General
Regions that are opening May 15 have to see a decline in COVID-19 cases and hospitalizations for 14 consecutive days. NYC has the least amount of metrics met for reopening. Why are we going against the mayors guidelines, risking our safety?
Medical research is considered essential by federal, state, and local guidelines.
Has the Mount Sinai leadership looked to practices and guidance from international contexts and bodies that have had success reducing transmission. Given the empirical evidence that NYS, NYC, and the CDC have not provided sufficient policies and action to protect our population, why should we continue to relay upon guidance provided by these entities?
We are following insight from all sources as well as relying on our own considerable expertise and experience.
Is there a pre-determined indicator for whether phase 1 is not as successful as we anticipate it to be? What event will be the threshold at which point we decide that we need to ramp up restrictions again? Or will we be assessing how we do day-by-day and making decisions on a case-by-case basis?
We will be monitoring the health of our research staff extremely closely. Success = no increased rate of infection. We are confident in this outcome–if people follow all precautions–based on finding that folks who have been working in Covid labs full time at 100% capacity over past two months show no evidence of increased infections.
Federal guidelines for essential workers: Workers, including laboratory personnel, that perform critical clinical, biomedical and other research, development, and testing needed for COVID-19 or other diseases.
As noted above, all medical research is considered essential.
Dr. Nestler, I would say that besides clinical trial research. Most of our "medical research" would not be considered essential and do not directly affect patient lives...
That is not correct. All medical research is considered essential.
There has been no mention of the employees being placed in the shared work program during the town hall meetings; having to find out last minute was disappointing as part of Mount Sinai family.. Why?
The shared work program has and will continue to help the medical center contain its very large financial losses. More information about this from dept/institute administrators.
Clinical Research
Regarding clinical research, how are we implementing social distancing, PPE, cleaning protocols, etc.? Also, how are we handling at-risk cohorts and/or at-risk researchers? Is this voluntary?
See website for specifics. Guidelines for resumption of outpatient clinical work are provided in detail.
For clinical trial groups, will a 25% ramp-up be in place as well for coming in to the office? Or is clinical research only focused on “come in when a research patient for an essential trials is coming in”?
Ramping up clinical trials is not based on a 25% rule for bringing subjects in for face to face encounters. Rather, these visits will be guided by institutional guidelines discussed at the Town Hall and as outlined in detail on websites. Please follow.
Why not ramp up ALL human research in a similar manner as the faculty practice and in a similar manner as wet lab research. This is a great set back!
Out of an abundance of caution, phase 1 is focused on For Benefit Interventional studies. There will be a phased approach taking into consideration the relative benefit of the studies, the impact on clinical activities, and the availability of remote options.
How about human research core facilities for non covid research?
See websites for specifics.
When can we resume human non covid research?
See guidelines on websites.
Is there going to be a broadcast email regarding non-covid clinical studies? What studies can start enrolling from May 18. If PPHS is going to review IRBs and notify us if we can start our studies on phase 1?
Yes. Stay tuned. And watch websites.
Would we be able to re-start screening and enrolling for our clinical trials, or is the May 18th date only for ongoing subjects?
Phase 1 will focus on enrolled subjects that require face to face visits for ongoing treatment.
Am I correct in understanding that if we need pros to outweigh cons then participants who do not receive direct benefits in a particular protocol will be seen in person in phase 2 but probably not phase 1? What are your suggestions?
Correct, Not for Benefit studies are not included in phase 1. Please see the more detailed announcement from the Dean’s office and Dr. Glenn Martin from PPHS that was sent 5/14.
To be clear- we can begin enrolling in new trials if the PI determines the benefits outweigh the risk, correct?
Yes
Are we free to resume (non-COVID-19) trials and clinical research work where patients are already attending a clinical site for other reasons? In other words: can we resume consenting and collecting data and tissue for clinical research, when the patient is already attending the clinic/office, (their primary reason to attend, is not for research).
