COVID-19 Research Guidance for MSHS

We have developed a streamlined process for reviewing COVID-19 protocols that our Mount Sinai investigators are developing as Investigator-initiated trials (IITs) or through collaborations with sponsors or other institutions. A centralized review by the COVID-19 Protocol Review Committee will serve as a mechanism for ensuring that the protocol’s scientific aims align with our overall institutional goals, there are adequate resources to support the trial and that there will be internal oversight of the conduct of the trial.

Learn More

To submit information about planned and ongoing projects related to the COVID-19 pandemic visit:
https://redcap.mountsinai.org/redcap/surveys/?s=T4CCLYNL39

A self-reported list of COVID-related projects is available at:
https://msdw.mountsinai.org

Information on ongoing projects approved by IRB is available at the following site:
http://digitalcommons.us/index

The New York metropolitan region has made great strides in managing the COVID pandemic, to the point where the city should begin reopening from June 8th.  Starting May 18^th, we initiated Phase 1 for restarting essential face-to-face research visits for projects that have a possibility of direct benefit to participants. We commend the research community for your adherence to the guidelines set forth for that first step to ensure a successful reopening thus far.  Building upon that and with the upcoming New York State and New York City relaxation in restrictions, in Phase II which will begin June 8^th, we will also begin allowing the resumption of face-to-face research that does not hold out the prospect of direct benefit to participants.

It is the intention of the ISMMS to expand clinical research activities in a safe manner that does not needlessly endanger subjects, staff, or clinical care at the hospitals and clinics. There is a fundamental principle in research oversight that requires research to be conducted in a manner that minimizes risks to subjects, consistent with sound research design. Importantly, this is not a return to pre-COVID normality and our success will again depend upon our research community adhering to the following guidance.

To that end:

• All subjects coming on campus or a Sinai office site must follow current COVID protections concerning pre-visit screening, temperature checks, wearing masks, etc.
  • It is the responsibility of the research team to reach out to participants within 24 hours of scheduled face to face visit(s) to conduct pre-visit screening for COVID-related symptoms and reiterating visitor policy.
  • All hospital, departmental and clinic rules regarding COVID-19 prevention must be adhered to once research subjects arrive on campus, including but not limited to pre-visit screening at an established ambulatory practice area, the Health System’s Visitor Policy, lab testing, etc.
• All subjects should be made aware of the risks involved with traveling to the medical center and being seen face-to-face.
• Efforts should be made to minimize the face-to-face exposure, both the duration and number of episodes. This means that activities that can be done remotely should be done remotely. This may include all or part of the informed consent process, completion of questionnaires, and rating scales etc. Activities that are tied to clinical visits should also be adopted to minimize time and disruption to clinic operations.
• Subjects that are at increased risk of COVID morbidities, e.g. age, obesity, diabetes, heart disease, etc. should be identified and the research procedures should be modified or postponed to minimize risks.
• Scheduling has to be tightly coordinated to location and should reflect added time to clean rooms, get through screening, etc.
• All research visits must be scheduled in such as a way as to minimize waiting and crowding in order to maintain social distancing and minimize the impact on clinical activities if that applies. These should be coordinated at the local level.
•  All recruitment activities taking place in clinic waiting areas or clinic office space are considered suspended. Activities may be allowed only with approval of the PPHS and will require appropriate assurances that the activities are consistent with current hospital rules and have the permission of the clinic.
• Procedures that generate aerosols are not approved at this time (e.g., spirometry, sputum induction).

Implementation:

• All projects need to obtain departmental approval before resuming face-to-face visits with subjects.
• All projects planning to reinitiate face to face encounters must complete a short online form found here: PPHS Not-for-Benefit Research Ramp up Form
• As the form will make clear, if you can attest to departmental approval, that the basic steps outlined in the above guidance have been taken to minimize risks, and that higher risk subjects are not involved in the research, then increased on-site activities may begin upon completion of the form.
• As the form will make clear, for other projects where special precautions have to be considered to protect subjects at increased risk for complicated and fatal COVID outcomes, more formal patient notification will be required and a specific mitigation strategy has to be reviewed by the PPHS. You MAY NOT begin on-site activities until receiving notification from the PPHS. The PPHS will endeavor to review these within 2 working days of submission.

If you have any further questions, comments or suggestions please contact the IRB at IRB@mssm.edu or Lori.Jennex@mssm.edu. You can also reach out to Rosalind Wright, MD MPH at rosalind.wright@msssm.edu.

The purpose of this update is to explain the process for resuming onsite clinical research activities with the Mount Sinai Health System consistent with the May 13^th Town Hall and the May 14^th memo. This pertains to potentially “for-benefit” studies only, as they are the only face-to-face projects eligible at this time.  As detailed in our earlier notice, departmental review and approval is required for all projects. That process will be handled at the departmental level.

As detailed previously:

• Special protections have to be considered for those studies that involve subjects at increased risk for complicated and fatal COVID outcomes. PPHS polices and Federal regulations mandate that investigators minimize risks to subjects consistent with sound research design. Telemedicine, remote monitoring, home infusions should still be utilized in most situations to minimize risks.BEFORE on-site activities resume, the PPHS must receive the plan for these subjects. This plan has to include a risk: benefit analysis and may also require an information sheet for PPHS review that will be shared with research participants.

Implementation:

All projects need to obtain departmental approval before resuming face-face visits with subjects.

All projects must complete a short online form found here: PPHS Phase I Clinical Ramp Up Form

As the form will make clear, if you can attest to departmental approval and that higher risk subjects are not involved in the research, then increased on-site activities may begin upon completion of the form.

As the form will make clear, for other projects where special precautions have to be considered to protect subjects at increased risk for complicated and fatal COVID outcomes, some form of patient notification will be required. You MAY NOT begin on-site activities until receiving notification from the PPHS. The PPHS will endeavor to review these within 2 working days of submission.

If you have any further questions, comments or suggestions please contact the IRB at IRB@mssm.edu or Lori.Jennex@mssm.edu

TO:        All Faculty, Staff, and Trainees

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

Rosalind J. Wright, MD
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

Glenn Martin, MD
Senior Associate Dean for Human Subjects Research
Icahn School of Medicine at Mount Sinai

DATE:    May 14, 2020

RE:         Ramping up on-site clinical research.

It is the intention of the ISMMS to expand clinical research activities in a safe manner that does not needlessly endanger subjects, staff, or clinical care at the hospitals and clinics. As mentioned at the Research Town Hall held earlier this week, activities will begin to ramp up beginning Monday May 18^th. As underscored in the Town Hall, this is a phased restart and for the initial weeks the following will govern. This policy impacts research at all Mount Sinai Health System sites that is approved by the ISMMS Program for the Protection of Human Subjects (PPHS)) as well as external IRBs.

ALL projects eligible to ramp up will need local and departmental approval before any changes can begin. Departments will need to coordinate and track these approvals. The PPHS will work with departments so we will not need to receive approval confirmation from each individual project. Certain projects will need to file a form with PPHS and await review and approval. Details will be provided in a separate communication that will distributed before the close of business Friday May 15^th.

For-benefit interventional trials that require face to face contacts are eligible to use on-campus resources. During this initial phase, which overlaps with the increase in clinical activities including ambulatory practices, departmental approval will be necessary so that resources, including waiting area space, line length, ability to navigate to ancillary departments, etc. are properly allocated. The expectation is that the most clinically impactful projects will be prioritized. The PPHS will reach out directly to the departments to coordinate. In addition:

• All hospital, departmental and ambulatory practice  rules regarding COVID-19 prevention must be adhered to, including but not limited to pre-visit screening at an established ambulatory practice area, the Health System’s Visitor Policy, lab testing, etc. Guidelines for Return to Practice.
• All recruitment activities taking place in ambulatory waiting areas or office space are considered suspended. Recruitment activities may be allowed only with approval of the PPHS, and will require appropriate assurances that the activities are consistent with current hospital rules and have the permission of the clinic.
• All clinical visits must be scheduled in such a way as to minimize waiting and crowding in order to maintain social distancing and minimize the impact on clinical activities. These should be coordinated at the local level.
• Special protections have to be considered for those studies that involve subjects at increased risk for complicated and fatal COVID outcomes. PPHS polices and federal regulations mandate that investigators minimize risks to subjects consistent with sound research design. Telemedicine, remote monitoring, home infusions should still be utilized in most situations to minimize risks.  BEFORE on-site activities resume the PPHS must receive the plan for these subjects. This plan has to include a risk: benefit analysis and may also require an information sheet for PPHS review that will be shared with research participants.
• For all studies, even those with subjects at no known increased risk of COVID, the use of Telemedicine, remote monitoring, home infusions, etc.  should still be utilized in many situations to minimize risks.

