COVID-19 Human Subject Research Guidance

TO: All Faculty, Staff, and Students

FROM:

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

Judith A. Aberg, MD
Dean, System Operations for Clinical Sciences
System Chief, Medicine Infectious Diseases
Icahn 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.

TO:
All Faculty, Staff, and Students

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

DATE:
June 28, 2022

RE:
Update on Research Procedures that may Generate Aerosol

Investigators may proceed with research procedures including sputum induction and spirometry without needing approval of infection prevention and control. Research staff performing these procedures should continue to wear PPE including eye protection, N-95 masks, and gloves. Gowns are optional per operator decision.

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

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
Dean, System Operations for Clinical Sciences
System Chief, Medicine Infectious Diseases
Icahn School of Medicine at Mount Sinai

DATE: February 01, 2022

RE: Update on Clinical Research and On-site Monitoring for Clinical Trials

• As the Omicron wave is fortunately decreasing in our area, we can resume face to face research visits following guidance across our health system for all on-site visitors.
• All subjects coming on campus or to a Mount Sinai office site must follow current COVID protections:
  • The research team must contact participants within 24 hours of visit(s) to conduct pre-visit screening for COVID-related symptoms and reiterate the visitor policy.
  • All hospital/departmental/clinic rules regarding COVID-19 prevention must be adhered to once research participants arrive on-site, including but not limited to pre-visit screening at an established ambulatory practice area, wearing masks, Visitor Policy, lab testing, etc.
  • All participants must wear a mask during encounters, regardless of vaccine status, with study-specific exceptions. For example, masks may be removed for oro-facial exams and any necessary oral procedures.

• Sample collection and processing should follow institutional rules, including modifications currently in place for SARS-CoV-2.

Monitoring for Clinical Trials

As we open to on-site monitoring, we must follow procedures to maintain social distancing and reduce infectious risk.

• Ensure monitors are aware of required safety measures.
  • All monitors must be fully vaccinated and have received a booster if eligible (e.g., 5 months after second dose of Moderna or Pfizer and 2 months after first dose of Johnson & Johnson).
  • Only one monitor is allowed on site at any given time within the research location involved.
  • Plan visits/procedures to allow physical separation of monitors from other employees in all areas including work areas, meeting/break rooms, etc. to maintain social distancing guidelines (≥ 6 feet).
  • Monitors must also comply with masking guidelines using proper face coverings over the nose and mouth. Monitors must wear a surgical mask, KF94, KN95 or N95 during their visit (see NY City DOHMH guidance: https://www1.nyc.gov/site/doh/covid/covid-19-prevention-and-care.page#face)
  • The research team will contact monitors within 24 hours of visit(s) to conduct pre-visit screening for COVID-related symptoms and reiterate the current visitor policy and confirm vaccination status.
  • Need to minimize both duration and number of episodes for on-site monitoring visits.
  • All monitoring activities that can be virtual/remote should remain virtual/remote.

• We continue to support remote monitoring for clinical trials. For guidance on the institutional workflow developed to facilitate remote monitoring, contact Catherine Sinfield at Catherine.sinfield@icahn.mssm.edu.
• Requests for on-site monitoring for Investigational Drug Services (IDS) must continue to be submitted at least 2 weeks in advance for approval. Please contact # IDSAnnenberg IDSAnnenberg@mountsinai.org for appointments.

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

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
Dean, System Operations for Clinical Sciences
System Chief, Medicine Infectious Diseases
Icahn School of Medicine at Mount Sinai

DATE: January 04, 2022

RE: Update on Non-essential Clinical Research and On-site Monitoring for Clinical Trials

As we continue to face challenges in the ongoing COVID pandemic, we want to provide updated guidance on non-essential clinical research and monitoring for clinical trials. As we start the New Year, unfortunately we are experiencing an ongoing surge with the more readily transmissible Omicron variant which requires the need to expand restrictions on clinical research in order to protect participants and staff. As this is still a fluid situation, please understand this guidance does not replace whatever more restrictive policies may currently be in place within the Mount Sinai Health System.