Yes. See websites for specifics.
If clinical trial visits are being held at other MSHS sites such as MSW, where should the pre-visit screening visits be done?
All sites will be open.
Are there locations for pre-visit screenings other than the main campus (i.e. for studies conducted at MSW, etc)?
Yes, all campuses.
For our MS Union Square clinical research patients, can they go the MSUS or MSBI covid screening sites? It is added risk to ask them to go first uptown and then come downtown.
Yes. See websites for specifics.
For research at MSBI, do subjects need to be uptown for pre-screening or will there be a downtown pre-screening location? Also, for subjects who are already enrolled in a clinical trial and have been monitored remotely during the pandemic - do we need to do this type of onsite symptom check before seeing them in-person?
All sites will be open.
Please answer the question about covid screening sites for clinical research patients at MSBI/MSUS.
All sites will be open.
Since there are so many asymptomatic carriers - this is a problem re “screening” patients - unless some rapid viral testing becomes available….
As you know, this is a national and local challenge. We are following all progress by federal, state, and city agencies while adding our own expertise.
Is on-site clinical trial monitoring allowed at this time?
On-site external monitoring visits for active clinical trial continue to be suspended. However, the institution can guide investigators on the workflow solution developed to facilitate remote monitoring. For further information, please contact: Dr. Catherine Sinfield at catherine.sinfield@icahn.mssm.edu
Will we need to submit to pphs to resume in person clinical trial visits? If so what is required?
Yes. See websites for specifics.
Is it still the standard that PPHS has to approve clinical trial reopening?
Please see the more detailed guidance announcement that was sent via the Research Listserv on 5/14 and posted on the Research Roadmap under Dean’s Guidance.
How will the IRB be involved in approving resuming research?
Per usual policies.
Are IRB modifications required to resume face to face research activities?
See above.
In regards to essential clinical research visits that will need to occur in person will we still be required to send these specific scenarios to the IRB for approval?
See Above
For our Industry sponsored clinical trials where monitoring is required, is there a method to provide limited remote access to the EMR for source document verification? If yes, who can be contacted for additional details?
The research informatics team is working on a more streamlined solution facilitating remote monitoring and there will be guidance provided on that soon.
What about research studies in which there is patient recruitment from our sites (like the ED)?
Don’t understand question. Covid research remains a priority.
Interventional trials have been mentioned, What about non-interventional trials, that collect information in an "opportunistic" fashion, for multiple studies?
Clinical research studies can begin to ramp up. Check websites for guidelines.
Can you please comment on the availability of Center for Biostatistics support, for development of new, non-COVID related projects?
Center should be available to help. Contact them directly.
COVID-19 Testing & Contact Tracing
Will testing be available off main campus?
Yes. All campuses.
Will the antibodies testing only be done at MSH?
No. Multiple sites.
Will antibody testing be available closer for those employees who live outside of the 5 burroughs?
Yes. All campuses.
Since people with antibody can still get re-infected, can antibody-positive employee still request to have Covid-19 virus test?
Yes, anyone who is symptomatic should and will be tested for virus.
What about antigen testing? Is it useful and available at the present time.
Nature of virus testing is also changing rapidly. Follow websites.
What kinds of antibody tests will be used?
This is rapidly changing. We will provide updates on websites.
Is antibody testing required?
No
Just to be sure, we will not be charged for the the antibody tests right?
No charge to employees or trainees.
Can family members also be antibody tested for free?
No. Not at this point.
Will there by a Mount Sinai antibody testing site in NJ?
We are evaluating this, but likely no.
I completed the EH antibody redcap survey a week ago and haven’t been contacted yet. Is there a different method to request a test?
Correct procedure. You WILL hear back! We ask people to be patient as we need to test 40,000 employees/trainees.
What are COVID-19 statistics among COVID-19 research personnel?
Detailed data will be made available when analyses are complete, but we’ve seen a lower risk among research and clinical personnel compared to the general population.
