At 5 o’clock on March 23, the world of clinical research at the University of Maryland, Baltimore (UMB) changed dramatically. Earlier that day, Interim President Bruce E. Jarrell, MD, FACS, announced in a letter emailed to the UMB community that as of 5 p.m., research restrictions would increase from moderate to severe, effectively shuttering hundreds of clinical research projects in light of the novel coronavirus pandemic.
In the letter, Jarrell explained the expectations of the new designation during this time of unparalleled change. “We expect that you will curtail all activities not critical to maintaining animals, unique reagents/cell lines, and essential equipment, at which point only 2-3 essential personnel [designated by the Principal Investigator] will be allowed in the lab and should be according to a defined employee schedule that ensures appropriate staggering," he wrote.
He continued, “UMB is proud to have some of the world's foremost experts in scientific fields most oriented toward fighting this pandemic and must support that work as much as possible. To that end, there will be further guidance regarding specific laboratories that will remain open while under Severe Research Restrictions. In general, these labs are associated with COVID-19 research, virology, and immunology.”
Of course, questions remained about the new restrictions and their implementation. That’s why on March 25, Jarrell was joined by Laurie Locascio, PhD, vice president for research, University of Maryland; E. Albert Reece, MD, PhD, MBA, dean, University of Maryland School of Medicine, and executive vice president for medical affairs, UMB; Natalie D. Eddington, PhD, FAAPS, FCP, dean, University of Maryland School of Pharmacy; and Scott Bitner, MBA, CPA, senior associate vice president and deputy CFO, for a virtual town hall that drew over 400 participants.
(Watch the video here.)
The informative question-and-answer session — which ran a little over an hour — ranged from administrative questions such as filling out timesheets to broader issues such as how to deal with National Institutes of Health grants.
Participants answered inquiries to the best of their abilities given the fluid nature of the COVID-19 pandemic. When asked when researchers could go back to normal working conditions in their labs, Jarrell, a surgeon, offered, “I don't think there's a magic equation. I'm an engineer, I always look for the equation. I don't think there's any equation here,” he said. “I think this is a judgment” that will be based on the advice of well-informed people, he noted, nodding to his fellow panel members.
“But it’s got to be safe,” he continued. “We’re not in the business of hurting people. We’re in the business of helping people, so whatever we do, we’ve got to make it safe.”
A transcription of the town hall has been edited for length and clarity.
Q: When will we be able to restart our research?
LOCASCIO: That's the most important question I think everybody has been asking is, when do we get to get back to work? And of course, as everyone knows, there's a lot up in the air right now. And we have to continually monitor the situation around us and watch what the governor is saying. And of course, pay attention to everything going on in terms of the increased numbers and the increased stress surrounding us in our state, and really our country. But when are we going to get back to work? One of the things that we had been discussing, I talked to President Jarrell earlier this morning, and we decided to put together a second task force. As most of you know, last weekend we had a task force, where we looked at what kind of restrictions we're going to lose on our research. And then what would be the trigger points from moving from our existing environment, which is normal operation to a more restricted environment, moving to moderate research restrictions, and then finally to severe research restrictions. And of course, we put that in place, the move to severe restrictions, earlier this week. Now, because the situation is constantly changing, we aren't sure where we're going to go next, or where things are going to end up in the next couple of months. We'd like to put together another task force that can consider: When do we reopen? When do we start having people come back to work? When can the situation be under control? Or when can we be in control, enough control of our own environment to allow people to come in back into work? And so this new task force we're going to put in place probably next week. We're still, honestly, quite in the middle of what I would say emergency operations where we're trying to get all of these new restrictions in place and make sure that we can have everybody safe and secure for the time being. Next week, when we launch this new task force, we're going to be looking at different scenarios for the coming months, depending on how the pandemic progresses and under these various scenarios of dynamic progressing, we'd like to figure out ways what would trigger us to be able to come back to work safely and secure thoroughly on our campus. And so I would say that's where we are right now. Again, a lot up in the air and I know everybody wants more definitive answers. I think that's what I can speak to as far as that topic right now.
EDDINGTON: I think we're looking at the same kind of drivers to help us make those decisions. As you mentioned, it's not going to be easy. But we need to have the data drive the decisions that we're going to make.
REECE: And I would just add that the way I see it is that I'm treating not just research as a scientist myself, but seeing it in concert with other activities. For example, we have reduced non-emergent surgeries significantly. And so the question we're asking today is, when are we going to restore that? Well, you can't, and certainly, it'll be a few weeks hence before we can even do that. It seems to me as if, as Dr. Locascio said, we will have to look at a number of parameters before we can even begin to restore some portion or some aspects of our work, but it certainly is not now, and it will have to be very much tempered by what happens with regard to the expansion or the transmission rate.
