For Investigators

"Getting Started" services support early development of study questions and design. There are five steps:

I.  Pre-protocol Development Meeting
II.  Community Engagement and Research Consultation
III.  Specimen Banking at Mount Sinai
IV. Data Mining at Mount Sinai

I. Pre-protocol Development Meeting – The Office of Research Services will conduct a pre-protocol development meeting to address seven key areas for protocol development. ORS will help you develop your plan to address these issues or facilitate your access to Mount Sinai experts that can get you started.

• Scientific rationale and background
• Clinical characterization and sample recruitment, inclusion/exclusion criteria, recruitment plans
• Research design and analysis
• Data management and monitoring
• Patient safety and Data Safety Monitoring Committee
• Ethical considerations
• Budget development

To learn more or to request a consultation submit a Pre-Protocol Development ticket to the Office of Research Services.

II. Community Engagement and Research Consultation – The Centers for Community and Academic Research Partnerships' Center for Education and Training offers a consultation service to work with investigators on community-relevant research projects for issues from subject recruitment to full-partnered research. Through training and mentorship we provide support for selecting research topics, finding mentors, protocol development, time management, community engagement, and project management.

For more information, contact Crispin Goytia at 212-824-7323

III. Specimen Banking at Mount Sinai – Are you planning a project that will include specimen collection, or would you like to know more about specimens that are available in Mount Sinai specimen banks?

BioMe™ BioBank Program– The Institute for Personalized Medicine Biobank is a large collection of DNA and plasma samples that are stored in a way that protects patients' privacy, allowing research to be performed on de-identified clinical information from Mount Sinai's data warehouse system. For more information, contact the BioMe™ BioBank Program.

Help with specimen banking – Biorepository and Pathology CoRE - The facility provides basic histology services, with capability to process, embed, and section fixed and frozen tissues for the Mount Sinai community. The facility will prepare unstained slides suitable for a variety of applications (histochemistry, immunohistochemistry, in situ hybridization, LCM), as well as hematoxylin and eosin sections for routine light microscopic evaluation.

This facility currently supports functions for tissue procurement, from both consented and anonymized collections. Pathologists in charge of procurement can be contacted for consultations to determine investigator requirements for human tissues in translational research, and then arrange procurement as feasible. For more information, contact the Biorepository and Pathology CoRE.

IV. Data Mining at Mount Sinai – Are you planning a project that will require data mining to identify potential populations?

Mount Sinai Data Warehouse – The Data Warehouse collects data generated by Mount Sinai's many patient care and business transactional computer systems. The source data are transformed into consistent and (where possible) standard formats, and stored in a large Oracle database. Master data (tables of diagnoses, caregivers, facilities, drugs, implants, etc.) that may differ among systems are aligned in the Data Warehouse. Tools are available to produce reports and/or datamarts supporting clinical and translational research, quality of care initiatives, and process and financial improvement projects. For more information, contact the Mount Sinai Data Warehouse.

If you need help designing or developing a custom database for your research project, contact Research IT Support System.

Community Engagement Public Health Databases
The Center for Community and Population Data Studies is in development under the leadership of Larry C. Kleinman, MD. This Center is intended to meet the needs of both community members and researchers who wish to ask questions that can be answered through the analysis of secondary data. Though housed in the Centers for Community and Academic Research Partnerships (CCARP), the Data Center is also a component of the Center for Bioinformatics and the Biostatistics, Ethics, and Research Design Program. It has three main functions:

1. Provide an accessible data resource for researchers, community partners, and faculty members.
2. Develop the data resource by obtaining databases, indexing them, and relating them to permit analyses to cross various databases, and develop user-friendly methods and procedures to access the data.
3. Expand the range of studies that can be accomplished using secondary data through the development and expansion of research methods and information science. We have a long-term goal of working with other CTSA-funded institutes to develop methods to identify which other neighborhoods and communities are comparable to our key communities of interest (Queens and East Harlem) to allow future studies of community factors to more easily cross neighborhood boundaries.

Individuals interested in contributing to the development of the Center or in using its resources should contact Crispin Goytia.

Last Updated: August 2023

Grants and Contracts Office (GCO) – The Mount Sinai research application is required for all research, fellowships, service, education, and training programs at Icahn School of Medicine (MSSM). You should complete Program for the Protection of Human Subjects (PPHS), Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Program protocols if relevant. 

