Research

Use this section to obtain standardized language describing research related institutional resources, plus other guidance and recommended language for use in specific types of grant submissions.

The Center for Comparative Medicine and Surgery (CCMS) is a centralized, shared resource supporting animal research via veterinary, husbandry care, and research collaboration with the faculty at Icahn School of Medicine at Mount Sinai. The program has been fully accredited by the Association for Assessment & Accreditation of Laboratory Animal Care, International (AAALAC - #00002), since 1967. The center also provides assistance with research protocol design, clinical and anatomic pathology, and training of research personnel in the care and use of laboratory animals. There are four primary sites of operation, with the central administration located in the Annenberg Research Building, 26th Floor. The other major housing areas are the Icahn Medical Institute (IMI); the Hess Center for Science and Medicine (HCSM) and the Atran Research building.

Annenberg Research Building

The largest variety of species is housed in this building. Administrative offices, large animal surgical support (one operating room and two catheterization labs), and a veterinary diagnostic laboratory are located here.

Icahn Medical Institute

This state-of-the-art rodent barrier facility offers fully automated rodent housing (ventilated caging and automatic watering), necropsy suite, and Animal Biosafety Laboratory (ABSL2/3) capability. Also located within this vivarium are the Mouse Genetics Shared Research Facility, Metabolic monitoring facility, and Gnotobiotic rodent facility.

Atran Research Building

This small facility provides overflow support for the Annenberg and IMI, respectively. Animals housed in this area reflect the general health profiles of the major support areas.

Hess Center for Science and Medicine

The HCMS vivarium is the newest and largest vivarium on campus. Designed to specifically support Imaging, Neuroscience behavioral studies, and Cancer research, the vivarium is adjacent to the Translational and Molecular Imaging Institute’s small animal imaging suites and large animal imaging capability. Fully automated, robotics, cage wash support and state-of-the-art environmental monitoring systems are additional key features of this facility.

The faculty of the CCMS consists of five full time veterinarians: (Director, DVM/DACLAM; Associate Director and Head, Small Animal Medicine, MS/DVM/DACLAM; Head, Veterinary Translational Medicine and Director of Behavioral Management Program, DVM/DACLAM; Head, Comparative Surgery Facility, DVM and Veterinary Pathologists, DVM). The Husbandry operation is managed by an Operations Manager and four full time Supervisors. All are certified at the Laboratory Animal Technologist level LATg) by the American Association of Laboratory Animal Science (AALAS). An ongoing in-house training and post-approval compliance program is in place and conducted by a full time Training/Compliance Coordinator (MS/LATg). The institution also supports a weekly AALAS certification training program for all husbandry and research personnel interested in certification.

Visit the Center for Comparative Medicine and Surgery or email Reginald Miller, DVM, DACLAM for more information.

Last Update: June 19, 2014

The Clinical Research Unit (CRU) is the hub for conducting clinical and translational research at the Icahn School of Medicine at Mount Sinai. There are more than 100 protocols being performed from a wide variety of specialties and subspecialties involving research participants of all ages. The staff includes nurse practitioners who can perform physical examinations, monitor participants, and perform infusions, and medical assistants who perform phlebotomy, electrocardiograms and process samples. A research dietitian is available for participant evaluations and assistance with dietary issues. The space, located on the second floor of 1184 5th avenue, includes private rooms, a bionutrition kitchen, telemetry, a laboratory for specimen processing and short term storage, a lounge with Internet access for research participants, entertainment for children, and work cubicles for research staff. The resource is available Monday – Friday from 8:00 AM – 5:00 PM.

Visit the Clinical Research Center or email Christine Hannigan for more information.

Last Update: September 25, 2015

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.  

The IDS sets up specific procedures and systems for each clinical trial to assure maximum benefit and safety for patients enrolled in studies. The clinical coordinators are available to consult with any investigator or sponsor to discuss the logistics of conducting their trial at Mount Sinai. All human subject trials requiring the use of medications must get authorization from the IDS prior to Program for the Protection of Human Subjects (PPHS) final approval (IDS and PPHS reviews occur concurrently).

Visit Investigational Drug Services or email Ivy Cohen for more information.

Mount Sinai Data Warehouse (MSDW) provides data access for planning and executing clinical and translational research as well as for quality of care and process improvement initiatives.

MSDW collects and organizes clinical, financial and operational data derived from patient care processes of The Mount Sinai Hospital and Mount Sinai Doctors Faculty Practice. Data Warehouse contains detailed inpatient and outpatient data since 2003 from over 20 different Mount Sinai systems/applications for more than two million patients and over two billion facts.

MSDW is compliant with New York State and HIPAA regulations and with Mount Sinai PPHS and IRB policies regarding protection of human subjects and participation in research.