Non-essential Clinical Research Restrictions

• Until further notice non-essential clinical research should be shifted to remote.
• Only essential face to face visits should occur, where the benefits to study participants outweigh the expanded risks. Researchers should not recruit participants to come to clinical research sites solely for the purpose of clinical research follow-up visits as this constitutes unnecessary exposure issues unless postponing follow-up constitutes a safety issue to the participant, every attempt should be made to re-schedule these visits. If the PI determines that a participant needs to be seen, institutional guidelines for screening for coronavirus must be followed (SARS SCREENING QUESTIONAIRE (mountsinai.org). To the extent possible, researchers and research staff should work from home and identify remote means of continuing productivity and study visit follow-up via Zoom meetings, phone interviews, electronic survey tools, etc.

• Research staff needing to be on campus for essential clinical research must continue to follow procedures to maintain social distancing
• Plan staffing to allow physical separation of employees in all areas including work areas, meeting/break rooms, etc. to maintain social distancing guidelines(≥ 6 Feet)
• Encourage safety measures to protect staff
  • Use N95 mask for all participant contact and in areas where participants may be seen.
  • Frequent hand washing with soap and water or alcohol-based hand sanitizer
  • Provide disinfecting wipes/cleaning materials for routine cleaning of frequently touched surfaces such as workstations, keyboards, phones, microwaves, printers, doorknobs, etc.
  • Employees who have symptoms of COVID-19 or who have sick family members should notify their supervisor, and others as required, e.g. Employee or Student Health Service, clinical department, etc., for guidance on staying home and clearance to return to work.
  • Employees who appear to have symptoms upon arrival or who become sick during the day should immediately be separated from others and sent home with instructions to follow up with Employee Health or Student Health.
  • Please complete the EHS survey at EHS Registry for Reporting Symptoms of COVID-19-Like Illness and High-Risk Exposure (mountsinai.org)
    
• All subjects must be made aware of the risks involved with traveling to the medical center and being seen face-to-face. We encourage implementation of services to minimize risk related to travel, e.g., arranging Uber/Lyft rides, car services, etc. should be considered if possible; negotiation for support for such by sponsors/funders should be pursued.
• All subjects coming on campus or to a Mount Sinai office site must follow current COVID protections:
  • The research team must contact participants within 24 hours of visit(s) to conduct pre-visit screening for COVID-related symptoms and reiterate the visitor policy.
  • All hospital/departmental/clinic rules regarding COVID-19 prevention must be adhered to once research participants arrive on-site, including but not limited to pre-visit screening at an established ambulatory practice area, wearing masks, Visitor Policy, lab testing, etc.
  • All participants must wear a mask during encounters, regardless of vaccine status.

• Sample collection and processing should follow institutional rules, including modifications currently in place for SARS-CoV-2.

Shift to Remote Monitoring for Clinical Trials

• Until further notice, all monitoring activities will shift to virtual/remote unless deemed necessary by the PI in discussion with Investigational Drug Services (IDS).
• Requests for on-site monitoring for Investigational Drug Services (IDS) must be submitted at least 2 weeks in advance for approval. Please contact # IDSAnnenberg IDSAnnenberg@mountsinai.org for appointments.
• We continue to support remote monitoring for clinical trials. For guidance on the institutional workflow developed to facilitate remote monitoring, contact Catherine Sinfield at Catherine.sinfield@icahn.mssm.edu.

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

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
Dean, System Operations for Clinical Sciences
System Chief, Medicine Infectious Diseases
Icahn School of Medicine at Mount Sinai

DATE: December 22, 2021

RE: Update for on-site human subjects research

Our Mount Sinai community has learned a great deal over the past several months on how to safely conduct clinical research that is central to the mission of our health system. In light of the current SARS-CoV-2 surge with the emergence of the Omicron variant, we are providing updated guidance and reminders to support clinical research in a manner that protects our participants and staff and allows us to continue to advance translational discoveries. Building upon the many lessons learned, we provide the following guidance regarding face-to-face research across our health system.

It is the intention of the ISMMS to support clinical research activities in a manner that protects all subjects, staff, and maintains clinical care operations. Importantly, success will continue to depend upon our research community adhering to the following guidance. Please be aware that this guidance does not replace more restrictive policies that may continue to evolve within the Mount Sinai Health System.

