IRB workshop.mp4

Name: IRB workshop.mp4
Uploaded: 2022-05-13T21:55:49.16Z
Duration: 32 min 13 s

May 13, 2022

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00:05Sometimes the HP, so the human
00:08research protection program and the
00:10name Irbs are used interchangeably,
00:12and I just want to make sure that
00:13you will like at the end of my
00:15quick presentation you will know the
00:17difference and you will be able to
00:19distinguish between the different roles.
00:22Human research Protection program is
00:24part of a larger office of Research
00:27administration and the human Research
00:30Protection Program is providing
00:32administrative support to a few groups.
00:35It's not just the Arab, although they yell.
00:39Arab is the largest group.
00:41We have 19 different panels.
00:42At the end you will,
00:44you will see a list of all of them.
00:47We provide support to greedy active
00:49drug research committee and.
00:51Investigational drug committee.
00:53So these are studies that involve or at
00:57pet center that involve radioactive drug,
01:00and that's actually one of the
01:03committees that we run as well.
01:05In addition,
01:06we also provide support to institutional
01:08conflict of interest Committee,
01:09so it's one of our committees
01:11that we schedule meetings for.
01:13We have policies and procedures in place,
01:15so that's part of our office, too.
01:18In addition to that.
01:20So these are the committees that we run.
01:22In addition to this,
01:23we work very closely with
01:25different bodies within Yale,
01:27so any ancillary committee that
01:29is that needs to review research
01:32and we have about 20 of them.
01:35We have workflows in place,
01:37so we work closely to make sure that
01:39we know how the information travels
01:41from that committee to the Arab.
01:44We work very closely with Yale
01:47Center for Clinical Investigations
01:48at Yale with conflict of Interest
01:51Office Office of sponsored.
01:52Projects we work very closely to make
01:55sure that grants actually match and
01:57contracts match the protocol and the
01:59consent language, and vice versa.
02:02So that's a large umbrella of what we do.
02:06I will focus mostly on the Arab.
02:09I know you can't see it very well,
02:11but that's on top.
02:12It says the nitpicking Arab,
02:14that's, I understand.
02:15That's how often people think about
02:17the Arabs that they're always there to
02:20find something that is wrong or get back to.
02:23Go back to you on and ask for
02:25revisions and clarifications,
02:27but in reality the IRB.
02:29So that's institutional review boards
02:31is there to protect the rights and
02:33welfare of research participants.
02:35So when you look at the regulations,
02:37that's what the mission of the IRB is,
02:40and I included some text from FDA guidance,
02:44for example,
02:45because it's like nicely described of
02:47what it is that IRB is supposed to do.
02:50The RB meets that mission so protects
02:52the rights and welfare of research
02:55participants by reviewing the
02:57documents that you need to submit,
02:59and they look through those
03:02documents to make determinations
03:03about very specific things.
03:06So if you actually ever
03:07attend any of our meetings,
03:09our reviewers have checklists in place.
03:12There are, based on the regulations.
03:14So, for example,
03:15when they look at the consent
03:17or the consent process,
03:19they need to make sure that.
03:20All of the elements that the regulations
03:23describe that the consent needs to have or
03:26there if they're looking at your protocol
03:29and how you're going to obtain consent,
03:31they need to make sure that what you're
03:34describing actually matches the regulations.
03:36They look at the data
03:38safety monitoring plans.
03:39That's why we ask you to always
03:41include that in your protocol.
03:43There is an approval criterion that
03:46talks about confidentiality of data.
03:48That's why our protocols and our protocol.
03:51I would be submission forms.
03:52Ask specific questions about
03:54confidentiality so everything that the
03:57IRB asks for is based in regulations.
04:00It's a highly regulated business.
04:03In addition to this,
04:04we need to make sure as an IRB
04:07that the approval criteria are met.
04:10But if you doing research in other countries,
04:13for example or in other states
04:16that the local regulations,
04:18the local policies and procedures.
04:21Were followed as well.
04:23But when do you actually need
04:25to even worry about the Arab?
04:28So in general,
04:29the IRB reviews research
04:32involving human subjects,
04:33so if it's not research that
04:35involves human subjects,
04:36I will be does not have to reveal it.
