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.
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.
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.
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.
The Office of Human Subjects Research Protections
Top 10 highest rated requirements from survey determined by research community:
Provide easy access to and identification of the currently approved study documents (ie, most recent approved consent, protocol etc).
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.
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.
System should provide easy access to most currently approved consent document.
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.
Ability to track the date the submission is received.
Ability to track who completed the IRB documents and who to contact if there are questions.
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.
Ability to submit non-compliance and unanticipated problems in the system.
System should provide dashboard/easy visualization of ongoing and upcoming tasks, events, submissions (all work-in-progress, queues, etc. for IRBO).