Guiding Principles

For research staff engaged in activities necessitating them to be on site, we must follow procedures to maintain social distancing

• All meetings should be virtual
• Plan staffing to allow physical separation of employees in all areas including work areas, meeting/break rooms, etc. to maintain social distancing ( > 6 Feet)
• Stagger work hours, lunch breaks, etc; encourage outdoor seating areas for lunch breaks

• Encourage safety measures to protect staff

Comply with masking guidelines. All staff must wear N95 masks in all areas where study participants are seen

(https://www.mountsinai.org/about/covid19/staff-resources/safety-hub/ppe)

• Frequent hand washing with soap and water or alcohol-based hand sanitizer
• Provide disinfecting wipes/cleaning materials for routine cleaning of frequently touched surfaces such as workstations, keyboards, phones, microwaves, printers, doorknobs, etc.
• Employees who have symptoms of COVID-19 or who have sick family members should notify their supervisor, and others as required, e.g. Employee or Student Health Service, clinical department, etc., for guidance on staying home and clearance to return to work.
• Employees who appear to have symptoms upon arrival or who become sick during the day should immediately be separated from others and sent home with instructions to follow up with Employee Health or Student Health.

All participants coming on campus or to Sinai office sites must follow current COVID protections:

• The research team will contact subjects within 24 hours of visit(s) to conduct pre-visit screening for COVID-related symptoms and reiterate the visitor policy.

• All hospital/departmental/clinic rules regarding COVID-19 prevention must be adhered to once research subjects arrive on-site, including but not limited to pre-visit screening at an established ambulatory practice area, wearing masks, Visitor Policy, lab testing, etc.

• All participants should be made aware of the risks involved with traveling and being seen face-to-face. We encourage implementation of services to minimize risk, e.g., arranging Uber/Lyft rides, car services, etc.; negotiation for support for such by sponsors/funders should be pursued.
• Continued efforts should be made to minimize face-to-face exposure, both duration and number of episodes. Activities that have been/can be done remotely should continue to be done remotely (e.g., all or part of consent process, completion of questionnaires.) Activities tied to clinical visits should also be adopted to minimize time and disruption to clinic operations.
• Scheduling must be tightly coordinated to location and should reflect added time to avoid crowding in waiting areas, screening, etc. This should be coordinated at the local level.
• Recruitment activities taking place in clinic waiting areas/clinic office space must be consistent with current hospital rules and have the permission of the clinic.
• Sample collection and processing should follow institutional rules, including modifications currently in place for SARS-CoV-2.

Implementation:

• All projects need to have continued local and departmental approval for face-to-face visits.
• All projects are covered by this guidance, irrespective of the IRB of record.

• Pre-Procedure COVID Testing for Research Procedures: The CRU is available for pre-procedure COVID testing – nasal swab by appointment. Contact Kaitlyn Ennis, Kaitlyn.Ennis@mssm.edu for application and fee information.
• Contact Beverly Cooper of MSH Clinical Labs at Beverly.Cooper@mountsinai.org or (347 931-4417) to set up/update your research account to facilitate pre-procedure COVID testing.
• Please note that only pre-procedure testing is available for studies. If you have a symptomatic subject, you should refer them to their primary care physician for further care.
• Procedures that may increase risk of contagion spread, especially those that generate aerosols require approval by Infection Prevention and Control (e.g., sputum induction).
• Requests for on-site monitoring for Investigational Drug Services (IDS) must be submitted at least 2 weeks in advance for approval. Please contact # IDSAnnenberg IDSAnnenberg@mountsinai.org for appointments. We continue to support remote monitoring for clinical trials. For guidance on the institutional workflow developed to facilitate remote monitoring, contact Catherine Sinfield at Catherine.sinfield@icahn.mssm.edu.

If you have any further questions, comments or suggestions please reach out to Rosalind Wright, MD MPH at rosalind.wright@msssm.edu.

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, FIDSA, FACP
Dean of System Operations for Clinical Sciences
Icahn School of Medicine at Mount Sinai

DATE: October 19, 2021

RE: Clarification regarding on-site monitoring for clinical trials – vaccination requirements

With the ongoing challenges we face with the COVID -19 pandemic, we want to provide clarification on the vaccination requirements for monitors conducting On-Site Visits for clinical trials.

