Yale Psychiatry Grand Rounds: July 10, 2020

July 10, 2020

Information

Departmental Talk: Research Reactivation

Stephanie O'Malley, PhD, Elizabeth Mears and House Jameson Professor of Psychiatry; Marina Picciotto, PhD, Charles B.G. Murphy Professor of Psychiatry and Professor in the Child Study Center, of Neuroscience and of Pharmacology

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00:00Research in a phased way so that they
00:03can get some experience with reopening
00:05across the entire campus as the pandemic
00:08wanes and we're fortunate to be in
00:11a state where things are improving.
00:13As John has talked about and they're
00:16doing it in such a way that if they
00:19need to tighten campus access that they
00:21could so phase one which were still in
00:24is one in which campus access is limited
00:27to those are absolutely necessary to
00:30be there for the research activity.
00:33Um, and during this period the
00:35laboratories have been opened so the
00:38basic labs here in the Department,
00:41psychiatry or now open.
00:43And there is also some opening up
00:46of certain clinical research which
00:49I'll describe.
00:50And then face to is what's coming up,
00:54which is anticipated to reopen in
00:56July of this month around the 20th,
00:58and this broadens access to campus
01:01for faculty, staff and trainees.
01:03And this is regardless of whether they
01:05absolutely have to be on campus so long
01:08as if there is continued appearance to
01:10the guidance on physical distancing,
01:13room density in public safety measures.
01:15However, they do recommend that
01:17people work from home if they can,
01:20and sometimes that.
01:21Because it's not possible to
01:23maintain social distancing,
01:25physical distancing,
01:26or reduce room density.
01:28If everyone's at work at the same
01:31time and then finally phase three.
01:34Is in the future,
01:35we don't have any guidance
01:37about that at this point,
01:39and that would be pretty much an open,
01:42much more open arrangement so.
01:45What I want to emphasize here for people
01:48that are doing human subjects research
01:51that there is a process for getting this
01:55approved and this involves an application
01:58for humans to the human subjects,
02:00Research Review Committee an it's
02:03done through the EHS integrator.
02:06Um, this this is reviewed.
02:08Your application is reviewed by a
02:11committee that's chaired by Eric Balaskas,
02:14an John Dovidio or Jack the video,
02:17and they.
02:18Sometimes they will look at
02:20some of those themselves,
02:22but it does come to this committee there,
02:26three subcommittees to get
02:28your proposal reviewed.
02:29You submit it through the EHS integrator
02:33and there is a link in the research.
02:36Yale.edu page that gives a video
02:38about how to do the submission.
02:40I don't think it's very difficult,
02:42but maybe someone like Marina can
02:45tell us since she's done it already.
02:48And what I want to emphasize is that
02:50the human subjects review committee
02:52does not evaluate the science,
02:54but rather your plans for meeting yell
02:56guidance for reopening with the goal
02:58of minimizing risk to participants,
03:00staff, and the community.
03:01And the other thing I wanted to let
03:04everybody know about Yale's policies
03:06and guidelines are really trying
03:08to be In Sync with state guidelines
03:11for reopening so that there is
03:13a sort of a structure here that
03:16dictates some of what we can do.
03:18So when you submit to the HS integrator,
03:21I want you to be on the lookout for
03:25emails that you might get from HS because
03:28it's a committee could send you
03:31questions about your protocol.
03:33And ultimately, just because the
03:35Dean or John has approved your
03:37protocol or someone else is approved,
03:39the protocol, the final approval
03:41really comes from the Provost Office.
03:43And that's only after it's been reviewed
03:46by the human subjects research committee.
03:48So that's a general overview
03:50of what happens there,
03:52and the let me see if I can get this to.
03:57But I think I can illustrate some of this
04:00by talking about what's already occurred.
04:03For human subjects research with.
04:06And during phase one.
04:09And I know that there's some questions
04:10or comments that might be coming in,
04:12and I can't really see them
04:13while I'm looking at my slide.
04:15So I'll look at those afterwards.
04:16We get back to them.
04:17If you have some questions at the end.
04:19So, uhm.
04:21So during phase one beyond
04:23the basic labs opening up,
04:26it was possible to open up human
04:29subjects research that was involved.
04:31A clinical or hospital setting where
04:34the participant needed to be present
04:37for otherwise necessary medical care,
04:39and the research aspects of the visit or
04:43carried out in concert with that care.
04:46So what that meant was if
04:49somebody was coming too.
04:51At the Cancer Center.
04:54For their cancer treatment,
04:56a research they could be engaged in
04:58research that occurred at that appointment.
05:01Now there are a lot of limitations to that,
05:04and I'll show you those some
05:06of those with the next slide,
05:09but that was one aspect and you couldn't.
05:12You couldn't be seeing patients
05:14separately from the Times
05:16that they would be coming in.
05:19There are other studies that were
05:20prevented if someone was being treated
05:22as part of a therapeutic protocol,
05:24so it could be that someone was receiving
05:26care that would be to their benefit,
05:29and it could be done in that context.
05:32At.