Researchers planning new studies or grant applications can utilize our online Cohort Query Tool and quickly search the Data Warehouse to quantify eligible cohorts.

MSDW can help research studies by identifying the study population and by providing daily/weekly/monthly reports. In addition, MSDW can provide datamarts or smaller subsets of data to study cohorts.

The cost of data delivery for research studies is based on the effort required by the data warehouse team to analyze and generate the desired output. Consultations up to one hour are provided free of cost. Assistance with estimating Data Warehouse costs for grant application purposes is available upon request.

Visit the Mount Sinai Data Warehouse for more information.

Last Update: October 3, 2015

Developed in response to the needs of Mount Sinai's ever growing research community, the Dean’s Office of Research Services (ORS) has been established to facilitate the conduct of research through a centralized infrastructure. ORS assists investigators and research personnel with regulatory oversight requirements and administrative processes for protocol development and grant submissions. Supported by Conduits – The Institutes for Translational Sciences, the ORS staff provides researchers with resources, information, and expertise on their projects in order to foster the research enterprise within Mount Sinai, its affiliates, and the broader community.

ORS offers a range of services to basic science, translational, and clinical investigators and research personnel. These services include:

  • Consultations on pre-protocol development;
  • Internal regulatory support to obtain IACUC and IRB approvals;
  • External regulatory support, including assistance with IND/IDE submissions to the FDA, Clinicaltrials.gov postings, and grant applications;
  • Research study recruitment and retention support, including assistance with developing brochures, newsletters, and web marketing (e.g., researchmatch.org); and
  • Assistance with accessing other valuable research resources and tools including biostatistics and research information technology.

Visit or email the Office of Research Services for more information.

Last Update: September 30, 2016

With full accreditation from the Association for the Accreditation of Human Research Protection Programs the Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital's Human Research Protection Program is a comprehensive program to ensure the protection of the rights and welfare of subjects in Human Research. The Program for the Protection of Human Subjects (PPHS) is a key component of the overall HRPP.

The PPHS supports researchers throughout the Mount Sinai Health System in assuring the ethical conduct of research and compliance with federal, state and institutional regulations and provides a professional office staff to assist investigators, participants, and Institutional Review Boards (IRBs). In addition, the overall HRPP includes organizational, administrative, and investigator components, and is based on all individuals fulfilling their roles and responsibilities. Essential aspects of the overall mission of human subjects protection are provided by the organized interaction of the PPHS with the Financial Conflict of Interest Committee, the Clinical Trial Office, The Office of Research Compliance, the Biosafety Program and the Radiation Safety Committee.

The PPHS office offers support to investigators and their research teams through one-on-one scheduled meetings with IRB analysts to review individual applications and answer questions. The office also offers short presentations to groups, departments, or divisions on the human subjects research submission process by experienced IRB analysts. The PPHS office also offers assistance to researchers during business hours by phone, or through the general email address which is answered daily.

Visit or email the Protection of Human Subjects for more information.

Last Update: June 17, 2016

Research Information Technology (Research IT) at Icahn School of Medicine includes Data Management and Data Warehouse services. Data management services primarily rely on the use the Mount Sinai Rapid Database Generator (RDG) toolset. RDG is a web-based application designed to present and store research data customized for an unlimited variety of projects and protocols.  Data is captured by user-defined web based forms and stored in dynamically maintained data tables. Fields can be added to the forms and to the tables using the User-Defined Field (UDF) functionality. RDG is delivered via Mount Sinai’s secure web portal and managed via Role Based Access Control security.

Investigators can assign a quality control role for record validation. The RDG allows records to be locked from further edits based on this role. The RDG also supports electronic signature with system date stamp which will be used with record locking to track and control database versions. Finally, there is complete audit logging showing user access to records for both view and edit including capture of old and new values on fields that have been edited. All data that is entered into RDG databases are available for users to extract and download into Excel or ASCII comma, tab or pipe delimited files as required to facilitate data sharing and import into commonly used statistical analysis software. Access to data extraction capability is controlled through security.

This system is managed entirely by Mount Sinai IT and extensive help and expertise are available with a phone call. In addition, everything is accessible via the Web through a password protected web portal available through any internet service provider via the secure HTTPS protocol. Security for the portal and the database are managed in accordance with industry standards for Role Based Access Control (RBAC) to create custom roles and permissions for each project and assign roles to each user. In addition, data access can be managed by location. For example, for multi-site collaborations, the PI or PPG statistician may be allowed to see all data for the study, but each participating location can see only their site’s data based on study design requirements. Passwords are managed in accordance with Mount Sinai’s institutional policies.