• All monitoring activities that can be virtual/remote should remain virtual/remote.
• For guidance on the institutional workflow developed to facilitate remote monitoring, go to Study Monitoring Policies, SOPS and Guidance
• If on-site monitoring is considered necessary, both duration and number of episodes for on-site monitoring visits should be minimized.
• Visits for On-Site Monitoring will be restricted to domestic monitors within the United States.
• Monitors conducting on-site visits are required to be fully vaccinated and show proof of vaccine at the visit.
• Given recent changes in the NYS travel policy related to COVID, domestic monitors will no longer be required to have a negative PCR test prior to their visit to our facilities. But all monitors will be subject to screening for COVID-19 symptoms.

Investigators determining that on-site monitoring is needed for their study must ensure the following:

1. Physical distancing guidelines in research related spaces must be able to be maintained.
2. The number of on-site monitors allowed per day is limited by the Department’s ability to provide appropriate, socially distanced space, and only one monitor per study is allowed on-site.
3. Masks are worn at all times on the premises.
4. No eating on the premises while monitors are here for their scheduled visit.
5. In order to accommodate the volume of monitoring requests, please allow sufficient time to schedule your visit with ancillary research areas where your monitor may need to visit:
   • Investigational Drug Service (IDS) – all visits to IDS must be scheduled in advance. Please contact IDS 2 weeks prior to the planned visit and limit the duration of the visit to 1-2 hour
   • IDS email information:
     # IDSAnnenberg – for non-oncology and oral oncology products
     #IDSRuttenberg – for oncology parenteral products/infusion
6. To Request clinical trial monitor/auditor access to Epic click here: https://researchroadmap.mssm.edu/industry/emr-and-epic-registration-of-clinical-trials/

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

Everyone,

It gives me great pleasure to forward the email from Vicki LoPachin which you should have already received. You’ll see that it describes the next step toward returning to normality in our research and educational enterprises. Effective this Monday, all vaccinated individuals will not have to wear masks or socially distance in non-clinical settings. Lab meetings, research seminars, classes, etc. should all be back to normal.

If you’re vaccinated, please be sure to get a vaccination sticker on your Mount Sinai ID card. Students: be on the lookout for emails from GSBS and Student Health on how to get your stickers; everyone else—all faculty, postdocs, and staff—should reach out to their department/institute administrators to get one.

And if you’re not vaccinated, please get vaccinated as soon as you can—for your own sake and to promote the health of your families, friends, and colleagues.

Many people have asked about the daily COVID-19 attestation app. We expect to no longer require this app—again for vaccinated individuals with a vaccination sticker on their IDs—very soon. We are just waiting for everyone to get stickers on their IDs.

We must of course remain vigilant and careful. Newly arising COVID-19 mutants will remain a potential threat which we must continue to monitor. But—we made it! Monday marks an amazing milestone for us all, recognition that this pandemic now should be in the rear view mirror while we get back to our normal lives and to the world-changing biomedical research that we do.

You can print out the attached flyer and post it or hand it out. A printable version of the table from the broadcast email is also attached.

Eric Nestler

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: April 09, 2021

RE:      Update for on-site monitoring for clinical trials

As we continue to face challenges in the ongoing COVID pandemic, we want to provide updated guidance on On-Site and Remote Monitoring for clinical trials.

• All monitoring activities that can be virtual/remote should remain virtual/remote.
• For guidance on the institutional workflow developed to facilitate remote monitoring, go to Study Monitoring Policies, SOPS and Guidance
• If on-site monitoring is considered necessary, both duration and number of episodes for on-site monitoring visits should be minimized.
• Visits for On-Site Monitoring will be restricted to domestic monitors within the United States.
• Given recent changes in the NYS travel policy related to COVID, domestic monitors will no longer be required to have a negative PCR test prior to their visit to our facilities. But all monitors will be subject to screening for COVID-19 symptoms.
• Investigators determining that on-site monitoring is needed for their study must ensure the following:

1. 1. Physical distancing guidelines in research related spaces must be able to be maintained
   2. The number of on-site monitors allowed per day is limited by the Department’s ability to provide appropriate, socially distanced space, and only one monitor per study is allowed on-site
   3. In order to accommodate the volume of monitoring requests, please allow sufficient time to schedule your visit with ancillary research areas where your monitor may need to visit:
      • Investigational Drug Service (IDS) – all visits to IDS must be scheduled in advance. Please contact IDS 2 weeks prior to the planned visit and limit the duration of the visit to 1-2 hour
      • IDS email information:
        # IDSAnnenberg – for non-oncology and oral oncology products
        # IDSRuttenberg – for oncology parenteral products/infusions
   4. To request clinical trial monitor/auditor access to Epic click here https://researchroadmap.mssm.edu/industry/emr-and-epic-registration-of-clinical-trials/

