ATTENTION

Ideates’s replacement, RUTH, the new IRB electronic submission and application tracking and review software rolls out on Wednesday, 9/23/20. All project submissions (paper and Ideate) will stop for a two week period between September 5th – September 22nd. No submissions will be accepted after the Friday, 9/4 at 5:00 p.m. deadline.

Contact PPHS if you have any questions IRB@mssm.edu (212) 824-8200.

Register here for RUTH training:
Morning Sessions
Afternoon Sessions

R2R Training in RUTH (External IRB Submissions)

We are days away from rolling out our new electronic IRB submission system, RUTH, on 9/23/20. We’ve been sending out information regularly to help with the transition.

Training sessions have been scheduled for R2R submissions, where study teams who rely on or plan to rely on an external IRB. It is a prerequisite that you have attended one of the RUTH training sessions prior to attending this session.

Please choose a time to attend training.

*The session will last approximately 30 minutes, though we have up to one hour to address any questions.

Links for registration:

Sessions max out at 100 people. If your whole team can’t attend, please be sure to send at least one person to the training session.

PPHS to End SubmIssion Deadlines for IRB Applications Beginning 9/23/2020

With the implementation of RUTH, the electronic application submission system on 9/23/2020, the PPHS will be ending its deadline submission policy and will begin accepting applications on a rolling basis with a pledge to complete its review within a fixed period. Of course, to meet that pledge requires the cooperation of the research team and the ancillary offices. In general, studies will be reviewed in the order in which they are received. IRB submission review times vary, as they are based on the regulatory review categories, the complexity of the protocol and the completeness of the submission. Follow the below submission guidelines when planning your IRB applications:

Our Service Pledge

Full Board Review: Greater than minimal risk projects will be presented at a board meeting within 6 weeks of a completed application.

Expedited reviews: Minimal risk projects will be approved within 6 weeks of a completed application.

Please note that as we transition to the RUTH system, review times will vary for the first 4 to 6 weeks of this new process.

Implementation Guidance

New Projects and Modifications

  • Can be submitted at any time
  • Minimal Risk (MR) studies: Submit at least six weeks before your study’s proposed start date or date you wish to enact proposed changes.
  • Greater than Minimal Risk (GTMR) studies: Submit at least six weeks before your desired IRB meeting date.
    • TIP: For GTMR studies, use the attached 2020 IRB meeting schedule to determine the best meeting date for your project by counting back 6 weeks from the desired IRB meeting date.

Continuations

  • Can be submitted at any time within the approval period. Please allow six weeks for review.
    • TIP: Projects are approved for up to one year, so if you renew early, your subsequent approval will expire less than one year from the current expiration date.
    • Don’t wait until the last minute to submit your continuation and risk your study expiring!
  • Minimal risk (MR) studies: submit at least 6 weeks prior to your study’s expiration date.
  • Greater than Minimal Risk (GTMR) studies: Submit at least 6 weeks before your desired IRB meeting date.
    • TIP: If a study team wishes to keep the same expiration date every year, this must be noted in the application. This would primarily be limited to NIH grants. The PPHS is able to link or de-link the approval periods, if requested.

2020 IRB Meeting Dates

Board IRB Meeting Date
C 9/22/2020
D 9/29/2020
A 10/6/2020
B 10/13/2020
C 10/20/2020
D 10/27/2020
A 11/3/2020
B 11/10/2020
C 11/17/2020
D 11/24/2020
A 12/1/2020
NO MEETING**
C 12/15/2020
D 12/22/2020
NO MEETING**
B 1/5/2021
C 1/12/2021
D 1/19/2021
A 1/26/2021
B 2/2/2021

 

PPHS - IRB Submission System Update (09/11/2020)

Fall is right around the corner and so is the roll out of the new IRB application submission system, RUTH!  Wednesday, September 23rd is the go live date!

As of Friday, September 4th at 5:00 p.m., PPHS no longer accepts new submissions (initials, continuations, or modifications) through Ideate or via paper.  For those who submitted their initial projects or responses required for approval before that deadline, the PPHS is working as fast as possible to move the reviews along – we ask that you also do the same when you receive an inquiry about your project.  Remember all other office reviews, such as FACTS, MSIP, GCO, FCOI, InfoSec, etc. will need to be completed before the PPHS can release your project approval, so don’t forget to finalize those processes too.

