Institutional Review Board (IRB) for Those Initiating Clinical Studies

Name: Institutional Review Board (IRB) for Those Initiating Clinical Studies
Uploaded: 2025-12-11T19:34:06.85Z
Duration: 48 min 35 s

December 11, 2025

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ID: 13697
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00:01Jonathan Gower from OAPD office,
00:03and, we are
00:04honored today to have, Gina
00:06Larson talking to us. I
00:08said lightheartedly toward the beginning.
00:09I went to a recent
00:10talk she gave on this,
00:12general overview information of things
00:13we should all know, and
00:14I learned so much
00:16that, I quickly invited her
00:18and asked her if she'd
00:18come talk to the next
00:19group.
00:21So great to have you.
00:23Thanks for joining us, and,
00:25look forward to, hearing you
00:27here.
00:28Thank you.
00:29Great. Thank you so much,
00:30doctor Grauer. And, likewise, I,
00:32had a wonderful time speaking
00:34with the the other group,
00:35so I'm always excited to
00:36come back and and talk
00:38about the IRB and human
00:39subjects research with our faculty
00:41as well. So thank you
00:42all for having me. I'm
00:43excited to be here. My
00:44name is Gina Larson. I'm
00:45Associate Director for the Human
00:47Research Production Program. And today
00:49I'm here to give you
00:50some general information about the
00:51Yale IRB and Human Research
00:53Production Program.
00:55We're gonna cover some just
00:56general information you should know
00:58when you're starting to engage
00:59with the IRB. We're also
01:01going to talk about what
01:02types of projects would require
01:04IRB review and approval and
01:06those that might not need
01:07IRB review and approval.
01:09And then I'll provide you
01:10with some tangible
01:12information and guidance on how
01:13to submit research studies to
01:14the Yale IRB.
01:16This includes anything from chart
01:18reviews to, interventional
01:20research, and I'll also give
01:21you some tips and tricks
01:23for things like requesting HIPAA
01:24waivers, which I know will
01:25be extremely useful for this
01:27group. I have left a
01:28good amount of time at
01:29the end for questions. So
01:31if you could hold your
01:32questions to the end, that
01:33would be fantastic.
01:34And I'll obviously,
01:35be excited and willing to
01:37answer any questions that you
01:38have at that time. Time.
01:39You also have access to
01:40these slides. There's a lot
01:41of great links that are
01:43embedded within the slide deck.
01:44So I encourage you to
01:45go back and look at
01:46these slides
01:47at your convenience after we
01:49we have this workshop.
01:51With all of that out
01:51of the way, all of
01:52that housekeeping,
01:53let's get started.
01:56So first, let's talk about
01:57what is the Yale Human
01:58Research Protection Program and what
02:00is an institutional review board,
02:01which I'm sure many of
02:02you are familiar with, but
02:03we'll go over the basics.
02:05So the Yale Human Research
02:07Protection Program supports Yale University's
02:09dedication to excellence
02:11by promoting the rights and
02:12welfare of people who participate
02:13in research that's conducted at
02:15Yale,
02:16or by Yale faculty, students,
02:19staff, or any Yale affiliates.
02:21We are an AARP accredited
02:23institution. I'm sure many of
02:24you have maybe come from
02:25other AARP accredited institutions. That's
02:28pretty much the gold standard,
02:30when it comes to human
02:31research production programs, ensuring that
02:34we go above and beyond
02:35the federal regulations
02:36to make sure that people
02:37people are protected in research,
02:39and our researchers are also
02:40going above and beyond. So
02:42we're really proud of that
02:43designation,
02:44and we do get reaccredited
02:45by aHARP every five years.
02:49So obviously, there's a lot
02:50of people that are working
02:51together to ensure that people
02:53are protected in research all
02:54across Yale, and that includes
02:56our researchers, our study
02:58coordinators, our PIs,
03:00our HRPP,
03:01and all of our other
03:02departments that we work with,
03:04within the context of of
03:06Yale.
03:06However, the biggest component of
03:08a human research production program,
03:10whether it's here at Yale
03:11or anywhere, is an institutional
03:13review board, also known as
03:14an IRB, and I'm sure
03:15that's the acronym you're probably
03:17most familiar with when it
03:18comes to human research studies
03:20and submitting those studies to
03:21an ethics board.
03:23IRBs ensure that research involving
03:25humans is conducted following the
03:27ethical principles outlined in the
03:28Belmont Report, which we'll talk
03:30about very briefly next, and
03:32all of those applicable laws,
03:33regulations, and human research standards.
03:36This includes all of our
03:37Department of Health and Human
03:38Service regulations,
03:40our FDA regulations,
03:42federal, state, and local regulations.
03:44So sometimes when you submit
03:46your applications to the IRB,
03:48you might think, you know,
03:48they're asking a lot of
03:49questions, and they're making me
03:51change this and they're asking
03:52me to clarify this point.
03:54I promise it's not because
03:55we're being mean or we're
03:56being nitpicky or anything.
03:58It truly is because we
04:00have to ensure that you
04:01are following all of these
04:02different regulations
04:04so that people are protected,
04:05but also you are protected
04:07as a researcher as well.
04:09IRBs also ensure compliance with
04:11university policies. We monitor for
04:13risk and safety concerns in
04:14human subjects research, and we
04:16consider the local context, so
04:18the interpretations,
04:19standards of practice,
04:20and community considerations
04:22of human subjects research. How
04:24is the community that you're
04:25working with going to be
04:26impacted by this research? We're
04:28considering all of that as
04:29well.
04:31Unfortunately,
04:32as you all probably know,
04:33the birth of the IRB
04:34resulted,
04:35from a history of unjustifiable
04:38crimes against humanity and unethical
04:40practices
04:41in the name of science
04:42and research.
04:44I do, this session I
04:46I go into depth about
04:47some of these things that
04:48we've seen. Obviously, you all
04:49know of the Tuskegee syphilis
04:51study,
04:51obviously, the atrocities that happened
04:53in concentration camps,
04:55during World War two,
04:57and,
04:57many other things that you
04:58see on your screen here.
