eIRB System Selection and Transition Communication 2

eIRB System Selection and Transition Communication #2

NIH Research Community,

As you know, the Office of Human Subjects Research Protections with the guidance of the NIH eIRB Steering Committee is beginning the process of considering alternative eIRB systems to our current system, iRIS by iMedris. We wanted to provide a brief recap around what has happened since our last communication in July.

August 2020

A few months ago we sent out an eIRB system selection survey to collect feedback from the research community around what they desired in a new system. This survey was created based on information provided by the steering committee members. Below is a high-level overview of around the feedback we received. For more details, please see the appendix to this document.

439 responses to the survey
- Percentage of responses by ICs listed in Appendix I
Top 10 highest rated requirements from survey determined by research community listed in Appendix II
Received 396 individual comments under “other comments not included in survey.” Major themes covered:
- Intuitive system
- User friendly
- Better document versioning
- Improved ability to “search”
- Improved reporting capabilities
- Welcome page/dashboard to understand where your protocols stand
- Improved status tracking of protocol
- Easier access to protocols/documents in system
- Improved ability to upload documents in system
- Access to “help” while using the system
- Ability to add comments on forms where appropriate

The feedback has been compiled and is being used to make decisions around functionality. We want to thank the research community for taking the time to take the survey and make additional suggestions.

October 2020

Since then, we have started working with Axle Informatics, a consulting firm, to further guide us through the system selection process. They have taken the survey response data, as well as the raw data from the steering committee that went into creating the survey, to begin to create a comprehensive list of system requirements to ensure a new system can function successfully within the constraints of the NIH IT landscape, while meeting the functionality needs of the NIH research community. Axle has engaged stakeholders individually across the NIH to provide additional feedback about their needs in a system, to ensure no stone goes unturned, and that we make an informed decision. These stakeholders include:

OHSRP iRIS IT team
Assembly of Scientists (representatives)
NIH Investigators who use iRIS (representatives)
Staff Clinician Council Chairs
Jason Levine (NCI CCR Office of Information Technology)
Jon McKeeby (CIO for the Clinical Center)
Kim Mitchell from the Clinical Center Office of Protocol Services
Office of Research Support and Compliance (ORSC)
Protocol Management Leadership across NIH

Axle has also started reaching out to vendors suggested by the eIRB Steering Committee, but also vendors they have found through their own independent research, to determine possible solutions. The eIRB Steering Committee will be made aware of which vendors at a high level can meet our needs. Once a deeper dive is completed, we will be reaching out to the NIH research community to attend vendor demonstrations of systems that are our top contenders. More information to come on dates for these sessions.

Closing

We will be updating the research community in blasts like this one throughout the duration of the project, so please check back here for additional information in the future. They will become more frequent as we have more information to share. Should you have any questions, please reach out to Meredith Mullan, who is leading this effort.

Thank you!

The Office of Human Subjects Research Protections

Appendix I:

Appendix II:

Top 10 highest rated requirements from survey determined by research community:

Question	Rating (Scale: 1-3)
Provide easy access to and identification of the currently approved study documents (ie, most recent approved consent, protocol etc).	2.95
Ability to enable electronic notification of study team when protocol approval is due for renewal at the defined points in time and when a study lapses.	2.90
Ability to verify that required fields are completed prior to finalizing submission and prevent submission of an incomplete application. Contain validations that will alert if submission contains inconsistencies.	2.85
System should provide easy access to most currently approved consent document.	2.83
Ability to manage documents taking into account the following: PDF creation for approved forms and attachments, manage approved study documents for study teams/IRB office review, ability to generate letters without active X, system generated pre set naming conventions for documents, version control and tracking of documents, easy comparison of different selections of application.	2.81
Ability to track the date the submission is received.	2.78
Ability to track who completed the IRB documents and who to contact if there are questions.	2.78
Ability for system to document and track regulatory determinations, and the ability to incorporate determinations into outcomes. Ability to select and document more than one pediatric risk category to support component analysis.	2.75
Ability to submit non-compliance and unanticipated problems in the system.	2.74
System should provide dashboard/easy visualization of ongoing and upcoming tasks, events, submissions (all work-in-progress, queues, etc. for IRBO).	2.74

eIRB System Selection and Transition Communication 1

eIRB System Selection and Transition Communication #1

NIH Research Community,

As you have already been informed, the Office of Human Subjects Research Protections with the guidance of the NIH eIRB Steering Committee is beginning the process of considering alternative eIRB systems to our current system, iRIS by iMedris. We have formed a steering committee that meets monthly to bring key NIH stakeholders together. The members of the steering committee include:

Bradley Alvarez
Bibi Bielekova, M.D.
Melissa Bryant
Marcelo Fontinha
Nancy Fryzek
Tiffany Gommel
Nicole Grant
Jonathan Green, M.D.
Ramesh Karuppiah
Jason Levine, M.D.
Jon McKeeby, DSc
Tracey Miller
Meredith Mullan
Sue Tindall

This is to ensure that various NIH interests are represented in determining an alternative eIRB system since this system will impact the entire NIH research community. However, input to this process does not stop with the NIH eIRB Steering Committee. We also need the input of the entire NIH research community to be able to make an informed decision. Over the next few months, we will be engaging you to provide your opinion in the following ways:

NIH eIRB System Selection Requirements Survey

The purpose of this survey is to gain an understanding of what the NIH research community needs in a system from a functionality perspective. The information gathered here will be used to determine which eIRB system vendors can meet the needs of NIH. The results will be anonymous

Vendor Demonstration Attendance

eIRB vendors will be brought in, (in person or virtually depending on circumstances at that time), to present their system to the research community. Feedback will be requested after each demonstration. More information around dates and times of these demonstrations to be announced

Based on the feedback received from the two forums listed above, the Office of Human Subjects Research Protections with the eIRB Steering Committee will work to come to a decision on which vendor to move forward with. When this decision is made, it will be communicated out, and an implementation plan will be put in place. The research community will be engaged again at a later date to better understand current state workflows that will help to mold the future state system.

We want to thank you for your participation in advance. The decision to move to a new system is not being taken lightly, and we want to thank you for your support as we consider making this change. Should you have any questions, please reach out to Meredith Mullan, who is leading this effort.

Best,

The Office of Human Subjects Research Protections