All projects in Ideate or paper, submitted before that deadline, will need to be finalized between 9/5 and 10/23 in order to be migrated to RUTH during one of the scheduled migration dates.  As a reminder, for all projects not approved or a determination not made by 10/23, the project will forever be left incomplete and to resurrect them, a completely new submission in RUTH will be required.

This week’s noteworthy news:

  • All required reportable new information submissions (HRP 224 reports) will need to be submitted to the IRB Inbox (irb@mssm.edu) via the paper form (found on the PPHS website).
  • Consider scheduling some time with your research team, on or close to the go live date of Wednesday, September 23rd, to update your profile and assign proxies to your studies.  All tasks are easy enough and required but because you’ll need to assign proxies per project, you may need a bit of focused time to do so. Only the PI can assign a proxy to a project.  The proxy will have authority to make changes and submit projects on behalf of the PI once assigned (and after the initial submission has been made).

Researchers, coordinators and staff training began 8/17/20 for one hour webinar sessions via Zoom.  Registration is open and training sessions are scheduled through Tuesday, 9/22/20 – sign up early and often!  Links for registration:  Morning Sessions  Afternoon Sessions.  If your entire team can’t attend, please be sure to send at least one person to the training session.

PPHS - Join Us Online! IRB University Classes - A New Day with RUTH - (9/16/2020 & 9/17/2020)

Did you hear? RUTH rolls out soon! Starting on Wednesday, September 23, all IRB submissions will be created and managed in RUTH.  Our new IRB University Classes will show you how to become familiar with the submission and review requirements. 

Register in advance for these webinars. You will receive a confirmation email after you sign up.

NEXT UP:

IRB 101 – September 16, 2020, 2:00 – 3:00 PM

Register Here: https://mssm.zoom.us/webinar/register/WN_ohQWl4nRQPiqL1uAi_D4zg

IRB 201 – September 17, 2020, 2:00 – 3:30 PM

Register Here: https://mssm.zoom.us/webinar/register/WN_VNHFZk9GS1C3iH8rxax9Og

What is RUTH?

As we move into the summer months, we are pleased to announce that RUTH, the new IRB electronic submission and application tracking and review software, is fully under development and is on track for her launch date of September 23.

The new system is named after Dr. Ruth Abramson who is warmly remembered by all those who knew her at Mount Sinai Medical Center and School of Medicine for her lifelong commitment to research and teaching. It is fitting to name our new system, which will support the review of all human subjects research, after Dr. Abramson who was so deeply aware of the importance of human research protections.

As a reminder to those who have offered their help and support as Champions, we will be in contact with you soon to begin the process of testing RUTH.

Despite the disruption due to COVID19, please know that with our continuing efforts over the coming months, and the ongoing support of the Mount Sinai research community, RUTH will go live on September 23. With that in mind, we remind you to submit your annual renewal applications by their assigned submission deadlines, and please close any projects that are no longer active. This will ensure timely review of your protocols and lead to a smoother transition to RUTH’s software system.

We will continue to keep you updated on everything RUTH is up to over the next few months.

Rosalind J. Wright, MD MPH
Dean for Translational Biomedical Sciences Icahn School of Medicine at Mount Sinai

Glenn Martin, MD, CIP
Senior Associate Dean for Human Subjects Research Icahn School of Medicine at Mount Sinai

Eric Nestler, MD, PhD
Dean for Academic and Scientific Affairs Icahn School of Medicine at Mount Sinai

RUTH Training Information

Summer is officially here and we are using it to mark the kick off of our teaching plan for RUTH. As you know RUTH, the new IRB application submission software system, is rolling out on September 23, 2020 which will be here before we know it!  With that, we are moving into teaching mode and want to let you know there are a number of ways to get to know RUTH.

Below is information for you to sign up for classes in August to learn how to use RUTH.  In collaboration with Research IT, the PPHS will host training webinars beginning on August 17th.  Randomly selected webinars will have a drawing for the attendees and someone will win a small gift.

  1. RUTH Champions – To ensure a successful roll-out, we have recruited colleagues to donate 2 hours of their time in mid-August to learn the new system and then take their knowledge back to their departments and be available to help their colleagues, researchers, etc.  If you are part of our Champion team, you’ll receive an email over the next few days inviting you to schedule your volunteer time via Zoom.  Details will be in the email message.  If you think you might want to be a Champion, please contact Lori Jennex (lori.jennex@mssm.edu) for more information.
  2. Researchers, coordinators and staff training will begin August 17th for one hour sessions via Zoom.  Registration for classes is now open with additional classes being added over the next few weeks – sign up early and as often as you like!
    Links for registration:
    Morning Sessions
    Afternoon Sessions
  3. Drop-in Zoom sessions will begin after September 23rd for direct hands on help with RUTH, the PPHS and Research IT staff.
PPHS - RUTH - IRB Submission System Update (8/31/2020)

Did you hear? RUTH, rolls out on Wednesday, 9/23/20. RUTH will sit in the cloud, fully secure, and without the need of having to use VPN/Tunnel to gain access. Hooray!

