RUTH, the new IRB electronic submission and application tracking and review software rolled out on Wednesday, 9/23/20. Please go to the Research Roadmap RUTH – IRB Submission System page for more information and/or contact PPHS if you have any questions IRB@mssm.edu (212) 824-8200. Refer to the RUTH Communication page to see an archive of announcements related to the new system.
RUTH Training Sessions
Sign up for an hour training session to learn how to use RUTH. These sessions are offered through late June 2021.
RUTH Support – PPHS and Research IT Drop-in-Sessions
- IRB 101: Basic Steps of the IRB Submission
- IRB 201: Document Analysis & Evaluation: Protocol and Consent
Upcoming Sessions – January 20th and 21st, 2021
IRB Initial Submission
Complete the Investigator Form (IF) in Sinai Central?
An IF number is required for your IRB application. This IF number is generated in Sinai Central for each study. For more information visit the Investigator Form (IF) page.
Exception – If you are using BRANY for both IRB review and contracting, this step is not required.
Start the GCO Application?
A GCO application must be started at the same time as your IRB application. The IRB will reject your submission if you have not started the GCO application and do not have an assigned InfoEd Project Development (PD) number.
For more information visit the GCO Application page.
Review the Program for the Protection of Human Subjects (PPHS) Information?
Please read the following information before submitting to the PPHS office for human research review.
The ISMMS Institutional Review Board (IRB) is responsible for assessing and approving all* research at the Mount Sinai Health System (MSHS) that is to be conducted in human subjects.
*All research includes:
- More than minimal risk studies
- No more than minimal risk (expedited) studies
- Requests for IRB exemptions
- Human subject research determinations
- Requests to rely (R2R) on an external IRB (commercial IRB, BRANY, SMART IRB)
- For more information, click here.
If you believe your research study is exempt from IRB oversight, see Worksheet HRP-312: Exemption Determination for more information. Note – Only PPHS can determine if your study is exempt from IRB review.
Types of Studies that Qualify as Human Subject Research
If you need a determination of whether your study qualifies as human subject research, see Worksheet HRP-310: Human Research Determination for more information. Note – PPHS makes the ultimate determination in cases as to whether an activity constitutes Human Research subject to IRB oversight.
All ISMMS IRB applications for human subject research must be made through the RUTH electronic submission system. This includes studies where an external IRB will be used (see below for guidance).
Note: The PI must submit the initial IRB application in RUTH. Subsequently, the assigned proxy will have the authority to make changes and submit on behalf of the PI.
Requests to Rely (R2R) on an External IRB
To determine whether your protocol meets the criteria to rely on an external IRB, refer to "Commercial IRBs, BRANY and NCI CIRB".
Note, all human subject research protocols being reviewed by an external IRB, must first be submitted to the PPHS office through RUTH. For detailed guidance on the Request to Rely (R2R) process, click here.
When an external IRB is used, ISMMS only cedes study review to the external IRB. ISMMS remains responsible for review of local requirements including conflict of interest reviews, conditional office review, state law, institutional policy and education requirements.
Documents Required in RUTH
New studies submitted in RUTH and previously approved studies being migrated over to RUTH will complete a newly designed HRP 503 IRB Application form, in addition to a standalone protocol (if applicable). Refer to the table below.
Templates are available in the library section of RUTH and on the PPHS website.
|Submission Type||Required Documents|
|Exempt determination request||503-E|
|Minimal risk with no subject interaction or intervention||503-R|
|Minimal risk with subject interaction or intervention||503-Full
|Greater than minimal risk||503-Full
|Request to rely on an external IRB||Protocol
What is an acceptable protocol format?
The project protocol can be provided by the sponsor, prepared for a grant, or written specifically for this application. The PPHS recommends using the NIH template found here if you are creating your own protocol for your submission. Teams cannot use the PDF of their IDEATE application or their previously approved HRP 503 template as their project’s protocol.
ISMMS Ancillary Office Reviews
Depending on the type of research activities involved, review from other institutional ancillary offices may be required. The study team is responsible for assigning the ancillary office reviews in RUTH.