Federal Conflict of Interest in Research (FCOIR) – As an academic institution, the Mount Sinai Health System must avoid all appearances of improper professional behavior by the institution and its faculty, employees, and trustees. A conflict of interest in research may arise when an investigator/covered person and/or the institution has a financial interest that could directly and significantly affect the approval, design, conduct, monitoring, or reporting of a research study.

The Financial Administration of Clinical Trials Services (FACTS) office at the Icahn School of Medicine at Mount Sinai (ISMMS) is the center for coordinating the financial aspect of your clinical trials. FACTS offers a range of services that assist investigators and research personnel with the pre-award submission process and the post-award management of industry-funded clinical trials. Contact FACTS for more information.

Please feel free to contact the staff at the ORS or CTBB regarding any questions you may have at research.services@mssm.edu or 212.824.7294.

Program for the Protection of Human Subjects - The Program for the Protection of Human Subjects is charged with review and approval of all research protocols being conducted at the Mount Sinai Health System, or by Icahn School of Medicine faculty, with the aim of protecting the rights and welfare of human subjects enrolled in these research protocols. 

Institutional Animal Use Committee (IACUC) – One of the main mandates of the Institutional Animal Care and Use Committee is to ensure that all vertebrate animal studies are conducted in accordance with Animal Welfare Act regulations and Public Health Service policies, and that such studies conform to the institution's Assurance1 document filed with the Office of Laboratory Animal Welfare of the National Institutes of Health. To fulfill this requirement, all studies involving vertebrate animals, including pilot studies and intramural projects, must be reviewed and approved by the IACUC. 

Institutional Biosafety Program (IBP) - The Icahn School of Medicine Institutional Biosafety Program monitors all laboratory activities involving biohazards, infectious or biologically derived infectious materials, and toxins that present a risk or potential risk to the environment. Several forms have been developed in order to assist the Principal Investigator with the required submissions and filings required by the federal regulatory agencies that have jurisdiction over research activities.

Investigational Drug Service (IDS) - The Department of Pharmacy maintains an Investigational Drug Service (IDS) to support research activities at Icahn School of Medicine. The IDS is a research pharmacy charged with maintaining the control and accountability of investigational agents (FDA approved and non-approved) in compliance with Good Clinical Practices, Good Manufacturing Practices , and other regulations and laws as appropriate. The IDS provides dedicated research support including protocol review, storage, preparation, dispensing and education to groups and investigators engaged in research.

Radiation Safety Office - The primary mission of the Radiation Safety Office (RSO) is to create a safe environment against ionizing radiation for all Mount Sinai staff, patients, and visitors. The RSO reviews all the regulations with regard to the use of radioactive materials and radiation-producing machines. By interpreting and implementing these regulations, the RSO keeps the institution in compliance. Some of these regulatory authorities include the New York City Department of Health, the New York State Department of Health, the U.S. Food and Drug Administration, the Nuclear Regulatory Commission, New York Police Department's Counterterrorism, NYC Department of Health, Department of Transportation, etc.

The RSO maintains various licenses and registrations that permit the use of radioactive materials and radiation-producing machines at the various Mount Sinai locations. Under the oversight of the institutional Radiation Safety Committee, the RSO implements an efficient radiation protection program and provides many support services. The goal of the radiation protection program is to ensure the health and safety of staff, patients, and visitors from potentially harmful effects of ionizing radiation by maintaining both external and internal exposures as low as reasonably achievable (ALARA).

For more information, contact:

Jacob Kamen, PhD, CHP
Senior Director and Radiation Safety Officer
212.241.2269
E-mail: rso@mssm.edu
Radiation Safety Office, Annenberg 2TM Floor, Room 312, Box 1633

Protocol Review and Monitoring Committee (PRMC) Cancer Studies - The Tisch Cancer Institute PRMC reviews all clinical cancer studies conducted under the auspices of Icahn School of Medicine, whether or not the research involves use of The Tisch Cancer Institute's clinical trials office shared resources.

All new protocols are reviewed and must receive full monitoring committee approval as well as approval from the PHHS before they can be activated. Ongoing studies will be monitored for protocol accrual. 

Cardiovascular Institute (CVI) Clinical Trials Compliance Committee - The goal of the CVI Clinical Trials Compliance Committee is to ensure that the research priorities of Mount Sinai are met through projects that encourage the use of new diagnostic techniques and therapies for the treatment and prevention of cardiovascular disease while adhering to the institutional compliance policies.