This week’s noteworthy news:

  • Earlier this month we mentioned CITIProgram.org (where your education requirements for human subjects research are stored) will begin to download your information directly to RUTH starting Wednesday, September 23rd. In order for your information to load correctly in RUTH, you need to be sure your Life Number and Mount Sinai email address are listed.  To double-check your information is correct, please follow these instructions:

Go to https://www.citiprogram.org/
At the top of the page, click Log in Through My Institution
Scroll down to and click: Icahn School of Medicine at Mount Sinai which will take you to the SSO page for Mount Sinai, then log in
Under Institutional Courses/Icahn School of Medicine at Mount Sinai, click View Courses
Scroll to the bottom and click Update Institution Profile
Fill in your Institutional email address (mssm.edu, mountsinai.org, nyee.edu, nychhc.org, icahn.mssm.edu, chpnet.org) and life number under Employee Number.

  • While you’re updating your information, you might want to also look at Sinai Central and Sinai 1 to be sure your information is listed correctly there too.
  • You may have noticed the new question in Sinai Central when completing your IF packet about team members involved in the consent process. Be sure to answer that question for each person you add to the packet.
  • Remember – All project submissions (paper and Ideate) will stop for a two week period between September 5th – September 22nd.  No submissions will be accepted after the Friday, 9/4 at 5:00 p.m. deadline. Submissions accepted for review will continue through the review process and must be completed by the updated date of 9/18/20 to be part of the first wave of migrated approved projects into RUTH. September 23 – October 23 is designated as a one month extension to clear up any projects not yet managed.
    • NOTE: For all projects not approved, a determination not made or not closed by 10/23/20 (paper or Ideate), they will forever be left incomplete and to resurrect those projects, a new submission in RUTH will be required.

Researchers, coordinators and staff training began 8/17/20 for one hour webinar sessions via Zoom.  Registration is open and additional sessions have been added through Tuesday, 9/22/20 – sign up early and often! Links for registration:  Morning Sessions  Afternoon Sessions. If your entire team can’t attend, please be sure to send at least one person to the training session.

 

Dean's Office - Research workflow improvements on 9/23/20 (8/28/2020)

This is a reminder about research administration workflow changes that will be rolled out on September 23 along with RUTH (our new IRB platform) going live.

  • School- (seed-) supported projects involving human or animal research will no longer go through InfoED and GCO. They will be processed directly through RUTH and eIACUC. This change will increase efficiency by reducing the number of steps and avoiding redundant entries. Department chairs and administrators will automatically be informed of such protocols and will alert the IRB or IACUC if they do not approve a particular protocol. (Note: Projects that do not involve animals or humans, or projects that require an endorsement by GCO – e.g., Data Transfer Use Agreement, study drug donation, etc., must continue to be submitted to GCO via InfoED.)
  • There will be a new IRB protocol creation process in RUTH – the ability to auto-populate personnel and other data from Sinai Central IFs (Investigator Forms) with a single click. This will eliminate the current requirement of manual data entry into multiple systems.
  • Ancillary Office (e.g. Radiation Safety, Biosafety, Investigation Drug Services, etc.) reviews will be independent of each other resulting in time efficiency during the protocol review process.
  • A new “Protocol Wizard” will provide information on appropriate routing to these ancillary offices and guide study teams on required steps.
  • A new FCOI Dashboard will provide financial conflict data to the FCOI Office in a transparent and user-friendly way.
  • New technical interfaces between InfoED, RUTH, eIACUC, and Sinai Central will enable better workflows and significant improvements in administration, operations, and compliance in research for all future projects.
  • DURC (Dual Use Research of Concern) questions will be in Sinai Central along with the IFs. (DURC involves studies of numerous infectious agents.)

All faculty, researchers, coordinators, and staff can register for training sessions via Zoom. You can register for classes here: Morning Sessions  Afternoon Sessions.

If you have any specific questions please feel free to email esupport@mssm.edu.