04:39I know that different institutions may
04:42have additional policies in place,
04:44so for example they will say you,
04:47even if you are doing a
04:50quality improvement project,
04:51you still need to come to the
04:53Arab for the determination.
04:54The rule in the regulation is
04:57if it's human subjects research,
04:59IRB needs to review it,
05:01and so I underlined the terms
05:04that are based in regulations,
05:06research and human subjects.
05:09Anytime you create a project
05:12and submit it for review,
05:14this is how we think about it
05:16and this is how we always tell
05:18our investigators to think about
05:20the projects too.
05:21The first question and they need to be
05:24asked in order is does your project
05:27fit the regulatory definition of research?
05:30Because it's again research
05:31is a regulatory definition.
05:33I I will go through that definition
05:35in a second.
05:36If you say no,
05:38what I'm doing is actually not research.
05:40It doesn't fit the regulatory
05:42definition of research.
05:43You do not need to come to the Arab,
05:45so there is no submission that is expected.
05:49Sometimes you will get questions
05:50from a publisher or from your
05:52colleague that will to that will
05:54prompt you to submit something to
05:56their be to get their determination
05:58that what you're doing is not
05:59research and we will not reject it.
06:01We'll give you that determination,
06:03but there is no expectation at
06:05Yale that you need to have it.
06:07But if you say yes,
06:08what I'm doing is research that
06:10fits that definition that the next
06:13question that you need to ask is
06:15does it involve human subjects.
06:17Human subjects is a regulatory.
06:19Definition I will go through it
06:21in a second as well.
06:23If you say no,
06:24I'm doing research by doesn't
06:26involve human subjects.
06:27You don't have to come to the IRB either,
06:29but if you say yes, I'm doing research.
06:32It involves human subjects.
06:33Then you know that you need to submit
06:36something to our office for some
06:38determination and I will talk about
06:40what those determinations might be like.
06:43Different levels of review.
06:44But let's start with the first one.
06:46Is it research?
06:48I included a citation to the regulatory
06:51to the regulation, so it's 45.
06:54Code of federal regulations.
06:55You can put it in Google,
06:57you'll you'll find that rights
06:58and I shorten it a little bit,
07:01but research is a systematic investigation
07:03that will need to generalizable knowledge.
07:07I underlined the keywords here.
07:09The systematic investigation and
07:11the generalizable knowledge because
07:14certain projects sound like research,
07:16but they are not because they do not
07:18produce or they're not intended to
07:21contribute to generalizable knowledge.
07:23A perfect example of something
07:24that may seem like research.
07:26Is not a journalistic activity,
07:29so we have students who may want
07:32to publish a or write an article.
07:34Talk to people about their experiences for
07:38for in order to for a journalistic activity.
07:42That's not research,
07:43even if you're talking to
07:45people and collecting data about
07:46them program evaluation.
07:47So if you get a contract in place
07:51from a program that is taking place
07:54regardless of your activities.
07:56And somebody asks you to evaluate
07:58how successful it is,
07:59whether it works or not,
08:01just for that purpose of that
08:03of that project of that program,
08:05we would say this is not research.
08:06IRB review is not required.
08:09And the case study will say this
08:11is not research because you don't
08:14have enough data from sufficient
08:16number of individuals to lead
08:18to generalizable knowledge.
08:19You don't need to obtain IRB approval.
08:23I know that a natural question is how many?
08:28How many individuals would constitute
08:32research like a case study?
08:33Is it just one or two?
08:35Or if I have five people that I
08:36want to write about or publish,
08:38is that research?
08:39We always go back to the investigator
08:42and ask that questions like how many
08:45people do you need to yield meaningful data.
08:49One person generally will say you
08:50can publish you as you need to
08:52ask for permission.
08:53Whether you can use that person's data,
08:56but that's not a research.
08:58There are certain activities
09:00preparatory to research,
09:01so if you're going to look
09:03at medical records,
09:04for example to see whether you
09:06even have sufficient population
09:08to pull from that activity.
09:09Self is not considered research.
09:11You just cannot write any identifiers down.