05:32One of the important things is
05:34even if your study was approved
05:36to continue during phase zero,
05:38it must be approved for phase one.
05:42And now they have these guidelines in place,
05:44and the one of the Sticklers That's
05:46one of the requirements that has
05:48been there is that it must be
05:50in University approved spaces.
05:52So what that started off with it could
05:55be in spaces that were managed by Yale,
05:58New Haven Hospital or by Yale Medicine.
06:01Now they're trying to open that up.
06:04So most recently the Alzheimer's
06:06unit has been approved for research
06:08that meets these criteria for phase
06:10one research an the why CCI Church
06:13Street Research Unit is now approved.
06:16So and I believe they will be open on Monday.
06:21So if you have a phase one human
06:24subjects research protocol an you've
06:26done everything you can to limit the
06:29contact with patients and all you
06:32need to do is draw blood or do some.
06:35Teaching or something in person periodically.
06:37At this time the place to do that would
06:41be the YCI Church Street Research Unit.
06:45If you're at an off campus
06:46site that's not currently
06:47approved now, the HR you
06:49itself is not yet available,
06:50but I think there are plans
06:52that are under way to try to at
06:54least free up a couple of beds.
06:56I think some of those beds are being
06:59used by the hospital currently.
07:01The other piece that's gone on is
07:03there some areas that are shared
07:06spaces or used by many investigators,
07:08such as the Pet Center in the MRCC,
07:11and they have been working on umbrella
07:14plans that sort of outline how work
07:16in those centers will be done safely,
07:19and then investigators that are using
07:21those sites will indicate that they'll
07:24comply with those safety plans,
07:26so there's a lot of lot of complicated
07:29issues related to getting those set up,
07:31but I.
07:32Believe the pet plan has been
07:36approved in the MRCC is in process.
07:40So one of the issues I brought
07:41up in I'm on the committee,
07:43so I can certainly try to help you.
07:46Sort out questions that might come up
07:48and I can talk to people to get answers,
07:50but one of the things that I've
07:52been arguing for is the idea that
07:54how are we going to get CMH?
07:56See in the VA open and.
07:59Really,
07:59I think one of the past.
08:01The VA's I believe has some plans
08:04and CMHC is working on some as well
08:07and Michael can say more or Chris,
08:10but these could be.
08:11I don't think he'll plans to manage.
08:14They can't manage the same agency and the VA,
08:17so I think if we can come forward
08:19with a plan for how will manage these
08:22guidelines then that would could get
08:25reviewed for the institutions as well.
08:28And then people could.
08:29Say that it would be complying
08:31with those plans,
08:33so that's a general overview of
08:35phase one clinical research,
08:36and this is an example of this
08:39kind of outlines.
08:40What people see when they go into
08:42the HM S Integrator for submitting
08:44a phase one protocol.
08:46So there's a request to have a
08:49brief summary of the research plan.
08:51Only 250 words.
08:52That kind of talks about what your goal is,
08:56but how you're going to meet
08:58the guidelines in the case of.
09:00Is one you would have to provide
09:03some information about participants
09:04so that we would know that it meets
09:07the guidelines of either being seen
09:09in clinic because they need to
09:11be seen or therapeutic protocol.
09:13And then one of the big folk foci
09:16has been how well do these protocols
09:19integrate in with the current
09:21clinical care system.
09:23So you may know from some of
09:25what John is presented that the
09:27hospitals are operating it.
09:29You know, they also need to D densify,
09:32and so they have fewer patients
09:35being seen at any one time.
09:37They are implementing a lot of procedures
09:40to keep everybody safe and they need.
09:43You need to coordinate with.
09:46Ticket.
09:47To not interfere with the clinical
09:49service and so they also want to
09:52know that you can be coordinated
09:54with clinical care service and who
09:56approved it and the it'll ask you about
09:59what you've done to reduce the time spent
10:02in face to face contact and efforts
10:04to limit this such as remote consent.
10:07The questions asked about the location
10:09of the research to make sure it's
10:11in their proof site an you have to
10:14talk about who will be there and
10:16they want only essential staff.
10:18An acknowledgement that you're going
10:19to be sure that everybody is trained
10:22in the use SUV and provided with PE,
10:24and that's going to be consistent across
10:27anything that would get submitted.
10:29And then finally the you have to provide
10:31information vector safety procedures,
10:33plans for disinfecting your iPad that you
10:36use to get ratings from the participants.
10:39For example,
10:39your plans for use of shared resources.
10:42Andy densification plans.
10:43So these safety plans will be
10:46there for any kind of protocol,
10:48so even in phase two,
10:50those will need to be included.
10:52So this gives you a sense and what the.
10:56What they've done is actually posted.
10:58These questions on the website so
11:00that you know what you need to get
11:03together before you do your submission.
11:05And something like that will be
11:08happening in phase two as well.
11:10So in phase two,
11:11now the research is going to be
11:14opened it up and it does not have to
11:16be people that are in in therapeutic
11:19protocols or an only being seen
11:22for their clinical appointments.
11:23So this would cover all other
11:26human subjects research.