EDDINGTON: I agree. I think that we have to look at the data to inform the decision. I know that this is always an active time for research across the School of Pharmacy, and I think it's challenging for those faculty members that are not in their labs on a daily basis. I think we understand that. We understand the issues that we face. So I think it's important to make sure that our research community understands the decisions that we're making, and how we're making those decisions, and be transparent.
REECE: If I could jump in and make one other comment and say that on a positive note the NIH has actually extended the deadline. And so, in my own lab, for example, we're putting on a program project that was due March 13. And they extended it to April 15. And they're willing to do another extension. So I think, from the standpoint of just timetable, the NIH is willing to be very flexible. And if you have any questions, Larry Tabak, who's No. 2 at NIH, said call your program officer and they will be very flexible and they are going to make every effort to accept all grants. So I think that has been a very positive accommodation by the NIH that I think we should take full advantage of.
Q: What is the plan for non-clinical and non-human research projects?
LOCASCIO: In last week's email from President Jarrell, there was quite a bit of discussion in one of the attachments on non-clinical research moving from moderate to severe restrictions. I'd be happy to share that with you again, or share that more broadly, or ask President Jarrell to do that.
I should give my email. It's email@example.com. I'm more than happy to answer any questions directly. But I can also put out some guidance on that. In general, I'm going to say that if your work does not require face-to-face interactions and can be performed remotely and it has been approved by IRB, then yes, everything can continue as normal. I would say that the issue is really with on-campus research activity in a laboratory where people are going to be needing access to space, and they're going to be in close contact with others on campus, obviously. And then the other guidance that we did put out was to do with clinical research because a lot of that involves, of course, face-to-face interactions, and it also requires on-campus access to facilities and so generally what I would say is if it can be done remotely, it's been approved by the IRB, and it can be performed in a way that it doesn't require access to facilities, you should still be able to continue in that research.
Q: How should time be recorded for contracts and grants?
BITNER: All work that is being performed on a contract and grant, whether on site or off site, should be charged to the contract and grant. If faculty or staff are not able to perform any work, they should charge administrative leave, unless they are using another type of leave due to their personal circumstances.
Q: Does it matter whether the sponsor is federal, state, or private?
BITNER: The answer is no. We should follow that same guidance for working on contracts and grants across the board.
Q: Should the employee funding profiles be changed as a result of using administrative leave?
BITNER: For the most part, no. At this time, the employee funding profile should not be changed as a result of using administrative leave.
Q: Should the old administrative leave be charged to contracts and grants?
BITNER: Yes, the administrative leave will be distributed — prorated — across the employee funding profiles accordingly.
Q: Will the sponsors pay for the administrative leave?
BITNER: Currently, we only have approval from the federal government that the administrative leave for COVID-19 and that will be an allowable charge. This should also apply to all pass-through awards through non-federal sponsors that originated with federal funds. We have had some pushback from the Maryland Higher Education Committee that they will not accept these charges, even though they have been allowed by the federal government. We have not received any guidance from the state or private sponsors on whether they will allow administrative leave at this time. So we'll continue to treat these awards like federal awards until further notice.
Q: If the administrative leave will not be covered through the contract, how will it be covered?
BITNER: For those contracts and grants that will not be covered, the administrative leave will be transferred off the grant to a revolving account.
LOCASCIO: I wanted to just add that the federal government is being extraordinarily generous as Dean Reece mentioned, and also Scott. There has been an issue with a few contracts. We've heard from some agencies that people are being asked to stop work on specific contracts. If that happens to you I've been finding that they have been very open to appeal and sort of quick contract lot modifications so that they can accept or allow this to happen under this condition.
If you have questions about any specific contract or grant, a lot of this is general guidance that we're giving you but there are some very much specifics that you're dealing with that we can help with so please send in any questions to the sponsor program office. We will be able to field those questions, send them to the right people and get back specifically to you about issues with your specific contract or grant if you have questions. I'd also encourage you to, as Dean Reece mentioned, reach out to your program officer, reach out to the person who's the program director because right now we are not as a university going back more broadly to the agencies at the university level. But we do encourage you to go back to your specific program officer, program director, and tell them this is what's going on at my university. Is there going to be any issue? So I encourage you to reach out and be in contact.
Q: If we're using social distancing, what's the harm in doing our research?
REECE: We, again, have followed the governor's lead. The government has made a directive that we have to reduce the volume of contact that we have within the workplaces where there is that essential work, high-priority work to do. We have been admonished that people should try to work at home, stay at home as much as possible. So I certainly understand very much that, in fact, that under the moderate restriction we did that. We basically allowed research to continue unimpeded under that rubric, because we thought as long as people were taking the social distancing principle, then working would not be a problem. Under the severe restrictions research is really where the governor increased his directive that we really want to have people stay at home and basically out of contact and not have a lot of interaction. Which really is the attempt to really flatten that transmission curve that we're trying to do in accordance with the public health recommendations and the government mandate.