05:00So because of all of
05:01these atrocities,
05:02we knew we had to
05:03put ethics boards in place,
05:04and we had to have
05:05laws and guidelines and regulations
05:08to ensure that people are
05:09protected
05:10in the research endeavor.
05:13One of the biggest
05:14ethical documents that came out
05:16of these atrocities was the
05:17creation of the Belmont Report
05:19in April of nineteen seventy
05:20nine. This is still to
05:22this day the cornerstone
05:24document and statement of ethical
05:25principles that guide human subjects
05:27research.
05:28If you haven't read the
05:29Belmont Report, I definitely recommend
05:31that you do so. It's
05:32only ten pages long and
05:34the writing actually still holds
05:36up to today's language. And
05:37we actually have really close
05:39ties here at Yale to
05:40the Belmont Report because one
05:41of our faculty members was
05:43one of the authors of
05:44the Belmont Report. So definitely
05:46something that you should check
05:47out if you haven't done
05:48so already.
05:49And there's three pillars of
05:51the Belmont Report. So when
05:53IRBs are reviewing research, we
05:54have to ensure that each
05:56of these pillars is being
05:57met in order for a
05:58study to be approved.
06:00The first pillar is respect
06:01for persons, so treating people
06:03as autonomous agents, ensuring that
06:05people have a decision about
06:07if they want to participate
06:08in research or not, and
06:10they're not being forced or
06:11coerced in any way.
06:13The second pillar is beneficence.
06:15So you're maximizing
06:16benefits of research as much
06:18as possible while minimizing harms.
06:20And then the third pillar
06:21is justice.
06:23So you're selecting participants in
06:25an equitable manner. You're not
06:27maybe targeting a very vulnerable
06:29group or vulnerable population that
06:31they're going to see receive
06:32all of the negative effects
06:34of research, but at the
06:35same time, you're not only
06:36offering really great treatments and
06:38research to individuals who have
06:40the means to be able
06:41to travel and access these
06:43clinical trials.
06:44So you're you're
06:46spreading out the the burdens,
06:48and also the benefits of
06:50research,
06:51equally amongst your populations.
06:55Let's go into some federal
06:56regulations,
06:57really quickly because these are
06:59some of the things that
07:00you will likely encounter when
07:01you're submitting your research studies
07:03and some of the things
07:04that you should be aware
07:05of. You don't have to
07:06be experts in the federal
07:07regulations. That's why we're here.
07:09We will help you through
07:10them, but it's good to
07:11know where your research may
07:13or may not fall depending
07:14on your funding source
07:16so that you know if
07:16there's, certain reporting requirements or
07:18something down the road and
07:20if something happens.
07:21So first, we have the
07:23HHS regulations.
07:25This is more commonly referred
07:26to as the common rule.
07:28This was created in nineteen
07:29ninety one. We actually had
07:31a revision to the common
07:32rule in twenty seventeen that
07:34became effective in twenty eighteen.
07:36So you might have seen
07:36there were some changes to
07:37like exempt research categories and
07:40some restructuring of the consent
07:42form that needed to happen
07:43with that new key information
07:44section. These are some of
07:46the things that changed with
07:47that revision to the common
07:48rule. But these are essentially,
07:50you know, this is the
07:50basic HHS policy.
07:53This provides us with all
07:54of the information we need
07:55to understand with regards to
07:57what is required for informed
07:58consent,
07:59how are you going to
08:01handle enrolling vulnerable populations in
08:03research. So the regulations say
08:05that pregnant women, fetuses, neonates,
08:08prisoners, and children are vulnerable
08:10per the regulations. Again, we
08:11know there's much more vulnerable
08:13populations than that, but those
08:15are the ones that are
08:16carved out in the regulations.
08:18So if you have any
08:20research that's funded by NIH,
08:23NSF,
08:24any of those, I think
08:25there's over, you know, thirty
08:26to forty departments that are
08:28regulated by HHS. If you're
08:30funded by any of those,
08:31you are subject to these
08:32regulations.
08:33However, even if you are
08:34unfunded,
08:35we do, like I said
08:36before, going by those ARP
08:38standards, we go above and
08:39beyond the regulations. So we
08:41do apply these regulations
08:43even to unfunded research as
08:45well. The only thing that
08:46we don't apply
08:47equally is if there's something
08:50like a,
08:51serious noncompliance
08:53or an unanticipated
08:54problem, we don't report that
08:55to HHS if it's not
08:57funded, but everything else remains
08:59the same.
09:00In addition to HHS, we
09:02have our FDA regulations.
09:04So if you're going to
09:05be working with a drug
09:06or a device,
09:07these are the regulations that
09:09pertain to you and your
09:10research studies.
09:11Thankfully, a lot of the
09:13basic policy is the same
09:14as the Department of Health
09:16and Human Services,
09:17but there are obviously other
09:19types of subparts with FDA
09:20regulated research just because of
09:22the nature of the research.
09:23Right? So we have part
09:25eleven compliance, you've probably heard
09:27of. Those are requirements for
09:29electronic signatures.
09:31And then obviously, we have
09:32various subparts for working with
09:35INDs,
09:36biological
09:37products,
09:38devices.
09:39So again, you don't have
09:40to be experts in all
09:41of these
09:42rules and and regulations, but
09:44certainly know that they may
09:46apply to your research. And
09:47it's important to be just
09:48familiar with the general structure
09:50of what we are abiding
09:52by when we're reviewing your
09:53research studies.
09:55So now that we've given
09:56you an overview
09:57of the landscape of IRBs,
10:00let's talk about what is
10:02and what is not human
10:03subjects research. Again, that that
10:05may or may not require
10:06IRB review and approval.
10:08And it's easier to start
10:09with what is not human
10:10subjects research. We get a
10:12lot of questions about various
10:13projects. What is something that
10:15you wouldn't need to submit
10:16to an IRB?
10:17One is data on deceased
10:19persons.
10:21So if you are looking
10:21at medical records or information
10:23from individuals who have passed
10:25away, you actually don't have
10:27to submit that to an
10:28IRB for review because as
10:29you'll see in the next
10:30few slides when we get
10:31into what is human subjects
10:32research,
10:33it's only about living individuals.