09:14So you cannot remove any Phi
09:16from a HIPAA covered entity,
09:18but that activity itself is not research.
09:21Another example,
09:22and that's where the Gray area happens
09:25is a quality improvement project.
09:27We say that called the improvement
09:30project is evaluation of how
09:32something works or you you put an
09:35intervention in place and then you
09:37check how it works in a very specific
09:41setting so your the the purpose of
09:43that activity is not to take it and
09:46generalizable to other other hospitals.
09:48For example,
09:49other healthcare operations
09:50you can publish
09:52about it. You can say this is
09:54what we did in our hospital,
09:56but you just have to call it call
09:58improvement project. And not research.
09:59And then you do not need IRB
10:01approval or review or approval.
10:03We have certain checklists in place
10:05that you can use to see whether or
10:08not your project fits that definition,
10:10but if it turns out that it is and it's
10:12very clear that it's quality improvement,
10:14you do not have to submit anything to the RB.
10:16You can. If you want to,
10:18but but you don't have to.
10:20So that was the first question,
10:21is it research?
10:22Is it a systematic investigation that
10:25will lead to generalizable knowledge?
10:27If you say no?
10:29As I said, no IRB review is required,
10:32but if you say yes,
10:33the next question is does
10:36it involve human subjects?
10:38That's a regulatory definition.
10:39A human subject is a living individual
10:42about whom you're going to obtain data,
10:45either through interaction with that
10:47person or interaction with their private,
10:50identifiable information.
10:51I underlined the key elements here.
10:56Sometimes we go back and forth
10:58with some of our investigators
10:59because they submit proposals and
11:01then it turns out that the data
11:04they're obtaining or the tissue that
11:06they're working with is actually.
11:08From diseased individuals and
11:09then it turns out well,
11:11this is this is research,
11:12but it doesn't involve human
11:14subject because the person needs
11:16to be living needs to be alive
11:18for IRB regulations to to apply.
11:22So what type of studies would not
11:25constitute human subjects research?
11:27If you're talking to people and
11:30you're asking questions about
11:32policies and procedures in place,
11:35you asking about a makeup of a hospital,
11:37for example,
11:38like how many people are working here,
11:40what is your policy on how
11:42you deal with this situation?
11:45Even though you're doing research
11:46and you're talking to people,
11:48you're not obtaining information
11:50about people, but rather things.
11:52We would say it's research
11:54doesn't involve human subjects.
11:56You don't have to come to the Arab.
11:58The example that I just gave.
12:00If you obtaining information
12:02about deceased individuals,
12:04HIPAA regulations may apply,
12:05but it's not human subjects research,
12:08so you do not require higher
12:10be review or approval.
12:12Or if you are getting a large data
12:15set with deidentified data that you
12:18cannot readily ascertain who the person is,
12:21who that data belongs to.
12:22We would say it's researching
12:24doesn't involve human subjects.
12:26You don't have to submit anything
12:27to the Arab.
12:31So that's it is that research
12:33doesn't involve human subjects.
12:35If you said yes, yes,
12:36that means that she have to
12:38submit something to the Arab.
12:39Now the submission is required,
12:41and when it comes through to us,
12:43we need to make determination
12:45about the level of review.
12:47So this shows how a
12:49stringent level of review is.
12:52We have exemption determinations
12:54then if that doesn't.
12:56If your submission doesn't fit the
12:58exemption determination or any categories,
13:01I will explain that in a second.
13:03Then you will go to expedited review
13:04and if it doesn't fit the expedited
13:07review categories then we send it
13:09to full board and that's where all
13:11those panels that you will see at the
13:13end come into a place because that's
13:16the panel that will review the submission.
13:18So let's start with the exemption.
13:21If you start reading the regulations
13:23about human subjects research,
13:25that's the 45 CFR 46.
13:28The way they start is by saying these
13:32regulations apply to all human subjects.
13:34Research,
13:35except these categories,
13:36and there are eight categories,
13:38so exemption,
13:40determination or exempt research means
13:42that the regulations don't apply to
13:46those research involving human subjects.
13:49There are eight determination.
13:50There are eight different categories.
13:52Most institutions,
13:53including Yale,
13:54is only using six of them,
13:57and the reason for it is that the
14:00two the exemption determinations that
14:02are described in the regulations.
