students) are automatically added into ROAMWyo and can be added to a protocol in HE. Unpaid UW personnel and/or outside researchers must be added manually by the ROAMWyo staff. Email ROAMWyo@uwyo.edu with their name, email, and current institution to have them added into the system. Once added they will receive an automated email with their login instructions. As a reminder, all research personnel must be added to a protocol and must therefore be added to ROAMWyo.

A. Training will be made available with both written step-by-step guidance as well as a recorded video walkthrough of the module. Both of those resources will soon be available on the Human Ethics website of ROAMWyo as well as on the UW Human Subjects webpage.