Biospecimen and registry trials:

• To the extent that activities take place at a clinical visit they should not occur unless there is minimal burden to clinical operations and infection control. For example, consenting should begin, and possibly be completed, before arrival. To minimize time spent in the clinic setting, questionnaires should be completed off-site.  Subjects should not be coming to the hospital/clinic outside of a clinical visit.
• All sample processing should follow institutional rules, including any SARS-CoV-2 modifications currently in place.

Other Not for Benefit projects are not included in this phase and are not authorized to use on-campus resources. Approved remote activities can continue.

External Monitoring Visits

On-site external monitoring visits continue to be suspended.

COVID-19 Public Health Emergency:

General Considerations for Pre-IND  Meeting Requests for COVID-19 Related Drugs and Biological Products

This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

COVID-19 General Considerations for Pre-IND Meeting Requests

This is an ARCHIVE of communication sent on 4/9/2020.

Visit the COVID-19 Protocol Review Process for Clinical Research page for details about submitting COVID-19 related protocols.

TO: All Faculty, Staff, and Students

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

Rosalind J. Wright, MD MPH
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

Judith A. Aberg, MD
Chief, Division of Infectious Diseases
Mount Sinai Health System

DATE: April 8, 2020

RE: COVID -19 Protocol Review Committee

As of today, we now require that all COVID-19 related studies are submitted for review through the process outlined below and represented in the attached flow chart –  Flow chart COVID-19 Trial Approval Process.

We have developed a streamlined process for reviewing COVID-19 protocols that our Mount Sinai investigators are developing as Investigator-initiated trials (IITs) or through collaborations with sponsors or other institutions. A centralized review by the COVID-19 Protocol Review Committee will serve as a mechanism for ensuring that the protocol’s scientific aims align with our overall institutional goals, there are adequate resources to support the trial and that there will be internal oversight of the conduct of the trial.

1. Email: COVID-19 Protocol Review Committee Administrator (email address: # COVID-19 Protocol Review).
2. Instructions will be emailed back with a short form for the PI to fill out and send back to the administrator.
3. The protocol and COVID-19 Protocol Review form will be sent to an assigned reviewer with relevant expertise from one of the established subcommittees; the turnaround is expected to be within 48 hours.
4. If the protocol is approved to proceed, then the PI will work with his/her respective group (i.e. CCTO, MCTO, etc) to move forward with other protocol development, including the budget development and contract negotiations.
5. Submit final protocol to the COVID Trials Oversight Committee and to the IRB.

**For trials including cancer patients, an additional pre-review by our Tisch Cancer Institute COVID-19 DFG must be done before sending the email to the institutional COVID-19 Protocol Review Committee. This will take the place of the standard DFG review.  PRMC review will also still be required but can be done in parallel with the final COVID Trials Oversight Committee sign off and IRB submission.

We will continue to work together to make this a very rapid process and avoid causing bottlenecks for our investigators to open important studies for our COVID-19 patients. If you have any questions please email # COVID-19 Protocol Review.

TO: All Faculty, Staff, and Students

FROM:

Eric Nestler, MD, PhD
Dean for Academic and Scientific Affairs
Icahn School of Medicine at Mount Sinai

Rosalind J. Wright, MD MPH
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

DATE: March 20, 2020

RE: COVID -19 Clinical Research Guidance – Further Update

Earlier today Governor Cuomo announced that all non-essential workers should stay home. Please note that those coming into Mount Sinai for research efforts that are continuing are considered essential. It is important that you always have your Mount Sinai badge with you so that you are allowed to enter.

COVID -19 Clinical Research Guidance
Clinical Research Guidance Update #2
Clinical Research Guidance Update #3
Clinical Research Guidance Update

TO:  All Faculty, Staff, and Students

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

Rosalind J. Wright, MD MPH
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

DATE:    March 20, 2020

RE:      COVID -19 Clinical Research Guidance Update #3

As has been stressed in previous clinical research guidance reports, it is paramount that we protect the health of patients and our workforce and preserve resources to address the pandemic, and, as such, Mount Sinai is standing down much of our human subjects research and modifying other existing protocols. At the same time, we want to protect the integrity of our research protocols, for which our patients have selflessly volunteered to participate in. In addition, as the pandemic continues to evolve, we will increasingly be prioritizing COVID-related research efforts across our health system.

We felt it would be helpful to summarize where we are and to offer further specific guidance as this dynamic situation continues to evolve:

• We are suspending in-person screening and enrollment visits in our clinical research studies, with the exception of studies evaluating interventions for COVID-19 or for other life-saving interventions. Please contact your IRB to ensure that your study falls in this category as previously advised.
• We are suspending in-person follow-up visits for all subjects unless discontinuing or deferring the protocol presents a clear and present harm to the study patient (see previous guidance).
• For patients already enrolled or randomized, please continue to collect protocol-specified data remotely via telephone or telehealth if possible. Data elements that can be collected remotely include medication adherence, quality of life and functional status instruments, hospitalizations, adverse events and complications. You can contact Yvette Hutson, Yvette.Hutson@mountsinai.org, in the Institute for Transformative Clinical Trials for consultation on methods for remote follow-up.
• Extension of protocol-defined data collection windows, where possible, will provide flexibility and will minimize data loss.  Obviously, late data is better than no data.
• Remote data collection and extension of data collection windows are strategies that can be implemented as modifications for previously approved research, as stated in 45 CFR 46.108 and 21 CFR 56.108 (to eliminate immediate hazards to human research subjects). Below, we provide some language that investigators may want to use to notify the IRB.

We anticipate that data collection on the (….) trial will occur via telephone, or, when the data collected are required to be collected in-person, out of the protocol-defined study visit window.  The study sponsor is aware of this change in practice and encourages us to capture data in a manner that would best protect our participants’ health.  We will record the details of each out of window visit and provide a summary to you at the time of our next continuing review request. The original protocol-defined study visit windows will be reinstated once our local guidelines allow for the resumption of on-site clinical research assessments.

Clinical Research Guidance Update
Clinical Research Guidance Update #2
COVID -19 Clinical Research Guidance

To: All Faculty, Staff, and Students

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

Rosalind J. Wright, MD MPH
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

Date: March 17th, 2020

RE: COVID -19 Clinical Research Guidance Update #2

As the COVID-19 pandemic continues to evolve, the impact on New York Metropolitan area will only intensify. In addition to free movement being sharply curtailed, the area’s health systems brace for equipment, supply, room and personnel shortages. It is imperative that the Mount Sinai Health System and the Icahn School of Medicine at Mount Sinai preserve its resources and maintain the health of its workforce. We also have an ethical and legal obligation towards those subjects enrolled in research studies; we must minimize the subjects’ risks. This reality is driving the need to stand down many of our current human subject research projects at ISMMS and modify many of the others.

We want to be clear that continuing visits should occur only if discontinuing or deferring the protocol presents a clear and present harm to the study patient.   If you plan to continue any such visits, you must discuss this with the PPHS ASAP, before visits can continue. Failure to defer or modify a protocol consistent with this policy will be considered non-compliance by the PPHS, and may be a reportable event to outside agencies, funders etc.

Once you have been approved to continue by PPHS you will be instructed to notify the IRB office via email that you will be submitting a protocol amendment in context of the COVID pandemic in the next 72 hours and then submit a modification within the next 2 weeks.

Clinical Research Guidance Update
COVID -19 Clinical Research Guidance

To: All Faculty, Staff, and Students

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

Rosalind J. Wright, MD MPH
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

Date: March 16th, 2020

RE: COVID -19 Clinical Research Guidance Update

As the COVID-19 pandemic continues to evolve rapidly we are providing updated guidance on the clinical research policy across the MSHS.  Our priority is the safety of our research subjects and study staff as well as our broader community.  Only essential face to face visits should occur, where the benefits to subjects outweigh these expanded risks. Researchers should not recruit subjects to come to clinical research sites solely for the purpose of clinical research follow-up visits as this constitutes unnecessary exposure issues.  This includes subjects involved in ongoing multi-visit protocols – unless postponing follow-up constitutes a safety issue to the subject, every attempt should be made to re-schedule these visits.  If the PI determines that a subject needs to be seen you must follow the institutional guidelines for screening for coronavirus, which have been previously circulated and can be found here on the MSHS intranet, prior to seeing these participants.  To the extent possible, researchers and research staff should work from home and identify remote means of continuing productivity and subject follow-up via Zoom meetings, phone interviews, electronic survey tools, etc.

We will continue to update you as the situation evolves.  Please feel free to contact Dr. Rosalind Wright at rosalind.wright@mssm.edu if you have any questions or concerns.

