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 Instituional 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.
Clinical Trials Budgeting - ORS's Clinical Trials Budget and Billing Office,(CTBB) in conjunction with the Grants and Contract Office, is the center for coordinating the financial aspect of your clinical research. As such, CTBB provides the necessary tools for conducting innovative and safe clinical testing in compliance with required financial and regulatory guidelines. CTBB offers budget templates, standardized fee schedules, and tools for identifying services to ease budget development, provide billing verification, and ensure compliance. It will also offer continuous training and updates on federal and industrial regulatory requirements in collaboration with other existing programs within Mount Sinai Health System.
Please feel free to contact the staff at the ORS or CTBB regarding any questions you may have at email@example.com or 212.824.7294.
Program for the Protection of Human Subjects (PPHS) - 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.
Embryonic Stem Cell Research Oversight Committee (ESCRO) Application Form - Complete the ESCRO authorization form, attaching a National Institutes of Health (NIH)-style biographical sketch along with the appropriate Material Transfer Agreement MTA forms. This paperwork should be turned in to the PPHS.
Institutional Animal Use Committee (IACUC) – One of the main mandates of the Institutional Animal Care and Use Committee (IACUC) 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 (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.
Radiating 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:
Clinical Research Centers Scientific Advisory Committee (SAC) - The Clinical Research Centers (CRC) provides the necessary infrastructure and training for Mount Sinai investigators to conduct their research studies, and resources are utilized by investigators who wish assistance in all aspects of research design, methodology, and the actual carrying out of the study, as the CRC is staffed by nurses with advanced degrees (i.e., nurse practitioners).
Each protocol using the CRC must be reviewed and approved by the Clinical Research Centers Scientific Advisory Committee, which meets on a monthly basis, prior to admission of patients. All studies must also be approved by the PPHS. Submissions to both committees may be made concurrently.
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:
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 click here to 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, e-mail firstname.lastname@example.org.
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 requires that all clinical trials be posted at http://clinicaltrials.gov. 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 email@example.com.
Grants and Contracts Office – Viewing a training webcast of pre- and post-award grant finance and compliance issues is mandatory for all research investigators and administrators at Icahn School of Medicine. The webcast is available in Sinai Central. .
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 (OSHA) standards regulating training, proper wearing, fit-testing, medical evaluation and surveillance, and proper storage and use of respirators (29 CFR 1910.134 at www.osha.gov).
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 firstname.lastname@example.org.
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 email@example.com.
Sonia Kleiner-Arje, MSRA, CHRC
Director, ISMMS ConduITS CTSA, Institutes for Translational Sciences
Director, Office of Research Services (ORS)
ConduITS is supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health through Grant Number UL1TR001433.
Any use of CTSA-supported resources requires citation of grant #UL1TR001433 awarded to Icahn School of Medicine in the acknowledgment section of every publication resulting from this support. Adherence to the NIH Public Access Policy is also required.