10:36However, one caveat here that
10:37I think is important to
10:38note is the HIPAA Privacy
10:40Rule protects the individually
10:42identifiable health information about a
10:44decedent for fifty years after
10:46they pass.
10:48So if you are looking
10:49at
10:50decedent information from somebody or
10:52a group that has passed
10:53away, you know, five years
10:54ago, ten, twenty, even though
10:56you don't need IRB approval,
10:58you will still need,
11:00approval from a HIPAA perspective.
11:01So I have linked
11:03a form here for you,
11:05which is a request for
11:06access to PHI for research
11:08purposes for decedents.
11:10So that will be, useful
11:12for you to have in
11:13your pocket.
11:14Also, what is not human
11:15subjects research is obviously data
11:17about health facilities, businesses, or
11:20organizations.
11:21So if you're not talking
11:22to somebody, you're not collecting
11:23their information,
11:25that's not human subjects research.
11:26If you're looking at processes
11:28at an organization
11:29or, you know, bus routes
11:31and and what that means
11:32from an engineering perspective, that's
11:34not something that you would
11:35interface with a human for
11:36and ask them about themselves
11:38or their opinions.
11:39So, obviously, those types of
11:40projects are not human subjects
11:42research. And then finally, on
11:44this slide,
11:45de identified
11:46human data or specimens.
11:48Now this is very important
11:50to note. This does not
11:51mean that you are going
11:52into the medical record and
11:53then de identifying that information
11:55yourself and then taking that
11:57data set and conducting research
11:58with that data set. It
11:59truly means that somebody is
12:01giving you a completely deidentified
12:03data set per the eighteen
12:05HIPAA identifiers.
12:06In those cases, you would
12:08need to submit that type
12:09of project to the IRB
12:10for review.
12:13Also, what is not human
12:14subjects research is a case
12:15study or a case report.
12:18As you're probably familiar with,
12:20these are presentations of a
12:21detailed critique, so the characteristics,
12:24evaluation, or treatment
12:25of one or more patients
12:26that share a common condition
12:28to provide insights into aspects
12:30of the clinical case. Let's
12:32say you have three individuals
12:33that share a very common
12:35disorder, and in the clinical
12:37sphere, you're seeing that a
12:39certain treatment is working really
12:40well for them, and you
12:41want to publish this and
12:42talk about this from a
12:43case study perspective to help
12:45others in your field
12:46understand this case.
12:48That would be okay to
12:49do without any type of
12:50IRB approval.
12:52The reason is because this
12:53is really analysis of a
12:54unique situation,
12:56and it does not include
12:57any activities defined as research.
13:00Again, similar to the decedent
13:02information we talked about a
13:03couple of slides back, when
13:05you're publishing case studies,
13:07don't refer to it as
13:08research, but you still need
13:09to obtain permission from the
13:11individual
13:12via a non research permission
13:14form in order to use
13:16their information
13:17for that case report or
13:18case study. Again, I have
13:20linked a form for you
13:21here that you can use
13:22for those purposes. And if
13:24you do have questions on
13:25this, feel free to reach
13:26out to me directly. I'd
13:27be happy to talk with
13:28you about any case studies
13:29or case reports you might
13:30be interested in in publishing.
13:34What is also not human
13:35subjects research is activities
13:37prepped to research.
13:38So let's say you're looking
13:39at medical records or other
13:41sources
13:42to determine whether there is
13:43a sufficient population to conduct
13:45the research that you want
13:46with meaningful results.
13:48You can look at the
13:49medical records. You can look
13:51at information.
13:52However, you cannot record any
13:54identifying information. You can't go
13:56into the record and then
13:57type in some notes about,
13:58you know, there's this many
13:59patients and these are the
14:01birth dates and this is
14:02the medical information tied to
14:03it. It really is you
14:05just looking at the medical
14:06record to see if there's
14:08information that would you would
14:10be able to create a
14:11a full research study out
14:12of and and look at
14:13that data, and then you
14:14would submit to the IRB
14:15to conduct that research that
14:17you want to.
14:19Probably the biggest question that
14:21we get about is my
14:22project something that needs to
14:24be submitted to the IRB
14:26is quality improvement projects. And
14:28I know there's a lot
14:29of questions on quality improvement
14:31because it's a huge gray
14:33area.
14:34I will say,
14:36if you have a quality
14:37improvement project you're conducting or
14:39you're you're not quite sure,
14:40please just reach out to
14:41me directly. I'd be happy
14:42to talk about that with
14:43you. We also have a
14:45really, really nice guidance document
14:47that we've created
14:48that goes through various case
14:50studies and shows what might
14:51be a quality improvement project
14:53versus a research project, and
14:55you can kind of check
14:56off this these checks check
14:57boxes we have,
14:59in that guidance document. So
15:00I certainly recommend that you
15:02take a look at that.
15:03But what is a quality
15:04improvement project?
15:06It's a data guided initiative
15:07designed to improve clinical care,
15:09health care operations,
15:11services and programs,
15:13or for developing new programs
15:15or services. This could be
15:16teaching evaluations,
15:18patient employee service surveys.
15:20Let me give you an
15:21example of a true quality
15:22improvement project. Let's say you
15:24are working in a clinic,
15:26and you're noticing that you're
15:27not quite happy with handwashing
15:29practices amongst the staff,
15:32the clinicians,
15:33so you wanna change that
15:34behavior.
15:35Let's say you do a
15:37pre survey
15:38to assess handwashing practices.
15:41You conduct the intervention,
15:43and then you do a
15:43post survey to see if
15:45there's been a change in
15:46behavior with handwashing.
15:48Maybe at the same time,
15:49you're looking at medical records
15:51of patients and assessing rates
15:52of infection. Right? So you're
15:54trying to link if the
15:55handwashing intervention,
15:57led to a decrease in
15:58infections in the hospital.
16:00That is a true quality
16:02improvement project. Right? It's applicable
16:04to a particular setting. It's
16:06not intended to be generalizable,
16:08and it shouldn't be referred
16:10to as research.
16:11We do have people that
16:12want to publish quality improvement
16:14projects, and that's certainly okay.