COVID -19 Clinical Research Guidance

To: All Faculty, Staff, and Students

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

Eric Nestler, MD, PhD
Dean for Academic and Scientific Affairs
Icahn School of Medicine at Mount Sinai

Rosalind J. Wright, MD MPH
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

Date: March 10th, 2020

RE: COVID -19 Clinical Research Guidance

Given the evolving nature the COVID-19 outbreak we wanted to reach out to the research community with guidance regarding clinical research at the MSHS.

First, we want clinical research to continue to the maximal extent possible during this evolving crisis.

In the abundance of caution, effective immediately, we urge research teams to increase use of remote monitoring/follow up (i.e., telephone, Zoom, Skype, etc) in order to reduce non-essential in-person study visits at the health system when possible.  While we urge researchers to consider appropriate modifications to their protocols to limit face-to-face visits, we want to ensure that our research program continues.

Research studies having circumstances where this cannot be fully implemented will be assessed on a case-by-case basis to develop an acceptable contingency strategy. If your research protocol includes aerosolizing procedures (e.g., spirometry, nasal/oral swabs or brushings, induced sputum, etc.), you should seek further guidance by emailing: rosalind.wright@mssm.edu.

In situations where face-to-face contact may be necessary, research staff should follow institutional guidelines related to COVID-19.  In order to ensure the safety of our patients and our staff we strongly urge everyone to call study participants ahead of their visits to screen for potential respiratory symptoms and travel.   You can find the MSHS COVID-19 Screening Algorithm, as well as other useful information, here: http://intranet1.mountsinai.org/inf_ctrl2/Corona_Virus/Corona_Virus_Landing.html.   The infectious diseases screening tool, http://intranet1.mountsinai.org/inf_ctrl2/NEW%20WEBSITE/Infectious%20Diseases%20Screening%20Tool%205Feb18.pdf, is administered at all points of entry (i.e., ED, clinics, and urgent cares). All study teams should implement  this for research study visits.   If a patient has recently traveled to an affected area (see CDC list of affected countries, https://www.cdc.gov/coronavirus/2019-ncov/summary.html) and has symptoms of an upper or lower respiratory tract infection, COVID-19 should be considered. The study participant and any accompanying persons should be offered surgical masks and immediately be moved to an airborne isolation room (if available) or a single room with the door closed.  Research staff should contact the covering investigator/clinician immediately if not present for the study visit.  Clinicians are asked to practice standard, contact, and airborne precautions with the addition of eye protection (face shield or goggles).  Individuals donning a N95 respiratory should be fit tested.  Please take a history including the travel history, potential exposure history, and symptom history. Please call Infection Prevention at your site if you do encounter a study participant where COVID-19 is in the differential.

Importantly, if any staff is ill with respiratory symptoms: DO NOT come to work and follow sick leave policy.   In addition please use meticulous hygiene. The virus can survive on surfaces for a few hours up to several days so staff should disinfect all surfaces before and after each study participant visit (e.g., exam tables, desktop tables, etc.).

Thank you and please feel free to reach out with questions.  We will continue to update you as the situation evolves.

***COVID-19 work is essential and will continue to be supported at 100%.

Animal Orders/Breeding

• For non COVID-19 aims, requests for animal orders and intra-campus transfers will be allotted a ramp up to support 25% of normal research demands and will be evaluated on a case by case basis by CCMS Director. Imports and exports will be reviewed and supported similarly.
• A ramp up to support 25% of normal on-site breeding of critical research animals will be allowed and we urge investigators to protect their critical lines by cryopreservation or other means.
• Within the ramp up, research related activities should support absolutely essential aims for ongoing studies or the health of the animal/line.

Scheduling access and controlling social distancing in the vivarium

   Personal Protective Equipment

• Investigators entering the vivarium are required to follow the mask requirements established for general entry to the campus.
• Surgical masks will be worn for survival surgery and all other protocols for which we have used these historically.
• Standard PPE (gown, hair bonnet, gloves for procedures) is required when entering the vivarium. (Homemade masks are NOT appropriate for use within the viarium).

   Social Distancing in the vivarium

• No more than two people in any common area including vivarium elevator lobbies, locker/rest rooms, breakrooms, gowning/de-gowning area.
• All investigators must schedule work time in the vivarium to limit the number of people in procedure and housing rooms. No more than two people/lab/time slot in large housing or procedure rooms and one person in small housing and procedure rooms. (Small rooms are those considered unable to achieve 6 feet physical distancing).
• Investigators will use the Microsoft Outlook room scheduling system to schedule both the use of housing and procedure rooms in blocks of no more than 2 hours. The facility supervisor will take steps to ensure equal access. (More than 2 hours needs to be justified and approved by Facility Veterinarian, or designee.) Instructions to reserve a Vivarium Room.
• Investigators with time scheduled in housing or procedure rooms can enter areas where they are not scheduled for a brief period (NO MORE THAN 5 MINUTES) to retrieve/return cages or supplies, quickly check a cage of animals, etc.
• Human and animal health and welfare are a priority. Time will be blocked in the Microsoft Outlook scheduling system for CCMS staff to complete their daily activities (husbandry/clinical) and allow them to maintain social distancing.

CCMS Staffing

• Animal care staff and veterinary technical staff are currently reporting to work daily at a staggered density and tours to support social distancing.
• Additional CCMS staff will increase on site presence and functionality as workloads dictate within the ramp up.

March 19, 2020

Dear Vivarium users,

In preparation for the Coronavirus (COVID-19) restrictions in New York City, CCMS is providing these important updates to prepare the animal research program for this rapidly evolving global emergency.

Immediate CCMS Actions:

1. Suspend all international/domestic/ commercial rodent imports (exception COVID-19 research)

Reason: The logistics of scheduling animal shipments creates opportunities for delayed shipments and subsequent animal injury.

2. Standardize all rodent research facilities to the industry standard 14-day changeout cycle

Reason: Most of our facilities have already adopted this industry standard and we have seen significant improvements in both resource and personnel management using it. This standardization will also facilitate staff cross-training for inter-site emergency coverage.  Rodent lines requiring more frequent changeouts (example: diabetic mice) will continue be serviced at more frequent intervals.

3. Increase the cryopreservation of sperm from irreplaceable transgenic models.

Reason: CCMS veterinarians have learned of several irreplaceable lines that have not been cryopreserved and we suspect there are others.

Contact Kevin Kelley ( kevin.kelley@mssm.edu ) for information and assistance with sperm cryopreservation.

Mandatory Research Lab Emergency Preparations:

1. Develop a list of animals and/or cages you need for ‘mission critical’ research
2. Develop a list of animals without an immediate or critical experimental purpose that can be prioritized for immediate euthanasia during a severe personnel or supply shortage
3. Suspend all animal breeding except for ‘mission critical’ research
4. Identify and provide names of and contact information for research personnel who can assist with animal care.   Forward this information to your facility supervisor ASAP.

‘Mission Critical’ research criteria:

1. All unique transgenic lines that are not available commercially
2. Animals within one week of study completion
3. Animals that received experimental manipulations/treatments required for a pending publication
4. Other serious considerations that are not immediately apparent will be considered on a case-by-case basis

Examples:

• Breeding animals needed for the maintenance of unique transgenic lines or difficult to obtain species
• The non-human primates on long-term behavioral studies

This is a good time to review and audit your colonies and look for ways to reduce colony size. We strongly advise immediate cryopreservation of irreplaceable transgenic lines.

In the unlikely event that the COVID-19 emergency causes serious staffing shortages and supply chain disruptions, CCMS will partner with the research community to institute the following additional measures:

1. Discontinue all studies restricting feed and water
2. Discontinue all studies using special feed or water
3. Move all animals to automatic watering systems (if available)
4. Discontinue all breeding with the exception of  ‘mission critical’ founder lines.  Pups born will be maintained and weaned if there are sufficient staff and supply resources.
5. Obtain each research group’s prioritization list identifying animals that can be immediately euthanized

Best regards

Jonathan

Jonathan A. Cohen, DVM, MS, DACLAM
Associate Professor and Director
Center of Comparative Medicine and Surgery
Icahn School of Medicine at Mount Sinai
One Gustave L. Levy Place, Box. 1031
Annenberg Building, 26-100
New York, NY 10029

office (212) 241-9939
fax (212) 860-9739

Message from the CRIO Office and Scientific Computing

De-identified Patient COVID-19 Data Now Available

A deidentified cohort of patients under investigation for or diagnosed with COVID-19 is now available. The cohort includes all patients with an encounter at a Mount Sinai facility (either in person or virtual) who have been diagnosed with Covid-19, who are under investigation for Covid-19, or who have screened negative for Covid-19. The data set will be updated regularly.

