Fundamentals of Research

Resources

Dean’s Office Announcements

Controlled Substance Policy (1/8/2024)

Any PI who needs a controlled substance of any schedule for use in animals, cells, or in vitro must either get his/her own license or collaborate with another PI who has such a license and is willing to oversee use of the drug for the new purpose (and that new purpose is consistent with the PI’s stated uses of such drugs).

Process for Ordering Pharmaceutical Agents for Basic Science Research (12/18/2023)

Effective January 1, 2024 there is a new process for ordering pharmaceutical agents for basic sciences research that were previously ordered directly from the Pharmacy Department. If you are ordering these agents through another vendor there is no requirement to change. This process will ensure that the Pharmacy Department is compliant with the conditions of its license and brings basic science research in line with the process currently followed in other areas of the School.

Teams that currently order pharmaceutical agents from the Pharmacy should initiate the following process as soon as possible to ensure that they are ready for this change:

Set up a blanket PO with AmerisourceBergen through Sinai Central.
Forward your approved PO to Anthony Curraro at Anthony.Curraro@mountsinai.org. Anthony will provide you with an application to set up an account with AmerisourceBergen.
After the account is set up take an on-line tutorial and then get access to the vendor’s on-line ordering portal.

Labs will place their orders directly through the portal. Products will be delivered directly to your location, and invoices will be charged against your standing PO.

Please reach out to Rachel Posner at Rachel.Posner@mssm.edu with any questions.

New Huron eDisclosure Management System (2/21/2023)

Dear Faculty:

Please see essential information below about transitioning financial disclosures and conflict of interest from Sinai Central to a new eDisclosure Management System (eDMS). This is important for anyone who is planning on submitting a grant application.

In particular, please be aware of grant deadlines around the transition date. Your PhD students and postdocs who are submitting an NRSA training grant for the April 8 deadline should be sure to complete their forms in the old Sinai Central system well before the grant deadline: all of this work should be completed by March 31. Your Department Administrators should be available to help you.

Please contact us with questions or concerns.

Eric eric.nestler@mssm.edu

Dear Chairs/Directors:

This is an extremely important email. On Monday April 10, 2023, a new Huron eDisclosure Management System (eDMS) will replace our current Sinai Central system for managing financial disclosures and conflicts of interests.

Grant submissions are currently initiated by the creation of a new Investigator Form (IF) in Sinai Central. Investigators are then required to update their Annual Report of Outside Relationships Form and complete the project-specific Financial Conflicts of Interest in Research Form (FCOIR). Both of these also occur now in the Sinai Central system.

To ensure a successful data migration and turnover process, we must implement hard deadlines for submitting and completing Investigator Forms (IF), Financial Conflicts of Interest in Research Forms (FCOIR), and edits to the Annual Report of Outside Relationships Form (Annual Form), while transitioning from Sinai Central to eDMS.

Faculty members, postdoctoral fellows, and students who are considering April grant/project submissions must plan ahead and prepare for our transition to eDMS:

March 31 @ 11:59 pm: All new Investigator Forms (IFs) need to be submitted in Sinai Central by end of day on March 31. No new IFs can be created in Sinai Central after this date.
April 1 – April 4 @ 5pm: Complete any edits to existing IFs, complete all FCOIR forms, and any edits to Annual Disclosures.
After April 4 @ 5pm: Sinai Central will be closed for all IF edits, FCOIR, and Annual Disclosures. No changes can be made after this point. Any FCOIR forms that have not been completed by this time will need to be restarted in eDMS.
April 10 – all new IFs will be created in eDMS. Investigators will have access to read only versions of old information in Sinai Central for reference purposes.

We are aware that April 1^st is a deadline for NIH continuations (RPPRs) and April 8^th is the NIH National Research Service Award (NRSA) Fellowship deadline, so it is imperative that our research community submit and complete IFs and FCOIR forms as early as possible and adhere to the above deadlines in order to avoid delays.

We are offering training sessions to help users learn to navigate this new software. Please sign up for eDMS training via this link. Trainings are divided into general and research populations.

Annual Disclosure – eDMS Training: Covers the steps required to take for the annual requirement to disclose outside relationships. Open to Non-Faculty & Staff, Faculty and Research personnel. This process will launch on April 10 and we encourage everyone to initiate their annual disclosures right away to be ready for future grant applications.