14:05Don't have any guidance that the
14:07the agencies federal agencies
14:09didn't give us much guidance
14:11about how to put it in operation,
14:14so it has to do with repositories
14:17and using data from repositories
14:19for people who provided the broad
14:22consent to use their data for future,
14:24it's very difficult to put it in practice,
14:27so we decided that at Yale and
14:29again as many other institutions,
14:31we only going to use 6 categories
14:34of exempt research.
14:35So it has to be a minimal risk study
14:38that fits in one of those six categories.
14:41There is a concept of limited IRB review.
14:45Two of those categories my my
14:49involve sensitive information.
14:51So for example you are talking to
14:53people and asking them questions
14:55and writing down identifiable
14:57information so their name but
14:59the topic is quite sensitive.
15:01So if somebody if somebody learned
15:04that information that actually
15:05may put people at risk for,
15:07there might be some legal or precautions.
15:09Or maybe there is risk to their harm.
15:11Reputation in those cases IRB needs to
15:14review it for one approval criterion
15:17and that has to do with confidentiality.
15:21Examples of research that could be exempt.
15:25I listed just a few of them,
15:27but it's usually talking about
15:29surveys or interviews, focus groups,
15:32observations of public behavior.
15:34I actually underline the public because
15:38you cannot propose going into church,
15:40for example, to observe people's behavior.
15:45There we would say that it's there
15:47is an expectation of privacy,
15:48so we would not issue.
15:50Exemption determination would actually
15:51send it to the next level of review.
15:54If you're doing research
15:56on educational techniques,
15:57you want to introduce two different
16:00ways of teaching and material
16:01to to different classrooms and
16:03then then compare the results.
16:05That could be an exempt determination.
16:08Research we have a benign
16:11intervention behavioral intervention,
16:12so you're asking people to.
16:15Play a video game and then you ask
16:17them questions about that video game.
16:19Those types of research studies
16:21would go through would received
16:23an exemption determination,
16:25so even though it's called exempt from the
16:28IRB reviewer exempt from the regulations,
16:30you still have to come to the
16:33AB to get that determination.
16:36So that's so that's exempt that
16:38that's that's exempt research.
16:39I think.
16:39I wanted to add something else to to this,
16:42but it just escaped me.
16:43It's in your best interest to know
16:46whether your study could be exempt or not,
16:49because the submission to the
16:51Arab to receive an exemption
16:53determination is very simple.
16:54It's just one form that you
16:56complete submitted and the
16:58turn around time is very quick,
17:00so why you do not need to know
17:02the difference between the
17:03expedited and full board,
17:05it's in your best interest to know whether
17:07you're study would qualify for exempt.
17:09Office or not,
17:10because there is just fewer
17:12documents that you need to fill out.
17:14OK, we said the first level is exempt.
17:17Research has to be minimal risk.
17:18Study fit into certain definition.
17:21Certain category.
17:22If you study does not fit
17:24in any of those categories,
17:26the next level is expedited.
17:28Expedited review is a misleading
17:30name because it has nothing to
17:32do with how fast it's done.
17:34It has to do with who can actually review it.
17:38The regulation states either
17:39the chair or a designee,
17:42which means that our regulatory
17:44analyst in the office majority of
17:47them are very experienced and they
17:49got this designation from the Chair
17:52to review research studies via
17:55expedited review and so it has to
17:57the study needs to be of minimal
18:00risk and fit one of the categories.
18:02I included a list here so you can
18:04click on it and we'll take you to the
18:06page that describes all the categories.
18:08Or if it's already an approved study and
18:11you're proposing a minor modification to it,
18:14an expedited review procedural kick in too,
18:17so it's only one person can review
18:19it if that person will say, well,
18:22the study doesn't actually fit
18:24approval criteria,
18:25it will have to go to a full board,
18:28or the reviewer will ask
18:29you to make some revisions.
18:31And if you say no,
18:32I really want to keep it that way.
18:33They cannot disapprove the study,
18:36so only a full board can disapprove research.
18:39So if the research your proposal
18:42does not fit exempts criteria,
18:44it does not feel expedited
18:47fit expedited criteria,
18:49or if the reviewer.