16:16I would recommend in those
16:18cases that you submit a
16:20not human subjects research application
16:23to the IRB.
16:24It's essentially a form that
16:25says, hey. I'm not conducting
16:27research. I'm conducting a quality
16:29improvement project, here's a really
16:30quick snippet of what it
16:31is, you send it to
16:32the IRB and we will
16:34issue a letter that says,
16:35yep, you're correct, we reviewed
16:37it, this is a quality
16:38improvement project, it's not reach
16:40research, but the IRB has
16:41taken a look at at
16:42it because sometimes journals will
16:44ask for that type of
16:45letter from the IRB assessing
16:47that. So I would say
16:48that even though you don't
16:49need to submit these projects
16:51at all to the IRB
16:52for review and approval,
16:54if you are hoping to
16:55publish, it might be something
16:56you might want to submit
16:57to the IRB just to
16:59have that letter that says
17:00an IRB did take a
17:01look at this.
17:04This is a nice, a
17:05very rudimentary
17:06graph that kind of shows
17:07you various elements of your
17:09projects and when it might
17:10fall into the research bucket
17:12versus quality improvement.
17:13So what is the purpose
17:15of your study or your
17:16project? What is the design?
17:18Are there benefits? Are there
17:19risks? And what are your
17:20publication intentions?
17:22And this helps you to
17:23determine if your research might
17:25fall in if your project
17:26might fall in the research
17:27bucket versus the quality improvement
17:29bucket. But again, if you
17:30have questions on this, it's
17:32a huge gray area.
17:33I'd be happy to chat
17:34with you about your project.
17:37So now that we've talked
17:38about what is not human
17:40subjects research, let's talk about
17:42what is human subjects research
17:43that would require IRB review
17:45and approval. And before I
17:46do that, the sun is
17:47in my face, so let
17:48me just pull this shade
17:49down really quickly. I appreciate
17:50that.
17:53Okay.
17:54So we're we go by
17:55the HHS definitions here, but
17:57the FDA have very similar
17:59definitions.
18:00Let's start with the definition
18:01of research and break it
18:02down a little bit.
18:04Research is a systematic investigation,
18:06including research development, testing, and
18:08evaluation
18:10designed to develop or contribute
18:11to generalizable
18:13knowledge. So you want to
18:14add to literature in your
18:15field,
18:16you want to contribute to
18:17that literature,
18:18and you have a hypothesis,
18:20you have research questions,
18:22that is the true definition
18:23of research, the systematic investigation.
18:26And a human subject is
18:28a living individual. Remember, we
18:30talked about decedents before? It's
18:32a living individual about whom
18:34an investigator conducting research either
18:36obtains information or biospecimens
18:39through intervening or interacting with
18:41somebody,
18:42or they obtain, use, study,
18:44analyze, or generate identifiable
18:47private information or biospecimens.
18:49So in order for you
18:50to have a project that
18:52requires IRB review and approval,
18:54it has to involve,
18:56human subject per this definition,
18:58and you have to be
18:59conducting research per this definition.
19:01And then that's something that
19:02the IRB would need to
19:03see.
19:05This is again another very
19:06simple decision tree for you,
19:09to help walk you through
19:10if you are conducting a
19:11research project, and it's essentially
19:13the definitions that we just
19:14went over in the previous
19:16slide.
19:18So we review a lot
19:19of different types of research.
19:21I know this is a
19:21very busy slide, but I
19:23will break it down for
19:23you step by step.
19:25We see
19:27research that involves
19:29interventional,
19:30drugs. We see devices.
19:33We see greater than minimal
19:34risk studies,
19:36we see studies that involve
19:38controversial
19:39issues, prisoners,
19:41most of that is reviewed
19:42at the full board level.
19:44That means that we have
19:45IRB chairpersons,
19:47experts in the field, community
19:48members that meet, and they
19:50actually review the study together.
19:52They go over the
19:54risks, the benefits,
19:56are all of the criteria
19:58per the federal regulations being
19:59met, is it ethical?
20:01So they're meeting to really
20:02talk about this, and you'll
20:03get your approval from the
20:05fully convened board. Again, these
20:07are those greater than minimal
20:08studies, drug device studies.
20:11The really cool thing about
20:12Yale, which may be different
20:13than some institutions that you've
20:15been at, is we actually
20:16have nineteen
20:18IRBs,
20:19which is a huge number.
20:20Some institutions only have, you
20:21know, one or two or
20:23three. Because we have so
20:24many IRBs, we meet several
20:26times a week. So once
20:27you submit your study, it
20:29will get assigned to a
20:30meeting,
20:31you know, very, very shortly.
20:32And as long as you
20:33are, working with us and
20:35when we're asking questions, you're
20:36getting back to us really
20:37quickly. Thankfully, we're able to
20:39approve those studies
20:41at a relatively,
20:43good good level, and then
20:45it doesn't take too long
20:46to approve those studies.
20:48We also have expedited studies
20:50that we see. So these
20:51are studies that are always
20:52going to be minimal risk,
20:54and they fit into one
20:55of the expedited categories that
20:57we have per the regulations.
21:00These are studies that maybe
21:02involve a it's it's not
21:03greater than minimal risk, but
21:05maybe there's, like, a blood
21:06draw involved, or there's some
21:07type of, like, physical intervention,
21:09or maybe it's a very
21:10sensitive research project,
21:12you're working with a very
21:13vulnerable population,
21:15that might be something that
21:16would push it into an
21:17expedited level,
21:19and again, it's
21:20not reviewed at this full
21:21board level so it's a
21:23little bit quicker of a
21:24process
21:25similar to exempt research. So
21:27exempt research is probably the
21:28most research that we see,
21:30and it's the lowest risk
21:32research, but there's a lot
21:33of different types of research
21:34that can be done under
21:35the exempt research categories.
21:38I will say here at
21:39Yale, we do require
21:41that investigators submit exempt research
21:43to the IRB. I know
21:44some institutions allow investigators
21:47to make their own exempt
21:48determinations.