Research Disclosure – eDMS Training: Covers the steps to take when initiating a new research project and then completing a project-specific financial disclosure within eDMS. Target Audience: Research personnel (faculty, trainees, and staff).

Please keep an eye out for regular announcements on the progress of the rollout of eDMS, including additional training offerings and important dates. And most importantly please make sure that all of your faculty, postdocs, and students are aware of these hard deadlines and plan ahead to avoid any delays in their grant submissions. Questions about eDMS can be addressed to Rhoda Sperling Rhoda.Sperling@mssm.edu and Ashish Narayan ashish.narayan@mssm.edu.

Eric

Other Support: Overlap Guidance Clarification and Reminder (1/24/2023)

Dear Research Faculty,

We want to issue this reminder about addressing overlap in your competitive grant application and issue one clarification.

Re: this initial statement in the communication below, “Submitting grants with overlap to different governmental agencies (DoD, NIH, CDC NSF, etc.) is allowed,” there is an exception.

The Biological Sciences Directorate at the NSF does not allow for overlap.

Excerpt from NSF’s Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 23-1)
2. Beginning Investigators (applies to proposals submitted to the Biological Sciences Directorate only)

Research proposals to the Biological Sciences Directorate ONLY (not proposals for conferences) cannot be duplicates of proposals to any other Federal agency for simultaneous consideration. The only exceptions to this rule are: (1) when the Program Officers at the relevant Federal agencies have previously agreed to joint review and possible joint funding of the proposal; or (2) proposals for PIs who are beginning investigators (individuals who have not been a PI or co-PI on a Federally funded award with the exception of doctoral dissertation, postdoctoral fellowship or research planning grants). For proposers who qualify under this latter exception, the box for “Beginning Investigator” must be checked on the Cover Sheet.

See the original communication below – NIH Grants Policy on Overlap of Research Grant Applications – (06/01/2021)
Refer to this communication for additional information – Informing the NIH When Applying to Multiple Funding Agencies

Human Subject Research Protocol Deviations During the NYSNA Strike (1/20/2023)

With the NYSNA contract now ratified at hospitals within the Mount Sinai Health System, the PPHS would like to remind the research community that any protocol deviations that occurred during the labor action must be submitted to the PPHS via RUTH as a Reportable New Information (RNI) submission. Unimpactful deviations can be batched together and submitted per study. If the deviations had an impact on safety or materially affected the study design, those should be reported individually.

Adverse events should be reported as usual.

Please contact us by email (IRB@mssm.edu) or phone 212-824-8200 as needed.

Added Guidance Re: Human Subjects Research Related to the NYSNA Strike (1/09/2023)

TO: All Faculty, Staff, and Students

FROM:Rosalind J. Wright, MD MPHDean for Translational Biomedical SciencesIcahn School of Medicine at Mount Sinai

Judith A. Aberg, MDDean, System Operations for Clinical SciencesSystem Chief, Medicine Infectious DiseasesIcahn School of Medicine at Mount Sinai

DATE: January 9, 2023

Please note that you are required to notify sponsors if this labor action impacts your clinical research activities.

Possible disruptions include lack of staffing for enrollments, follow up visits, medication administration and phlebotomy.

We have also learned that some carriers will not be delivering or picking up specimens. Please check with your vendor for available services during the strike.

Please also note that the NIH policy on delegation logs is that end dates do not need to be completed for short term absences however please check with your sponsor on their individual policies.

Should you have any additional questions, please do not hesitate to contact ORS via Research 411.

Update on On-site Monitoring for Clinical Trials (10/04/2022)

TO: All Faculty, Staff, and Students

FROM:

Rosalind J. Wright, MD MPHDean for Translational Biomedical SciencesIcahn School of Medicine at Mount Sinai

Judith A. Aberg, MDDean, System Operations for Clinical SciencesSystem Chief, Medicine Infectious DiseasesIcahn School of Medicine at Mount Sinai

DATE: October 4, 2022

Monitoring for Clinical Trials

Effective October 4, 2022, more than one monitor may be on the premises as space allows.
Monitors will not be required to show proof of vaccination or a negative test. However, they still have to wear masks and New York State requires us to keep doing symptom check for patients and visitors at the entrances to our facilities.
Please continue to contact pharmacy at least 2 weeks in advance to schedule visits.