11:27The again,
11:29you'll have to submit your
11:32protocol they're working on.
11:35Finalizing the integrator.
11:36Questions that you would need to respond to.
11:40And they are trying to work on the
11:42questionnaire such that it's designed.
11:44So you'll be asked to affirm that you're
11:47complying with social distancing safety.
11:49Andy densification restrictions
11:50and requirements of phase two.
11:51So when I buy the why this term deed,
11:54densification is really about cutting
11:56down on how many people are in a
11:59space that you know the space should
12:02allow for people to be 6 feet apart.
12:04An at 50% of occupancy.
12:06If the room was a shared room.
12:08So if you have an office space
12:10with two people, for example.
12:12You can only have one in there at a time.
12:16OK so but we all have to realize that
12:20for some of our clinical protocols
12:22or all of our research protocols,
12:24you can't always stay 6 feet apart from
12:27your participants and so there you
12:29need to indicate how you'll mitigate
12:31those risks through either enhanced PP,
12:33personal protective equipment or
12:35how you limit time in contact with
12:37the participants will be given
12:39the opportunity to do that,
12:41and it's not to say that that
12:43would be looked at.
12:45There's a public Health Committee.
12:47That I believe,
12:48is providing some guidance about
12:49what kind of PPY you'd want to
12:51use for things like a blood draw.
12:53I don't think that's been posted yet,
12:55but it should be coming.
12:58So that's the general idea.
12:59Now the other thing I want to encourage
13:02you to think about if it's appropriate,
13:05you may,
13:05if you have a study that is
13:08a therapeutic protocol,
13:09or is one where you could just
13:11see patients when they were in
13:14care for their regular care.
13:15You could choose to apply
13:17for the phase one approval.
13:19The advantage to that is that you
13:21would not have to stop your work
13:24if circumstances required having to
13:26go back to phase one restrictions.
13:28So that's something for you to think about.
13:31Now the anticipated phase two is July 20th.
13:34The goal of this committee is to
13:36have these questions ready soon
13:38and to be able to begin to review
13:41protocols prior to the July 20th date,
13:44so that process can go forward
13:48in a timely manner.
13:50Now you probably,
13:51I believe you've all gotten
13:53the return to campus email,
13:55and again here the date is July 20th
13:58and this is a return to campus for
14:01people coming back to their offices.
14:04Their primary workspace.
14:05So somebody could be coming
14:07back to campus that has.
14:09No,
14:10it's not to human subjects
14:12research or to do in person,
14:14human subjects research and they can do that.
14:17There are some steps that are involved.
14:20Hum.
14:21I want to highlight for everyone
14:23there's this return to work place
14:26work checklist that you can use as
14:28you set up your personal space is
14:31to have people come back to work.
14:33It's a useful websites meant for departments,
14:35but your Department could be your lab group.
14:39The other thing is,
14:40before people can come back,
14:42They should do the research.
14:43Re activation,
14:44training an and on the days that
14:46they are back then they could conduct
14:49the daily health check and that can
14:51be done on the website or there's an app.
14:54I've heard the website maybe
14:56is a little easier to do.
14:59Some of the other requirements when
15:01people returned to campus is that
15:03they need to wear a face covering.
15:06In public spaces,
15:07there needs to be physical
15:09distancing of 6 feet.
15:10Shared offices must be at 50% of capacity.
15:13Undergraduates are not permitted on
15:15campus during phase one and phase
15:18two an prior to having people.
15:19Santee staff coming back,
15:21they must be given a weeks
15:23notice about returning.
15:27And then finally,
15:28I think this is a kind of in a way,
15:32a summary of some of the things
15:34that we've gone over to give you a
15:37general idea that the Department also
15:40has a plan and you know every group
15:42will who's coming back or you have
15:45a research group would designate a
15:47lab safety officer in your group,
15:49and really, that person is
15:51responsible for safety compliance.
15:52They Mayfield requests for
15:54information about what the policies
15:56are and they may help resolve.
15:58Any concerns about people
16:00not adhering to the plan?
16:03So that's an important person in your
16:06group to designate someone who will
16:08stay on top of all the information.
16:10And part of the Department of plan
16:12for your group is to identify and
16:14make a plan for shared spaces,
16:16including shared equipment, room,
16:17seminar rooms, and bathrooms.
16:18I think it GAIL.
16:19Currently,
16:19the guidance is only one person
16:21in the bathroom at the at a time,
16:23for example.
16:24You should be determining a policy
16:27for lunch and eating locations,
16:30generally recommending that
16:32people eat lunch in their rooms
16:35or separate outside that.
16:37Things like refrigeration,
16:39refrigerators and coffee pots or discouraged.
16:43And then it's important to the COVID-19
16:45training before on the shooting.
16:47Initiating the Asia's plan.
16:48So this is really the return
16:50to work training.
16:54I've already mentioned that everyone
16:56will do health and symptom monitoring.
