Human Subject – Institutional Review Committees
COVID-19 Related Studies
Cancer Related Research – Protocol Review and Monitoring Committee (PRMC)
All cancer related studies that require the consent of subjects must be reviewed and approved by the Tisch Cancer Institute’s Disease Focus Groups (DFG) and the Protocol Review and Monitoring System (PRMS).
Cancer Related Research is defined as research that has cancer endpoints or has a cancer population as part of or all of its targeted population. This includes protocols studying patients with cancer or those at risk for cancer.
Protocols must be reviewed and approved by the DFG & PRMC prior to the IRB submission. Note, all protocols must be first reviewed by the applicable Disease Focus Group (DFG) prior to PRMC review.
Interventional investigator initiated protocols will require review by the Biostatistics Design Workshop (BDW) prior to submission to the DFG.
For detailed guidance on the DFG & PRMC application and review process, see the Protocol Review and Monitoring System webpage.
Clinical Research Unit (CRU)
Data Use Committee
The Data Use Committee reviews agreements related to data derived from humans (identified or de-identified data) that will be used by/disclosed to an external party, and agreements that allow a commercial party to utilize Mount Sinai data.
Examples of data disclosures that must be approved by the Data Use Committee include:
- Private information regarding patients or employees
- Data generated from human research (disclosures to federal funding agencies is managed by PPHS)
- Data from pharmacy records
- Claims data
- Patient data released to registries
The Data Use Committee is also available to provide guidance on new project ideas so that project sponsors can consider how Mount Sinai’s policy may impact future projects.
Mount Sinai Innovation Partners (MSIP) and/or the Office of General Counsel reviews all agreements with data-related terms and confirms that approval by the Data Use Committee is needed. Agreements can be sent to MSIP directly by the project sponsor, or may be sent to MSIP by other department reviewing an agreement (e.g. FACTS, GCO, etc).
After submission, MSIP Contracts and/or the Office of General Counsel will notify you if Data Use Committee approval is needed.
Approval by the Data Use Committee is required prior to sharing any Mount Sinai data, derived from humans, with an external party. The agreement with the external party must be finalized and signed by both parties before Mount Sinai data can be disclosed. MSIP and/or the Office of General Counsel will confirm when the agreement is fully executed.
- For questions regarding identifying optimal digital resources and solutions at Mount Sinai and beyond for research projects, contact Anar Poltinnikov, at Anar.Poltinnikov@mountsinai.org.
- For questions regarding Mount Sinai Innovation Partners, contact MSIPinfo@mssm.edu.
- For questions regarding Data Use Committee operations, contact Joy.Dicker@mssm.edu.
Embryonic Stem Cell Research Oversight Committee (ESCRO)
The Embryonic Stem Cell Research Oversight (ESCRO) committee provides oversight of all issues related to derivation and use of human embryonic stem cell (hESC) lines and facilitates the education of investigators involved in hESC research. Review is required when research involves:
- Human embryonic stem cells (hESCs)
- In vitro culture of any intact human embryo
- Induced pluripotent stem cells (IPS )
- Non-embyronic stem cells, including adult stem cells, fetal stem cells, placental stem cells and umbilical cord stem cells
ESCRO authorization is required prior to initiating work with hESCs. Refer to the ESCRO Application Form for guidance on when to submit proposals to the ESCRO Office.
Principal Investigators are required to complete and submit the ESCRO Application Authorization Form.
Contact the ESCRO Office at firstname.lastname@example.org.
Financial Administration of Clinical Trials Services (FACTS)
The Financial Administration of Clinical Trials Services (FACTS) office conducts a review of research applications to determine if a clinical trial requires a Medicare Coverage Analysis (MCA). A MCA is required for trials in which tests, procedures and interventions will be billed to patients or third-party payers.
The FACTS review is concurrent with IRB review. Alternatively, study teams may opt to initiate the MCA review process prior to IRB submission.
The electronic IRB application (RUTH) requires you to indicate if study protocol required services will be billed to patients or third-party payers. The FACTS office reviews all research applications submitted in RUTH to identify studies that require a Medicare Coverage Analysis (MCA). If a MCA is necessary the investigator will be notified and FACTS will coordinate the process of having BRANY complete the MCA.
Institutional Biosafety Committee (IBC)
Review is required when research involves the use of the following materials:
- Experiments involving the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules, into one or more human research participants (For reference, please see Section III-C of the NIH Guidelines: https://osp.od.nih.gov/biotechnology/nih-guidelines/.
- Examples include the use of viral vectors and plasmids (in vivo or ex vivo).