This is an evolving data set. New data elements will be added over the coming days and weeks, including imaging, historical diagnoses, medications and more.

The data set, along with a list of projects for potential collaboration, is available at: https://msdw.mountsinai.org at the top of the page in yellow, under Covid-19 Research.

Research Informatics Support for COVID-19 Related Projects

Per the Dean’s Office, we are establishing a comprehensive registry of patients with respiratory distress and other serious Covid-19 symptoms as a sharable resource available to the entire Mount Sinai community. To anticipate and meet the needs of our researchers, we need you to submit information about planned and ongoing projects related to the COVID-19 pandemic at the following site https://redcap.mountsinai.org/redcap/surveys/?s=T4CCLYNL39. Researchers can view all existing projects to identify collaborators and similar efforts.

Information on ongoing projects approved by IRB is available at the following site: http://digitalcommons.us/index.

For any further assistance with digital resources, please feel free to use the Digital Concierge service which provides weekly virtual clinics and 1:1 consultations via ticketing requests. The Digital Concierge will assist projects to ensure that they are consistent with regulatory requirements.

Feel free to open a ticket with our Digital Concierge Service any time: http://osticket.mssm.edu/support/.

How to submit to ticketing system:

Please submit tickets online at: http://osticket.mssm.edu/support/
Directions: Open a new ticket – Select Digital Concierge – Enter your contact information – Select the requested service – Include any additional details:

Message from the CRIO Office

The Office of the Chief Research Informatics Officer is pleased to announce widespread availability of electronic consenting platform that supports interactive multimedia engagement into clinical trials, administration of informed research consents, and survey data collection.

The E-Consent Electronic Consenting Platform is now available for free, at no cost for all clinical research projects.

E-Consent is a multipurpose, scalable, electronic informed consent system that can be used in a multitude of settings. The platform allows research staff to easily upload multimedia information about a research protocol together with an approved informed consent. These materials are then delivered to potential study participants electronically, in an easy-to-understand and user-friendly way. The system is compatible with a wide range of devices and display sizes, including tablets, mobile devices, laptops, desktops, and others. Further details are available at https://www.ncbi.nlm.nih.gov/pubmed/31349301.

E-Consent has been developed in collaboration with the Mount Sinai IRB to ensure regulatory compliance: IRB-19-02049 Assessment of Multipurpose Scalable Electronic Informed Consent Platform.

If you would like to explore and/or use this offering for your research projects, please contact Daniel Robins, MD <daniel.robins@mountsinai.org> or open a ticket with the Digital Concierge service at http://osticket.mssm.edu/support/.

Message from the CRIO Office and Scientific Computing

Research Informatics Support for COVID-19 Related Projects

Per the Dean’s Office, we are establishing a comprehensive registry of patients with respiratory distress and other serious Covid-19 symptoms as a sharable resource available to the entire Mount Sinai community. To anticipate and meet the needs of our researchers, we need you to submit information about planned and ongoing projects related to the COVID-19 pandemic at the following site https://redcap.mountsinai.org/redcap/surveys/?s=T4CCLYNL39. Researchers can view all existing projects to identify collaborators and similar efforts.

Information on ongoing projects approved by IRB is available at the following site: http://digitalcommons.us/index.

For any further assistance with digital resources, please feel free to use the Digital Concierge service which provides weekly virtual clinics and 1:1 consultations via ticketing requests. The Digital Concierge will assist projects to ensure that they are consistent with regulatory requirements.

Feel free to open a ticket with our Digital Concierge Service any time: http://osticket.mssm.edu/support/.

How to submit to ticketing system:

Please submit tickets online at: http://osticket.mssm.edu/support/

Directions: Open a new ticket – Select Digital Concierge – Enter your contact information – Select the requested service – Include any additional details:

The Digital Concierge Service: Informatics and Data Science Walk-in Clinics will be all digital and not meeting in person until further notice.

Digital Concierge walk-in clinic hours are every Wednesday from 4-5pm: join virtual room at https://zoom.us/my/digitalconcierge

For help with Informatics and Data Science, open at Support Ticket: http://osticket.mssm.edu/support/
or write Daniel.Robins@mountsinai.org

For help with the Mount Sinai Data Warehouse (MSDW) or Cohort Selection Tools, open a Support Ticket: https://scicomp.mssm.edu/jira/servicedesk/customer/portal/4
or write Oketha.Petty@mssm.edu

For help with REDCap open at Support Ticket by writing REDCap-Support@mssm.edu
or write Scott.Robertson@mssm.edu

The ISMMS Wet Lab Ramp Up Checklist is a guidance checklist developed by EH&S to aid laboratories as they ramp up research. It provides safety guidance on entering the laboratory after a long absence, physical hazards to be aware of, chemical safety and other general safety protocols.

ISMMS Wet Lab Ramp Up Checklist

ISMMS DSO Contact List – Google Drive

Plan to Resume Limited (25%) Wet Research Laboratory Operations on May 18

The following is our plan to begin the process of gradually easing the current restrictions on wet research laboratories within the several research buildings at Mount Sinai (Atran plus upper floors of Annenberg, Hess, and Icahn). The plan has been vetted and approved by School and Health System leadership as well as the relevant offices including Housekeeping, CCMS, Infection Prevention, Environmental Health & Safety, and the Clinical Laboratories). Of note, the large majority of laboratory floors use a separate bank of elevators which help separate research from clinical and educational functions. Computational researchers, and administrative/financial staff that support laboratories, should continue to work from home except when it is necessary to come to campus in which case the below provisions apply.

The current restrictions allow each laboratory to have a skeleton crew of 2-3 individuals (up to 4 for larger laboratories) to maintain critical animal and cell lines. In addition, laboratories doing Covid-19 research are functioning at normal, higher levels. In all cases, people are expected to maintain social distancing.

Effective May 18, research staff are expected to adhere to the following:

1. Laboratories will be permitted to increase their lab census to one-quarter (25%) of the normal density at any point in time. Each laboratory bay can have only one person (instead of the normal 2-4) at work at any given time (exceptions must be approved by Dr. Nestler – see below contact information). Each laboratory PI will decide how to achieve this metric: e.g., by having people work on campus on different days or during different shifts per day.
2. Returning to the lab is voluntary for all trainees and staff. No one should feel coerced or pressured to return during this initial phase, and should report any such coercion or pressure through the new Feedback Form, HR, department/institute/division chairs/directors, or Dr. Nestler.
3. All laboratory personnel must wear face masks at all times in the laboratory and within the medical center hallways. A plan has been developed to provide all lab personnel with a new face mask each day. Frequent hand washing and glove etiquette within labs will be maintained.
4. Each laboratory will be responsible for cleaning work spaces at least 2 times per day (start/end each day or start/end of different shifts). Normal housekeeping schedules (garbage removal, floor cleaning) will resume.
5. Crowding of elevators and elevator lobbies will be avoided. All individuals entering elevators must wear a mask or face covering. Elevators will also be cleaned more frequently. Gloves should not be worn in elevators unless being used to transport biohazardous materials (which must be in freight elevators only).
6. Occupancy of all procedure rooms, cold rooms, tissue culture rooms, etc., which normally might have several people in them at any given point in time, will be limited to ensure ≥6 feet in social distancing at all times. Online scheduling, organized at the lab or department/institute level, will be used to manage this occupancy.
7. The same is true for lunch and break space. Social distancing must be maintained with assigned shifts if need be. Conference rooms on each lab floor will be available for lunch and breaks, and staff will be responsible for cleaning surfaces after use.
8. All staff should monitor themselves for symptoms of SARS-CoV2 infection (e.g., fevers, sore throat, cough, shortness of breath). Anyone with symptoms should immediately remove themselves from the laboratory and notify their PI. Those who develop symptoms at home should notify their PI. Staff will be referred to either Employee Health Service or Student Health for further guidance and recommendations for return to work.
9. Each PI will be responsible for maintaining these precautions. Designated safety officers in each department/institute, along with Environmental Health & Safety, will do regular rounds and will be available for consultations. Any laboratory that is noncompliant will be closed immediately for a period of at least one month during which time an assessment will take place to determine whether the laboratory should reopen.
10. There will be no in-person group meetings of any size. This includes no WIPs, seminars, thesis committee meetings, etc. All meetings will continue to operate through Zoom only.

We will evaluate how well this plan is working as well as monitor closely rates of COVID-19 infection among lab personnel before considering further easing restrictions on wet lab research work. We are heartened by considerable data showing no increased risk for infection (in fact, the data show reduced risk) among healthcare workers and laboratory personnel over the past two months. We will also continue to be guided by the Governor’s guidelines for New York State, which importantly have consistently designated all medical research as essential.