16:59And we all need to be prepared to ramp
17:01down quickly if there's exposure to
17:04someone who is covid positive in your
17:06group and then finally you know if you
17:09have concerns about adherence to plans,
17:11those can be reported to the lab
17:14safety officer, your Supervisor,
17:15Department of leadership, Doctor Crystal,
17:17who's the designated for the entire
17:20Department or made to the Yale hotline.
17:23So this is a generally what I
17:26wanted to cover in my presentation,
17:28and I thought we could.
17:30Give other people.
17:32Let me go back to this in this slide.
17:40Open it up if Marina or Chris or anyone
17:48else who's. In a bit involved in,
17:51this wants to make any comments.
17:53Sure, I'd, I'd like to
17:55make a couple of comments.
17:57First of all, UM, one of the things
18:01that we've learned from opening up
18:03the The Wet Labs is how important
18:06it is to get peas who are in shared
18:10spaces together talking very early,
18:12so that was extremely successful in,
18:15for example, the 9th floor of George Street,
18:18the CMH space where there is for example,
18:21shared equipment,
18:22their shared procedure rooms.
18:24Uh, people from different labs may
18:27in fact share offices so well ahead
18:30of the the July 20th deadline,
18:33even though EA chess questions
18:35are not yet finalized.
18:37You can start talking to other members
18:40of the group who are sharing space
18:43and those discussions are going to
18:46be especially around bathrooms,
18:47shared meeting rooms and so on.
18:50The other thing that I would urge you to
18:53do now is to get all of the personnel,
18:57trainees, staff.
18:58All of the faculty to do the COVID-19
19:01training on line immediately.
19:03It's very quick,
19:04it's very easy and that is essential for
19:07anyone being added to your protocol, so.
19:10You will be able to get your protocols
19:13approved more quickly if you start
19:15now that's available to everyone.
19:17This minute.
19:18The other thing that I want
19:20to be clear about,
19:21because we didn't really understand this
19:24when they gave a deadline for phase one.
19:27Reopening is that even though
19:28there is a start date,
19:30it is not an end date.
19:32That's when people will begin to get
19:35approvals and will begin to get the
19:38possibility to go back into space yell space.
19:41So, uh,
19:41there was a rolling approval process.
19:44As soon as the HS integrator is
19:46available for you to upload your plans,
19:49I would go ahead and do it because there
19:52will be a rolling approval at each level.
19:56So there are multiple levels of oversight.
19:58As Stephanie noted,
20:00departmental medical school and
20:01then all the way up to the Provost.
20:04And until you get the final
20:07letter from the Provost,
20:08basically you're not allowed to go in now.
20:11Matter who else has approved.
20:13So the sooner you start to get
20:16the materials together the better.
20:18Um, finally, uhm.
20:19I think that it's really important
20:22to note that.
20:23Rooms that are that are therefore seminars
20:26and so on will probably be used by
20:29people to get together for lunch and so on.
20:32Unless you close them.
20:34So although it is not part of the protocol,
20:37I personally would recommend that you
20:39think about closing off common shared
20:42spaces that are not essential to the work.
20:45We've been encouraging everyone
20:46who can to eat off site,
20:48and it's just very tempting to
20:50be able to talk to someone while
20:53you're eating your lunch,
20:55and that's that is really where we are at.
20:58Risk, otherwise,
20:59I think most of the activities that
21:02are being done will be done with
21:05PP and therefore are lower risk.
21:08For those who have already opened
21:11under phase one,
21:12phase two doesn't actually change very much,
21:15and you are not required to file a phase two
21:19plan if you are not changing from phase one,
21:22it allows for gathering with social
21:25distancing in PE of five people or less.
21:28I think at this point,
21:30unless there's an essential reason for that,
21:33I would I would avoid it again,
21:36personal recommendation, not part of the.
21:39Of the guidelines,
21:40but for those who've opened under phase one,
21:42phase two will not change very much.
21:45All of the distancing,
21:46all of the density requirements
21:48will stay the same.
21:50The other thing that was necessary
21:52for the lab HS protocols was the
21:55uploading of floor plans for the
21:58space that you plan to open and
22:00designation for each space of what the
22:03occupant maximum occupancy would be.
22:06Uh, I maybe Stephanie.
22:07Can you hear me?
22:09OK, yeah I can hear you
22:11fine, yeah um sorry My Internet is not
22:14great today so you may want to start
22:17thinking about getting together a
22:19floor plan of space that you would be
22:21using an then getting an idea of how
22:24many people would be allowed to be.
22:27For example in each office or
22:29in each space at one time.
22:31Finally, one thing that I didn't fully
22:34realizes that the EHS integrator site
22:36Can be a little difficult to navigate,
22:38so when you go in there will be a
22:41big red sign saying COVID-19 plans.
22:43Make sure that you go straight to that
22:46because that's where you'll be able to
22:49upload all of the information and it
22:51really does a good job of guiding you
22:53through step by step pieces of information.
22:56I think for phase two you will not be
22:58able to get all of the questions yet,
23:01or maybe any of the questions yet,
23:04but it may be worth going into the
23:06HS integrator site. Just a familiar.
23:08Familiarize yourself with what
23:10the step one process looks like.
23:13Phase one process.