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

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: January 26, 2021

RE: Update for on-site monitoring for clinical trials

As we continue to face challenges in the ongoing COVID pandemic, we want to provide updated guidance on On-Site and Remote Monitoring for clinical trials. Supporting guidance and resources can be found on the ORS Research RoadMap Monitoring and Audits section here. A summary of the updates for onsite monitoring is provided below:

• All monitoring activities that can be virtual/remote should remain virtual/remote.
• For guidance on the institutional workflow developed to facilitate remote monitoring, contact Catherine Sinfield at Catherine.sinfield@icahn.mssm.edu.

• If on-site monitoring is considered necessary, both duration and number of episodes for on-site monitoring visits should be minimized.
• Any worker coming from outside NYS (from a non-contiguous state) to Mount Sinai Health System must have a negative PCR test within 24 hours of their arrival to NY and prior to their visit to our facilities. This is the policy of MSHS, and a regulation as set forth by our Governor. If the monitor plans to remain in NY for longer, a repeat PCR is needed on day four after arrival. Monitors will not be considered as essential workers, and therefore they are not exempt from state requirements.
• Any travel from high-risk areas (CDC Level 2 or higher) internationally is not advised
• If you have any further questions you can also reach out to Rosalind Wright, MD MPH at rosalind.wright@msssm.edu.

Guidance and Recommendations for Onsite and Remote Monitoring 

The last update from the Dean’s Office (7/30/2020) regarding study monitoring advised that monitoring activities that can be virtual/remote should remain virtual/remote until further notice, with only limited exceptions for onsite monitoring.  As the situation persists, the ORS has worked with the Department of Medicine,Clinical Trials Office (MCTO) to produce on guidance and recommendations for remote monitoring activities.  The guidance and recommendations may  evolve and we will continue to update the research community.

It can be found on the Research Road Map: Monitoring and Audits. There you will find a link to the SharePoint environment available to MSHS employees to access the documents.

Remote Access to EPIC for Monitors

As part of the guidance we describe how Mount Sinai provides restricted access to the electronic medical record, EPIC.  EPIC is certified by the Office of the National Coordinator for Health Information Technology (ONC).  The Monitor/Auditor is granted access only to trial subjects’ records and it is restricted based on date ranges / encounter numbers for research visits.  There is an unique password, read-only access to the EMR system assigned to the Monitor.  Monitoring is restricted to 3-5 days and access to records is revoked thereafter. An audit trail is available in EPIC.

We have made resources for remote monitor access available via Research Roadmap.  There are step-by-step instructions on “How To Request EPIC Access For Remote Monitors” this is for the research team and not to be shared externally of Mount Sinai. They are also located in the SharePoint environment accessible only to MSHS employees.  An SOP, Research 001: Remote Access to Epic for Monitors is available to be provided with the Monitor/Auditor to set-up an account, along with guidance for workflow once they have been provisioned an account. Mount Sinai Health Information Management (HIM) Policy for external collaborators to access EPIC remotely has been updated for external collaborators to access EPIC remotely including a confidentiality form (appendix 6) which must be completed by the monitor / auditor. This policy can be provided in addition to the SOP if requested by the Sponsor.

We encourage you to visit the Research Roadmap Monitoring and Audits and Research Roadmap information and the link to SharePoint environment. If you still need help, there are contacts listed within the documents in SharePoint to help answer questions.

FROM:

Scott L. Friedman, M.D.
Dean for Therapeutic Discovery
Fishberg Professor of Medicine
Professor of Pharmacologic Sciences
Chief, Division of Liver Diseases

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

DATE: August 28, 2020

RE: Prior Approval Required for all COVID-19 Protocols

This is an important reminder that all COVID-19 related studies must be submitted for review by the COVID-19 Protocol Committee prior to registering or signing agreements (contracts, collaborations, etc.), to conduct a clinical trial.

The streamlined process for submitting COVID-19 protocols for review is found here:  https://researchroadmap.mssm.edu/reference/covid-19-protocol-review-process-for-clinical-research/

Centralized review by the COVID-19 Protocol Review Committee ensures 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.