Questions about this plan should be directed to Dr. Eric Nestler (eric.nestler@mssm.edu), Dean for Academic and Scientific Affairs.

ISMMS Biosafety Guidelines and FAQs for SARS-CoV-2 in Research Labs_Version 2_May 4, 2020

To:      All Research Staff

From: The Office of Environmental Health and Safety (EH&S)

Re:      Guidance on Respiratory Protection, Fit Testing, and N95 Respirators

Thank you all for the essential research you are conducting. The COVID-19 related research performed by the Icahn School of Medicine research community is instrumental in understanding and solving this global pandemic.

This document provides guidance on respiratory protection, fit testing, and types of N95 respirators used in research settings.

Respiratory Protection:

Current guidance from the CDC (https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html), the Mount Sinai Institutional Biosafety Committee (IBC), and Environmental Health and Safety (EH&S) requires the use of NIOSH approved N95 respirators in specific research environments.

N95s must be utilized by users that are authorized to access the following facilities:

• BSL3 Emerging Pathogens Facility (EPF)
• BSL3 Conventional Biocontainment Facility

Work with COVID-19 patient specimens must be performed in BSL2+ Designated Areas at a minimum.  If specific manipulations cannot be performed within a biosafety cabinet, N95s, or other appropriate respiratory protection, must be utilized.

Principal Investigators, Lab Supervisors, and DSOs can contact the IBC (biosafety.ibc@mssm.edu) for additional guidance.

Medical Clearance:

All laboratory staff considering the use of a N95 respirator must obtain medical clearance from Employee Health Services prior to getting fit tested or wearing a N95 respirator.

Principal Investigators, Lab Supervisors and DSOs can contact Bobbi-Jo G Choudhury, FNP-BC, MSN, RN (bobbi-jo.choudhury@mountsinai.org) in Employee Health Services to obtain medical clearance for their research staff.

Fit Testing:

Fit testing is required for all staff who wear N95 respirators. Fit testing is critical to ensure that the respirator creates a proper seal around your nose and mouth to provide the necessary protection. A fit test must be repeated at least annually, when changing mask model/type, or major physical changes (weight loss/gain).

The fit test is specific to the manufacturer, model and size of respirator (e.g. Manufacturer: 3M, Model: 1860, Size: Small). If you were previously fit tested on one model, and have transitioned to a new model, you must be re-fit tested before using the new model.

You must be clean shaven for your fit test and every day you wear your respirator. Beards, stubble, and other facial hair prevent the respirator from creating the proper seal and will not protect you against airborne hazards.

Principal Investigators, Lab Supervisors and DSOs can reach out to Environmental Health and Safety (AskEHS@mssm.edu) to schedule a fit test session for their research staff.

N95 Respirators:

Mount Sinai Hospital and the Icahn School of Medicine have traditionally used two types of N95 respirators:

Manufacturer: 3M
Model: 1860
Size: Small and Regular

Manufacturer: Halyard (Duckbill)
Model: 46867
Size: Small and Regular

Due to increased worldwide demand, these above respirators may not be available through the traditional means (e.g. through requests to Materials Management or direct orders through a distributor). When considering the purchase of an alternative respirator type, please be aware of the following:

• Environmental Health and Safety must review, evaluate, and approve all new respirators before purchase and use in research labs.
• There are a variety of knock-off respirators, respirators that are not NIOSH or FDA approved, and respirators of poor quality that have been introduced to the market and will not provide adequate protection.
• Additional information on approved PPE can be found in the Mount Sinai PPE Directory.

Please contact Environmental Health and Safety if you need further information on sources of NIOSH approved N95 respirators for conducting COVID-19 research. We are in this together!

https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs.html

MSHS Update 05-11-2020

NIH awardees can donate Personal Protective Equipment (PPE) from their awards.

FAQ From NIH

Can recipients donate Personal Protective Equipment (PPE) and supplies acquired with NIH grant funds to local hospitals and health care facilities in support of COVID-19 efforts?

Answer: Yes, recipients may donate PPE and other lab supplies in support of efforts related to COVID-19. Recipients may re-budget grant funds to repurchase supplies at a later date, use large unobligated balances, or submit an administrative supplement request to the funding IC.

Instructions from Dr. Miller

As we ramp down our lab operations the question has come up of whether the labs have any Personal Protective Equipment (Gloves, Gowns, Mask) that could be donated to the hospital. The specific ask is for Surgical Masks, N95 Masks, and Protective Gowns. These must be in unopened boxes or packing materials. If your lab can donate any of the above please respond directly to reginald.miller@mssm.edu.

In your response please indicate:

• Type of PPE
• Quantity of material (s)
• Lab location
• Best time to pickup

Med students will come to your areas to pick up the supplies. Thanks in advance for your assistance.

Please see the other COVID-19 related grants management notices recently issued by the NIH.

• Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19
  (NOT-OD-20-087)

• Flexibilities for Assured Institutions for Activities of Institutional Animal Care and Use Committees (IACUCs) Due to COVID-19
  (NOT-OD-20-088)

A complete list of NIH resources is available at this site.

• Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding

Please check the GCO website for updates as well.

• https://icahn.mssm.edu/research/portal/resources/gco/application

https://nexus.od.nih.gov/all/2020/03/13/covid-19-resources-for-applicants-and-recipients-of-nih-funding/

Special Edition: Coronavirus Update – March 17, 2020

COVID-19 Resources for Applicants and Recipients of NIH Funding

By Mike Lauer

Due to the potential exceptional impact of the declared public health emergency, we want to assure our recipient community that NIH will be doing our part to help you continue your research. See a video message from Dr. Mike Lauer discussing the flexibilities available for applicants and recipients. Continue reading →

Top Stories

Guidance for NIH-Funded Clinical Trials and Human Subjects Studies Affected by COVID-19

For details on expanded flexibilities, such as mid-project period extensions and administrative supplements for unanticipated costs, see NOT-OD-20-087. Continue reading →

NIH Late Application Policy, Administrative Flexibilities, and FAQs Related to 2019 Novel Coronavirus (COVID-19)

When delays occur because the applicant or recipient organization is officially closed or unable to submit grant applications due to the effects of COVID-19, the NIH will consider accepting applications late, on a case-by-case basis. Continue reading →

Flexibilities for Assured Institutions for Activities of Institutional Animal Care and Use Committees (IACUCs) Due to COVID-19

See NOT-OD-20-088 for flexibilities provided in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) that are applicable to implementing a pandemic plan for animal care and use programs. Continue reading →

Special OLAW Webinar on March 19: Pandemic Contingency Planning and Its Impact on Animal Care

Are you testing or implementing your institution’s pandemic response plan for the first time? Do you have questions about flexibilities provided by the PHS Policy that may be helpful during a pandemic? We are hosting a special webinar on March 19^th to help your institution prepare for a pandemic that may impact the animal care and use program. Continue reading →

Calendar

• Canceled    – NIH Regional Seminar in Baltimore (4/20-4/22)  
• Postponed – 21^st Annual HHS Small Business Program Conference (4/28-4/30)
• Extended   – Deadline for Feedback on NIH Strategic Plan (4/1)

To subscribe or unsubscribe from the listserv, visit the subscription center. Having trouble? E-mail the editor. You can also get updates through the NIH Extramural Nexus RSS feed, or by following us on Twitter:@NIHgrants

Notice Number:NOT-OD-20-087

Key Dates
Release Date: March 16, 2020

Related Announcements

NOT-OD-20-082
NOT-OD-20-083
NOT-OD-20-086

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this notice is to provide guidance outlining the flexibilities available to recipients conducting NIH-funded clinical trials and human subject studies, that are impacted by the declared public health emergency for COVID-19. NIH recognizes the significant effects that this emergency is having on NIH-funded clinical trials and other human subjects studies. First and foremost, NIH is concerned about the safety and welfare of human subject participants and research staff. Institutions should take all steps necessary to ensure the safety of all human participants and research staff involved in NIH-funded clinical trials and human subjects studies.

At this time, NIH encourages recipients to consult with their IRB and institutions about potential measures to protect participants and research staff. Examples of such measures are:

• Limiting study visits to those needed for participant safety or coincident with clinical care.
• Conducting virtual study visits
• Arranging flexibilities for required laboratory tests or imaging needed for safety monitoring to occur at local laboratories or clinics
• Canceling large gatherings of 50 or more people
• Limiting or suspending unnecessary travel

Recipients will likely encounter delays to ongoing research based on the effects of COVID-19. As outlined in NOT-OD-20-086, recipients may submit late financial and progress reports, if research is delayed due to COVID-19, and may carryover unobligated balances on active grants without requesting prior approval.

