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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