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 "Requests to Rely (R2R) On an External IRB".

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.

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.

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 RUTH application or their previously approved HRP 503 template as their project’s protocol.

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

• BioMe® Biobank Steering Committee
• Clinical Research Unit (CRU)
• Financial Administration of Clinical Trials Services (FACTS)
• Financial Conflict of Interest in Research Committee (FCOIRC)
• Cybersecurity Risk Assessment
• Institutional Biosafety Committee (IBC)
• Investigational Drug Services (IDS)
• Radiation Safety Committee (RSC)
• Transfusion Medicine and Cellular Therapy

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.

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.

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  "Requests to Rely (R2R) On an External IRB".

Questions

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

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.

Ancillary Review(s) for Modifications
Some modification submissions require certain ancillary office reviews. In order to assign the correct ancillary offices to review your modification submission, use the HRP-388 worksheet as a guide. This worksheet is located in the RUTH library, on the Worksheets tab. The HRP-388 worksheet is not required to be uploaded in your RUTH application. 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.