Below are additional details related to current and expanded flexibilities.

Delays in Research Progress:

As outlined in the NIH Grants Policy Statement 8.1.1.3, recipients may extend the final budget period of the approved project on active grants one time for up to 12 months without requesting prior approval from NIH.

To support participant health and safety, and continuity of research during this public health emergency, NIH will allow for additional extensions, including mid-project period extensions, for awards supporting NIH-funded clinical trials and human subjects research. Recipients should contact the awarding Institute or Center (IC) to provide details on the effects of COVID-19, and the need for an extension. NIH is committed to working with its recipients during this public health emergency.

Typically, project periods for NIH awards supporting clinical trials and other human subjects research are limited to seven years. NIH will allow project periods to extend beyond the 7-year timeframe for extensions related to COVID-19.

Unanticipated Costs

As a result of COVID-19, recipients may incur unanticipated costs. For example:

• Costs incurred to arrange for participants to receive care at their local sites or virtually, rather than the study site, for required visits.
• Supply chain disruptions
• Personnel disruptions due to illness or closure of facilities
• Additional lab testing (e.g. for COVID-19)
• Increased transportation costs

If unanticipated costs are identified due to impacts of COVID-19, and unobligated balances are not available to rebudget, recipients may request administrative supplements from the funding ICs (see PA-18-591Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). ICs will make funding decisions on a case by case basis in an effort to support the safety and welfare of participants and sustain research during any delays.

Additional NIH resources related to COVID-19 are available here which includes FAQs that include, but are not limited to, human research and clinical trials specific questions. NIH is continuing to monitor the situation and will publish any additional information regarding this ongoing public health emergency in the NIH Guide.

Inquiries

Please direct all inquiries to:

Division of Grants Policy
Office of Policy for Extramural Research Administration
Office of Extramural Research
Telephone: 301-435-0949
GrantsPolicy@nih.gov

TO: All Research Faculty, Administrators and Research Personnel

FROM:
Giorgio Martinelli, DSc., PhD,  IACUC Chair
Janice Gates-Porter, PhD, MOAM, MBA, CM, Director, IACUC Operations

RE: Telecommuting of IACUC office due to COVID-19

Due to the COVID-19 pandemic and in an effort to keep our staff and users safe, the IACUC office will be telecommuting. This will have no impact on our ability to assist our researchers. For a seamless experience we will offer remote assistance to any PI who wishes it via GoTo meeting or Zoom. Below we have provided a list of helpful resources. We will keep you apprised of any updates.

We thank you for your cooperation and patience as we work to assist you during this time.

IACUC Resources:

I. IACUC Website https://icahn.mssm.edu/research/iacuc

II. IACUC email:iacuc@mssm.edu

III. Signatory:

Janice Gates-Porter, PhD, Director

Giorgio Martinelli, Dsc, PhD, Chair

Randy Albrecht, PhD, Vice-Chair

*Please route all signatory requests through the IACUC office

IV. Comparative Review questions:

Shekhar Patil, Ph.D.

Shekhar Patil shekhar.patil@mssm.edu

V. Topaz log in or animal fund account linkage queries:

CCMS Dept:

Ms.Veronica Mosesveronica.moses@mssm.edu

or Ms.Viviana Badillo viviana.badillo@mssm.edu

VI. eIACUC programming issues

Email: esupport@mssm.edu or create a ticket at http://osticket.mssm.edu/support/

VII. Sinai Central Log in issues

ITHelpDesk@mountsinai.org
x4HELP (212.241.4357)

ClinicalTrials.gov has not changed their requirements and if they do, ORS will notify research teams.

If your study has been put on hold due to COVID-19 please contact the ORS via our ticket system and indicated if your study is suspended (study expected to resume in the future) or terminated (study terminated early). If your study is terminated, please also provide the date (month, day, year) of the last study visit or the last date that data was collected, AND the total enrollment number.

The New York metropolitan region has made great strides in managing the COVID pandemic, to the point where the city should begin reopening from June 8th.  Starting May 18^th, we initiated Phase 1 for restarting essential face-to-face research visits for projects that have a possibility of direct benefit to participants. We commend the research community for your adherence to the guidelines set forth for that first step to ensure a successful reopening thus far.  Building upon that and with the upcoming New York State and New York City relaxation in restrictions, in Phase II which will begin June 8^th, we will also begin allowing the resumption of face-to-face research that does not hold out the prospect of direct benefit to participants.

It is the intention of the ISMMS to expand clinical research activities in a safe manner that does not needlessly endanger subjects, staff, or clinical care at the hospitals and clinics. There is a fundamental principle in research oversight that requires research to be conducted in a manner that minimizes risks to subjects, consistent with sound research design. Importantly, this is not a return to pre-COVID normality and our success will again depend upon our research community adhering to the following guidance.

To that end:

• All subjects coming on campus or a Sinai office site must follow current COVID protections concerning pre-visit screening, temperature checks, wearing masks, etc.
  • It is the responsibility of the research team to reach out to participants within 24 hours of scheduled face to face visit(s) to conduct pre-visit screening for COVID-related symptoms and reiterating visitor policy.
  • All hospital, departmental and clinic rules regarding COVID-19 prevention must be adhered to once research subjects arrive on campus, including but not limited to pre-visit screening at an established ambulatory practice area, the Health System’s Visitor Policy, lab testing, etc.
• All subjects should be made aware of the risks involved with traveling to the medical center and being seen face-to-face.
• Efforts should be made to minimize the face-to-face exposure, both the duration and number of episodes. This means that activities that can be done remotely should be done remotely. This may include all or part of the informed consent process, completion of questionnaires, and rating scales etc. Activities that are tied to clinical visits should also be adopted to minimize time and disruption to clinic operations.
• Subjects that are at increased risk of COVID morbidities, e.g. age, obesity, diabetes, heart disease, etc. should be identified and the research procedures should be modified or postponed to minimize risks.
• Scheduling has to be tightly coordinated to location and should reflect added time to clean rooms, get through screening, etc.
• All research visits must be scheduled in such as a way as to minimize waiting and crowding in order to maintain social distancing and minimize the impact on clinical activities if that applies. These should be coordinated at the local level.
•  All recruitment activities taking place in clinic waiting areas or clinic office space are considered suspended. Activities may be allowed only with approval of the PPHS and will require appropriate assurances that the activities are consistent with current hospital rules and have the permission of the clinic.
• Procedures that generate aerosols are not approved at this time (e.g., spirometry, sputum induction).

Implementation:

• All projects need to obtain departmental approval before resuming face-to-face visits with subjects.
• All projects planning to reinitiate face to face encounters must complete a short online form found here: PPHS Not-for-Benefit Research Ramp up Form
• As the form will make clear, if you can attest to departmental approval, that the basic steps outlined in the above guidance have been taken to minimize risks, and that higher risk subjects are not involved in the research, then increased on-site activities may begin upon completion of the form.
• As the form will make clear, for other projects where special precautions have to be considered to protect subjects at increased risk for complicated and fatal COVID outcomes, more formal patient notification will be required and a specific mitigation strategy has to be reviewed by the PPHS. You MAY NOT begin on-site activities until receiving notification from the PPHS. The PPHS will endeavor to review these within 2 working days of submission.

If you have any further questions, comments or suggestions please contact the IRB at IRB@mssm.edu or Lori.Jennex@mssm.edu. You can also reach out to Rosalind Wright, MD MPH at rosalind.wright@msssm.edu.

The purpose of this update is to explain the process for resuming onsite clinical research activities with the Mount Sinai Health System consistent with the May 13^th Town Hall and the May 14^th memo. This pertains to potentially “for-benefit” studies only, as they are the only face-to-face projects eligible at this time.  As detailed in our earlier notice, departmental review and approval is required for all projects. That process will be handled at the departmental level.

As detailed previously:

• Special protections have to be considered for those studies that involve subjects at increased risk for complicated and fatal COVID outcomes. PPHS polices and Federal regulations mandate that investigators minimize risks to subjects consistent with sound research design. Telemedicine, remote monitoring, home infusions should still be utilized in most situations to minimize risks.BEFORE on-site activities resume, the PPHS must receive the plan for these subjects. This plan has to include a risk: benefit analysis and may also require an information sheet for PPHS review that will be shared with research participants.

Implementation:

All projects need to obtain departmental approval before resuming face-face visits with subjects.

All projects must complete a short online form found here: PPHS Phase I Clinical Ramp Up Form

As the form will make clear, if you can attest to departmental approval and that higher risk subjects are not involved in the research, then increased on-site activities may begin upon completion of the form.