The Mount Sinai Data Warehouse (MSDW) consists of clinical, operational, and financial data derived from patient care processes of The Mount Sinai Hospital and Mount Sinai Faculty Practice Associates. Detailed inpatient and outpatient data are extracted from transactional systems, transformed and loaded into MSDW nightly. MSDW contains data since 2003, sourced from 20 transactional systems, encompassing over three million patients and approaching one billion facts. The principal objective of the Data Warehouse is to make data easily accessible for planning and executing clinical and translational research and for quality of care and process improvement projects. A secondary objective is to monitor and improve data quality and integrity across Mount Sinai’s many transactional systems. MSDW is compliant with HIPAA and New York State privacy and security regulations and with Mount Sinai IRB policy regarding protection of human subjects and participation in research. Researchers planning new studies or grant applications can quickly search the de-identified Data Warehouse to quantify eligible cohorts. For IRB-approved research or CQI projects, datamarts tailored to specific eligibility and data analysis requirements are prepared. Datamarts may be de-identified, or may contain PHI with appropriate approvals.

Visit or email Research Information Technology for more information. 

Last Update: April 23, 2012

Mount Sinai has a strong commitment to providing excellent and ongoing instruction in the Responsible Conduct of Research (RCR) for all students, postdocs and faculty involved in biomedical research. The RCR curricula at Mount Sinai have long surpassed the guidelines described in NIH issued NOT-OD-10-019 “Update On The Requirements for Instruction in the Responsible Conduct of Research”. Reginald W. Miller, DVM, DACLAM, was appointed in 2009 as the Mount Sinai Research Integrity Officer in the Office of the Dean. He has overseen a coordinated increase in RCR education at all levels of the institution that adds even greater vitality to a program that has been a long-standing institutional commitment. All trainees will participate fully in these RCR course offerings upon entrance to the training program, and will partake in the bi-annual refresher course required by the school.

Format: Two graduate courses in the Responsible Conduct of Research (RCR) are offered annually. One is for PhD and Master’s students, and the other for MD/PhD students; both courses are considered an integral and mandatory constituent of part of the core curricula. There are also condensed courses for postdoctoral trainees and graduate students who have not taken the RCR course for 4 years, which also ensure a more closely matched peer group to facilitate discussions and relevant experience. A key element of the course is elucidation of best practices in research as they related to reproducibility and transparency. These rigorous courses entail a series of presentations in different formats that include presentations by guest speakers. This material is supplemented by additional assigned reading, use of selected videos, and other special materials. Each session includes didactic material and discussions of relevant case studies.

Subject Matter: 1) Specific topics for the eight sessions include: (i) Research misconduct: Definitions and related issues; (ii) Laboratory notebooks, experimental design, and data management; (iii) Protection of Human Subjects; (iv) Welfare of Laboratory Animals; (iii) Conflicts of Interest; Intellectual property, (iv) Mentor and Trainee Responsibilities; Collaborative Research; (v (vi) Experimental Design and Data Management Practices; (vii) Publication, Authorship, and Peer Review; (viii) Peer Review, the Grant Process, and Fiduciary Responsibility; (ix) cognitive biases; (x) scientists as ethical members of society. While as indicated above issues related to transparency and reproducibility are discussed and constitute an important and explicit rationale for the course, as consistently explained to the students, Mount Sinai has recently implemented a complementary mandatory course (in the spring, following the mandatory RCR in the fall for all first-year students) that will specifically review issues of experimental design and statistical analysis addressing best practices for reproducible results.

The main resources for these RCR courses are the materials on the NIH Office of Research Integrity (ORI) website, which presents the most recent official NIH positions on most of the issues covered in the course. At the end of the course trainees are required to take and pass (>85 percent correct answers) an online test produced by the Collaborative Institutional Training Initiative (CITI) to ensure that the trainees meet the broad standards for RCR.

Faculty Participation: Charles Mobbs, PhD, Professor of Neuroscience and Geriatrics, directs the RCR course. Guest lecturers have included the Executive Director and Chair of the IRB, the Chair of the IUCAC, a representative from the Office of Industrial Liaison, and the Mount Sinai Ombudsperson. Small group discussion leaders have been knowledgeable faculty at Mount Sinai who serve on a rotating basis.

Duration of Instruction: The Graduate RCR course is now composed of 8 one-hour sessions over the course of eight weeks. The refresher course is composed of 4 one-hour sessions. The first part of each session entails didactic material (e.g., the NIH definition of misconduct, best practices in note-book keeping and data management, the role of the IRB and IUCUC committees, forms of cognitive biases, etc) followed by class discussions of case studies illustrating the complexities and ambiguities in applying these principles to real-life situations. Participation is monitored by sign-in sheets which are maintained by the instructor. Students are allowed to miss up to 2 sessions for reasons approved by the instructor (e.g., illness or other unavoidable conflicts) but must review the material and submit a report indicating such (often the instructor will review the material in a one-on-one basis: failure to attend this mandatory course occurs at a relatively low rate so this is generally feasible). At the end of the course trainees are required to engage in the ORI interactive video (THE LAB) and submit a report indicating decisions made and outcomes.