21:49We do not allow that
21:50at Yale. So you will
21:51need to submit those chart
21:52reviews to us. You will
21:54need to submit those interview
21:55and survey studies to us,
21:56and we'll get you that
21:57approval. Again, it's a pretty
21:58quick it's a it's a
21:59pretty quick turnaround for our
22:01exempt research. So it's
22:03within a few days to
22:04a week as long as
22:05you're getting back to us
22:06if we have questions to
22:08you. So that's that's really
22:09great. And I'll walk you
22:10through that process in just
22:11a few slides.
22:13So, again, these are all
22:14of our minimal risk surveys,
22:15interviews, focus groups, observation of
22:18public behavior, research on educational
22:20techniques,
22:21review of data that is
22:23either publicly available or no
22:24identifiers are being recorded.
22:26And the biggest one that
22:27we see is the HIPAA
22:29category, essentially, is what we
22:30call it. So that's secondary
22:32research use of identifiable private
22:34information
22:35or identifiable biospecimens
22:37regulated under HIPAA. So many
22:39of our medical record reviews
22:41that we see. It also
22:42includes this new interesting category
22:44that was added in the
22:45twenty eighteen regulations
22:47called benign behavioral interventions.
22:49So,
22:50that was a new one
22:51that was interesting for us
22:52to, navigate as as that
22:55was added in the regulations.
22:57Okay. So let's talk a
22:58little bit about chart reviews
23:00because I know many of
23:00you are going to be
23:01submitting these to the IRB.
23:03So these are found at
23:04exempt category four.
23:07You will have when you're
23:08submitting these to the IRB,
23:10there's going to be an
23:11exemption request form that's going
23:12to ask you about the
23:14category you believe your research
23:15is. You don't have to
23:16be right. The IRB will
23:18help you out here, but
23:19it's good to know if
23:20you are conducting a medical
23:21record review, it will be
23:22that exempt category four.
23:24Specifically, this little,
23:27little little I, three little
23:28i's or or number three.
23:30So this is secondary research
23:32for which consent is not
23:33required.
23:34Secondary research uses of identifiable
23:36private information or identifiable biospecimens
23:39if at least one of
23:40the following criteria is met.
23:42So for those chart reviews,
23:44it's this third point here.
23:46The research involves only information
23:48collection and analysis involving the
23:50investigator's use of identifiable
23:52health information
23:54that is regulated under these
23:55regulations
23:56and for the purposes of
23:58health care operations
23:59or research. So, again, this
24:00is that HIPAA category to
24:02be aware of.
24:04So how can protected health
24:05information be used in research?
24:07There's a few different ways
24:08that you can use PHI
24:10in the conduct of your
24:11research.
24:12One is just obtaining a
24:14participant's authorization. So in order
24:16to use or disclose PHI
24:18for research, you can obtain
24:20authorization
24:22from the individual.
24:23Let's say you're doing a
24:24drug study or a device
24:25study or even a a
24:27focus group and you're talking
24:28with somebody or you're intervening,
24:31obviously it's important for you
24:33to get that consent from
24:35that individual and if you're
24:36dealing with protected health information
24:38in addition to consent
24:39you will need that HIPAA
24:40authorization.
24:42At Yale, our consent templates
24:44templates actually have a built
24:45in HIPAA authorization form as
24:47well, so they only essentially
24:49sign one document
24:50that contains an embedded
24:52research authorization form, but you
24:54can also have a standalone
24:55form as well if that's
24:56something that you're interested in.
24:58What do I mean by
24:59using or disclosing PHI for
25:01research?
25:02Use is the use of
25:04PHI.
25:05Use means communicating, utilizing, examining,
25:08or analyzing
25:09PHI within the covered entity,
25:12And disclosure means the release,
25:14transfer, provision of access to,
25:16or divulging in any manner
25:17of information outside the entity
25:19holding the information.
25:21It's a very technical terms,
25:22but essentially,
25:24are you taking somebody's
25:26PHI? Are you identifying? Are
25:28you, is it leaving the
25:29covered entity? Is it leaving
25:31Yale? Is it going to
25:32other researchers at other institutions?
25:35So, again, if you have
25:36questions on that, let me
25:37know, but just wanted to
25:38provide the definitions for you
25:40here.
25:42In order to
25:43use or disclose PHI, you
25:44could also request a waiver
25:46of HIPAA authorization.
25:48This is what you're going
25:49to need to request when
25:50you're looking at those medical
25:51record reviews, those chart reviews.
25:54Obviously, it's not always possible
25:56to obtain informed consent or
25:58obtain HIPAA authorization
26:00from individuals.
26:01Let's say you're looking at
26:02a thousand records, right, or
26:04you're looking at ten thousand
26:05records or five hundred records.
26:07It would be impractical
26:09for you to go and
26:10get consent and research authorization
26:12for those, from those individuals
26:14to access their data for
26:16research purposes.
26:17So you can request a
26:18waiver of HIPAA authorization from
26:20the privacy board, which here
26:21at Yale, the Yale IRB
26:23serves as the privacy board.
26:24So you can request that
26:26authorize waiver of authorization
26:28in your IRB application, and
26:29I'll show you how to
26:30do that. And then finally,
26:31you can certainly use and
26:33disclose PHI for research when
26:34you're working with decedents, which
26:36we already talked about, and
26:37activities prep to research.
26:41So what are the criteria
26:42for a waiver or alteration
26:44of HIPAA authorization?
26:46In order to use or
26:48disclose PHI, we have to
26:50ensure that
26:51that disclosure is going to
26:52involve no more than a
26:54minimal risk to the privacy
26:55of individuals
26:57based on the presence of
26:58the following elements. One, is
27:00there an adequate plan to
27:01protect the identifiers
27:03from improper use of disclosure?
27:05Is there an adequate plan
27:06to destroy the identifiers
27:08at the earliest convenience?
27:10Is there an adequate written
27:11assurance that the PHI will
27:13not be reused or disclosed
27:15to any other person or
27:16entity?
27:18And can the research not
27:19be practically carried out without
27:21the waiver or alteration
27:23and, cannot be conducted without
27:25access to and the use
27:27of that PHI? So, again,
27:29for the most part, many
27:30chart reviews are going to
27:31meet this this criteria, and
27:33you're going to be able
27:34to request that waiver of
27:36HIPAA authorization.