- Cellular Therapy
- Autologous Cells
- Monoclonal Antibodies (mAb)
Review of the initial application by the Institutional Biosafety Committee (IBC) review is concurrent with IRB review. An IBC application (IBC Risk Assessment Form) should be submitted prior to, or simultaneous with, initial submission to the IRB. The form and additional information is available on the Institutional Biosafety Committee website.
The study team is responsible for completing the Ancillary Review Form in RUTH and assigning ancillary review to IBC via the Manage Ancillary Review tab. A PDF copy of the REDCap Ancillary Review Form must be included with the IRB/RUTH submission. The study team will be prompted to either submit the IBC application (IBC Risk Assessment form), or if an application has already been submitted to upload the IBC approval letter in RUTH and provide the IBC protocol number for reference. Investigators will receive notification of approval via email communication with the IBC.
Institutional Review Board (IRB)
The ISMMS Institutional Review Board (IRB) is responsible for assessing and approving all* research conducted in human subjects at the Mount Sinai Health System (MSHS).
*All research includes:
- More than minimal risk studies
- No more than minimal risk (expedited) studies
- Requests for IRB exemptions
- Requests to rely on an external IRB
- For more information, refer to “Icahn School of Medicine at Mount Sinai IRBs and External IRBs“.
- Non-human subject research determinations
- Note: Only the IRB can determine if your research is Non-human subject research.
- For more information refer to HRP-309 Worksheet.
All new ISMMS IRB applications for human subject research must be made by creating a new protocol through the RUTH electronic submission system. Click here for guidance.
IRB approval is required prior to beginning human subject research.
Investigational Drug Services (IDS)
All Investigational agents used at the Mount Sinai Medical Center must be approved by the Investigational Drug Services (IDS) within the Department of Pharmacy. Review is required for research involving the use of drugs or biologics including:
- Drugs and/or biologics that are not part of standard practice (including FDA approved drugs/biologics when given in a way that differs from standard practice)
- Controlled substances
- Drugs and/or biologics supplied by the research sponsor or purchased with study funds
The Investigational Drug Service review is concurrent with the IRB review. During the RUTH submission, all trials using an investigational drug should be prompted to complete an Ancillary Review Form in RUTH. Once completed and submitted in RUTH the Investigational Drug Services (IDS) review is assigned.
The research team will be required to complete the Ancillary Review Form in RUTH and based on the response provided on the form, the research team may need to assign IDS review via the Manage Ancillary Review tab in RUTH. A copy of the completed Ancillary Review Form must be included in the IRB/RUTH submission. Investigators will receive notification of approval via email communication with the IDS and/or through RUTH.
Information Security (InfoSec)
All projects that involve software development, utilization of third-party information technology and/or software requires an IT Security Risk Assessment.
The InfoSec assessment is conducted during the IRB/RUTH submission. Research teams will be required to complete an Ancillary Review Form in RUTH and will be prompted to answer a series of InfoSec questions. Based on the responses, research teams may be required to submit a Security Risk Assessment Intake Form to InfoSec via email and will need to assign Ancillary Review to InfoSec via the Manage Ancillary Review tab in RUTH. A PDF version of the completed Ancillary Review Form must be included in the RUTH submission (upload under Local Site Documents). The InfoSec team will communicate with the research team via email once they have received the Security Risk Assessment Intake Form. The Intake forms should be submitted to ITSecRiskAssessment@mountsinai.org (IT Security Risk Assessment).
The average time to complete a risk assessment is typically 2-6 weeks, however, due to the large number of security risk assessments typically within the InfoSec risk department’s queue, there may be a backlog. Generally the prioritization is first in, first out. However, grants/funding deadlines usually take a higher priority.
Laser Safety Committee
Review is required when research involves the use of lasers.
The Laser Safety Committee (LSC) review is concurrent with IRB review.
If the research involves use of lasers, the IRB will route your application to the Laser Safety Committee (LSC) for review. The outcome of the safety review will be reflected in your IRB communications.
Radiation Safety Committee
Review is required when research involves ionizing radiation for imaging or therapy, including:
- CT scans
- Nuclear medicine tests
- Radiation therapy
The Radiation Safety Committee review is concurrent with the IRB review.
The study team is responsible for completing the Ancillary Review Form in RUTH where they will be prompted to answer questions regarding the radiological procedures involved in the study. Based on the responses, the team may be required to assign ancillary review to the Radiation Safety Committee via the Manage Ancillary Review tab. In addition, the study team will be required to complete and submit a Dosimetry form, and include the radiation risk language generated after completion of the Dosimetry form, to their consent form. A link to the Dosimetry form will become available based on the answer to imaging questions (if you answer “Yes” to use of ionizing radiation due to research). The Dosimetry form is also available on the Radiation Safety website.
A PDF copy of the REDCap Ancillary Review Form and Dosimetry form must be included with the IRB/RUTH submission. Investigators will receive notification of approval via email communication with the Radiation Safety Committee and/or through RUTH.