As the form will make clear, for other projects where special precautions have to be considered to protect subjects at increased risk for complicated and fatal COVID outcomes, some form of patient notification will be required. You MAY NOT begin on-site activities until receiving notification from the PPHS. The PPHS will endeavor to review these within 2 working days of submission.

If you have any further questions, comments or suggestions please contact the IRB at IRB@mssm.edu or Lori.Jennex@mssm.edu

TO:        All Faculty, Staff, and Trainees

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

Rosalind J. Wright, MD
Dean for Translational Biomedical Sciences
Icahn School of Medicine at Mount Sinai

Glenn Martin, MD
Senior Associate Dean for Human Subjects Research
Icahn School of Medicine at Mount Sinai

DATE:    May 14, 2020

RE:         Ramping up on-site clinical research.

It is the intention of the ISMMS to expand clinical research activities in a safe manner that does not needlessly endanger subjects, staff, or clinical care at the hospitals and clinics. As mentioned at the Research Town Hall held earlier this week, activities will begin to ramp up beginning Monday May 18^th. As underscored in the Town Hall, this is a phased restart and for the initial weeks the following will govern. This policy impacts research at all Mount Sinai Health System sites that is approved by the ISMMS Program for the Protection of Human Subjects (PPHS)) as well as external IRBs.

ALL projects eligible to ramp up will need local and departmental approval before any changes can begin. Departments will need to coordinate and track these approvals. The PPHS will work with departments so we will not need to receive approval confirmation from each individual project. Certain projects will need to file a form with PPHS and await review and approval. Details will be provided in a separate communication that will distributed before the close of business Friday May 15^th.

For-benefit interventional trials that require face to face contacts are eligible to use on-campus resources. During this initial phase, which overlaps with the increase in clinical activities including ambulatory practices, departmental approval will be necessary so that resources, including waiting area space, line length, ability to navigate to ancillary departments, etc. are properly allocated. The expectation is that the most clinically impactful projects will be prioritized. The PPHS will reach out directly to the departments to coordinate. In addition:

• All hospital, departmental and ambulatory practice  rules regarding COVID-19 prevention must be adhered to, including but not limited to pre-visit screening at an established ambulatory practice area, the Health System’s Visitor Policy, lab testing, etc. Guidelines for Return to Practice.
• All recruitment activities taking place in ambulatory waiting areas or office space are considered suspended. Recruitment activities may be allowed only with approval of the PPHS, and will require appropriate assurances that the activities are consistent with current hospital rules and have the permission of the clinic.
• All clinical visits must be scheduled in such a way as to minimize waiting and crowding in order to maintain social distancing and minimize the impact on clinical activities. These should be coordinated at the local level.
• Special protections have to be considered for those studies that involve subjects at increased risk for complicated and fatal COVID outcomes. PPHS polices and federal regulations mandate that investigators minimize risks to subjects consistent with sound research design. Telemedicine, remote monitoring, home infusions should still be utilized in most situations to minimize risks.  BEFORE on-site activities resume the PPHS must receive the plan for these subjects. This plan has to include a risk: benefit analysis and may also require an information sheet for PPHS review that will be shared with research participants.
• For all studies, even those with subjects at no known increased risk of COVID, the use of Telemedicine, remote monitoring, home infusions, etc.  should still be utilized in many situations to minimize risks.

Biospecimen and registry trials:

• To the extent that activities take place at a clinical visit they should not occur unless there is minimal burden to clinical operations and infection control. For example, consenting should begin, and possibly be completed, before arrival. To minimize time spent in the clinic setting, questionnaires should be completed off-site.  Subjects should not be coming to the hospital/clinic outside of a clinical visit.
• All sample processing should follow institutional rules, including any SARS-CoV-2 modifications currently in place.

Other Not for Benefit projects are not included in this phase and are not authorized to use on-campus resources. Approved remote activities can continue.

External Monitoring Visits

On-site external monitoring visits continue to be suspended.

To: Human Research Principal Investigators and Study Coordinators
From: Glenn Martin, MD, CIP – Senior Associate Dean for Human Subjects Research and Executive Director, PPHS

It is expected that all projects will be conducted in compliance with the latest Health System and School guidelines around COVID-19 prevention, detection and treatment as it affects subjects and research personnel, including screening before arrival, use of PPE, etc. Without waiting for PPHS approval, protocol changes to achieve this should be implemented immediately, and/or protocols should be paused until those requirements can be met.

Given the inevitable increasing number of asymptomatic carriers with community spread, the PPHS asks that researchers be particularly sensitive to procedures that generate aerosols or provoke coughing. If the project is not designed to potentially benefit the health of the individual participants, then these procedures should be eliminated from the protocol or the project should be put on hold. Pausing a protocol does not need to be reported to the PPHS, but should be well documented in the researcher’s records.

After making safety changes to protocols:

• Notify the PPHS at IRB@mssm.edu within 72 hours
• Include a brief description and rationale
• Include PROTOCOL CHANGE NEEDED FOR COVID-19 RESPONSE in the subject line
• Submit a complete modification application for formal review within 2 weeks

The PPHS expects that many projects will experience a substantial number of scheduling issues and there is a high likelihood of certain tests, exams, interventions, etc. occurring outside of their protocol window. All of these deviations need to be recorded by the researcher. Do not report to the PPHS on a case-by-case basis but deviations of this sort should be batched and reported on a weekly or monthly basis, determined by numbers of events. However if a missed event posed a risk to the subject, e.g. missing a needed safety related blood test,  that should be reported to the PPHS promptly with a corrective action/mitigation plan.

The PPHS greatly appreciates the work of the research community to protect our research subjects during this pandemic while continuing to productively address scientific and clinical questions that ultimately will benefit us all. Please contact as needed for clarifications and guidance.

To:  Human Research Principal Investigators and Study Coordinators
From: Glenn Martin, MD, CIP – Senior Associate Dean for Human Subjects Research and Executive Director, PPHS

1-The PPHS acknowledges that the research response to COVD-19 will require flexibility on our part to prioritize time-sensitive reviews.  Please be sure that the analyst working on the project is aware of any timing issues and contact Lori Jennex or Glenn Martin directly if needed.

2-For those with open projects that can be modified to respond to the new virus we will expedite as possible. Please interact with the PPHS analyst early on as some modifications may require full board review, and some may require starting a new project.

3-Safety changes to protocols can be initiated prior to IRB notification and approval. For example, if there is a need to change a protocol to minimize subject visits, this can be done prior to PPHS review. Please note the PPHS has to be notified promptly. We urge researchers to be prudent, and to avoid unintended consequences, e.g. unsafely cutting back on monitoring visits to avoid COVID exposure.

4-Clinical research should proceed. We want as minimal disruption of our clinical research enterprise as possible while taking appropriate steps to minimize risks to participants and researchers. This holds for studies with a prospect of direct benefit to subjects as well as for studies that do not offer such direct benefit.

5-We urge researchers to consider telemedicine and other modifications to minimize face-to-face visits. The mandate to protect subjects is particularly important with normal controls and in projects without direct benefits. If there is a decision to pause a study, prior approval is not needed but please notify the PPHS.

6-As of March 10, 2020 and until future notice, all IRB meetings will be held remotely.

Please download the form below to request autopsy tissue from COVID-19 cases for research projects

COVID-19 Autopsy Tissue Utilization Committee Form_April 2020 (Word Doc Form)

To: Basic Sciences Research Personnel

From:
Reginald W. Miller, DVM, DACLAM
Dean for Research Operations & Infrastructur

Re: Cryopreservation Support (Freezers, C02, Liquid Nitrogen – LN2) During COVID-19 Lab Disruptions

Thank you for participating on the recent Basic Sciences Town Hall Webinar on March 18th. This document addresses several concerns related to cryopreservation support that came up during the call:

Liquid Nitrogen (LN2) and Carbon Dioxide (C02):

The primary vendor for LN2 and C02 in the Metropolitan NY Area is TW Smith. This vendor delivers large, 50 gallon, tanks to campus 2-3 times per week. As a critical care vendor to hospitals and other essential services, TW Smith has received approval to continue operations during emergencies as an Essential Service. Furthermore, healthcare facilities/research institutions receive priority delivery during any shortages in supply. Deliveries of LN2 will continue, without interruption. Labs should plan to have someone on site to receive scheduled deliveries. Note: By design, LN2 tanks continuously evaporate during use or storage to prevent dangerous pressure build-up. Thus, it is impractical to store extra tanks on campus to prevent shortages. Regular deliveries are the best option.