27:38So I'll show you this
27:39in just a few, slides
27:41here, but when you're going
27:42to be submitting your research
27:44studies to the IRB, if
27:45it is exempt research, maybe
27:47it's that exempt category four,
27:49you're looking at medical records,
27:51there's a question on the
27:52exemption request form, it's question
27:54number seven. It's going to
27:56ask you to list all
27:57health information that will be
27:59recorded for the research.
28:00Only the items that are
28:02listed on this exemption request
28:04form may be recorded. Okay?
28:06So you have to make
28:07sure that every identifier you're
28:08going to be looking at
28:09in the medical record is
28:11included in your exemption request
28:13form.
28:14If you're using an Excel
28:15spreadsheet to provide,
28:17JDAT with your request, you
28:18can upload the document in
28:20IRS IRB
28:21and include a reference to
28:22the spreadsheet in this section
28:24of the exemption request form.
28:26So I'm sure many of
28:27you have done this. If
28:28you have not, whenever you
28:29want to look at medical
28:30records for research purposes that
28:32are not your own records,
28:33they're, you know, in epic
28:34or something and you're interested
28:36in a certain population,
28:38you first need to get
28:39IRB approval to do so.
28:40You have the list of
28:41identifiers that you're going to
28:43want access to, and you'll
28:45work with the joint data
28:46analytics team who is going
28:47to ask for your IRB
28:49approval, and they're the ones
28:50that actually provide you the
28:52information
28:53that you're requesting. So just
28:54keep that in mind.
28:56Some common identifiers that are
28:58quite obvious that you might
28:59be looking for
29:00are things like name, address,
29:02social security number, medical record
29:05number, phone number, email, a
29:07full face photo.
29:08But there's also less obvious
29:10identifiers. So if you want
29:11to collect these or,
29:14you don't realize that these
29:15also might be identifiers that
29:17you shouldn't be sharing or
29:18accessing,
29:19those include things like just
29:21general dates. This could be
29:22dates of
29:23visit, dates of surgery,
29:25health plan number, account number,
29:28license number, license plate,
29:30device number, IP addresses is
29:33something we don't think about
29:34a lot,
29:35finger and voice prints, or
29:37other unique identifying
29:39numbers, characteristics,
29:41or codes.
29:43So these, I
29:45if there's anything that you
29:46remember from this presentation, I
29:47hope it's a lot, but
29:48I would say the next
29:49two slides will be very
29:50useful for you to have
29:52in your pocket when you're
29:53submitting your studies to the
29:54IRB.
29:56This first slide is sample
29:58text that you can use
29:59when you're trying to describe
30:01how data is going to
30:02be recorded so that subjects
30:04will not be identified.
30:05So you will need to
30:06tailor this as appropriate for
30:08your study, but you'll essentially
30:09be able to copy this
30:10information,
30:12and then paste it when
30:13it's asked of you in
30:14the IRB application or the
30:15exemption request form.
30:17So, you can see on
30:19your screen here, it's just
30:20indicating that, you know, patient
30:22medical record numbers obtained from
30:23a JDate request will be
30:25recorded onto a master list.
30:27There's going to be a
30:28code. This is how it's
30:29going to be assigned.
30:30The master list is going
30:32to be stored in an
30:33Excel spreadsheet on SharePoint. It's
30:35only going to be available
30:36to x y z individuals,
30:39and then it talks about
30:40password protection. So this should
30:41be really useful for you
30:43when you're submitting your projects
30:44to the IRB.
30:46And then the second one
30:47is the request for a
30:49waiver of HIPAA authorization for
30:51those chart reviews. So, again,
30:52you'll need to tailor this
30:53as appropriate to your study,
30:55but this is essentially the
30:57language that can be used
30:59to request that full waiver
31:00of authorization.
31:01Again, this is something that
31:02you can find in the
31:04exemption request form,
31:06or the IRB submission form,
31:08which is the document that
31:09would you would instead use
31:10if you are conducting a
31:11drug or a device trial.
31:15So now that we've talked
31:15about all of the basics,
31:17how do you actually submit
31:18your research application to the
31:20Yale IRB?
31:21Before you submit, ask yourself,
31:23can you serve as the
31:24principal investigator?
31:26So we go by the
31:27Yale faculty handbook regarding who
31:29can serve as a principal
31:30investigator.
31:32I would say that most
31:33faculty are able to serve
31:34as PI's. The only individuals
31:36that we don't allow to
31:37serve as PI's, from a
31:39faculty perspective is adjunct faculty.
31:42So in those cases, adjunct
31:43faculty will need to give
31:45special permission to serve as
31:46the PI from the dean
31:48of their department. So we
31:50do have a form that
31:51can be completed in those
31:52circumstances.
31:54Also, ask yourself,
31:55what training does your team
31:57and and do you need
31:58to complete?
31:59We do require human subject
32:00protection training.
32:02This is done via the
32:03CITI
32:04program, which I'm sure many
32:05of you have worked with
32:06before.
32:07We also require HIPAA training
32:09that's done within here within
32:11Yale that for anyone that's
32:12going to be working with
32:13protective health information.
32:15And then if you're going
32:16to be conducting a clinical
32:17trial,
32:18you will need to take
32:19GCP
32:20training as well, and that
32:21can be done via the
32:23CITI program. So I have
32:24included links for you here.
32:26Also, are any ancillary groups
32:29going to need to review
32:30your research as well? Just
32:32to give you an idea,
32:33if you're working with, you
32:34know, radiation, we have a
32:35radiation safety committee that will
32:37need to review your research.
32:38If you're working with children,
32:39we have a pediatric protocol
32:41review committee that reviews all
32:43research involving children. So once
32:45you submit your application to
32:46the IRB,
32:47we might tell you that
32:48you need to contact these
32:49ancillary groups
32:51in order to get their,
32:52approval for your study as
32:54well. Thankfully,
32:56that can be accommodated for
32:57the most part in the
32:58IRIS IRB system, which is
33:00the system that you'll use
33:02to submit your IRB applications.