Frequency of Instruction: Mount Sinai is committed to recurring and ongoing instruction in RCR for all students, postdocs and faculty. All first year PhD and MD/PhD graduate students, along with all new trainees, participate in the mandatory graduate course in RCR, and are required to take the refresher course after 4 years of training. All trainees are required to take the biannual refresher RCR course in order to maintain the NIH mandated instruction in RCR every 4 years. Because our RCR courses are continually updated, with variation in lectures, case studies, and group discussions to reflect important issues and current cases, our RCR course is a valuable and fresh learning experience each time it is taken throughout a scientific career.

Other RCR training and resources at Mount Sinai: Furthermore, it is recognized that proper instruction in RCR requires an ongoing dialogue about these important issues that is not satisfied by recurring course work. Informal instruction in RCR occurs normally in the course of laboratory instructions and mentor/trainee interactions and other informal situations during training. In addition, Mount Sinai has had an ongoing program in bioethics since 1980, under the direction of Rosamond Rhodes, PhD, Professor of Medical Education and Director of Bioethics Education at The Icahn School of Medicine. The Bioethics program includes several semester long courses offered to trainees. Trainees will participate in ethics seminars and luncheons which have been ongoing at Mount Sinai for many years as an integral part of our training program, as follows:

  • Attendance at the monthly Mount Sinai Center-Wide Ethics Luncheons convened by Dr. Rosamond Rhodes. At each luncheon, a guest speaker presents a case that poses an ethical dilemma. Faculty, trainees, students, and other medical professionals participate in stimulating conversation and debate on issues confronted in clinical practice and research. Recent focuses of discussions have been transplant tourism, end-of-life decision making, and surrogate decision making. These luncheons have always had a significant proportion of sessions discussing issues in Human Genetics, partly because Kurt Hirschhorn, MD, a medical geneticist and member of our executive faculty committee, founded these luncheons in 1970. We anticipate that the advent of translational genomics research will generate even more ethical discussion sessions of great interest to our trainees.
  • Attendance at Research Ethics Seminar Series Course Directors: Karin Meyers, MA and Rosamond Rhodes, PhD. This semester-long seminar, offered as part of the Clinical Research Education Program, addresses the key issues related the use of human subjects in biomedical research. It involves seminar discussion, extensive reading, and a research paper. Topics include: the evolution of clinical trial oversight, informed consent, assent, assessment of risks and benefits, research design, research with minors and other vulnerable subjects, inducements for research subjects, conflict of interest, payments for researchers, confidentiality, privacy, scientific fraud, authorship, attribution, and whistle blowing. This is a graduate-level seminar attended by students in the MS degree programs in Clinical Research and in Genetic Counseling, the Certificate in Clinical Research program, and the medical and graduate students. Dr. Rhodes also will be available to consult with trainees on ethical issues and to mentor them.

Each trainee will complete mandatory online training programs on HIPAA regulations, and an on-line course of instruction developed by the National Cancer Institute designed to educate investigators in the ethical conduct of research. This course is designed around the NIH Handbook, "Human Participant Protections-Education for Research Teams” and covers issues of scientific integrity, mentoring, scientific record keeping, authorship, peer review, the use of animals in biomedical research, institutional review boards, ownership of data and intellectual property, conflict of interest, scientific misconduct and new topics of great importance such as use of human fetal tissue and stem cells in research and clinical research in developing countries. Upon successful completion of this course, each fellow will obtain a certificate.

Furthermore, ethical consultation services are available on a per need basis to all members of Mount Sinai including trainees, as follows:

  • The Clinical Ethics Consultation Committee of the Medical Board of the Mount Sinai Hospital is available for consultation and guidance on ethical issues concerning patient care and treatment (Ian Holzman, MD, Richard Stein, MD, Rosamond Rhodes, PhD). Kurt Hirschhorn, MD, a member of our executive faculty committee, founded this committee in 1970 and was chairman for 30 years.
  • The Research Ethics Consult Service helps clinical and translational investigators to identify bioethical issues in their research proposals and helps them design their studies and carry out their research to meet the highest ethical standards. Members of the Consult Service are available for consultation and guidance on ethical issues concerning the conduct of human subject research. Nada Gligorov, PhD, Rosamond Rhodes, PhD, and Glenn Martin, MD, CIP, who teach research ethics at Icahn School of Medicine and in the Mount Sinai Bioethics program, provide this consultation service. Dr. Rhodes has a particular academic interest and expertise in the bioethical issues associated with genetics and genomics. Researchers may consult the service directly or through referral by a department chair, the IRB, or any one of the other consultation services.
  • Institutional Animal Care and Use Committee (IACUC) is available for consultation and guidance on ethical issues concerning the use of animals in research. Consultation is available during the study design process and during the conduct of research. The IACUC Chair is Giorgio Martinelli, PhD.