18:52It says that it doesn't fit approval
18:54criteria and wants to send it to board.
18:57That's when your study will
18:58be sent to full board review.
19:00Both actually take similar time to review,
19:03so there is no much difference.
19:05When I look at the metrics of
19:07how fast it takes. And again you
19:09don't need to know the difference.
19:11You're not requesting expedited versus
19:13fulbert review when you submission comes in,
19:15that's where it's triaged
19:17to that appropriate level.
19:19So let me walk you through
19:21quickly the submission process
19:23when study comes to Yale IRB,
19:25I am not going to talk
19:27about our system in detail.
19:29If you want me to come back and to
19:30give you training on the system,
19:32I'm happy to do so.
19:33We have monthly trainings as well
19:35so you can come to one of those
19:37trainings and and we will train you
19:39on how to use electronic system.
19:42What I will say is that when studies
19:45created in electronic IRB system,
19:47we refer to as. Iris IRB.
19:50It goes through different States
19:52and the first state is preview.
19:55Preview is the moment where HRPP analysts,
20:00so they're not from.
20:01They're not representing IRB,
20:02they're representing the HRPP
20:04or looking at your submission,
20:07and there are reviewing it to
20:09make sure that you compliant
20:10with institutional requirements.
20:12So if they ask you for clarifications,
20:15they're usually about.
20:16Maybe you didn't.
20:18Usually about institutional requirements,
20:19so they're looking at your
20:21training they're looking at.
20:22At the conflict of interest disclosures,
20:25they're going to look at whether or
20:27not you have all the other ancillary
20:29approvals that might be applicable,
20:31or if you didn't submit it correctly,
20:33they were going to ask for it too.
20:35But once the preview is completed,
20:38so the institutional review is completed,
20:40that's when the study moves
20:42to the Arab review.
20:43And if you get questions from the
20:45RB that's about approval criteria.
20:48So IRB review is very focused.
20:50They're all looking at does your study fit?
20:53The approval criteria are as
20:55described in the regulations.
20:58What are the institutional requirements?
21:00I only included a few of them
21:02and that's people.
21:03How how people would start with.
21:04So the first thing that we always
21:06look at this institutional review
21:08stage is whether or not you can
21:10serve as the principal investigator.
21:13Faculty Handbook has very specific
21:15criteria of who can and cannot
21:18serve as the principal investigator
21:20Pi on the sponsor project and
21:23our office adopted those rules.
21:25So if your appointment at Yale.
21:27Doesn't fit that criteria.
21:29We will either look for special
21:31permission to serve as the investigate
21:33Pi as the principal investigator.
21:35There are different ways of getting it,
21:37or if you consider a trainee,
21:39we're going to ask you to identify
21:42a faculty advisor.
21:43Have the faculty advisor to
21:45complete that station that they take
21:47responsibility for your research,
21:49and upload it in our system.
21:52Another thing that we look for,
21:54and actually this is number one
21:55reason why we send submissions.
21:57Back right at the first stop
22:00is the training requirements.
22:02If you're from a HIPAA covered
22:04entity entity and and you are,
22:06you need to have a HIPAA training.
22:08You need to have human subjects
22:10protection training taken within
22:11the last three years, and in addition,
22:14if your study fits the NIH criteria for
22:19clinical research for clinical trial,
22:23you also need to have good
22:25clinical practice training.
22:26So it's not just you.
22:28As a principal investigator,
22:29it's every single person that
22:31is listed on your study.
22:32So if somebody doesn't have the training,
22:34we'll send it back to you so that
22:37you can either take the person
22:39off the study or we submit with
22:41the full training completed.
22:43We going to look for conflict of
22:46interest disclosures for for anybody
22:48who is listed as an investigator.
22:50So if your π or investigator,
22:52we're going to make sure that you
22:54have disclosures on file with the COI
22:57office we're going to review that.
22:58Disclosure to see whether there is
23:01any significant financial interest
23:03that is related to the study,
23:04and if there is,
23:05will inform the IRB to say oh,
23:07you need to review this disclosure
23:10because there might be conflict of interest.