Transfusion Medicine, Apheresis and Cellular Therapy
Studies that require use of data, collection and/or transfusion of blood derived products must be reviewed by the Transfusion Medicine and Apheresis Services. Studies that require use of data, collection, processing, storage and/or infusion of live cells must be reviewed by the Apheresis and Cellular Therapy Services.
Transfusion Medicine, Apheresis and Cellular Therapy review is assigned through the IRB/RUTH submission system.
The research team will be required to complete the Ancillary Review Form in RUTH and assign Transfusion Medicine, Apheresis and/or Cellular Therapy review via the Manage Ancillary Review tab. A copy of the completed Ancillary Review Form must be included in the IRB/RUTH submission. Investigators will communicate with the assigned Ancillary Services and receive notification of approval via email through RUTH.
Department or Institute Specific
BioMedical Engineering and Imaging Institute (BMEII)
BMEII provides biomedical imaging support for basic and clinical research, including:
- Human Imaging (MRI, MR/PET, CT)
- Human Mock MRI
- Human and Animal Imaging Peripherals
- Human and Animal Anesthesia and Monitoring
- Large Animal Imaging (MRI, MR/PET)
- Small Animal MRI
- Small Animal PET/CT
- Small Animal Optical Imaging (Fluorescence, Bioluminescence, Near-infrared)
- Staff-Assisted Imaging
- Imaging Processing and Data Analysis
Department of Anesthesiology, Perioperative and Pain Medicine
Faculty and trainees in the Department of Anesthesiology, Perioperative, and Pain Medicine who are interested in initiating or participating in a research study must receive approval from the Vice Chair for Research.
Industry Sponsored Clinical Trials – Approval from the Vice Chair for Research is required prior to IRB submission and is recommended during study design for Industry Sponsored Trials and Investigator Initiated Projects.
Contact Jim Leader or call (212) 824-5468.
Department of Genetics and Genomic Sciences
All PI- initiated clinical research (funded), grant proposals, and Industry-sponsored projects conducted in the Department of Genetics and Genomic Sciences requesting Genetics Clinical Trial Office services must receive prior approval.
Industry Initiated Studies – The Principal Investigator should contact the Genetics Clinical Trial Office prior to initiating a CDA. The Genetics CTO will assist with CDA negotiation, study feasibility, and subsequent start-up activities.
Investigator Initiated Studies – The Principal Investigator should contact the Genetics Clinical Trial Office during protocol development. The Genetics CTO can assist with protocol design, budget development, regulatory support and implementation.
Department of Medicine – Protocol Review Committee (PRC)
All clinical studies conducted in the Department of Medicine under the auspices of the Mount Sinai Health System (MSHS) must be reviewed and evaluated by the Department of Medicine Protocol Review Committee (PRC). PRC review assesses the protocol to ensure the trial is safe, scientifically sound and has a high probability of meeting enrollment goals. Ongoing studies will be monitored for protocol accrual.
All protocols must be reviewed and approved by the PRC prior to IRB submission. The IRB review process will not take place without a written notification from the PRC that the protocol has been reviewed and approved.
The Principal Investigator will collaborate with the CTO Administrative Director, Michele Cohen, and submit the following documents via email.
- Final Protocol (After FDA Review, if applicable)
For more information, refer to PRC Policies and Procedures.
Contact the CTO Administrator Director, Michele Cohen or call (212) 241-7734.
Department of Neurosurgery
All PI-initiated clinical research (funded and non-funded), grant proposals and Industry-sponsored projects conducted in the Department of Neurosurgery must obtain approval from the Neurosurgery Clinical Research Feasibility Committee. The Committee evaluates study protocols to ensure they are of scientific merit, have appropriate statistical methods, realistic recruitment strategies, achievable enrollment goals and the budget recovers the cost of time, effort and any resource utilized to conduct the clinical research.
The PI is instructed to contact the Feasibility & Quality Assurance Manager, Timolin Jeffers, to obtain the Neurosurgery Pre-Review Study Summary Form, which is required for submission, and the following study documents:
- Study Protocol or Protocol Template
- Informed Consent (If Applicable)
- Contract (If Applicable)
- FDA Letter (If Applicable)
- Sponsor Budget and/or MSSM Budget (If Applicable)
Submission packages must be must be submitted to at a minimum of two weeks prior to the monthly committee meeting. The study is then added to the committee’s agenda and then further reviewed by the committee.
Approval from the Neurosurgery Clinical Research Feasibility Committee is required prior to IRB submission and contract negotiation for new studies. For continuing studies, a yearly review is also required to be submitted for approval.
Contact the Feasibility & Quality Assurance Manager, Timolin Jeffers.
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