Q: If you are employed by UMB research, can your PI redeploy you to COVID-19 testing research?
EDDINGTON: This is a difficult one. I think my perspective is this might be something that a staff member is wanting to know now about research that might be going on. So all I can say for this is that I think that research, we don't have research in the School of Pharmacy that is so essential that is also looking at supporting research around the virus. So we don't have any examples of that. I do think that I can respond from my perspective. If the research that's ongoing in a lab in my school, that could be helpful and is high level, I would want to continue that.
REECE: If I think I understand the question, well, then I apologize if I didn't quite understand it. And that is I'm assuming this. We all live in a free country. So if someone is not being compelled to come back and do research or something vital research but I think that is all in support of trying to get to the right answer. I would be very much opposed to compelling someone or trying to insist that somebody must come back, that would be out of line. But I think that you have a number of research programs ongoing in the School of Medicine in particular that has to do with either vaccines or therapeutics or clinical trials related to the COVID virus and if an individual gladly wants to be part of that team, by all means. And if the team could use that person's effort, I fully endorse that. Maybe we could make a breakthrough. And we would all be happy and all been sharing, but it must be with some level of someone's willingness to do and not by compulsion.
LOCASCIO: I'll just back that up and say that everyone knows that we are allowing COVID-19 research to continue. And this is true, I think, across the United States. While there should be research restrictions across the U.S. and all the universities, almost across the board, people are still allowing COVID-19 research. But for a lot of reasons, people may just not be comfortable coming back to work for many reasons. And we all know that we're in the middle of a public health crisis. People have various degrees of pressures externally, various degrees of comfort being outside, various people that they could expose to COVID-19 if they brought it home. That would really be worrisome. And so I think I really would strongly back Dean Reece by saying please, don't feel compelled to be here if that is just not something you can do because of their level of comfort, or because of extenuating circumstances outside of your control. But I would say that we will allow COVID-19 research to continue in the middle of the public health crisis. So whatever we can do as a university to help would be wonderful.
Q: Are there any opportunities for researchers or bench scientists whose projects are not related to COVID-19 to assist in any other research efforts?
REECE: That's a very good question and a very magnanimous offer. And I would say that I obviously couldn't answer by saying yes, there is a particular need here and here, but my suggestion would be for you to contact a few people. I'd suggest you send an email to Dr. Kathy Neuzil. She is the Levine Professor and director of the Center for Vaccine Development. She has a bandwidth that would be able to give you some sense as to the need or possible opportunities. The other person I suggest that you contact is Dr. Matt Frieman.
Q: How do you record your time for grants and contracts during this time?
LOCASCIO: I think just generally, if you are still working and you're working remotely, you record your time as you normally would, because you get credit for working remotely on those projects. Time that you aren't working remotely, you want that as administrative leave. And on the grants, we'll be keeping track of time spent on administrative leave. On federal grants, that time is allowed. You can charge that time. On specific contracts it's unclear, which is why I said it's important to reach out if you have a question about your contract. But I would say continue to charge on your grant either as real time spent, or as administrative leave if you can't access your laboratory unless you receive specific guidance not to.
REECE: As Dr. Locascio said, and that is just to remind everyone that most of us have continued to work and even though you may not be physically in the lab to continue to work. Most of us are lab scientists. We're using this time to write lots of papers that we didn't have time to write. So we have an opportunity, we have an in-built opportunity to either write or rewrite our grants or write publications, manuscripts, that becomes a real-time effort that you can record. So don't undermine all the wonderful work that you're doing. Not necessarily in the lab, but outside the lab.
Q: When do you think this will all be done?
JARRELL: I don't know any better than any of you. I think that Dr. Locascio gave a good answer and that is we need to be prepared to iteratively increase research, as the local environment allows us to do so. And that's going to be a judgment, there's not going to be some magical moment. It will be based also on the number of safety things put into place to make sure that it's safe for people to come back in the labs. So I think we don't want the labs to not be operating in person or only remotely. So obviously we're in a planning process already on what would be the steps and what would we need to put into place to make that happen?
Q: For those of us that are clinically active and will respond to the clinical demands of the pandemic yet have budgeted efforts in time that we would necessarily reduce to meet our clinical duties. Do we have to do anything regarding notifying changes in our percent effort?
REECE: You know, we're funded by the NIH, for example. I wouldn't think you need to do that just now. I think that if this thing goes on for a very long time, then that may be a possibility, but given the fact that it's so unknown, I would advise not to do anything just now. I think you're fine.
JARRELL: If you want to defend yourself, keep records to show the amount of time you're working in the lab, because that would be one other piece of evidence to say yes, I'm taking my research seriously.
LOCASCIO: And depending on the timeline of work and deliverables promised, you know, as it progresses you should probably talk to your program officer if it goes on for an extended period of time, as long as it doesn't go below 25 percent.