The following is a list of Ancillary Office Reviews that may be assigned within RUTH. However, other institutional committee reviews are required outside of RUTH. For an overview of the Institutional approvals that may be required, refer to Approvals Needed for Research.
Ancillary Offices Assigned in RUTH
- Clinical Research Unit (CRU)
- Financial Administration of Clinical Trials Services (FACTS)
- Financial Conflict of Interest in Research Committee (FCOIRC)
- Information Security (InfoSec)
- Institutional Biosafety Committee (IBC)
- Investigational Drug Services (IDS)
- Radiation Safety Committee (RSC)
- Transfusion Medicine and Cellular Therapy
- Complete the Ancillary Review Form in RUTH (located under the Study Scope tab in RUTH) to understand which ancillary offices need to be assigned.
- A PDF version of the completed REDCap form is required to be uploaded in RUTH under Local Site Documents.
- Study teams will need to assign review to the Ancillary Offices in RUTH via Manage Ancillary Review.
- FCOI must be assigned to all submissions with some exceptions (final reports, some BRANY studies, etc.) It is not necessary to assign ancillary offices, other than FCOI, for continuations.
Training, Ongoing Workshops & Office Hours
IRB Virtual Office Hours
The PPHS Office offers walk-in Office Hours providing ISMMS faculty and staff the opportunity to consult with the IRB. During these consultations the PPHS staff can assist with all questions related to the IRB submission process, etc.
Every Wednesday: 2:00 – 3:00 pm
RUTH Instructional Modules & Reference Guides
To access, click here.
The PPHS IRB University Program offers training courses for investigators and research teams who are involved in the design, conduct, and/or reporting of human subject studies at the Mount Sinai Health System. The courses provide hands-on training on the IRB submission requirements, protocol and consent writing, as well as useful tips to ensure documentation is complete and compliant.
- IRB 101: Basic Steps of the IRB Submission
- IRB 201: Document Analysis & Evaluation: Protocol and Consent
Step Right Up
PPHS hosts monthly Step Right Up questions and answers sessions with the IRB. Principal investigators and their study teams are encouraged to come with their questions for one-one-discussions with the IRB.
Upcoming sessions are announced through the research administration emailing system, Research Listserv. Click here to sign up for Research Listserv.
Virtual Clinical Research Forum
PPHS hosts a monthly Clinical Research Forum to facilitate ongoing communication between research personnel and the administrative offices that regulate and process research projects (e.g., IRB, IACUC, GCO. Topics discussed at the forum include, NIH regulations, institutional processes and procedures, and research compliance. All clinical research personnel are encouraged to attend.
Date: First Wednesday of Every Month
Upcoming forums are announced through the research administration emailing system, Research Listserv. Click here to sign up for Research Listserv.
IRB Continuing Review and Modifications
Regulatory Requirements - IRB Continuing Review
Before you submit your continuing review, a new IF# must be generated in Sinai Central and all research staff must complete their Financial Interest in Research Disclosure Form under this new IF#. The Investigator Form (IF) is used by the institution to generate notification emails to each investigator and key personnel listed on the project-specific IF form to complete the Financial Interest in Research Disclosure Form. Principal investigators or their delegates must complete the Investigator Form (IF) in Sinai Central for ALL research projects at the time of continuing review in order for co-investigators and key study personnel to complete the Financial Interest in Research Disclosure Form under the newly assigned IF#.
Studies using an external IRB are also required to complete an IF form in Sinai Central (exception – studies using BRANY for both IRB review and contracting). When an external IRB is used, ISMMS only cedes study review to the external IRB. ISMMS remains responsible for FCOIR reviews, conditional office reviews (Biosafety, IDS, Radiation Safety etc.) and ensuring study teams meet the institutional training requirements. For detailed guidance on the Request to Rely (R2R) process, click here.
For more information visit the Investigator Form (IF) Instructions page.
An application to the GCO is required to be submitted each year of the project.
For more information visit the GCO Annual Submission page.
