COVID-19 Related Studies
All COVID-19 related studies must be reviewed by the COVID-19 Protocol Review Committee.
BioMe® Biobank Steering Committee
All BioMe Biobank specimen or data requests, or requests for BioMe’s recall services for prospective, IRB-approved research studies, must be approved by the BioMe Biobank Steering Committee.
The BioMe Biobank Steering Committee’s review is concurrent with the IRB review but can initiate with a protocol review prior to the Investigator’s submission in RUTH. During the RUTH submission, all projects planning to use the BioMe Biobank resource will be prompted to complete an Ancillary Review Form in RUTH. Once completed and submitted in RUTH, the BioMe Biobank review is officially 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 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 from the BioMe Biobank and/or through RUTH. Investigators can email BioMeBiobank@mssm.edu with questions. Protocols are submitted through email, and there is a communication exchange via email with the study team. The Steering Committee meets every two weeks but can meet ad hoc, per the BioMe protocol. No separate application needs to be completed. RUTH captures the required review by the Steering Committee.
Study teams may reach out to BioMe with questions.
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.
Last Updated: September 2023
Clinical Research Unit (CRU)
Cybersecurity Risk Assessment
Research studies that involve software development or utilization of third-party information technology and/or software require a cybersecurity risk assessment. Effective on March 31, 2023, the Cybersecurity Risk team is rolling out further enhancements to reduce assessment turnaround time without compromising security. These enhancements were approved by the ISMMS Academic DTP Steering Committee.
- New Criteria for when a risk assessment is not required. Instruction for these enhancements and support contacts are provided on the Ancillary Offices (AO) form in REDCAP.
- Reusable Vendor List (RVL) – Third parties listed on the RVL have been through a rigorous cybersecurity risk assessment and completed the required remediation. This list is available on the AO form in REDCAP and also in OneTrust. If a third party selected for a research study is already listed on the RVL, a risk assessment is not required.
- Industry-funded Studies – If a research study’s source of revenue is from an external industry sponsor and the sponsor is an established business entity with 50 or more employees, a cybersecurity risk assessment is not required. The Financial Administration of Clinical Trials Services (FACTS ) office has updated the contract to address the cybersecurity concerns. However, if the sponsor employs fewer than 50 employees, there is no change to the process. The research staff must submit a cybersecurity risk assessment intake and assign Cybersecurity as an ancillary review office.
- NIH-Managed Protocols – If the research study is an NIH-Managed Protocol (NIH Clinical Trial Network), enter the NIH-managed protocol ID on the AO form. A cybersecurity risk assessment is not required.
- Other – When a study does not involve the use and/or outward transmission of PHI or other sensitive data, a cybersecurity risk assessment is not required.
- New Criteria for when a security review is required. If the system is developed internally or by a third party for internal use. Instructions are provided on the AO form.
A third-party cybersecurity risk assessment is conducted during the IRB/RUTH submission. Research teams will be required to complete an Ancillary Office Survey Form in REDCap and will be prompted to answer a series of cybersecurity questions. Based on the responses, research teams may be required to submit a request for a cybersecurity assessment via Mount Sinai’s OneTrust Portal, at https://mountsinai.my.onetrust.com/welcome or click on the icon in the App Launcher.
The Cybersecurity Assessment team will review the request and communicate with the research team via the OneTrust Portal for follow-up questions. The average time to complete a risk assessment ranges from 2 to 6 weeks. The default prioritization is first in, first out. However, grants/funding deadlines will be considered and prioritized accordingly.
- For assessment-related inquiries email CyberRiskAssessment@mountsinai.org
- For questions related to NIH-Managed Protocols submit a Research 411 Ticket
To ensure the successful adoption of these enhancements, the following resources are available to you:
- Third Party Risk Management (TPRM) – Cybersecurity Risk Teams Channel responding to your questions during business hours
- Training – Training on the changes to the Ancillary Offices (AO) form will be available in PEAK. This training can be found by searching “cybersecurity” under the categories of “DTP Security” or “Research.”