This will be achieved by an initial committee review of all new human subject projects and an annual follow-up review to ensure that the scientific and financial goals of the project are being met.

The CVI Clinical Trials Compliance Committee meets on a weekly basis to review new projects and retrospective studies. Biomedical Research Alliance of New York (BRANY) projects should be presented for discussion and review at this time.

Primary protocol discussion points address:

• Research question and project goal
• Significance and scientific quality of proposed research
• Statistical methods of data analysis
• Regulatory and/or safety plans
• Recruitment strategies

For more information, contact:

Jessica Bustamante
212.659.9181
Fax 212.849.2674

External Approvals

Investigational Drug Studies (IND) – For research involving use of a Food and Drug Administration (FDA)-approved drug in any way that varies from the FDA approval (e.g., target population, route of administration, dose and/or frequency, etc.) a submission to the FDA for an IND or an IND exemption may be required.

Investigational Device Studies – For research involving devices, please see the documentation provided under PPHS Guidance.

CMS Approvals - Devices, associated procedures, and services used in clinical trials may qualify for reimbursement under Medicare guidelines. For help in determining whether or not your device study qualifies for reimbursement, please send an email us.

Biomedical Research Alliance of New York (BRANY) - The BRANY is an alliance of academic medical centers designed to conduct high-quality trials for the pharmaceutical and biotechnology industries in a rapid, efficient, and cost-effective manner. This research organization is a consortium owned by some of the finest institutions in the New York metropolitan area, including Icahn School of Medicine. 

Clinicaltrials.gov posting: The Food and Drug Administration Amendments Act of 2007 require that all clinical trials be posted on their website. Journals that adhere to International Committee of Medical Journal Editors (ICMJE) standards will not consider publication for trials that are not registered. In addition, there may be penalties for noncompliance. For more information on this requirement, e-mail research.services@mssm.edu.

Certifications

Program for the Protection of Human Subjects (PPHS) - It is essential that all investigators and their staff understand the regulations that govern experimentation with human subjects. Documentation of appropriate education is seen as the first building block in the protection of human research participants. Similarly, appropriate efforts toward protection of patient privacy and data confidentiality via the Health Insurance Portability and Accountability Act (HIPAA) must be learned through understanding the law and its implementation at Mount Sinai. Listed are the requirements that must be met before any involvement in human subjects research:

• Human Research Protection Education Requirement
• Research HIPAA
• Data Security

Institutional Biosafety Program (IBP) - In laboratories handling large-scale microorganisms classified as risk group 2 (RG-2) and higher, the risks associated with an exposure, the procedures and equipment used to protect personnel from the associated hazards, and risks of working in that laboratory must be explained in a written standard operating procedure. All lab personnel and support staff must have access to the written procedures at all times and should receive annual training in those procedures. Bloodborne agents have specific requirements stipulated in OSHA's 29 CFR 1910.1030 Bloodborne Pathogens Standard. 

Any use of respirators by personnel must conform to the Occupational Safety and Health Administration standards regulating training, proper wearing, fit-testing, medical evaluation and surveillance, and proper storage and use of respirators (29 CFR 1910.134).

Employees handling HIV, HBV, or other pathogenic agents must follow the procedures outlined in the "Bloodborne Pathogens Exposure Control Plan" and in the document "Biosafety in Microbiological and Biomedical Laboratories," which are located at the Centers for Disease Control website. All employees handling these agents must attend training sessions annually.

InfoEd Electronic Research Administration (ERA) – If you are going to submit grants or protocols using InfoEd ERA software, you must first complete the Grants, Human Subjects, or Animal compliance training modules.

To register for training, e-mail infoed@mssm.edu.

Clinical Trials Budget and Billing Video - If your study has routine care costs to be billed to someone other than the sponsor, you must view and complete the video entitled "Clinical Research Billing Rules for Investigators." For more information, e-mail research.services@mssm.edu.

