ATTENTION

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 November.

Training for Single Site Submissions – click here
Training for Request to Rely (R2R) Submissions – click here
Training for Request to Serve (R2S) Submissions – click here

RUTH Support –  PPHS and Research IT Drop-in-Sessions

Morning sessions: Tuesdays & Thursdays from 10-11am
Afternoon sessions: Tuesday & Thursdays from 4-5pm

IRB Initial Submission

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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.

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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.

Exceptions:
1.  Investigators submitting Just-In-Time IRB applications are not required to start a GCO application as they have already submitted an application to the GCO.
2.  A subset of ISMMS projects do not require submission to the GCO via InfoEd. Refer to Does My Project Need to be Submitted to the GCO?

Please be reminded that if the grant is funded, you will need to submit a non competitive continuation application to the GCO each year.

For more information visit the GCO Application page.

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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.

IRB Submission

What

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.

Exemption Determination

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.

How

New Submissions
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.

RUTH Account Access
RUTH - Use you MSHS network login/password.
For additional information regarding regarding training, technical support, refer to RUTH - IRB Submission System.

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.

External IRB Study Review

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
Protocol
Greater than minimal risk 503-Full
Protocol
Request to rely on an external IRB Protocol
HRP-232

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

What

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

How

  1.  Complete the Ancillary Review Form in RUTH (located under the Study Scope tab in RUTH) to understand which ancillary offices need to be assigned.
  2.  A PDF version of the completed REDCap form is required to be uploaded in RUTH under Local Site Documents. 
  3. Study teams will need to assign review to the Ancillary Offices in RUTH via Manage Ancillary Review.
  4. 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.

 

International Research

Form HRP-231- International Research

Researchers who are travelling internationally to conduct any research activities that may include (but are not limited to) data collection and analysis, interaction with human subjects, access to identifiable health information of human subjects are required to submit form HRP-231-Form -International Research to the IRB. The form should be uploaded in the electronic IRB submission system.

IRB Continuing Review and Modifications

IRB Continuing Review

Investigator Form (IF) in Sinai Central?

Before you submit your continuing review, a new IF# must be generated in Sinai Central and all research staff must make their annual FCOIR disclosure under the 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 more information visit the Investigator Form (IF) Instructions page.

Start the GCO Yearly Renewal Application?

If the IRB has provided a three year approval and there is no external sponsored project funding (e.g., ISMMS, industry clinical trials negotiated by FACTS, and cooperative trial research projects), GCO submissions are also only then required every three years.

For more information visit the GCO Annual Submission page.

Review the Program for the Protection of Human Subjects (PPHS) Information?

Please read the outlined information before submitting to the PPHS office for human research review.

What

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 Office of Industry Engagement and Conflict of Interest Office ("COI Office) independent of the project approval committee.

When

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.

How

ISMMS IRB

For studies where ISMMS is the IRB of record, continuing review applications are required to be submitted in RUTH.

Legacy or Paper Studies: These studies have been transitioned to RUTH.  Continuation , modifications and amendments for legacy studies must be submitted through RUTH.

External IRBs

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  "Icahn School of Medicine at Mount Sinai IRBs and External IRBs.

Questions

Contact the PPHS at (212) 824-8200 or IRB@mssm.edu.

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.

ISMMS IRB

 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.

External IRBs

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.

When

  • 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 Closeout

When

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.

How

ISMMS IRB

For studies that were initiated through Ideate, close out reports are required to be submitted in Ideate.

Legacy or Paper Studies

Legacy or Paper Studies are studies that were originally approved by the IRB before the Ideate system was implemented. They were submitted on forms via email to the IRB. Notification of closeout, terminations and suspensions for legacy studies do not go through Ideate, instead they continue to utilize FORMS and email irb@mssm.edu for submission. Refer to FORM HRP-212 for specific submission instructions.

External IRB

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 Ideate.

Study Termination or Suspension

What

If a study is terminated or suspended the study team is required to notify the governing IRB immediately.

How

ISSMS IRB

Study termination or suspension is reported via Ideate.

Legacy or Paper Studies

These are studies that were originally approved by the IRB before the Ideate system was implemented. They were submitted on forms via email to the IRB. Notification of closeout, terminations and suspensions for legacy studies do not go through Ideate, they continue to utilize FORMS and email for submission.

External IRB

Study termination/suspension is reported to the external governing IRB. Study teams are also required to report study termination/suspension to ISMMS PHHS.

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
Learn More

RUTH Instructional Modules & Reference Guides

To access, click here.

IRB University

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

Upcoming training sessions are announced through the research administration emailing system, Research Listserv. Click here to sign up for Research Listserv.

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
Time: 12-1pm

Upcoming forums are announced through the research administration emailing system, Research Listserv. Click here to sign up for Research Listserv.

Average Turnaround Time

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.

PPHS > For Researchers

2020 ISMMS IRB Review Deadlines & Board Meeting Dates

Research 411 Portal

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