If you have any further questions, you can also reach out to Rosalind Wright, MD MPH at rosalind.wright@msssm.edu.

NIH Grants Policy on Overlap of Research Grant Applications - (06/01/2021)

Eric Nestler, MD PhD
Director, Friedman Brain Institute
Dean for Academic and Scientific Affairs

Reginald Miller, DVM, DACLAM
Senior Research Integrity Officer, MSHS
Dean for Research Operations & Infrastructure

Jessica Moise
Grants and Contracts Officer
Senior Associate Dean for Sponsored Programs

Hello All,

We are writing to remind you of the NIH Grants Policy on Overlap of research grant applications. Please note the guidance below:

Submitting grants with overlap to different governmental agencies (DoD, NIH, NSF, etc) is
- If funding proceeds, overlap must be addressed during the negotiation process.
- Prior to submitting materials under the Just-In-Time (JIT) link procedures, it is essential to be sure that all concerns of overlap have been resolved. In addition, if you believe that no overlap exists, but that some portion of the text, such as a similar title or aim, might lead the reviewer to believe that there is overlap, clearly explain why none exists. (e.g., “While it might appear that…., in fact….”)
With very limited exceptions, submitting overlapping grants to multiple NIH entities (NCI, NIMH, NINDS, etc) is prohibited and a violation of the NIH Grants Policy Compliance.
- NIH entities routinely screen grants for overlap (e.g., Specific Aims) and inform the PI and institution when concerns of overlap arise. Such grants will not progress to review until overlap concerns are resolved.
- Individuals submitting grants with overlap and failing to acknowledge such during the submission process (InfoEd submission) are subject to sanctions by NIH for Failure to Disclose.
- It is therefore imperative to NOT submit grants with any overlap to NIH without very clearly specifying areas of overlap upon submission.

To help you better understand what NIH is looking for to determine overlap, please see the following guidance from an NIH Program Officer on the NIH Policy on Similar, Identical, or Essentially Identical Applications, NOT-OD-18-197.

If you have any questions, please be sure to contact Jessica Moise and her team in our Grants and Contracts Office. We are here to help you navigate these matters.

Below is the NIH instructions the Division of Receipt and Referral staff for determining overlap:

What Do We Look for?
“Significant and substantial change in content and scope” is what we consider when we determine if one application is indeed new or overlaps with another application currently under review or submitted for the same or overlapping review round.
When we compare applications, we examine all parts, particularly the Specific Aims and Research Strategy sections.
Examples of Changes that Could be Substantial

Using significantly different model systems
Changing the disease model
Using a similar methodological approach for a substantially different question
Asking a significantly different question
Using a very different methodological approach to address a similar issue

Examples of Changes that Are Not Substantial

Rewording large sections of the application while retaining the scientific goals and objectives
Making changes to sections such as the Significance or Innovation but not changing the intent of the application
Adding one or more new collaborator(s)
Including additional preliminary data
Making substantial additions to the pre-existing Approach when the majority of the old design persists in the “new” application
Requesting assignment to a different NIH Institute/Center or review by a different Scientific Review Group
Submitting the application to a different program announcement (PA, PAS or PAR)

Please contact the Grants Management Office at NIH if you have any questions or need assistance.

New Focus for the Icahn Genomics Institute - Announcement of Brian Brown, PhD as Interim Institute Director (04/14/2021)

To: Faculty, Postdocs, and Students

From:

Eric Nestler, MD, PhD
Dean for Academic and Scientific Affairs

Dennis Charney, MD
Anne and Joel Ehrenkranz Dean
Icahn School of Medicine at Mount Sinai

Date: April 14, 2021

Re: New Focus for the Icahn Genomics Institute – Announcement of Brian Brown, PhD as Interim Institute Director

We are very pleased to announce the refocusing of the Icahn Genomics Institute at the Icahn School of Medicine at Mount Sinai. Moving forward the Institute will provide a formal nexus for Mount Sinai’s pioneering research and medical practice in gene and cell therapy and nucleic acid-based drugs.

The Icahn Institute has been an important multidisciplinary hub at Mount Sinai for a decade, and has been reimagined twice in order to optimize its value to our research programs. Originally focusing on genomics and multiscale biology, over time the emphasis shifted to data science and genomic technology. Now, to take advantage of emerging opportunities and capabilities, the new focus on gene and cell therapy will position the School for breakthrough discoveries in this field.