Quick Links for Frequently Requested Resources

• Research 411 - use this link to ask general questions about ISMMS research operations and resources
• Biostatistical Support and BERD - use this link to request ConduITS supported biostatistical support services
• ClinicalTrials.gov - use this link to request guidance from the Office of Research Services (ORS) for registration and reporting of clinical trials in ClinicalTrials.gov
• Imaging Core/BMEII resources - initiate a project using BMEII Imaging Core resources
• Office of Research Services (ORS)- view all resources offered by the ORS
• eRAP requests - use this link to request assistance with electronic data capture using eRAP
• REDCap requests - use this link to find out more about REDCap, a secure web application for building and managing online surveys and databases

Biostatistics, Epidemiology & Research Design (BERD) offers an integrated resource for clinical and translational investigators at Icahn School of Medicine in study design, biostatistics, and bioethics.

Researchers can attend a session of BERD’s STAT-CHAT: Walk-in Consultation Service, Mondays, 2:00-3:00 pm in room L2-82 on the Second Floor of the Icahn Medical Institute, 1425 Madison Avenue.

To apply for BERD’s consultation service, researchers can submit their request via the BERD Service Request. Under "Service Requested," select "Statistical Advisory Service” and fill in the applicable form. Please note that the CTSA no longer supports the free BERD consultation service.  BERD Consultations are now charged at $125/hour. At the end of the project, they send an invoice, which can be paid by departments through Sinai Central. If you are interested in obtaining financial support, ConduITS has set up a voucher program for limited support to selected projects. Please email for information about applying.

All other requests for information and assistance should be directed to Yvette Hutson.

CePORTED

The overall mission of the Center for Patient Oriented Research, Training, Education, and Development (CePORTED) is to facilitate the recruitment, training, mentoring, and retention of individuals considering or committed to careers in clinical/translational (C/T) research in order to improve individual patient care and the well-being of society. To accomplish this, CePORTED integrates C/T research opportunities within the institutes and centers of the Mount Sinai Health System, provide central organization and oversight for C/T research education and training programs, introduce a PhD program in clinical research, oversee a faculty career development (KL2) program, expand clinical research experiences for medical students, and maximize integration among existing interdisciplinary degree- or certificate-granting programs.

ConduITS Community Engagement programs connect faculty and community members so that the values and culture of the community are respected throughout the research process. To achieve these goals, their services are directed to both community and academic members to create a unique environment where both groups learn from one another. They also develop and implement mentoring and educational programs for researchers, trainees, and community partners.

Federated Biobank
Biobanking efforts ongoing at ISMMS reflect particular strengths and major institutional investments. The ISMMS CTSA Federated Biobank aims to accelerate collaborations across the MSHS and the CTSA Network by linking ISMMS repositories of biological samples relevant to key developmental periods across the lifecourse with corresponding sociodemographic, clinical, and environmental information using a multi-stage planning and implementation approach.  

Biobanking Resources
To facilitate federated tissue banking, ConduITS has licensed and implemented the LabVantage biorepository management system and trained a core staff to help each biorepository or specimen-collection group to streamline the specimen collection workflow, improve the data integrity and accuracy, facilitate data linking and integration, and lower the initial barrier for biobanking. To learn more about ConduITS LabVantage Biorepository Management System, please contact Xin Zheng, PhD.

International Center for Health Outcomes and Innovation Research (InCHOIR) is an academic clinical research center of MSHS, whose mission is the design, conduct, and analysis of multi-center trials and observational studies.

Office of Research Services (ORS)The ORS staff answers all categories of research questions or directs questions to the appropriate office or individual who can provide the answers to members of the research community. ORS offers consultation services for investigators and their teams, providing guidance on submissions. Create a login (one-time process) with the ORS Help Center to ask a question or request support.

• ClinicalTrials.gov
• Investigational New Drug (IND)
• Pre-protocol Development
• Recruitment of Research Participants
• Electronic Medical Record (EPIC) Participant Recruitment for clinical research

Research Information Technology provides services and resources to support the research institutes, centers, and laboratories within the Icahn School of Medicine at Mount Sinai. Through our tools and guidance, we meet your information technology needs through every step of the research process. 

Team Science
This site provides numerous resources and links to educational materials of relevance to the conduct and science of Team Science. To provide added value to the research community at large, links are included for previous CePORTED and SINAInnovations conference materials related to Team Science, to further enhance career development of new investigators, allied health care professionals and stakeholders as well as new career opportunities for those investigators who are more established at ISMMS, the Graduate School of Biomedical Sciences, the MSHS and the community.