23:14I'm relatively certain I've already
23:17forgotten that you should be on
23:19a Yale VPN when you access that.
23:23That's all that I wanted to say.
23:25I'm happy to answer questions
23:27along with Stephanie
23:28and Chris. And the actual questions
23:30from phase one are posted on
23:33that website that I mentioned.
23:35So if you want to go there,
23:37but I think you can sign up to be on EHEHS
23:42integrator sooner than that,
23:43but you won't get the question.
23:46We should already all be any HS integrator.
23:49That is, we we anyone who
23:51has any research protocol,
23:52any kind of approval for bio safety or
23:56so on will already have through your
23:58net ID access to EHS integrator. Great.
24:03I think as
24:04many I wanted
24:05to say a few
24:06words about the VA. Yeah thanks Stephanie. I
24:08just want to make sure people
24:10know that the VA has its own
24:13process and you have to follow it.
24:15And it's complicated if you're at the VA and
24:18you have yell protocols and Yale employees,
24:20you have to follow both processes.
24:22But for the VA right now,
24:24investigators who want to resume studies
24:25have to fill out an investigator
24:27COVID-19 risk assessment form.
24:29That's going to go to an ad hoc committee
24:32that's been set up led by Fred,
24:34right, including? I'm on it.
24:36Some other people from the VA here
24:38it gets reviewed by the committee,
24:40but that's not the end of it after that,
24:43thread right?
24:44Has to write a letter to Central Office
24:46because we're on an administrative
24:48hold here in West Haven.
24:50And until the last lifted,
24:52you can't resume research.
24:53So one of the.
24:55120 some clinical trials, and we've
24:56only received not just in psychiatry.
24:58This is across the whole VA.
25:00We've only received about 20 some forms.
25:02It may be that some people are
25:04not planning on resuming studies,
25:06but I just want to make sure
25:08people aren't confused and don't
25:10realize that there is a whole VA
25:12process that you have to do.
25:13It's not enough just to
25:15do the Yale process so.
25:23Thank you, sweetie, that's really helpful.
25:25It's and there are a lot of I think
25:27that's a really important point you
25:29have to follow the institutional rules,
25:31and so the same HC has their guidelines.
25:34the VA has their guidelines.
25:36I don't know if Michael still on.
25:38And we had to get of.-.
25:42I can speak briefly. This only have
25:45Michaels here, great.
25:46Think it just reflects what is mean
25:49is saying in that we're trying to
25:51balance both emails requirements
25:53in the states. And, uh. And
25:56you know somewhat more
25:58challenging and that it's in
25:59the middle of a clinical space.
26:02So right next to or traveling
26:04through an inpatient
26:05unit. So we're going
26:06to have challenges there.
26:08But you know, we're eager to work on
26:10trying to figure out how to do this as
26:14quickly as possible.
26:15I think the basic science
26:16reactivation went very nicely,
26:18and hoping to do that with
26:20clinical research too.
26:23There were a couple of
26:25questions that came through.
26:26I just thought I would respond briefly.
26:28One is in phase two.
26:30It does not have to be a therapeutic trial,
26:33so it could be a human subject study.
26:35That's a more basic mechanistic study.
26:37Those would be allowed if all
26:39the other things are in place.
26:41All your approvals from the VA or CMH.
26:44See and the pet center all these things.
26:46That's not precluded.
26:47And the other question was,
26:49would we get access to the phase two
26:52questions and those will be posted on the.
26:54Our research researchjail.edu site as
26:56soon as they are available so that you
26:59anticipate what's going going to be there,
27:01but I think you could.
27:03I'm sure the questions about the
27:05safety questions that are in phase
27:07one will be the same questions that
27:09you'll have to answer in phase two,
27:11so you could start on those along with
27:14your looking at how they're environmental
27:16plan will work within your building.
27:24Stephanie are
27:31muted. Are there any other
27:38questions or comments
27:40people wanna? About for multiple labs
27:42and share the space with one office
27:46suite that who are collaborating.
27:48Each Pi will still have to
27:51do a separate application.
27:52So even though the shared spaces are
27:55coordinating that kind of coordination
27:57plan is In addition to the individual
28:00plan per pee and I think you may have.
28:05Uh, did you already at answer
28:07the question about in person
28:09community based research?
28:11No, I didn't
28:12see that one. Again,
28:14that's will be possible in phase two.
28:17So there are just there are two committees.
28:20There's a Field Committee
28:22Field Research Committee,
28:24an bio medical committee,
28:25and there was some discussion about
28:28where like our studies might go,
28:31and if it's quite possible they'll
28:33be some guides about which committee
28:36you should be submitted to ya'll.
28:38Be given an option,
28:40but probably most of our studies would
28:43go to the bio medical committee even
28:46if they are field studies though.
28:49There's it,
28:50I want to return
28:51to briefly to Elisa's question about
28:53shared space and collaborating group,
28:55something that we found very useful
28:57in the lab side was we figured
28:59out a plan for shared space,
29:01and we made a series of standard
29:03operating procedures at CMH.
29:05See. So there isn't a separate
29:06DHS protocol for the group.