Visit Research Environment or contact Charles Mobbs  for more information.

Last Update: June 14, 2016

The Icahn school of Medicine at Mount Sinai has developed the Dean's COREs Program (also known as institutional COREs) to provide substantial support for innovative, state-of-the-art technologies essential to our research programs in Translational and Basic Sciences. The compact size of Mount Sinai makes it possible for all investigators to have essentially unlimited and easy access to these resources.

Support for the COREs by the Icahn School of Medicine at Mount Sinai described below totals approximately $1.5 million per year, of which user fee charges to investigators recovers 70% of direct costs. The school subsidizes the remaining 30 percent. The school also contributes directly to the purchase of new equipment often matching funds from Departments/Centers or Institutes. This makes it possible to charge investigators reduced fees, which promotes increased use of the facilities, and to prevent duplication of these technologies in individual departments or laboratories. An important ancillary result is that the COREs enhance the potential for collaboration in multidisciplinary research programs, since CORE directors can bring together investigators working in similar research areas. This also facilitates the adoption of new experimental approaches by PI’s, especially in situations where crossover requiring basic science data is needed to underpin and to test clinical hypotheses. Thus, Icahn School of Medicine views its commitment to the COREs as a significant part of its cost sharing.

A website was developed that is linked to individual COREs. On the individual websites, there is information about the services, fees, protocols for preparations and where appropriate, the opportunity to sign up for usage on a web-based calendar.

Structure and Governance of the Dean's COREs Program

The Dean's CORE Program reports to the Dean for Basic Sciences and Graduate School of Biological Sciences, John Morrison, PhD. The program is administered through the Dean's Office by the Senior Associate Dean for Research Resources (SADRR), Reginald W. Miller, DVM, DACLAM. Operational oversight of the COREs is through a dual, peer review mechanism. Each CORE has a dedicated Scientific Advisory Committee of five to seven members chosen from its user group. COREs are reviewed by one to two external reviewers and one internal reviewer from the advisory committee on a two to five year cycle, External Reviews. The external review criteria include publication credits, technology, and personnel expertise. These reviews assist the institution in determining the need for continued support, emerging trends in technology, and obsolescence of technology. Fiscal oversight and administrative support for the COREs is provided through the office of the Vice President for Finance, Mr. Stephen Harvey via Mrs. Veronica Moses. Dr. Miller works closely with this group to monitor the finances of the COREs. Each SRF is directed by an expert who provides research services, educates investigators on the use of the technology, and helps them develop studies using new technologies in support of their research projects. A senior member of the veterinary staff also serves as ex-officio on all the advisory committees of animal-based COREs. Advisory committees meet semi-annually to evaluate and recommend improvements and updates to the SRF technology and services.

Proposed new COREs are reviewed by: 1) Executive Scientific Advisory Committee – scientific merit in support of institutional research goals; 2) Engineering / Facilities - infrastructure needs in support of new technologies; 3) Dean’s Office- business plan, final approval incorporating recommendations from the two previous reviews. New COREs are given three years to succeed.  The Executive Scientific Advisory Committee is composed of Institute Directors, Senior Faculty, and CORE Directors.

Instrument capital costs are not recovered through user fees but rather through instrumentation grants, Dean’s funds or Departmental contributions with matching funds from the Dean.

 

Flow Cytometry SRF

The Flow Cytometry SRF provides instrumentation and expertise for automated cytofluorimetric analysis and the sterile sorting of specific cell types. The equipment of this facility is state-of-the art; it consists of multiple high-speed cell sorters and analytical flow cytometers with the capacity to analyze up to 18 simultaneous fluorescent colors in real time with data rates exceeding 10,000 per second.

Major instruments provide for cell sorting by trained operators, including four BD FACSAria II high-speed cell sorter and a 6-way BD Influx high-speed cell sorter. For cell analysis, the equipment is available continuously to trained operators, including BD FACSCantoII, BD LSRII, and Beckman Coulter Gallios instruments.  Three of the BD FACSAria II cell sorters reside within Class II biosafety cabinets, allowing for isolation of unfixed human samples, including samples from HIV patients. The need for contained sorting of live human cells is increasing rapidly along with the emphasis on translational research. Sorting of human samples on cell sorters in conventional rooms is widely deemed unsafe because the sorting process generates an aerosol, and carries the risk of the transmission of pathogens to users and operators.. The BSL2 cell sorting facility was completely funded by the institution ($1.8M) and is absolutely critical to the efforts of the institution in translational research, in particular in the areas of stem cell biology, immunology, cancer, and infectious diseases.