The Trial Innovation Network (TIN) is a collaborative national network that focuses on operational innovation, excellence and collaboration and will leverage the expertise and resources of the CTSA Program. The Trial Innovation Network will feature a single IRB system, master contracting agreements, quality by design approaches, and a focus on evidence-based strategies to recruitment and patient engagement. For more information, visit the CTSA Trial Innovation Network website or submit a ticket to the Office of Research Services through the Research 411 portal.

Pilot Projects

The intent of the CTSA Translational Pilot Program is to develop innovative technologies and methodologies, to test the feasibility of novel approaches, and to stimulate inter-disciplinary collaborations that test generalizable solutions to translational research problems. Read more in the “Pilot Projects” accordion below.

Career Development

• KL2 Scholars Award for Clinical and Translational Research Career Development
• PORTAL Program
• Sinai Team-based Translational Education Program: the URM Propeller (STTEP-UP) Initiative in Science and Medicine

Other Related Resources

BioMe Biobank is an electronic medical record-linked biobank that enables researchers to rapidly and efficiently conduct genetic, epidemiologic, molecular, and genomic studies on large collections of research specimens linked with medical information.

Charles R. Bronfman Institute for Personalized Medicine (IPM)

The IPM explores how genetic information and environmental exposure affect each person's risk to develop certain diseases and response to medication. IPM provides an innovative, integrated genomic and translational research hub for groundbreaking research to redefine complex diseases on a molecular level. Our programs enable Mount Sinai researchers to define genetic risk, molecular pathogenesis, and molecular diagnosis of common, complex diseases in unique and well-characterized patient populations that are accessible for studies through a rich fabric of outstanding disease research centers at Mount Sinai.

Clinical Research Unit (CRU) provides the necessary infrastructure to perform clinical and translational research studies effectively and safely. Resources include outpatient space, nursing, and specimen processing.

Dean’s CoREs bring state-of-the-art, crucial instrumentation, and methodologies for modern biomedical research within reach of all Icahn School of Medicine at Mount Sinai investigators, post docs, and graduate students. The facilities are staffed by experts who provide research services, act as sources of instruction and training, and, therefore, constitute a major educational resource for those wishing to diversify or explore new avenues of research. CoREs are administered through the Office of the Dean and partially subsidized by institutional funds.

Drug Discovery Institute (DDI)

Working with Mount Sinai investigators and external partners, the Drug Discovery Institute designs and executes projects to deliver proof-of-concept candidates. DDI works on a traditional “fee for service” basis, and offers the opportunity for collaboration to develop a novel therapeutic. DDI works with the Principal Investigator to develop an experimental plan and apply for a grant or enter into collaboration.

Investigational Drug Service (IDS)

The Department of Pharmacy maintains an Investigational Drug Service (IDS) to support research activities at Icahn School of Medicine. The IDS is a research pharmacy charged with maintaining the control and accountability of investigational agents (FDA approved and non-approved) in compliance with Good Clinical Practices (GCPs), Good Manufacturing Practices (GMPs) and other regulations and laws as appropriate. The IDS provides dedicated research support including protocol review, storage, preparation, dispensing and education to groups and investigators engaged in research.

BioMedical Engineering and Imaging Institute (BMEII) is advancing the science of imaging, from the development of new visualization technology to improved contrast agents. The Institute is applying imaging modalities in both preclinical basic science and clinical research settings to improve diagnostic accuracy increase the understanding of pathophysiology and metabolism, and measure therapeutic efficacy.

Last Updated: August 2023

Pilot research project opportunities for emerging investigators are available through the CTSA. These opportunities include pursuing community relevant and clinically impactful research, and cross-disciplinary research training “mini-sabbaticals”. The projects serve as a framework to drive career development and innovation in key areas reflective of our nationally regarded research programs including: 1) Precision Medicine; 2) Clinical Informatics; 3) Data Science & Computational Biology; 4) Genomics; 5) Integrative NeuroResilience; and 6) Exposomics and GeoMedicine. This unique ecosystem facilitates novel systems development and data generation.

A Request for Proposal (RFP) is typically announced annually in June via the Research Listserv . Awards of up to $40k are granted. Submissions in the areas of therapeutics, devices, diagnostic technologies, and digital health are all eligible.

If you are interested in these awards, sign up for the Research Listserv to be notified when an RFA announcement is made.

If more information is needed, submit questions to the Office of Research Services through the Research 411 portal.

Last Updated: August 2023