As a PI, if one of our group becomes symptomatic during this period, do we have a “contact tracing” mechanism and coordinator in place such that our Dept/Instit. can be aware and be proactive. Given the range of symptoms that patients have displayed, do we have a list to work from. Fever alone should not be the only symptom…or is it?
Contact tracing will be instituted but it’s not yet in place per NYS guidelines. For now, people exposed should simply monitor themselves closely (see websites).
A colleague has been on leave for close to two months after positive COVID-19 test. You’re saying he can be cleared to come back and his colleagues will be safe so long as he is wearing a mask - even though he has sporadic coughing? Is he still contagious with these coughs?
Clearance should be governed by EHS or student health.
Deliveries & Supplies
Will the loading docks be open to receive deliveries and distribute the packages to the corresponding labs?
Yes, deliveries will be permitted. Loading docks have remained open during the ramp down time.
We need gases to start our instruments. Are gas suppliers are allowed to come. Also some instruments need servicing. What are the protocols for these?
All supplies and deliveries are allowed. (They never stopped.)
Hiring & Visa Extensions
Can we proceed with hiring staff on gift money for research? I.E. post doc fellows
Yes, but must fit within approved budgets.
Will we still be able to hire research personnel that were slated for hire and whose hires were put on hold during the closure?
Yes, hiring on grants should proceed. Hiring on seed funds is possible but must be within approved budgets.
What about visiting research scientists, whom are part of the grant work?
We are evaluating a visitor policy now. Stay tuned. Visitors will be allowed at some future point soon but not yet.
Do we know if VISA applications overseas are being processed? The consulates are closed in many regions.
Please work with international office and alert us if obstacles are encountered.
Is there any concern for those who need to extend their H1B or J1 visas sometime soon.
Please work with international office and alert us if obstacles are encountered.
Will candidate post-docs oversees to be hired on work visas be permitted to move forward this summer at Mount Sinai?
Yes, hiring may proceed.
Dr. Nestler, can you claify the summer intern policy? Is the decision finalized, I.e. should we alert our summer students that they will no longer be able to intern?
We should assume that no summer interns wil be permitted on campus. This is very unfortunate but unavoidable.
A high school student has reached out to me to volunteer in the summer for lab work. An undergrad is also asking about physician shadowing. Do these fall into internship that will not happen this summer?
Unfortunately, summer interns won’t be allowed on campus.
Will this be compiled into a summary/guidance document for reference and dissemination? Or will this portion of the PPT be shared?
Link to PPTs and Video.
researchroadmap@mssm.edu looks like an email address—do I understand correctly that this is a website? Perhaps it should be researchroadmap.mssm.edu
Correct address: https://researchroadmap.mssm.edu/rrm/
Went into researchroadmap@mssm.edu but cannot navigate to EvHS. Pls advice
Here is the correct link – https://researchroadmap.mssm.edu/reference/covid-19-guidance/#ehs
Labs
Why is safe for covid-19 labs to do research at full capacity but is not safe for labs NOT working with covid -19 to come at even 50% capacity?
We think it is safe but out of an abundance of caution are ramping up slowly.
Is the 25% capacity per lab, 25% the number of total people in the lab across the entire campus or per area (as in 25% of the lab in wet lab space, 25% in animal procedure space?)
Every area should have 25% of normal human density.
Dr. Nestler mentioned about 1 person/ bay in research labs, unless the bay is really spacious. In our lab at Hess, for example, each bay has 4 research benches, which are actually spacious (6 ft distance possible if people sit diagonally). Could you elaborate a little please?
Use common sense. Overall human density in any given area should be 25% of normal.
As mentioned, given that rotation students are encouraged to return, will safety officers be notified of which labs will have rotation students, so that if a trainee and post-doc mentor are in closer proximity for the sake of learning a new technique, etc., it will not lead to an immediate penalty of the lab, as a whole?