Please visit the website or email Jordi Ochando for more information.

Last Update: October 9, 2015

Biorepository and Pathology

The facility provides a consultative service to determine investigator requirements for human tissue and fluid biospecimens in translational research, and then arranges procurement as feasible. After meeting with the investigators about their respective research needs, Core personnel determine the best mechanism to obtain samples and implement the collection. This is made possible by the physical location of this Dean's Core in the Icahn School of Medicine Department of Pathology, and the ability to collect both deidentified and consented 'waste' biospecimens not required for clinical diagnosis. If the requested specimens are not feasible through the Mount Sinai health care system alternative sources will be explored.

The facility also offers basic histology services with the capability to process, embed and section fixed and frozen tissues for the Mount Sinai research community. We also prepare unstained slides suitable for a variety of applications such as histochemistry, immunohistochemistry, immunofluorescence, in situ hybridization as well as hematoxylin and eosin (H&E) stained sections and basic histochemical stains for routine light microscopic evaluation. The Core has the requisite equipment for a fully operational translational research laboratory including tissue processor, embedding station, microtome, cryostat, automated immunostainer, complete digital scanning system, image analysis software, and a semi-automated tissue micro-arrayer. The Core is also able to provide DNA / RNA extractions from all tissue types as well as blood samples and has the capabilities to routinely isolate circulating tumor cells, cell-free DNA as well as serum / plasma.

PDFs provided on the Cores website instruct and guide users on "Human Tissue and Fluids Handling Risks and Safety Precautions", "Human Specimen Single User Agreement" and "Commercial Use Policy and Disclosure". The Core serves to educate investigators about the appropriate human subjects considerations when requests for human materials are made, thus assuring that all human biospecimen applications are in full compliance with HIPAA and IRB regulations.

Please visit the website or email Michael Donovan for more information

Last Update: June 17, 2016

Irradiator

The use of gamma irradiation to the whole body in animals (rodents) and/or cells has been a major research model for many years. The Mount Sinai Medical center hosts two Shepard, Cesium source irradiators in support of this research. Due to regulatory and Homeland Security concerns the two irradiators were brought under the CORE program. As a result a dedicated technician has been hired and trained to oversee the equipment but more importantly to assist researchers with their studies. Rather than training new post-docs and students on the use of the machine(s), the technician performs all exposures. The result has been greater consistency and reduced down time for the machines. These machines are housed within the central vivarium due to the proximity of the animals used in the various studies. A separate entrance has been designed such that non animal users are not required to enter the main animal barriers.

Please visit the website or email Kevin Kelly for more information.

Last Update: June 10, 2016

Microscopy

The Microscopy CORE offers access to high-end instrumentation for light and electron microscopy and to computer workstations for image processing, image deconvolution, and image analysis. CORE staff scientists provide expertise, hands on training, and free consultation services in support of studies using fixed and living preparations. Staff scientists can also be engaged to carry out broader experimental initiatives. Instrumentation includes three conventional laser scanning confocal microscopes (Zeiss LSM780 and two Leica TCS SP5 microscopes) and a confocal microscope that can also be used to acquire super-resolution images (Zeiss LSM 880 with Airyscan); one Yokogawa CSU-XI spinning disk microscope; an Olympus FV1000 MPE multiphoton microscope; five widefield systems specialized for tiled acquisition, structured illumination, time lapse imaging, and polarized light imaging (two Zeiss AxioImagers.Z2 with ApoTome2; one Leica DM6000; one Olympus IX70, one Zeiss Axioplan2); one stereomicroscope equipped for brightfield and fluorescence acquisition (Olympus MVX10). Automated long term, multi-field time lapse recording of living cells can be accomplished on several systems equipped with motorized stages, autofocus, filters, shutters, fluorescence and brightfield optics, and stage-top incubators. An anesthesia delivery system is provided for intravital imaging. Software available for deconvolution, 3D rendering, and multiple modes of image analysis includes AutoQuant X3, Amira, Volocity, and MetaMorph. All instruments and workstations are accessible to trained users 24/7.

Please visit our website for more information.