Please read the outlined information before submitting to the PPHS office for human research review.
All research studies are required to submit continuing review applications to the IRB. The frequency of review is determined by the IRB. Refer to the expiration date listed on your project's most recent IRB approval letter.
Effective January 21, 2020, the PPHS has determined that certain minimal risk protocols will no longer require an annual continuation and will be granted a three year approval period. The PI/Research Team is responsible for ensuring CITI refresher training is completed every three years, and that Financial Conflicts of Interest are managed a by the FCOI committee in the Conflict of Interest Office independent of the project approval committee.
For studies using the ISMMS IRB, continuing review applications must be submitted at least 6 weeks prior to the study/project expiration date that is listed on the most recent IRB approval letter.
- 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.
- 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
To coordinate your submission, refer to the PPHS website for the ISMMS IRB Board Meeting Dates.
For studies where ISMMS is the IRB of record, continuing review applications are required to be submitted in RUTH.
Legacy Studies: These studies have been transitioned to RUTH. Continual renewals, modifications and amendments for legacy studies must be submitted through RUTH.
Studies using an external IRB are required to submit continuing reviews to the external IRB of record.
ISMMS PPHS Requirements: Once continuing review approval has been obtained from the external IRB, study teams are required to make a follow on submission in RUTH. For more information, refer to Continuations under Requests to Rely (R2R) on an External IRB.
Contact the PPHS at (212) 824-8200 or IRB@mssm.edu.
If BRANY is being used for both contracting and IRB review, you are exempt from creating an IF and submitting your FCOI disclosure in Sinai Central. BRANY has their own FCOIR forms and all key study personnel (i.e. involved in the design, conduct, or reporting of the research) must disclose financial interests by completing BRANY FORM 01 and FORM 02 (if applicable) and submitting these forms along with their IRB application through the BRANY IRB Manager platform.
IRB Modifications and Reportable New Information
All proposed modifications to a study require IRB approval prior to implementation.
Exempt Studies: If the research is determined to be "exempt", and a proposed modification affects the design and conduct of the research in the approved protocol, a modification must be submitted to the IRB.
Note - if a modification is a personnel modification, you must assign an FCOI review in RUTH via the Ancillary Review Form.
For studies where ISMMS is the IRB of record, modifications are required to be submitted in RUTH.
Legacy Studies: Legacy studies (paper submissions) have been transitioned into RUTH. Follow on submissions (continuing reviews and modifications) must be submitted through RUTH.
Studies using an external IRB are required to submit all modifications and unanticipated problems to the external IRB of record.
ISMMS PPHS Requirements: Refer to Requests to Rely (R2R) on an External IRB.
- Can be submitted at any time
- Minimal Risk (MR) studies: Submit at least six weeks before the 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.
IRB Study Closeout
IRB Study Close Out
The principal investigator is required to close out the study with the governing IRB when the following conditions have been met:
- Enrollment is closed and research related activities, interventions or interactions with human subjects have been completed
- All queries have been resolved
- PHI data, and records are no longer required by study team or sponsor (data locked)
- Sponsor has conducted a close out visit and issued a close out letter (sponsor grants permission to close the study with the IRB)
Reports should be submitted within 30 days of the completion of the study.
For studies where ISMMS is the IRB of record, close out reports are required to be submitted in RUTH by clicking the CR link.
Legacy or Paper Studies
Legacy or paper studies have been transitioned to RUTH. Notification of closeout, terminations and suspensions must be submitted through RUTH.
Submit a close out report to the external governing IRB.
ISMMS PPHS Requirements: Study teams are also required to report the study closure to ISMMS PPHS via RUTH.
Regulatory Requirements - Study Termination
If a study is terminated or suspended the study team is required to notify the governing IRB immediately.
Study termination or suspension is reported via RUTH.
Legacy or Paper Studies
These are studies have been transitioned to RUTH. Notification of closeout, terminations and suspensions for these studies must be submitted through RUTH.
Study termination/suspension is reported to the external governing IRB. Study teams are also required to report study termination/suspension to ISMMS PHHS.
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