Thank you,

Eric Nestler

PPHS - RUTH IRB Submission System Update (8/20/2020)

Surfs up, summer is here and RUTH, rolls out on 9/23/20.  We hope summer has wrapped its arms around you like a warm, cozy blanket, your days are long and lovely and your masks are on. We’ve been sending out information regularly to help with the transition to RUTH.

This week’s noteworthy news:

  • For projects that should be submitted during the 2 week system shut down (9/7 – 9/22) or any projects expiring through 10/31/20, you’ll want to submit them to the PPHS for IRB review now and they will not be rejected for being submitted too early.  Remember that you are still required to have all education requirements met, FCOI completed and an Infoed submission started.  Keep in mind the change of not having to submit School sponsored projects to Infoed doesn’t begin until 9/23.
  • In RUTH, you will need to update your profile with your current CV or resume the first time you login so be sure your CV or resume is current.
  • If your project is under review now or will be on 9/4, remember some of the conditional offices use a longer period of time to review projects (i.e. InfoSec, FCOI, etc.).  If your project involves a conditional office that requires extra time for review its best to submit your project ASAP and get that process started now.  Don’t jeopardize the migration of your project into RUTH by not having it approved by 9/18.  If you think the project may be held up, consider waiting until the roll out to submit initial projects.
  • Remember – All project submissions (paper and Ideate) will stop for a two week period between September 7th – September 22nd.  No submissions will be accepted after the Friday, 9/4 at 5:00 p.m. deadline. Submissions accepted for review will continue through the review process and must be completed by the updated date of 9/18/20 to be part of the first wave of migrated approved projects into RUTH.  September 23 – October 23 is designated as a one month extension to clear up any projects not yet managed.
    • NOTE: For all projects not approved, a determination not made or not closed by 10/23/20 (paper or Ideate), they will forever be left incomplete and to resurrect those projects, a new submission in RUTH will be required.

Researchers, coordinators and staff training began 8/17 for one hour sessions via Zoom.  Registration is open now – sign up early and often!  Links for registration:  Morning Sessions  Afternoon Sessions.  If your entire team can’t attend, please be sure to send at least one person to the training session.

Remember you can always find all the notifications about RUTH on the Office of Research Services Research Road Map at New IRB Platform – RUTH.

PPHS - RUTH IRB Submission System Update (8/10/20)

We are approximately a month away from the 9/4/20 deadline to submit an application in Ideate before that system stops accepting applications and about six weeks away from rolling out our new electronic IRB submission system, RUTH, rolls out on 9/23/20. We’ve been sending out information regularly to help with the transition.

Noteworthy News:

  • If you joined the CR Forum last Wednesday you heard that applications within RUTH will require a protocol and a newly designed HRP 503 PPHS/IRB Application. This will be true for all projects needing IRB review, unless it is strictly a chart or specimen project with no contacts with research subjects. In that case, we will provide a combined research summary/application form. For the rest of the studies, submissions will require a written protocol which can be provided by the sponsor, or prepared for a grant, or written specifically for this application. Protocols should follow the generally accepted NIH format which can be found as well as a wizard here. We urge teams to familiarize themselves with this new requirement before new applications are accepted beginning 9/23.
  • Human subjects education requirements won’t change with the RUTH rollout but the way the information feeds into RUTH is different. In order for the information to display correctly in RUTH, each person listed on a project must have their Mount Sinai email address and Life # listed in their CITIProgram profile. Visit CITIProgram.org, click Log in Through My Institution, at the top of the page, navigate to your member profile, and check the information listed.
  • As we transition to RUTH the PPHS will only use one IRB number along with the IF and GCO numbers. Your migrated project will keep it’s assigned HSM number as the project’s identifier. Be sure to have that number available so you can easily search for your project in RUTH and cross reference projects if you currently use the Ideate number now. The HSM# can be found on your approval/determination letter sent by the PPHS team.
  • Remember – All project submissions (paper and Ideate) will stop for a two week period between September 7th – September 22nd.  That means no submissions will be accepted after the Friday, September 4th at 5:00 p.m. deadline. Submissions accepted for review will continue through the review process and must be completed by 9/22/20 to be migrated into RUTH. September 23 – October 23 is designated as a one month extension to clear up any projects not yet managed.
    • NOTE: For all projects not approved, a determination not made or not closed by 10/23/20 (paper or Ideate), they will forever be left incomplete and to resurrect those projects, a new submission in RUTH will be required.