Thank you for your cooperation. If you have any questions please contact Research411.

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

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

DATE: July 30, 2020

RE:      Updated guidelines for on-site monitoring for clinical trials

We commend the research community for your patience with our reopening strategy and, in particular, your adherence to the guidelines set forth to ensure a successful reopening of clinical research studies across the health system thus far.  Building upon that success, we want to update the research community regarding on-site monitoring for clinical trials.  As of Monday August 3, 2020, we will be relaxing the restrictions as outlined below.

Importantly, this is not a return to pre-COVID normality and success will once again depend upon our research community adhering to the following guidance. As this remains a fluid situation, please understand this guidance does not replace whatever more restrictive policies that may evolve for the Mount Sinai Health System, for example restrictions on travel related to COVID hot spots.

Guiding Principles for On-site Monitors

• All monitoring activities that can be virtual/remote should remain virtual/remote; for guidance on the  institutional workflow developed to facilitate remote monitoring, contact Catherine Sinfield at Catherine.sinfield@icahn.mssm.edu.
• Need to minimize both duration and number of episodes for on-site monitoring visits.
• Individuals traveling from the New York/New Jersey/Connecticut/Pennsylvania and other states that are not NYS designated hotspots are allowed to do on-site monitoring visits. However, greater consideration should be given to those states at some distance from NYC as this requires travel that may have greater exposure risk (e.g., air travel).
• Individuals from states listed as hot spots on the New York State travel advisory list will not be allowed to conduct on-site monitoring (https://coronavirus.health.ny.gov/covid-19-travel-advisory).

Implementation

• Ensure monitors are aware of required safety measures
  • It is the responsibility of the research team to reach out to monitors within 24 hours of scheduled campus visit to conduct pre-visit screening for COVID-related symptoms and reiterate visitor policy.
  • All should be made aware of the risks involved with traveling to campus and steps to mitigate risks by masking, social distancing, practicing hand hygiene, avoiding crowds or modes of travel that increase potential exposure (e.g., subway, etc).
  • All hospital, departmental and clinic rules regarding COVID-19 prevention must be adhered to when monitors are on campus, including but not limited to screening and temperature checks upon arrival, Health System’s Visitor Policy, etc.
  • Plan visits/procedures to allow physical separation of monitors from other employees in all areas including work areas, meeting/break rooms, etc. to maintain social distancing guidelines (>6 feet).
  • Monitors must comply with masking guidelines https://www.mountsinai.org/files/MSHealth/Assets/HS/About/Coronavirus/MSHS_ProperUseFaceCovering-June24-2020.pdf using proper face coverings over the nose and mouth.
  • Frequent hand washing with soap and water or alcohol-based hand sanitizer.
  • Provide disinfecting wipes/cleaning materials for routine cleaning of frequently touched surfaces such as workstations, keyboards, phones, microwaves, printers, doorknobs, etc. in space designated for completion of monitoring activities.

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.

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

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

DATE: June 30, 2020

RE: Continued opening of on-site human subjects research

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 (e.g., clinical trials). As of June 8^th, Phase II marked the resumption of face-to-face visits including research not holding out immediate direct benefit to subjects (e.g., observational studies). We commend the research community for adherence to the guidelines set forth to ensure a successful reopening thus far.  Building upon that success, we will expand resumption of all face-to-face research in Phase III which will begin July 1^st with few restrictions noted below.  Thus far, return of staff on-site has been on a voluntary basis in coordination with investigators. As we expand research re-opening in Phase III, staff engaged in activities necessitating them to be on site will be required to come in beginning July 13^th which allows time for planning per guidelines laid out below.

We want to underscore that the COVID pandemic is far from over and restrictions on travel and our work environment may be reinstituted in the coming months. Researchers should prepare for that eventuality, even as they reopen more widely during this hard fought lull in the metropolitan area.

It is the intention of the ISMMS to expand clinical research activities in a manner that protects all subjects, staff, and maintains clinical care operations. Importantly, this is not a return to pre-COVID normality and success will again depend upon our research community adhering to the following guidance. As this is still a fluid situation, please understand this guidance does not replace whatever more restrictive policies may currently be in place within the Mount Sinai Health System.