29:08The protocols are all associated
29:10with an individual P.
29:12But if you figure out what your
29:14collaborative protocols are going to be,
29:16and write them up and
29:17standard operating procedures,
29:18then each Pi can simply attach
29:20those standard operating procedures
29:22to your protocol,
29:22and so then most of your protocols
29:24done because it's in the form of
29:27those standard operating procedures.
29:28So that's a process that we
29:30found very helpful.
29:31Yet seeing the same HP labs
29:33to coordinating shared space
29:34amongst multiple groups.
29:35But the HS protocol is
29:37linked to a specific Piers Marina
29:39said yes. Your question. What
29:411 one question that I was very
29:44concerned about ahead of time is
29:47about PE supplies and how they'll be
29:49provided to research groups for masks.
29:52Those are provided appan approval
29:54to go back into Yale space and
29:57everybody gets a welcome packet
30:00that is dropped off at the approved
30:03space with enough masks to cover.
30:05I think 30 days for each person
30:08who is in the protocol an approved
30:11to be on the protocol. However,
30:14hand sanitizer and wipes are not provided.
30:17Each of the basic labs part of the
30:20of the protocol is actually pre
30:23approval preparation of space,
30:26which includes sterilizing surface is
30:29clearing any kind of Clutter out of
30:32surface is and we were able to order
30:35from the Yale Medical School stockroom.
30:39Things like 95% ethanol that
30:41could be used to make.
30:43Uh, sanitizer and to wipe down
30:47surfaces so those sanitizing materials
30:49are not going to be provided to us.
30:53They are that we have to obtain
30:57those separately.
31:00Great and I know that there are
31:02people you reach out to people
31:04that have already done that.
31:06I think Trish's on some ordering.
31:08For example, there was one question
31:10related to the Pi focus an I believe
31:13that you have to do it per protocol,
31:15so because the circumstances may
31:17be different by each protocol,
31:19but your General Safety
31:20plans might be the same,
31:22so it's not that difficult,
31:23but I believe it's by protocol.
31:26That's for human subjects.
31:28Science labs yeah yeah
31:31for human subjects. Uhm, the other, uh,
31:33one of the other questions that came up
31:36is if you were to take your protocol.
31:39An modify it so it was totally remote.
31:41You know you never see a
31:43participant face to face.
31:44Then you do not have to go through
31:46the human subjects Research Committee.
31:48You just have to do that through the IRB.
31:51Although
31:52there is a question to his meaning about
31:54whether that's also true for the VA.
31:59I don't think so.
32:00I think you'd still have to do
32:02this risk assessment and just click
32:05that you're not doing it face to face.
32:07And then of course you have to get ARB
32:10approval 'cause you're changing
32:12your protocol. The form for
32:13the VA is really simple. I mean it's
32:15just a couple of checkboxes.
32:18But there's you know you don't
32:19have to do that.
32:21Then there is a question about
32:23whether dry lab for data analysis
32:24can only reopen in phase two.
32:27It depends on whether there's any way
32:29to get access to that data remotely.
32:31If you can only get access to
32:33that data from Yale facilities,
32:35you can do a phase one
32:37protocol for that at this time.
32:43I know there was a.
32:44Naomi had a question that I
32:46think we missed earlier,
32:48which was if a protocol war is if a
32:50particular project involves work both
32:52at the mercy of the VA where things
32:54aren't aren't quite ready to go yet and
32:57at other Yale spaces that are approved,
32:59can that protocol go ahead to support
33:02the work that's at Yale spaces?
33:03and I believe the answer to that is yes,
33:06you can write your protocol to
33:08use spaces that are approved,
33:10for example at the Church Street,
33:12South Clinical site, or at the Mr.
33:14Center. Once that is approved.
33:15And then once CMH, see or.
33:17Once you get permission to CMH,
33:19see other via.
33:19That could be added at a later
33:21date so you don't have to wait for
33:23every single site to be approved
33:25before you can go through.
33:27That's
33:27my understanding.
33:27Stephanie is that that's right,
33:29as long as you specify that
33:30you're using that space and
33:32don't put students on your
33:33protocols when you submit them,
33:34because they will
33:35get the client rejected. Yeah,
33:36so even if that you've previously used
33:38someone if they're working remotely,
33:40then you would say they're working remotely,
33:42but they don't need to be on there for that.
33:44Now I do want to tell you one bit of.
33:47Other information that is may slow
33:49down the reopening to some extent,
33:51and so I think I would try it, which is that.
33:57Oh, ultimately you're going to have
33:59to have approval for the location
34:02that you're doing your work,
34:04even in phase two,
34:06and some of that involves getting
34:08approval through the powers that be.
34:11That space is suitable for
34:13doing human subjects research,
34:15and they're going to prioritize spaces
34:17where there are multiple peas working,
34:20for example, but it's a little complicated.
34:23So just because July 20th rolls around,
34:26it doesn't necessarily mean you can just
34:29resume your operations in your space.
34:32So if you have protocols and your space
34:35is not currently on that list that I've
34:38talked through at the very beginning.