Last Update: October 7, 2015

Mouse Genetics and Gene Targeting

The institutional Mouse Genetics and Gene Targeting (MGGT) CORE has been established to provide the Mount Sinai research community with access to state-of-the-art facilities for the production of transgenic and gene targeted mice, as well as related rodent embryology techniques, on a fee-for-service basis. The MGGT CORE can produce transgenic mice by injection of DNA fragments of varying length (including bacterial artificial chromosomes) into pronuclear stage single-cell mouse embryos. The facility uses CRISPR technology to do genome editing in vivo to create various gene-targeted mouse models, such as knock-outs or knock-ins. The facility can also assist laboratories with the production of targeted mutant lines of mice through the use of mouse embryonic stem (ES) cells. Targeted clones are used to create novel lines of mice by injection of ES cells into blastocysts to create chimeric mice which are mated with wild-type mice to establish germline transmission of the targeted gene.

In addition to the creation of novel transgenic and targeted mutation lines, the MGGT CORE can assist laboratories with the maintenance of existing lines through the cryopreservation of sperm. Cryopreservation of mouse sperm allows investigators to successfully bank lines that are not in active use. Shipment of cryopreserved sperm can also serve as an alternative method for transferring lines to collaborators at other institutions. Through collaboration with the Center for Comparative Medicine and Surgery (CCMS), the MGGT CORE also provides investigators with the means to import novel lines from other institutions by recovering mice from cryopreserved embryos or sperm, live embryos, or through the use of IVF rederivation of individual males that are shipped to Mount Sinai. This service is an excellent alternative to the importation of rodents via live animal quarantine. The staff of the MGGT CORE is also available to assist investigators with other rodent surgical techniques, such as vasectomies, ovariectomies, ovary transplants, etc.

Please visit the website or email Kevin Kelly for more information

Last Update: June 10, 2016

Quantitative PCR

qPCR Shared Resource Facility (Venugopalan Nair, Ph.D. Director) This state-of-the-art facility provides access to instrumentation and technical expertise for high throughput real-time PCR, droplet digital PCR, Nanostring nCounter assays, robotic pipetting, automated RNA/DNA extractions, and various analysis software tools. The facility also offers custom services and bioinformatics support for real-time PCR and digital nCounter mRNA quantification in small- to large-scale experiments. In addition, the facility has expanded into the area of PCR-based diagnostic assays resulting in significant institutional cost savings and improved detection of pathogens (pinworm and helicobacter).

Please visit the website or email Reginal Miller for more information.

Last Update: October 8, 2015

 

The Icahn School of Medicine at Mount Sinai (ISMMS) ranks 14th among the nation's 130 medical schools in receipt of research support from NIH and administers more than 600 NIH grants awarded to over 350 Principal Investigators. ISMMS has the fastest-growing medical school research program in New York. The National Institutes of Health (NIH) funding to ISMMS totaled $267.3 million in Fiscal Year 2015, an increase of 8.2 percent from the previous year and 57.2 percent since 2005.

Visit the Research page or contact Jessica Moise for more information.

Last Update: October 15, 2015

As of February 5, 2007, the National Institutes of Health (NIH) began to allow grant applications with multiple PIs on grant mechanisms utilizing the SF 424 submission packet. NIH’s web-page devoted to this policy may be accessed here. The Agency for Healthcare Research and Quality (AHRQ) accepted this policy effective with new applications submitted on or after October 1, 2016 NOT-HS-16-018

Program Highlights

  1. Multiple PIs are all primary PIs – NIH/AHRQ  has never formally recognized a Co-Principal Investigator designation, and this policy will continue. Never use the term Co-Principal Investigator on a NIH/AHRQ  grant.
  2. A substantial level of effort in itself does not qualify an investigator for PI status.
  3. The PIs must share responsibility for the scientific and technical direction of the project as a whole and will remain accountable to the grantee organization and to the NIH/AHRQ  for the proper conduct of the project or activity.
  4. Inclusion of a “weak” or inappropriate PI will reflect negatively on both the “Approach” and “Investigators” review criteria and make the grant less competitive/less likely to be funded.
  5. NIH/AHRQ  is not requesting separate budgets for each MPI at this time.
  6. You must designate a contact PI at the institution receiving the award. In other words, if the grant will be awarded to Mount Sinai, the contact PI must be from Mount Sinai. The contact PI is the person who will be allowed to speak to individuals at NIH/AHRQ  regarding the grant. No other privileges are conferred.
  7. A leadership plan is required of all grants proposing multiple PIs. This plan will be scored. ISMMS has developed guidance and standard required language to include in the leadership plan of your application. Please see below.
  8. NIH/AHRQ  and Institutional prior approvals will require all PIs’ signatures.

InfoEd Requirements

  1. Only the Contact PI completes the “Finalize” tab of the InfoEd application. The other PIs do not.
  2. If there are other PIs at Mount Sinai, they will be prompted to sign off on additional required PI certification language before the InfoEd application is routed to the department(s).

