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We will be going live on Tuesday, January 17, 2023, inside the NIH firewall. As you know, two issues impacted our timeline. Below it is explained how they have been addressed. As part of the implementation process for any new software system at NIH, an in depth security scan is performed by the NIH Information Security team. Through this process, security issues were brought to light. Many of these issues have been addressed by Huron. For those that haven’t, a plan to mitigate these issues was presented by Huron and accepted by the Clinical Center and OD ISSO. We are permitted to go live INSIDE the fire wall in January. This will only impact the ability of external users (our unaffiliated IRB members and non-NIH sites) to access the system. Huron is currently working to address the issues keeping us from going outside the firewall. Once this is complete, our goal is to go outside the firewall in Spring 2023.
We have a system name! ‘PROTECT’
Our system naming campaign has concluded and we have chosen the
name ‘PROTECT’ for the new eIRB system that will replace iRIS. Some
of our favorite nominations we received referenced Greek mythology,
strong character, integrity, ethics, and even our longest-standing
Director of NIH—Francis Collins! It was a joy to read your suggestions.
Thank you to all who put thought and time into this engaging
exercise!
On March 15, 2022, the AAHRPP Council granted the NIH IRP full accreditation for another 5 years (through March 15, 2027). Thank you to the NIH IRP community and the NIH IRB for representing the best of the NIH Human Research Protection Program.
OHSRP Newsletter - 2022 Q1
As we head into the middle of 2022, much of OHSRP’s efforts
are focused on the design and implementation of our new eIRB
submission system. As you can imagine, this is a complex project with
lots of moving parts. The Huron team and OHSRP have been meeting
multiple times each week to go over all aspects of the system design.
In addition, the teams are working closely with representatives of the
Scientific Review Groups, Office of Protocol Services, Radiation Safety,
Institutional Biosafety Committee, and the Deputy Ethics Counselors
to address each group’s requirements. We are excited about the
system and are confident that in the end, the change will be a positive
experience for all users. Please see the detailed update later in this
newsletter. Keep an eye out for upcoming presentations and demos
as our team hits the road to introduce you to the new system.
We enter 2022 having come off a successful site visit from our accrediting body (AAHRPP). A big thank you to the entire intramural community for supporting our site visit. The success of the visit reflects the high priority that the entire research community places on protecting the rights and welfare of our subjects. Your commitment shows and was recognized by the site visitors...
We enter 2022 having come off a successful site visit from our accrediting body (AAHRPP). A big thank you to the entire intramural community for supporting our site visit. The success of the visit reflects the high priority that the entire research community places on protecting the rights and welfare of our subjects. Your commitment shows and was recognized by the site visitors.
Resource Index - do we need it
We Are Listening
Over 130 individuals responded to our IRB investigator survey. While I wish I could say we got “straight A’s” in our evaluation, we did not. The good news is that we were provided with feedback on which we can act. One of the major themes that came out of the responses is that investigators feel a lack of transparency. We recognize that the experience of interacting with OHSRP is different than the legacy IRBs. We are larger both in the number of staff and the workload and are separate physically and administratively from the ICs. The good part is that this separation has provided the IRB with the independence needed to effectively review and oversee research. The bad part is we are being experienced as less accessible...Read More Below
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.
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 Update
Over the past year, the Office of Human Subjects Research Protections, with the guidance of the NIH eIRB Steering Committee, has considered alternative eIRB systems to our current system, iRIS by iMedris. After careful analysis and many discussions, we are pleased to announce that Huron was selected as our new vendor!
The project will officially initiate on September 30, 2021. We will meet with Huron within the next two weeks to discuss how the project will progress, key activities, and timeline. Members of the NIH research community will be engaged throughout the duration of the project to provide input to help us shape the new system. We will also provide a robust education and training program, to provide needed support to our user community and to ensure all have a strong understanding around how to use the new system.
We appreciate the input and engagement of the NIH Intramural community thus far, and look forward to your continued participation. Please be on the lookout for additional communications in the near future with more information about the project!
Thank you,
Office of Human Subjects Research Protections
Posted:
Website Governance Meeting Agenda 07/15/2021
Updates on Requested Changes from the Last Meeting:
- Exposure on other NIH websites
- Now listed on the NIH.gov main site
- Listed on the clinical center website (Nicole's link)
- Could not find links anywhere else on any other institutes website
- Survey link posted on the IRB website
- Added Home button
Updates:
- Steering Committee website
- Kevin: https://nih.sharepoint.com/sites/OD-IRBOOfficeSite/SitePages/IRB-Analyst-Page.aspx?web=1
In Process:
OWS-196 - Create IRB Process Page OPEN - Create IRB Process Page
OWS-194 - Participants Page - Anonymous Form OPEN - Participants Page - Anonymous Complaint Form.
- Additional Guidance documents can probably be reorganized
- Julie has her documents there and is waiting for us to finish our changes; might want to create a NHSR page where her documents can live
OWS-197 - Additional Guidance Documents - Organize OPEN - Additional Guidance Documents - Organize
IRBO Metrics Page Language - https://ohsrp.irbo-stage.nih.gov/confluence/display/ohsrp/OHSRP+Dashboards
OHSRP Main Page Language
Questions:
Updates:
Add pictures to the about us page: https://ohsrp.irbo-stage.nih.gov/confluence/display/ohsrp/OHSRPTeam
Tiffany has potential pictures for the website main page.
The AAHRPP virtual Site Visit will take place Tuesday November 30th through Thursday December 2, 2021. We expect to receive the agenda for the site visit the week of October 18th. Following receipt of the agenda, interviewees will be notified and prepared for their site visit interviews. For more information about what to expect, review the videocast for the "Reaccreditation of the NIH Intramural Research Program Human Research- August OHSRP Education Session." For questions, contact Heather Bridge (bridgeh@od.nih.gov) or Chris Witwer (chris.witwer@nih.gov).
I am sure that each and every one of us is more than ready for a summer where we can finally spend some time with loved ones and perhaps even enjoy some travel. May you all have well deserved R&R this summer, and we look forward to seeing you fully restored at the IRB meetings! If you have not yet signed up for meetings this summer, please take a moment to do that now on the website.
The Step 1 Application has been submitted to AAHRPP. Thanks to everyone who provided us with data and support during this process! Now we are waiting on AAHRPP’s review of our policies and materials. During this review AAHRPP may ask for minor changes to our policies or procedures. We will keep you abreast of these changes if they will impact study teams. Once AAHRPP is satisfied that our policies and procedures meet the AAHRPP accreditation standards, we will be invited to submit a Step 2 Application later this year. The site visit will take place approximately 3 months after the Step 2 application is accepted by AAHRPP. We will begin prepping NIH staff selected by AAHRPP to be interviewed during this time period. If you are selected, we hope you will be honored to represent the NIHIRP and the great work it does.