33:05So, again, these are some
33:06documents that you might need
33:07for review. I will say
33:09one great thing about our
33:10system is it's a very
33:12heavy document upload system. So
33:14instead of having, like, fifty
33:16pages that you have to
33:17complete, there's only a few
33:19pages in the IRB application,
33:21that electronic system,
33:22but we ask you to
33:23upload a lot of those
33:24documents. So your protocol, consent
33:26forms, recruitment materials,
33:29anything else that you're going
33:30to need to conduct your
33:31study, that those are going
33:32to be uploaded as documents
33:34in the application,
33:35but it's pretty straightforward about
33:36where you actually need to
33:37put those documents.
33:39So I'll start out with
33:40when you're conducting exempt research.
33:42Let's say you're do those
33:43you're doing those chart reviews,
33:45those interviews, focus groups,
33:47you will complete this exemption
33:49request form that I've linked
33:50for you there.
33:52This can be uploaded as
33:54your protocol, essentially, in IRS
33:56IRB.
33:57And, obviously, in addition to
33:58that, you'll upload any consent
34:00documents you may or may
34:01not be using, surveys,
34:03questions,
34:04recruitment materials, letters of support,
34:06etcetera. So that's a pretty,
34:09easy application
34:10to complete this form and
34:11then upload into IRS IRB.
34:14If you are conducting
34:15expedited or full board research,
34:17so let's say you're working
34:18with drugs or devices,
34:20you will need to complete
34:22a protocol
34:23and the IRB submission form
34:25and upload those in IRIS
34:27IRB.
34:27We do have templates available
34:29for you in the IRIS
34:30IRB library that you can
34:32use for your protocol. We've
34:33got various biomedical templates, social
34:36behavioral templates,
34:38and we are actually revising
34:39those then. They're looking really
34:41good. Those should be available
34:42in the spring, so we're
34:43happy about that, but we
34:44do have some nice templates
34:45for you there currently.
34:47You will also need to
34:48upload this IRB submission form.
34:51This is essentially a complimentary
34:53document to the protocol that
34:55asks a little bit more
34:56information about your study with
34:58regards
34:59to local context.
35:00So what waivers are you
35:02requesting? Let's say you're doing
35:03that drug device trial, you
35:05need to request some type
35:06of HIPAA waiver, that's actually
35:08done in the IRB submission
35:09form instead of the exemption
35:11request form obviously,
35:13and more information about recruitment
35:15is is asked in the
35:16IRB submission form. So keep
35:18in mind if you're conducting
35:19that full board or expedited
35:21research, both of these documents
35:23will need to be uploaded.
35:25Regardless of if your research
35:26is exempt, expedited, full board,
35:28everything else also needs to
35:30be uploaded. So, again, those
35:31consent documents, assent documents, we
35:34do have templates available for
35:35you in the library.
35:37Something that's great to to
35:38announce is that we did
35:39just update our ascent forms.
35:41So for adolescents and children,
35:43we did just update those
35:45forms to be more user
35:46friendly for children. So those
35:48are available in the Iris
35:49Iribe library.
35:51And, again, upload any other
35:52documents that are going to
35:53be part of your research.
35:56If you are conducting international
35:58research, we also will ask
35:59that you complete this international
36:01checklist
36:02and upload it in IRIS
36:03IRB as well.
36:06This is the iris IRB
36:07library. What's nice about iris
36:09IRB is it's you log
36:11in with your Yale NetID.
36:13So if you just Google
36:14iris IRB, or I've provided
36:15a link for you later
36:16on, you will log in
36:18with your Yale NetID and
36:19password. You don't have to
36:20sign up for a separate
36:21account, so it's pretty easy
36:23to navigate and and get
36:25into the system.
36:26If you go to the
36:27library, which is this banner
36:29up top, you can access
36:31our protocol templates. Again, that's
36:33where you're going to find
36:34the exemption request form, all
36:35of our biomedical and social
36:37behavioral templates.
36:38If you click on the
36:39breadcrumbs here, this is where
36:40you can also access consent
36:42form templates,
36:43our handbooks and manuals, so
36:45our SOP manual, our investigator
36:48manual.
36:48And then if you click
36:49on the IRB tab that's
36:51up here,
36:52you will also have access
36:53to our help center, which
36:55has some really nice guides
36:56about
36:57submitting,
36:58clarifications
36:59back to the IRB
37:00and other types of training
37:02videos.
37:05So the last thing I'll
37:06talk about is what happens
37:08once you submit that project
37:10to the IRB. What does
37:11the review process and the
37:13flow look like?
37:14Investigators,
37:15when they submit all those
37:16documents in IRS IRB,
37:18that application is going to
37:20be assigned to a Yale
37:21IRB regulatory
37:22analyst. They're going to conduct
37:24a pre review of your
37:25application. They're going to make
37:26sure that all of your
37:27training is complete,
37:29that you have uploaded everything
37:31correctly,
37:32and then they'll either triage
37:34that application to the fully
37:36convened IRB for, again, those
37:37greater than minimal risk or
37:39drug device
37:40studies, or they will, send
37:42it to an IRB chair
37:43or a designated reviewer for
37:45exempt or expedited research.
37:47They're going to look at
37:48your study. They may have
37:49questions for you, so please
37:51note that once you submit
37:52your study, you might get
37:54emails from the IRIS IRB
37:56system saying there's action needed
37:57from you.
37:58Please, please complete those
38:01clarifications
38:02as quickly as possible because
38:04the sooner you get back
38:05to us, the sooner we're
38:06gonna approve your study.
38:08So we might just have
38:09one or two things you
38:10need to change, just get
38:11that done quickly
38:13so that you can start
38:14your research,
38:15quickly and and everyone's happy.
38:17So once we are done
38:19cleaning up your application, all
38:20clarifications
38:21from the IRB have been
38:22addressed.
38:23You will receive an email
38:25that has a link to
38:27your approval letter. So then
38:28you are ready to begin
38:30your research once you do
38:31receive that approval letter from
38:32the IRB.
38:33It'll be a a PDF
38:35document
38:36in your IRIS IRB application
38:38that you can certainly download.
38:40Be sure to read that
38:41letter also before you start
38:42your research because there might
38:44be information the IRB needs
38:45to convey with you convey
38:47to you in that in
38:48that letter. So certainly read
38:50the the approval,
38:51before you you begin your
38:53research.