Since the 1990s Mount Sinai researchers have been advancing the science of gene and cell treatments, including for inherited genetic disorders, cancer, and heart disease. We have also been at the forefront of utilizing gene therapy in the clinic, particularly for hematological malignancies, where we have been leaders in using gene-engineered T cells, encoding chimeric antigen receptors (CAR), to treat our patients with multiple myeloma, lymphoma or leukemia.

The Icahn Genomics Institute will bring together experts from a range of disciplines and scientific focuses, including gene and cell engineering, RNA therapeutics, viral vectors and oncolytics, microbiotics, and regenerative medicine, with the goal of improved treatments for cancer, infectious disease, inherited genetic disorders, neurodegeneration, heart disease and other conditions. We are currently leading a search for a Director for the Institute. In the interim, the Institute will be led by Brian Brown, PhD, Professor of Genetics and Genomic Sciences and Associate Director of the Precision Immunology Institute (PrIISM). Dr. Brown is a leader in the field of gene therapy whose laboratory invented new ways to target vectors and viruses to particular cell types and tissues that are now being evaluated in the clinic for cancer treatments.

The past decade has seen a revolution and realization of gene-, cell- and nucleic acid-based therapies that includes highly effective treatments for many different diseases, the development of CRISPR gene editing tools and new methods of vaccination based on mRNA and adenoviral vectors that are helping to end the global COVID-19 pandemic. Mount Sinai and the Icahn Genomics Institute will further lead this important new area of medicine into the future and bring better treatments to our patients.

We encourage you to contact Dr. Brown to discuss opportunities for collaborating with the Institute’s exciting new focus.

eSafety - New Biosafety Platform (04/12/2021)

To: Faculty, Staff, Postdocs, and Students

From:

Eric J Nestler, MD PhD
Institutional Official (IO)
Dean, Academic and Scientific Affairs
Director, The Friedman Brain Institute

Reginald W Miller, DVM DACLAM
Dean for Research Operations and Infrastructure
Senior Research Integrity Officer

Viviana Simon, MD PhD
Chair, Institutional Biosafety Committee
Professor, Department of Microbiology

Ashish Narayan, MS MBA
Associate Dean, Research Administration IT, Academic, and Research Informatics

Randy A Albrecht, PhD
Director, Institutional Biosafety Program
Responsible Official, Select Agents and Toxins Program
Director, Emerging Pathogens Facility
Associate Professor, Department of Microbiology

Date: Monday, April 12, 2021

Re: Implementation of eSafety, a biosafety protocol management application

Dear Faculty, Staff, Postdocs, and Students,

We are excited to announce that the Icahn School of Medicine at Mount Sinai is implementing an online biosafety protocol management application on Friday, May 7, 2021. In line with the successful implementation of eIACUC (research animal protocol management application) and RUTH Portal (IRB system), eSafety, the new biosafety protocol management portal is part of the multi-phased plan to enhance and consolidate research operations and administration.

Like eIACUC and RUTH Portal, eSafety is a regulatory compliant and streamlined system provided by Huron Research Enterprise Suite and will provide a similarly simplified biosafety application form and a refined workflow. Key features of eSafety are:

Cloud-based and Single Sign-On
Smart-forms
System rapidity and stability
Protocol copy function for easy duplication of protocols
Integration with eIACUC to link research animal protocols requiring biosafety review
Training and certifications imported directly from external sites (e.g., CITI Program)
Tools to compare different versions of protocol

Training materials are being developed and will include weekly Zoom training sessions (beginning April 21, 2021) and training videos that will be available on Research Administration Portal (eRA) as well as IBC and the Institutional Biosafety Program websites. Zoom training session schedule will be available shortly to register at eRA.

Thank you very much for your support of the crucial school initiative. Please reach out to Jermaine Foskey (jermaine.foskey@mssm.edu), Business Analyst, Research Administration IT with questions regarding eSafety or to Shekhar Patil (shekhar.patil@mssm.edu), PhD, Administrative Director, CoREs and Shared Resources with questions regarding biosafety protocol submission process.

Regards,
Eric, Reg, Viviana, Ashish, and Randy

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