23:13Some studies require ancillary
23:15committee review and approval.
23:18As I said earlier,
23:19there were about 20 of them.
23:21For example,
23:22if you're doing research with minors,
23:24there is pediatric Protocol Review
23:26committee that will need to review it.
23:28If you doing research with.
23:32What is it that research with
23:34oncology patients there is a
23:36committee that reviews it.
23:37So if there is something that it was
23:39a applicable ancillary committee,
23:41we're going to look at this to make
23:43sure that you already have the.
23:46Approval in place or sometimes
23:47we use our system to communicate
23:49with that ancillary committee.
23:51So we're going to initiate that as well.
23:54We're also going to look at
23:56the necessary documents.
23:57I include that links to the
23:59training and COI disclosures.
24:01So if you get the slides and if you need it,
24:03you can just click on them
24:04and we'll take you there.
24:06So what are the necessary documents?
24:08There are quite a few of them.
24:10You always need to have a
24:11protocol unless you have.
24:12Unless it's an exempt request,
24:15then instead of protocol.
24:16Going to use exemption request
24:18and again it's much much shorter.
24:20Yale doesn't have a very
24:22specific form for a protocol.
24:25I will go through it in a second.
24:26You always need to have an IRB submission
24:29form because there are certain things
24:30that wouldn't be in a protocol.
24:32There will be an IRB submission form that's
24:35a document available in Iris IRB library.
24:37So in our system,
24:38because we are doing research
24:40during pandemic,
24:41we still have a form called safety
24:43protocol during pandemic.
24:44That's just one.
24:46Page document that just describes
24:48how we're going to protect your participants,
24:51but also stuff that works with
24:53you or or third party.
24:55Anybody who can come into contact
24:57with you during this research to
24:59make sure that we're not exposing
25:01people to unnecessary risk.
25:02If you're obtaining consents,
25:04you're not asking for a waiver of consent,
25:08we're going to look at the
25:10consent script or the document.
25:11Or if you asking for a waiver of consent,
25:14that something that you would ask in
25:16either be submission form any measures
25:18created for the purposes of the study,
25:21we need to be uploaded.
25:22If you're doing international research,
25:24we're going to look for their
25:26specific checklist that we require.
25:28There is letters of support from local
25:30like NGOs that will help you with that.
25:32Research and if you need to have
25:35special permission, we're going to
25:37look for those documents as well.
25:39As I said earlier,
25:41Yale does not require a specific
25:43protocol template.
25:44If you come.
25:45If you come from a different
25:48institution and you had a temple like
25:50to using at a different institution,
25:51you can use that as well,
25:53as long as has all of
25:55those required elements,
25:57we have a subscription to protocol builder,
25:59which is a software.
26:00There was a link on our website
26:02I included here too that will
26:04help you build the protocol
26:06by asking specific questions.
26:08We have some word.
26:09Portions of the templates from
26:11protocol builder in our library
26:12you can use that as well and
26:14there are some other tools that
26:16included here that you can you.
26:18You may actually like some of
26:20those protocol templates too.
26:22In terms of consent,
26:24if you're very familiar with regulations,
26:26you can definitely just
26:28draft your own consent.
26:29Just make sure that all of
26:31the elements are included.
26:32We created templates for
26:35your for our investigators,
26:37so if this is not externally sponsored study,
26:40you have to draft consent.
26:41You can go to the consent form
26:44section in our library in the system,
26:46and there are some templates available for
26:48you already has all the required elements.
26:51Just asked you to fill in.
26:52Certain pieces of information.
26:54If you working with colleagues
26:56from a different institution and
26:58they are sponsoring the study.
27:00So they wrote the protocol,
27:01they wrote the templates or if
27:03you working with a sponsor.
27:04So somebody already gave you a template,
27:06use those.
27:07Don't don't try to copy everything
27:09and move it into like a yell version.
27:11Use the templates that you were given.
27:14There is a document called consent
27:16Glossary in the consent section
27:19that includes all of the required.
27:22Language that we want to see
27:24in consent forms.
27:25Like if your study is taking
27:27place at PET Center,
27:29Pet Center has language that needs to go in.