Q: So my question pertains specifically to patients who have already been enrolled into a clinical trial and are receiving an investigational drug. Do we need to seek advanced permission to have these clinic visits maintained?
JARRELL: The general response is, you have to balance a number of things and you always have to do the same clinical research. So our first priority is to maintain patient safety and welfare as the driving goal here. If a subject is already enrolled in a clinical research trial, receiving a medication or an intervention, and withdrawing that medication or an intervention would be harmful to them then obviously you should not be stopping that medication, and you should be continuing to care. Now, you might want to ask yourself a question about how frequently do I need to see this subject and follow up, etc., because the other thing you're balancing here is that you just finished commenting that your patient's immunosuppressed. And so you certainly want to limit their exposure to COVID-19, but the same as you want to limit it to yourself, and they're perhaps even more vulnerable than you are. So you need to balance those various things to try to optimize the care. My advice to you would be where there's a question, you ought to talk to the IRB chair and get his advice as to how he would balance these things. And if you're concerned about that, the institutional official, Susan Buskirk, has the authority to make the decision about something makes sense or doesn't make sense. What we didn't want to have happen was business as usual. We're doing clinical research. There's no harm in pausing this, if there's no harm in pausing this, you should pause it, if there's harm in pausing it or if it's a serious disease, and you need to continue the treatment with the hope that it's therapeutic, then that's the position you want to be in. But the bottom line first is subject safety and welfare and withdrawing medication might not support the subject's health and welfare.
Q: Are we looking to research labs that have capabilities to fast track testing, etc., to fill in gaps that the hospital had?
REECE: First of all, let me, I'm always very excited when I hear research faculty want to help out in something that's practical, needed, important, and imminent. And I would say, when he said, email, let me tell you why we are using as a research group working with a clinical group, and trying to fast track testing as we speak. I never want to turn down volunteer work. I mean, the fact that you're eager and willing to either volunteer or give ideas or I don't want to turn that down. So send me an email because at this moment we think we are on something positive, but I always want to have an alternative. You may have a brilliant idea, and I want to hear it. So send me an email and I will make sure that we will incorporate your ideas or your group as well.
JARRELL: One constraint that we have, of course, is if we're actually testing for the virus, or things such as that there are a lot of State Department of Health rules which we have to work with in order to stick with the law. So right now, we do have to be careful about testing that's not in a certain approved kind of situation. So just be aware that there are constraints that the Department of Health puts on us.
Q: Is the IRB continuing to consider requests at this time?
Q: Will there be an extension on the tenure clock for junior faculty?
JARRELL: The IRB was the first group to go completely 100 percent teleworking. They've been teleworking for a long time. In terms of phasing that in, they are fully engaged and they are considering new protocols, etc., with the proviso that when something's approved, it doesn't necessarily qualify under the current restrictions, but as soon as things would change, you'd be able to go ahead with the research.
The second question, I think Dr. Ward answered that yesterday. The regents have been very generous to the chancellor to allow a liberal interpretation of our policy, our policy we just recently changed to allow to, I'm going to put quotes around the word "automatic." So if you have family obligations, like a new child in your family, you're allowed up to two years. We had the liberty to allow a third year. And I think the answer that I would give at the campus level was we would want a very liberal interpretation of extending the tenure clock.
Q: What is the criteria that will be used to bring things back to normal order?
JARRELL: I think it's going to be a combination of things. I think you already heard that we're following the lead of the governor, you should be all very proud of the position that the governor has taken in terms of being in front of this whole process. I've been very pleased with what he's done. And so we've tried very hard to stay in mind with his thinking on this. So one measure would be that the state is taking a more permissive view on this. And the second determinant would be again, the availability of safety equipment. So you all know that there was a huge rush on N95 masks and other protective equipment. And were that to become a lot more available, that would be a second variable. A third variable we would be to look out into the community. So you may have heard Dr. Fauci speaking this morning of how some communities are very hard hit and other communities have not been hard hit and Maryland happens to be one of those where we have done a good job in containing this. And we can liberalize, that would be another way to make that judgment. I don't think there's a magic equation. I'm an engineer, I always look for the equation. I don't think there's any equation here. I think this is a judgment. And it'll be based upon the advice of well-informed people around the group of the people you see on the screen and others, listening to the best advice. Having said all that, you know, research is like the economy. And although I've heard it said, you flip the switch, and it suddenly starts; it doesn't work that way for research, I'm sure. And so the longer we're out of commission, the more difficult it's going to be to get things back up and running and labs working and people efficient and generating the ideas that we need to have, etc., etc. So to me there is a compelling reason to get it sooner rather than later. But it's got to be safe. I mean, we're not in the business of hurting people. We're in the business of helping people, so whatever we do, we've got to make it safe. So that'll be a major, major part of the judgment.