- Disclosing Mount Sinai Data to External Parties Frequently Asked Questions
- For additional access and workflow details visit the OneTrust page.
Every Wednesday 11:30am – 12:00pm
Zoom Link: https://mountsinai.zoom.us/j/4455725852
Office hours are held every Wednesday where a Cybersecurity Risk representative will be available to answer any questions related to the TPRM process.
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 Irena Parvanova, at Irena.Parvanova@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 email@example.com.
Financial Administration of Clinical Trials Services (FACTS)
The Financial Administration of Clinical Trials Services (FACTS) office conducts a research billing compliance 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 study team is responsible for assigning FACTS review during IRB/RUTH submission. Alternatively, study teams may opt to initiate the MCA review process prior to IRB submission.
The electronic IRB application (RUTH) requires the research team to indicate if study protocol required services will be billed to patients or third-party payers. The FACTS office reviews 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.
Last Updated: June 2023
In-Patient Nursing Resources
Clinical Trials requiring nursing services on impatient units require review and approval from the Nursing Executive Committee (NEC) prior to implementation of a study.
Inpatient Feasibility Forms should be submitted to the Nursing Executive Committee as soon as possible in the planning process. Submissions are required prior to IRB approval. The Nurse Executive Committee (NEC) will review submitted forms within 1 week of submission.
Completed Inpatient Therapeutic Trial Nursing Feasibility Forms should be emailed to Kavita Rampertaap.
Contact Kavita Rampertaap.
Institutional Biosafety Committee (IBC)
An eSafety research registration is required when a human subjects protocol involves the following:
- Human Gene Transfer (HGT) 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/wp-content/uploads/NIH_Guidelines.pdf
- Examples include the use of viral vectors, plasmids, and mRNA (in vivo or ex vivo).
- Cell Therapy or cell-based gene therapy
- Autologous cell therapy
- Biohazardous Agent, pathogenic organism or biological toxin
The IBC must perform an Ancillary Review of the human subjects protocol submitted in RUTH to assess biosafety issues related to the clinical research (e.g., safety profile, administration, shedding).
Clinical study teams with research involving the clinical use of the materials mentioned in the previous section should submit an eSafety research registration for review by the IBC prior to, or simultaneous with, the initial human subjects protocol submission in RUTH (IRB review). Guidance for submitting an eSafety research registration is available on the Institutional Biosafety Committee website.
Ancillary review by the IBC in eSafety is concurrent with the IRB review in RUTH.
The study team is responsible for completing the Ancillary Review Questionnaire in RUTH concurrently with submission of the RUTH human subjects protocol. The study team will be prompted to either submit an eSafety research registration or to upload the IBC approval letter in RUTH and provide the eSafety registration number. The Principal Investigator (PI) of the study team will receive notification of approval of the eSafety research registration via e-mail communication from the IBC and in the eSafety dashboard.
Last Updated: July 2023
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.
Please visit our webpage for additional information and a list of IDS contacts for the Mount Sinai Health System for any clinical trial related questions.
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 infusion of blood derived products must be reviewed by the Transfusion Medicine and Apheresis. Studies that require use of data, collection, processing, storage and/or infusion of cell-based investigational therapies (i.e. living cells/tissue) 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. Feasibility assessment for clinical studies involving cellular therapy products may be needed before IRB submission as provided in this informational sheet.
Consultations of the Transfusion Medicine and Cellular Therapy are encouraged prior to IRB/RUTH submission. 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.
Last Updated: April 2023
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 via email firstname.lastname@example.org or call 212 241 5468.
Last Updated: June 2023
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.
Last Updated: May 2023
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 Research Strategy Committee (RSC). 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 Research Program Coordinator, Sarah Torres, to obtain the Neurosurgery Pre-Review Study Summary Form, which is required for submission through RedCap, 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 submitted at a minimum of two weeks prior to the monthly committee meeting and applications are reviewed on a rolling basis. The study is then added to the committee’s agenda and then further reviewed by the committee.
Approval from the Neurosurgery Research Strategy Committee (RSC) 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.
Last Updated: May 2023