Common Errors

NIH piloted the program over the Fall of 2007 on a limited number of RFAs. The most common errors that they found were:

  1. In some cases, applications described projects that included PIs that did not have an identified function within the leadership team based on their expertise and the nature of the project.
  2. In some cases applications identified PIs who seemed too junior to function in a leadership role and in other cases it appeared that senior PIs were included in what might be a considered a “courtesy role”.
  3. In other cases, it appeared that the leadership team had been expanded only to justify additional salary support for involved personnel.

Please use the multiple PI option judiciously and contact the GCO if you have additional questions or concerns.

Last Update: December 29, 2016

The Grants and Contracts Office (GCO) boilerplate language for the human subject and vertebrate animal sections of the training program plan in competitive NIH training grants is intended for applications where: 1) research involving human subjects and or animals is solely part of other research projects and 2) no portion of the training grant award will be used to support the research.

Please review the excerpt from NIH’s Training Grant Instructions (T.420 10. Human Subjects / 12. Vertebrate Animals) below and use GCO’s suggested language if applicable.

Human Subjects

NIH Instructions:
If trainee participation in research involving human subjects is solely as part of other research projects and no portion of the Training Grant Award will be used to support this research, describe how the institution will ensure that trainees only participate in (a) exempt human subjects research or (b) non-exempt human subjects research that has IRB approval.

GCO Suggested Language:
Trainees that participate in research involving human subjects do so as part of other approved research projects. No portion of the training grant award will be used to support human subject research. Any activity involving nonexempt human subject research cannot commence without Institutional Review Boards (IRB) approval and exempt activities can only commence after a determination of exemption has been made by the IRB. Mount Sinai’s Program for the Protection of Human Subjects (PPHS), comprised of five IRBs, assures the ethical conduct of research and compliance with federal, state and institutional regulations. The PPHS’ accreditation by the Association for Accreditation of Human Research Protection Programs is an affirmation of the overall excellence of Mount Sinai’s human research protection program and demonstrates its pursuit of the highest ethical practices and principles.

Vertebrate Animals

NIH Instructions:
Describe how the institution will ensure that trainees only participate in IACUC approved vertebrate animal research when: the training program uses live vertebrate animals only as part of other research project grants, and the Training Grant Award does not support the purchase, use, or husbandry of live vertebrate animals for this research.

GCO Suggested Language:
Trainees that participate in research involving the use of live vertebrate animals do so as part of other research projects. No portion of the training grant award will be used to support the vertebrate animal research. Any activity involving of the use of live vertebrate animals in biomedical research, training, or teaching cannot commence without IACUC approval. The mandate of the IACUC is to ensure that all activities involving the use of vertebrate animals are conducted ethically, humanely and in accordance with federal regulations and the guidelines contained in the Animal Welfare Act Regulations, Public Health Service Policy and the National Research Council Guide for the Care and Use of Laboratory Animals Guide.

Last Update: December 29, 2016

In an effort to better prepare graduate students and postdocs in the biomedical research workplace, the NIH is encouraging institutions and mentors to use Individual Development Plans (IDPs) to assist graduate students and postdoctoral researchers in identifying and achieving their career goals.

Effective October 1, 2014, all annual progress reports must include a section describing whether grantees use IDPs for graduate students and postdoctoral researchers associated with the research award. See NIH Notice NOT-OD-14-113 for additional information.

For those projects in which there are no participating graduate students or post docs, IDPs do not need to include any extra information in the annual progress report.

For those projects in which there are graduate students or post docs working at least 1 calendar month in the current budget period, regardless of whether that person is compensated from the grant, please follow the instructions below. Do not include the actual IDP. The NIH is interested in obtaining information regarding the implementation of the IDP rather than the specifics of the actual plan.

NIH Progress Report Instructions for the Research Performance Progress Report (RPPR)

  1. In Section D. Participants, include the name, role, Commons ID, and calendar months effort of the graduate student(s) and post doc(s)
  2. In Section B. Accomplishments, Question B. 4, include a brief description of how IDPs are used to help manage their career development. Please use the suggested language below.

Suggested Language for NIH IDP Information Requirement (RPPR Section B.4)

Grants with Graduate Students (PhDs)
“IDPs are mandatory for all graduate students (PhDs). All second and fourth year students are expected to fill out an IDP as a prelude to discussing their career plans in a formal graduate school setting as well as with their advisor.”

Grants with Post-Doctoral Researchers
“IDPs are mandatory for all postdoctoral researchers. The post doc completes an IDP as part of the yearly evaluation with his/her mentor. When the postdoctoral researcher is at the end of his/her fourth year, the IDP includes explicit information regarding the next career phase after the fellowship ends in the fifth year.”

Last Update: December 29, 2016