34:41I would highly recommend that you
34:44write your protocols are submitted.
34:46Amendment to be able to do some of
34:49your assessments in the YCI space
34:51where it is where you can operate.
34:54I think they're going to be increasing
34:57their hours and other things to make
35:00things possible, but that's the issue.
35:02Mary Kate has a list of all the
35:05locations she's looking into,
35:07what steps we need to do to
35:10get those spaces OK?
35:12So there are two levels.
35:13One is just okayed for coming back to
35:16your office to work from your office.
35:18And I think that the bar for that's a lot
35:21lower than the bar forcing human subjects.
35:24So the human subjects part,
35:25I believe is going to have to get
35:27approval by why CCI or Yale Medicine?
35:30So that's going to be a
35:31little bit of a delay.
35:36There are a couple more
35:38questions Stephanie one is,
35:39if the projects are community
35:41based an will be virtual.
35:43Will you need to register an EHS
35:45for that kind of human research?
35:48If there, um, virtual know and then will the
35:51CMH spaces be available on July 20th?
35:54Or do you anticipate that
35:56there will be a delay?
35:58I think that
35:59I think there is likely to be
36:03a delay. Still being developed,
36:05another question is who to contact
36:07to determine what procedures
36:08can occur at Church Street.
36:12Well, I think I don't know who
36:14that is a week I can try to
36:16find that out for you Sarah.
36:18If you just send me an email,
36:20will see what we can.
36:21I think you can probably look
36:23online at the YCCI website.
36:24There may be some contact information.
36:26Why don't you give that a try and then
36:28if that doesn't work give me an email.
36:33I think that's
36:35all the questions. I don't
36:36know if if we missed any.
36:42Up, here's another one would appear.
36:44I need to submit an entirely new
36:46EHS application for phase two.
36:48If they had previously submitted an
36:50application for phase one but been denied,
36:52you can just clone that previous application,
36:55but there will be additional
36:56questions for phase two.
36:58So yes, you will have to.
37:01Hit the phase two button which
37:03will be completely different
37:04from the phase one button,
37:06largely because the fields and the
37:08information gathered will be different.
37:13To be clear that the phase
37:14two Stephanie said earlier,
37:16those questions aren't yet finalized.
37:17I just checked DHS Integrator 5 minutes ago.
37:20That's not yet available on ahs integrator
37:21so you can start to put together your
37:24information as we've been discussing,
37:26but you cannot yet initiate your protocol.
37:28Stephanie, do you have?
37:29Do you know when gas is to, when it will
37:32become available? I I don't know.
37:34I'm hoping they've been
37:35working on the questions.
37:36They look pretty close to final to me,
37:39so hopefully soon, but I don't know.
37:42Uh, another question from O'heaney's.
37:44Are there remote procedures that can be
37:46started while waiting for phase two approval?
37:49Do you mean in terms of preparation
37:51for opening like pre screens?
37:53Um again, anything that is not in
37:56person and that you can do without
37:59patient contact should not require a
38:01DHS integrator protocol at this time.
38:04So if you can do prescreening,
38:06I think that's that's allowed.
38:08Yeah, as long as it's in your.
38:11Yeah, that's important. These
38:13things and there have been some blanket.
38:16Hi, see changes that make it easier
38:18to shift to shift screening over
38:21to remote access, so those are.
38:23At least a couple months ago
38:25were being approved very quickly
38:27because of blanket HC changes.
38:29But you do need those changes to
38:30the underlying HSE protocol to
38:32permit things that had previously
38:34been done in person to be shifted.
38:36Such a screen in pre screening
38:37to be done remotely
38:39and you may want to be a little
38:41cautious because you don't know
38:42how long it will really take for
38:44your protocol to be approved,
38:46so you may be doing a lot of pre
38:48screening and losing people.
38:50That's more of a research issue.
38:52The other thing I just wanted to mention is.
38:54The they're working on a information
38:57sheet for participants about
38:59COVID-19 and what risk there might
39:01be in coming into an appointment
39:03and how those will be mitigated,
39:06as well as the responsibilities of
39:08the participant to self monitor
39:10for symptoms and so forth,
39:12so that's not finalized yet.
39:14But the goal would be that once that's done,
39:18you don't have to modify your protocol
39:21to include all of that in it you.
39:24Just have to provide this sheet to
39:27people before they come in and and then
39:29document that they have reviewed it
39:32when they come into the appointment.
39:34and I have any questions answered.
39:36And of course there are lots of things
39:38that are involved with pre screening
39:41people on the phone before they come in,
39:43so that's intended to kind
39:45of make it easier for you.
39:47Ultimately, when you're doing these studies.
39:51There's a question from Bryan Koo asking
39:53if we can contact and talk to potential
39:55subjects to recruit them right
39:57now before phase two approval for
39:59protocols that are yet to be approved.
40:02The this approval process that
40:03we're talking about is for in person
40:05work under covid restrictions,
40:07but if your protocol is already
40:09approved by the Hi C.
40:11Then Yes, you can reach out to potential
40:13subjects and work with them remotely,
40:15as long as it's approved by the HSE.