Yes. Common sense will prevail.
Are the labs working on Covid-19 research also are subjected to the social distancing rules and will operate at 25% like the rest of the other labs?
Covid labs can continue at 100% capacity.
Will graduate and MD/PhD students be able to rotate through labs this summer?
Yes
I work on the 21st floor in Annenberg where there is currently no lunch room for wetlab employees. Is there going to be a temporary room on floor 21 where we can have lunch without worrying about taking elevators or stairs to different floors to find a lunch location?
Thank you for pointing this out. Rm 21-230 will be made available for lunch/breaks.
PPE
How will PPE be obtained for lab members?
See website for specifics.
Will masks be provided for the coordinators conducting in-person visits for clinical trial subjects?
Yes
Can you wear your own mask or have to use an issued on for lab research? What kind of mask issued for lab research ? Surgical?
We recommend using issued surgical masks. Regular surgical mask.
About the mask to go to animal facilities, could you clarify if we need to change mask in the dressing room or if we can get inside with a mask we wore outside the facility?
The vivarium will provide PPE so for consistency it is best to use the masks provided by CCMS when entering the facility. Note: In general, masks are NOT required in the vivarium, but if needed are available as above.
Are cloth face masks acceptable for wearing in labs?
While individuals can wear cloth masks to work, we encourage everyone to change into a surgical mask in the labs. The cloth masks are not made as consistently as are the surgical masks. Of course, the most important thing is for everyone to wear some type of face covering at all times while on campus.
What about providing dispenser with sanitizers for the PI's offices and admin offices?
Hand sanitizers now available on all research floors in several locations.
Social Distancing on Campus
Will there be reprecussions if you report if PI is forcing you to go into the lab even if I am just a grad student? I do not feel safe going in now.
Absolutely not. No repercussions. Return to campus is voluntary in phase 1. Anyone who feels pressured or coerced by a PI should let us know. Use feedback form, report to HR, alert chair/director, or contact Dr. Nestler directly.
Is the school library open as well?
Library will begin to reopen but will function largely remotely. Please see websites.
How often will common/shared areas, conference rooms, and lunch areas be cleaned?
Everyone is responsible for cleaning up after themselves.
What are the recommendations for commuters?
What are the recommendations for commuters?
There is concern related to public transportation. Any possible help in that area?
I don’t see how we can help. Remember, phase 1 is voluntary, which gives people more time to plan. By the time phase 2 occurs we expect NYC and tri-state authorities to ensure the safety of public transportation.
How safe is it for those individuals that have to take the subway to work?
Based on the observation that our staff–a large fraction of whom come to our campuses via subways and buses–show lower rates of infection compared to the general population, we are confident that people can get to work via public transportation very safely.
Are there best practice guidelines from the institute for the use of mass transit safely to reduce the potential of compromise?
See Above
Some people will be driving now to avoid public transportation. Any possible parking help.
We will, unfortunately, have to return to normal parking conventions; we don’t yet have a date when that will occur. As everyone knows, parking capacity is very limited in proximity to our campuses.
Will parking still be free at the Sinai lots so that we can drive into work rather than taking the subway?
See answers above.
Will the free parking for employees continue?
Only for a limited time. Specifics to be announced in the ensuing weeks.
Will parking continue to be supported for essential COVID-19 supporting workforce?
See above.
Will parking meters continue to be free for Sinai workers? What about Mt. Sinai parking lots?
See Above
Since there are many of us who commute in from outside the city, are there any plans to ramp up shuttle services and/or offer free shuttle passes?
This isn’t feasible given diversity of locations from which our employees and trainees travel. See above regarding public transportation.
Is the Mount Sinai Shuttle system still working?
All shuttles running as scheduled and we added second buses to the Elmhurst and Westside routes to enable distancing.
Have the Shuttle buses been cleaned regularly?
This is important and we will do our best to maintain a high level of housekeeping and cleaning.