Cryogenic Storage Facility

Although deliveries are expected to continue, best practices suggest establishing back-up plans for unanticipated emergencies (natural disasters, work stoppages, etc). The use of small, Dewer LN2 units, is a common practice within many labs using cell lines. These units, due to their small size, require frequent refilling. The ISSMS has established a Cryogenic Storage Facility outfitted with several large, stainless steel, LN2 tanks, each with a capacity for 700 boxes. These units have an LN2 tank duration of four (4) weeks. Each tank is temperature monitored 24/7 with remote call-out features. It is highly recommended that researchers consider establishing a back up supply of critical cell lines in this facility. Please see below the information for the Cryogenic Storage Facility:

Cryogenic Facility

We maintain a state-of-the-art cryogenics facility for long-term storage of cell lines by ISMMS investigators. We can accommodate deposit and delivery of cells as well as viable freezing of cells on a regularly scheduled basis. You can rent a safety deposit box, which contains space for 81 individual vials for $60 per year. We can provide back-up to investigators who have their own freezers or serve as the primary means of viable cell storage. A cost estimate can be obtained by filling out a Cryogenic Facility Rental Request Form. Contact Shen Yao at shen.yao@mssm.edu for additional information.

Freezers (-150, -80, -40) and Refrigerators (4C).

Each laboratory should ensure current contact information is attached to each freezer on campus. Contact information must include one external number for after-hours emergencies. Ideally, each unit would also be attached to a temperature monitoring system with a remote call out feature. Finally, where feasible, emergency power should be prioritized for (-80) freezers or other critical storage units (expensive reagents, valuable specimens). Freezers should be checked daily to ensure proper operation.

Freezer Failures:

Failures are an unfortunate reality for all mechanical equipment and freezers are no exception. These failures often occur after-hours or on weekends resulting in catastrophic losses. The ISMMS has engaged with a commercial entity, LabVendor, for after-hours responses to freezer emergencies. The company provides specimen relocation into one of the Hess Freezer Farm back-up units.

To access this service see the Hess Freezer Farm under https://icahn.mssm.edu/research/portal/resources/deans-cores/freezer-farm.

Contact: Tamjeed Sikder- Manager, Hess Freezer Farm to make arrangements for specimen transfers. Please contact the Hess Freezer Farm if you have specific questions on this program.

Offsite Housing for Freezers:

The ISMMS has maintained an offsite freezer farm in the Bronx, NY, for many years. Storage is free to all Mount Sinai researchers. Due to the limited space on campus for freezers, shortage of emergency power, and best practice of back up storage, investigators are encouraged to explore the off-site freezer storage option. All archival samples should be maintained off-site rather than using valuable on-campus space. Please contact Shekhar Patil, PhD- Core Admin Director (shekhar.patil@mssm.edu), to discuss off-site freezer storage at Brooks, Inc.

Dry Ice

The campus vendor for dry ice is Dry Ice Corporation. While there are other smaller vendors, most are subcontractors with Dry Ice, Corp. This vendor is recognized as an Essential Service and thus operates during emergencies. Deliveries of dry ice will continue uninterrupted. However, during the decrease in lab activity, the amount of dry ice required will decrease as well. We must use caution in reducing dry ice delivery amounts as the vendor may prioritize those facilities with the greatest perceived need. Note: Many clinical operations also require small amounts of dry ice (specimen shipping, etc) thus reductions in deliveries may affect those areas. Any reductions in dry ice ordering should be discussed with the Dean’s office before moving forward.

The preceding guidelines should be consulted during and after this COVID-19 emergency as best practices to ensure sample protection and research continuity. Please do not hesitate to contact me directly if you have any questions or suggestions.

The Dean’s Stem Cell Engineering CoRE is beginning to establish models of lung and airway epithelia derived from human pluripotent stem cells for use in COVID-19 studies.

SARS-Coronavirus-2 (SARS-CoV-2) has been identified as the etiological agent causing COVID-19, the severe acute respiratory syndrome that is currently causing a pandemic of unprecedented magnitude. SARS-CoV-2 can infect mice, ferrets, hamsters, and primates. However, none of these animals develop a disease with the clinical manifestations of COVID-19. Better disease models capturing the human pathophysiology are direly needed. Lung airway epithelia provide a platform for mechanistic studies and for preclinical assessment of therapeutic interventions. This new platform is available from the Stem Cell Engineering CoRE co-directed by Drs. Eirini Papapetrou and Samuele G Marro. All ISMMS researchers interested in strengthening COVID-19-related federal grant applications are encouraged to contact the Stem Cell Engineering Core.

In an effort to gauge interest of the ISSMS community in these models, we invite all interested investigators to please contact us as soon as possible to discuss their research plans.

Samuele G Marro, PhD
samuele.marro@mssm.edu

Eirini Papapetrou, PhD
eirini.papapetrou@mssm.edu

Face Mask Request Form:
https://mountsinai.formstack.com/forms/research_ppe_request_face_mask_form

If you have any questions, please send to researchPPErequest@mssm.edu.

From: Reginald W. Miller, DVM, DACLAM
Dean for Research Operations & Infrastructure
Office of the Dean

To: Departmental/Designated Safety Officers (DSO)
Date: May 6, 2020
Subject: Research PPE – Face Mask Distribution Plan
Cc: Departmental Chairs, Institute Directors, Administrators, Materials Management

Hello All,
Thank you for taking on the responsibility to ensure safe laboratory practices as we begin ramping up research again. As you have heard, the target date for ramp up is May 18th, (subject to change based upon local and state government), so we want you to be prepared. A group of your colleagues, the Research PPE Working Group_[1], has worked to construct a seamless process for all DSOs to provide your respective research labs with a continuous supply of face masks. As we expect the quantity of masks to vary as research increases we are asking each DSO to begin surveying the departmental needs for the weekly usage rate. The calculation rate should be based on: 1 mask/ person/ day or 5 masks/person/week. Each area should develop a method to secure PPE to conserve resources. The outline below details the process:

• Estimation
  • Labs provide the DSOs with the weekly PPE needs based on above metrics.
• Request PPE: Google Docs Form: Research PPE Request (Face Mask Form)
  • DSOs submit form for quantity for each department they oversee.
  • Indicate pick up time on the request form. If any changes occur, please communicate through the dedicated mailbox (below).
  • After successful submittal receive an email confirmation as receipt.
  • Data (type, amount, name, etc) will automatically export into an Excel spreadsheet, managed by Anthony Smalls.
  • Forward total requested amount to Materials Management to provide a weekly supply of face masks. Request by Wednesday for receipt on Friday.
    • DSOs must submit PPE request forms by Wednesdays to ensure replenishment for the following week.
    • Materials Management deliver PPE on Fridays to drop- off location(s).
• Distribution Times
  • On Mondays DSO or designee pickup PPE:
    • Morning (9:30 am – 12:00 pm) or
    • Afternoon (3:00 pm – 4:30 pm).
• Distribution Points
  • Three locations for distribution:
    • Annenberg Conference room 20-55A
    • Hess 6th Flr Conference room 6-101
    • Icahn Medical Institute (IMI): Conference room: L3-36 (3rd for)
• Dedicated Mailbox: researchPPErequest@mssm.edu
  • This dedicated mailbox is available to the research community to ask questions, change pickup times, provide feedback, etc.
  • If you cannot make your pickup window contact Anthony Smalls at: researchPPErequest@mssm.edu or (212) 241-0640 (ext. 40640).
  • For your reference, the current list of DSO is available at: Google Doc List of DSOs

_[1]Research PPE Working Group: Chris Cannistraci (HPIDH), Fanny Tang (GGS), Chen Wang (Microbiology), Bill Janssen (Neuroscience), Sandy Hatem (Precision Immunology/TCI), Josef Ehntholt (EvH&S), Anthony Smalls (Dean’s Office), and Kaware Richardson (Dean’s Office).

Dear Research Community,

Icahn School of Medicine at Mount Sinai (ISM) is deeply concerned for the health and safety of its staff and employees involved in the day to day operations and sponsored programs including those supported by Federal and Non Federal sponsors, and about effects on its biomedical enterprises.

The purpose of the new policy (link below) is to set forth the administrative flexibilities that will apply to all sponsored programs.
https://icahn.mssm.edu/files/ISMMS/Assets/About%20the%20School/Flexibilities-Available-to-Recipients-for-Federal-Financial-Assistance-Affected-by-COVID-19.pdf

Please review the policy in its entirety. Below is an excpert re: salaries and stipends.

Please contact Sponsored Projects Finance at 646-605-4023 if you have any questions about this policy.

Primer v2.1
Protocol v2.1
Clinical Guidelines v2.1
Alarm Protocol v2.1
Operating Checklist [VPAP ST] v2.1

Dr. Charles Powell of Mt. Sinai hospital in New York is part of a team converting BiPAP machines into much-needed ventilators: https://www.facebook.com/cnn/videos/2640448356232121/