27:31We also included certain paragraphs
27:33that we know our IRB likes to see,
27:37so that's a preferred language
27:39that was previously approved for
27:41like risks of certain procedures.
27:43So just make sure that it matches.
27:45Go through that document and see
27:47if you need to use any of this,
27:50but don't try to copy and paste it.
27:53Let me talk very quickly about external Irbs,
27:56because almost 50% of our studies
27:58that are externally sponsored
28:00actually go to external Irbs.
28:02So Yale IRB is the IRB of record for Yale,
28:07but we have agreements with other
28:09IRB's from other institutions we
28:12have agreements with a commercial
28:14certain commercial IRB's.
28:15There are some some studies or networks
28:18of studies that it's actually requirement
28:21that if you're doing research.
28:23Is part of stroke net.
28:24We have to go through a very specific
28:27IRB so we have those agreements as well.
28:30Or sometimes maybe you have a a colleague
28:33that you want to work with and now the
28:35regulations actually require a single IRB.
28:37If it's multi site research and
28:40that colleague is going through
28:41his or her institution,
28:43we will be able to enter into agreement
28:45with that institutions that we can
28:47see the review to the IRB as well.
28:49So if you ever asked from someone,
28:52does Yale.
28:52Need to review or enter into
28:55reliance agreement with other Irbs.
28:57The answer is yes.
28:58We we work with Irbs all the time.
29:01But even if you go to a different IRB,
29:05that institutional review that I just
29:07described earlier about the training,
29:09the making sure that you have the COI
29:12disclosures still needs to happen
29:14because it's the institutional review.
29:17So even if you want to go to an external IRB,
29:20you still have to submit something
29:22in our system will do that review of
29:25institutional compliance or compliance
29:27with institutional requirements.
29:28We'll check whether we have a
29:30reliance agreement in place.
29:32If not,
29:32we'll establish one and then we'll
29:34write a letter saying that you're
29:36OK to go to that external IRB and
29:39submit your proposal to the other IRB.
29:42We just need to keep track of those
29:44studies in our system after you
29:47get approval from the external IRB,
29:49you still need to make sure that
29:50our system is updated with all the
29:52approval letters and up to date so you
29:55don't have to submit all the modifications,
29:57but you need to keep the most recent
30:00approval letter for the study in our system.
30:03But all the modifications continuing
30:05reviews go directly to the external IRB.
30:07It's just that young needs to
30:09keep track of all those studies
30:10because we are as an institution,
30:12we are responsible for them.
30:15I included a list of some of our
30:18individuals in our office so that
30:21you may work with most of our office
30:23is of course at this point remote,
30:25but we have our offices are 25 science park,
30:28so if you wanted to meet with
30:30someone in person,
30:31you can schedule a meeting.
30:32We'll meet you there included
30:34the names of all the assistant
30:37directors and advisors within the
30:39office and names of the managers.
30:42Because I expect I suspect that you
30:44will probably go directly to a manager.
30:46If you have questions about yeah.
30:48Irby or your protocol,
30:50these are the people that you will be
30:52working with and sometimes if they don't,
30:55they cannot answer your question.
30:56They're going to triage or
30:57to somebody on their teams,
30:59like a regulatory analyst that can.
31:01That can answer the question if you ever
31:03need to have like a general question,
31:06you can send it to HR Pate l.edu.
31:09We check those emails daily and their
31:11triage to someone who is on call that day.
31:14So every day there is a different person.
31:17And we'll get back to you.
31:18Or you can leave a message,
31:19but I think email is nice because then
31:21you can see that information in writing.
31:24This is a list that included the
31:26link to our panel information,
31:28but this is the list of all of our
31:31panels and when they meet and who serves
31:34as the chair and the vice chair so you
31:36can see what what's panels, we have.
31:39Some of them are very specialized.
31:41You don't request a review by specific
31:43IRB we sent when your study comes in.
31:47They were we we have like very
31:49specific schedule so we send your
31:51study to the next available IRB.
31:53If it's Pi initiated we send it
31:55to the we give ourselves two weeks
31:57to work through your protocol,
31:59but everything else goes to the
32:01next available so that it's just
32:03a week waiting time.
32:04OK, so this is what I had.