Phase III Guiding Principles

As research staff return on-site, we must follow procedures to maintain social distancing

• Plan staffing to allow physical separation of employees in all areas including work areas, meeting/break rooms, etc. to maintain social distancing guidelines (>6 feet)
• Stagger work hours, lunch breaks, etc; encourage outdoor seating areas for lunch breaks
• All meetings should remain virtual
• Encourage safety measures to protect staff
  • Comply with masking guidelines (https://www.mountsinai.org/files/MSHealth/Assets/HS/About/Coronavirus/MSHS_ProperUseFaceCovering-June24-2020.pdf); use proper face coverings over your nose and mouth
  • Frequent hand washing with soap and water or alcohol-based hand sanitizer
  • Provide disinfecting wipes/cleaning materials for routine cleaning of frequently touched surfaces such as workstations, keyboards, phones, microwaves, printers, doorknobs, etc.
  • Employees who have symptoms of COVID-19 or who have sick family members should notify their supervisor, and others as required, e.g. Employee or Student Health Service, clinical department, etc., for guidance on staying home and clearance to return to work.
  • Employees who appear to have symptoms upon arrival or who become sick during the day should immediately be separated from others and sent home with instructions to follow up with Employee Health or Student Health.

• All subjects coming on campus or to a Sinai office site must follow current COVID protections
  • The research team will contact subjects within 24 hours of visit(s) to conduct pre-visit screening for COVID-related symptoms and reiterate the visitor policy.
  • All hospital/departmental/clinic rules regarding COVID-19 prevention must be adhered to once research subjects arrive on-site, including but not limited to pre-visit screening at an established ambulatory practice area, wearing masks, 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. We encourage implementation of services to minimize risk related to travel, e.g., arranging Uber/Lyft rides, car services, etc. should be considered if possible; negotiation for support for such by sponsors/funders should be pursued
• Continued efforts should be made to minimize face-to-face exposure, both duration and number of episodes. Activities that have been/can be done remotely should continue to be done remotely (e.g., all or part of the informed consent process, completion of questionnaires, etc. Activities tied to clinical visits should also be adopted to minimize time and disruption to clinic operations.
• Subjects at increased risk for COVID-19, e.g. age, obesity, diabetes, heart disease, etc. should be identified and research procedures should be modified or postponed to minimize risks.
• Scheduling must be tightly coordinated to location and should reflect added time to avoid crowding in waiting areas, clean rooms, get through screening, etc.
• Visits must be scheduled to minimize waiting/crowding to maintain social distancing and minimize the impact on clinical activities. These should be coordinated at the local level.
• Recruitment activities taking place in clinic waiting areas/clinic office space can be resumed if activities are consistent with current hospital rules, do not lead to increased crowding or unacceptable delays, and have the permission of the clinic.
• Sample collection and processing should follow institutional rules, including modifications currently in place for SARS-CoV-2.

Implementation:

• All projects need to obtain local and departmental approval before resuming face-to-face visits.
• All projects are covered by this guidance, irrespective of the IRB of record.

• Pre-Procedure COVID Testing for Research Procedures The CRU is available for pre-procedure COVID testing – nasal swab by appointment. Contact Joane Zephir, Joanne.Zephir@mssm.edu, for application and fee information.
• Contact Beverly Cooper of MSH Clinical Labs at Beverly.Cooper@mountsinai.org or (347 931-4417 to set up/update your research account to facilitate pre-procedure COVID testing.
• Please note that only pre-procedure testing is available for studies.  If you have a symptomatic subject, you should refer them to their primary care physician for further care.

Continued Restrictions

• Procedures that may increase the risk of contagion spread, especially those that generate aerosols or require close prolonged contact remain restricted for on-site visits (e.g., spirometry, sputum induction). Please contact the PPHS to discuss restarting these once a plan has been developed that has local approval, and other necessary input, e.g., infection prevention.

• On-site monitoring is still not allowed.  Notification will go out when the situation changes.  For guidance on the  institutional  workflow developed to facilitate remote monitoring, contact Catherine Sinfield at Catherine.sinfield@icahn.mssm.edu.

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 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.

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

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

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.

Essential Study Visit Guide – COVID-19_FINAL
TCI_CCTO- COVID-19 Response_03.16.20
TCI Clinical Research Update 3.20.20
COVID-19 Protocol Review Process for Clinical Research