Researchers, coordinators and staff training begins August 17th for one hour sessions via Zoom. Registration is open now – sign up early and often! Links for registration:  Morning Sessions  Afternoon Sessions. Sessions max out at 100 people. If your whole team can’t attend, please be sure to send at least one person to the training session.

PPHS - RUTH IRB Submission System Update (7/24/20)

The electronic IRB submission system, RUTH, rolls out on September 23, 2020.  While it may sound far into the future, its only about nine weeks away!  We have some important information for you to read to prepare for the GO LIVE date:

  1. Project submissions will HALT for a two-week period in September to allow the PPHS time to process all projects under review and move them to a finished status.  Access to Ideate to submit a review request will not be available.  Applications/projects previously submitted and currently under review at that time and applicatons accepted for the 9/4 deadline will continue through Ideate.  If you miss the 9/4 deadline or your application is incomplete and rejected (education requirements missing, no InfoEd submission started, missing paperwork, incorrect or missing IF#), you will have to wait for 9/23 to submit your request through RUTH.
    • Important dates:
      • September 4, 2020 at 5:00 p.m. is the last submission deadline for Ideate applications to be accepted
      • September 7th through September 22nd no submissions will be accepted (including initial, continuation and modification applications, 224s, commercial IRB requests, etc.).  Information on submitting time sensitive submissions (i.e. risk-related reportable new information) during the two-week shut down will be shared at a later date.
      • September 23rd RUTH comes alive!
    • Check your approval letter to know and plan for your submission window.  Projects with a submission window of 9/7-9/22 can be submitted for the 9/4 deadline or will be prioritized in RUTH once submitted in the week of 9/23-9/25
    • Its recommended that you assess your portfolio and close any projects that are finished
    • IRB Meetings will continue as usual
    • For projects submitted by the 9/4 deadline that do not get finalized before RUTH goes live, a 30 day extension through October 23rd will occur
    • For all projects not approved, a determination not made or not closed by 10/23 in Ideate, they will forever be left incomplete in Ideate.  To resurrect those projects, a new submission in RUTH will be required.
  2. Researchers, coordinators and staff training begins August 17th for one hour sessions via Zoom.  Registration is open – sign up early and as often as you like!  Links for registration:  Morning Sessions  Afternoon Sessions
  3. Drop-in Zoom sessions for RUTH will begin after September 23rd for direct hands on help from the PPHS and Research IT staff.
Dean's Office - Research Workflow Improvements (7/23/2020)

Everyone,

We are delighted to share upcoming research workflow changes that should significantly improve our efficiency and make your lives just a little bit easier. I want to thank Ashish Narayan and Joseph Finkelstein, along with numerous leaders and administrative offices on campus, for their hard work over the past several months to enable the following changes, which will take effect on September 23, when the new IRB platform, RUTH, goes live.

  • School- (seed-) supported projects involving human or animal research will no longer go through InfoED and GCO. They will be processed directly through RUTH and eIACUC. This change will increase efficiency by reducing the number of steps and avoiding redundant entries. (Projects that do not involve animals or humans, or projects that require an endorsement by GCO – e.g., Data Transfer Use Agreement, study drug donation, etc., must continue to be submitted to GCO via InfoED.)
  • There will be a new IRB protocol creation process in RUTH – the ability to auto-populate personnel and other data from Sinai Central IFs (Investigator Forms) with a single click. This will eliminate the current requirement of manual data entry into multiple systems.
  • Ancillary Office (e.g. Radiation Safety, Biosafety, Investigation Drug Services, etc.) reviews will be independent of each other resulting in time efficiency during the protocol review process.
  • A new “Protocol Wizard” will provide information on appropriate routing to these ancillary offices and guide study teams on required steps.
  • A new FCOI Dashboard will provide financial conflict data to the FCOI Office in a transparent and user-friendly way.
  • New technical interfaces between InfoED, RUTH, eIACUC, and Sinai Central will enable better workflows and significant improvements in administration, operations, and compliance in research for all future projects.
  • DURC (Dual Use Research of Concern) questions will be in Sinai Central along with the IFs. (DURC involves studies of numerous infectious agents.)

We will be incorporating these changes into the RUTH training classes. All faculty, researchers, coordinators and staff training will begin August 17 for one hour sessions via Zoom. You can register for classes here: Morning Sessions  Afternoon Sessions.

Stay tuned for more information regarding these changes. If you have any specific questions please feel free to email esupport@mssm.edu. We look forward to your feedback.

Eric Nestler

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