Human Subject – Institutional Review Committees

What

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.

When

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.

How

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.

What

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.

When

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.

How

For detailed guidance on the DFG & PRMC application and review process, see the Protocol Review and Monitoring System webpage.

Last Updated: September 2023

Resources

The CRU provides infrastructure to perform clinical and translational research studies including:

• Outpatient Space
• Nursing Support
• Specimen Processing
• Walk-in Phlebotomy
• Pre-procedure COVID testing (for research studies only)

More Information

What

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.

How

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.

Questions

• For assessment-related inquiries email CyberRiskAssessment@mountsinai.org
• For questions related to NIH-Managed Protocols submit a Research 411 Ticket

Resources

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.

Office Hours

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.

What

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.

For more information, refer to Data Use Committee – FAQ and the MSHS Combined Data Use Policy.

How

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).

To submit an agreement to MSIP, use the MSIP Agreement Portal. For detailed guidance, refer to Data Use Committee – FAQ.

After submission, MSIP Contracts and/or the Office of General Counsel will notify you if Data Use Committee approval is needed.

When

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.

Questions

• 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.

Resources

• Data Use Committee – FAQ
• Combined Data Use Policy

What

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

When

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.

How

Principal Investigators are required to complete and submit the ESCRO Application Authorization Form.

Questions

Contact the ESCRO Office at escro@mssm.edu.

What

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.

When

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.

How

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

What

Clinical Trials requiring nursing services on impatient units require review and approval from the Nursing Executive Committee (NEC) prior to implementation of a study.

When

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.

How

Completed Inpatient Therapeutic Trial Nursing Feasibility Forms  should be emailed to Kavita Rampertaap.

Questions

Contact Kavita Rampertaap.

What

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).

When

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.

How

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

What

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.

How

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.

When

IRB approval is required prior to beginning human subject research.

What

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

When

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.

How

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.

What

Review is required when research involves the use of lasers.

When

The Laser Safety Committee (LSC) review is concurrent with IRB review.

How

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.

What

Review is required when research involves ionizing radiation for imaging or therapy, including:

• X-ray
• Fluoroscopy
• CT scans
• Nuclear medicine tests
• PET
• Radiation therapy

When

The Radiation Safety Committee review is concurrent with the IRB review.

How

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.

Resources

• Policy for Radiation Safety Review of IRB Protocols Involving Ionizing Radiation

What

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.

When

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.

How

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