40:18This the phase to go bit approval that
40:20we're talking about is for the is an
40:23additional layer for in person contact,
40:25but as long as the as long as your
40:27HC approved to begin recruitment
40:29and that can be done remotely,
40:31then yeah, that can be initiated.
40:33Although as Stephanie points out,
40:35there is a risk of building a list
40:37of potential subjects and then having
40:39a longer than anticipated wait.
40:41For your protocol to be approved,
40:43which, which becomes a challenge
40:46to holding onto those subjects.
40:48Up There
40:52are a couple questions about uhm.
40:56Issues related to charging staff and faculty
40:59to grants who are not actively working,
41:01and I think that's something that will have
41:05to be discussed on a case by case basis.
41:08If anyone is absolutely not working at all,
41:11NIH guidance is that they
41:13cannot be charged to grants,
41:15but I think most people are likely
41:18working from home in one way or another,
41:21and that's something that you should
41:24contact a Stephanie Chris or I about.
41:26And will connect you with Mary,
41:29Kate and Steve and others who can
41:31discuss the specifics of that.
41:33There's a question that I'll refer
41:35to Stephanie for those doing
41:37alcohol and or tobacco research.
41:39Would doing breathalysers insio monitors
41:41be allowed, or is that too risky?
41:44Well,
41:44it's that's a really interesting
41:46question that I've been looking
41:48into and there I can send you some
41:51information from one group about how
41:53one can try to do breathalysers.
41:55I think there's some advantages to they do.
41:58Involving expired air.
42:00So you know if you can do
42:03salivary test or urine test,
42:06it might be preferable during this period so.
42:11So I don't need to close because
42:13it's after 11, but it's up to
42:16you whether you want to continue.
42:20Marina, you do have more time if
42:22you need it great, OK, thanks.
42:25I just wanted to comment the question
42:27about charging staff to grants
42:29said that the unit suggested that
42:31that was going to be impermissible.
42:33As of mid July and I want to
42:35clarify that in fact that is that
42:37we just did receive that guidance.
42:40But then we received revised guidance
42:42that in fact we can't charge staff
42:44who are not working to federal grants.
42:47As of June 17th, right?
42:48So so the original date was June 17th,
42:51then it was revised to July.
42:53Then it was revised back to June 17th.
42:56So I just want to clarify.
42:58That it is a huge challenge if you if you
43:01have a concern about that,
43:03you should. I would go talk
43:05directly to Mary. Kate DeMarco.
43:07I wouldn't come through us because
43:09I think they're trying to do all the
43:12changes in charging literally as we speak,
43:14so she's reaching out for people
43:16where there might be a question.
43:18But if you have a concern,
43:20please contact her directly.
43:23It's a question about what's the
43:25protocol to request approval to
43:27conduct research in appease lab space.
43:29If that's patient facing research,
43:31then it's this phase two protocol
43:33that we've been discussing.
43:34If that's basic science or non patient
43:37facing research than that can be
43:39done through the phase one protocol
43:42which is available on ahs now.
43:44Both of those are available through
43:45links on the HS integrator website.
43:49And again, your space might have
43:51to be approved, so that's the
43:52other you know wrinkle in that.
44:06Looks like the that should
44:09be most of the questions.
44:14I see some questions from Robin
44:17though, and I think they
44:20may be hard to answer.
44:22It sounds like a more individualized.
44:25Discussion I don't. I
44:27think they're similar to the questions
44:29that suggest are raised that are
44:31going to be case by case in that
44:33need to be discussed 1 on one.
44:38OK. Any final questions?
44:46Oh, I think Dana's question is
44:49specific to how does she start the
44:52procedure to get human subjects work?
44:55Started in a space so so space approval.
44:59What's the process?
45:00Well, I think I've reached out to
45:03Brian Smith about this and I I I'm going
45:06to suggest that we just come up with the
45:10spaces that we are trying to get approved
45:14and bring that to their attention.
45:16See see how we might move that forward.
45:19I think that they're going to prioritize
45:22space where there multiple peas.
45:24But I don't have a good answer for you
45:27right this moment, so it's that's the
45:30part that's a little vague, and, uh,
45:32we don't have very specific guidance,
45:35except that they're going to
45:36be working on it.
45:38Took awhile to get the space approved for
45:41the Alzheimer's clinic and for the why?
45:43CCI clinical research unit.
45:45But maybe that is partly because
45:47they're quite big spaces.
45:53If you can, if you have other questions,
45:55I certainly feel free to contact us.
45:57And if we don't know the
45:59answer will try to do it.
46:01If you have concerns,
46:02I know I've heard some concerns
46:04and I'm conveying those to the
46:06committee that I'm on but will try
46:08to do what we can to answer them.
46:10And just keep checking that
46:12website because I think that lies
46:15out a lot of the information.
46:17OK. Well, thank you everyone.
46:21Appreciate you being here today and,
46:23uh, for the everyone's hard work
46:26to try to move this forward.
46:29Take care,
46:30yeah, good luck
46:31everybody here everyone.