38:54So these are our additional
38:56resources I wanted to share
38:57with you.
38:58We have our website. We
38:59have our policies and procedures,
39:01our our standard operating procedure
39:03manual, our investigator manual,
39:05and a link to IRIS
39:07IRB.
39:08I will also say if
39:09you're new to Yale or
39:10even if you're not new
39:11to Yale, a really useful
39:13guidance document is our guidance
39:15four ten. This is all
39:16about research recruitment at Yale
39:18and Yale New Haven Hospital.
39:20How do you work with
39:21MyChart
39:22to send out MyChart messages?
39:24What is acceptable with regards
39:26to approaching somebody in health
39:27care facilities and asking them
39:29to participate in research? So
39:31we just updated this a
39:33little over a year ago,
39:34and we worked with our
39:36colleagues at the health system
39:37as well. So this is
39:38a really nice document to
39:39get you,
39:41fully educated on what we
39:43allow or don't allow when
39:44it comes to research recruitment.
39:45So take a look at
39:46that. And the last thing
39:48I'll say before I take
39:49any questions from the group
39:50is we truly are committed
39:52in our office to a
39:53partnership with our research community.
39:55We're always available to answer
39:57questions,
39:58to talk with you about
39:59your project,
40:00and we're always going to
40:01ensure that you are supported
40:03so that you can conduct
40:04all of the great research
40:05that you do and ensure
40:06that the research that you
40:08do conduct is safe and
40:09ethical. I promise we're a
40:10very friendly bunch, and, again,
40:12we're always happy to to
40:14collaborate with you.
40:15So with that being said,
40:17I did wanna leave a
40:18good amount of time for
40:19questions, and I'm happy to
40:21take any questions at this
40:22time.
40:27Thank you so much.
40:30Maybe as people if people
40:32have plenty of questions, but
40:34one that I'm always surprised
40:35on is how quick the
40:37process is. You know, with
40:38exemptions being the most common
40:40other than when
40:41the people submitting
40:43kinda don't follow through on
40:44the queries to them. How
40:46long would you tell people
40:47it should take on average?
40:48Like, do you see coming
40:49out of the office? Like,
40:51what do you tell people?
40:52Yeah. That's a great question.
40:54So I would say that
40:55for exempt or expedited research,
40:57as long as you are
40:58responding to the IRB,
41:00a week to two weeks
41:01from when you submit is
41:03when you should receive your
41:04approval, which is we're really
41:05proud of that. So, obviously,
41:07there's outliers, as you say,
41:08doctor Grauer. So if you
41:10submit your study and the
41:11IRB the next day ask
41:13for clarifications and you don't
41:14respond for a month, that's
41:15another thing. But for the
41:16most part, I'd say one
41:17to two weeks max probably
41:19for those.
41:20For full board, it's a
41:22it just depends on full
41:23board. I would say that
41:24it can be as little
41:26as
41:28three weeks,
41:29but it just depends on
41:31the
41:32study, how elaborate the study
41:34is, the interventions involved, if
41:36there's a vulnerable population. So
41:37that's a little bit harder
41:38to parse out.
41:40Yeah.
41:41Good question. I would tell
41:42you my experience with expedited
41:44or exempt is is even
41:45faster than that. You are
41:46certainly, if anything, overestimating.
41:48Okay.
41:49Well, good. I'm glad to
41:50hear that. You yes. It
41:52can be a a day
41:53sometimes for exempt research, but
41:54I like to,
41:55just in case, give ourselves
41:57a little bit of of
41:58leisure. Great that you do,
41:59but just everyone knows, it's
42:01it's pretty fast. So it
42:02surprises me. Glad you've had
42:03a good experience with that.
42:05Yeah.
42:06Am I one other kind
42:07of before we kinda push
42:08for anybody else? But one
42:10of the things I find
42:10is it's a little anonymous
42:12feeling when you kinda send
42:13to these, like, general mailboxes,
42:16but I've been very impressed
42:18how quickly it becomes
42:20a email dialogue with a
42:21person, as opposed to a
42:22general mailbox. Because I I
42:23don't know. Y'all kinda feel
42:24like some of these
42:26office, like, centralized things, it
42:29you kinda feel like, is
42:30somebody really reading that? And
42:31my experience has been
42:37if asked for.
42:39That's thank you for saying
42:40I'm I'm I'm so glad
42:41that that's been your experience,
42:42but you're you're totally right.
42:43As soon as you submit
42:44your application, there is somebody
42:46that is assigned to your
42:48So you're gonna start getting
42:49emails from that person. That
42:50person is dedicated to your
42:52research study. I will say
42:53even if you send like,
42:54you have you see our
42:55our
42:56email there, it's h r
42:57p p at yale dot
42:58e d u. That's our
42:59general email.
43:00We have staff members,
43:02looking at those emails
43:04every single
43:05basically, twenty four seven because
43:07the world that we live
43:07in, we have to be
43:08on call to ensure that
43:09there's not emergencies happening.
43:11So when you submit that,
43:13we are going to have
43:14a response to you, I'd
43:15say, within a couple of
43:16hours. We say twenty four
43:18hours, but we've never I've
43:19never had anyone not be
43:21responded to in,
43:22twenty four hours. So we're
43:24proud of that as well.
43:25But, again, if you do
43:26have individual questions as well,
43:27you can always contact me,
43:28and I'm always happy to
43:29either field the question or
43:31or talk with you directly
43:32about that.
43:35Gary, do you have any
43:35it looks like you might
43:36have a question. I had
43:37a question. I actually had
43:38a couple of questions. The
43:39first, can you give me
43:40their email address to contact
43:42IRB? I've been looking for
43:43a address if I had
43:44questions.
43:45So what what is the
43:46email address if I have
43:48questions to ask?
43:50Sure. So the general one
43:51is this h r p
43:52p at yale dot e
43:53d u.
43:54H r p
43:56p? Yes. H as in
43:58human, r as in Ralph,
44:00and p and p as
44:01in pen and pen.
44:04At,
44:05h r p p at
44:06human research?
44:08At yale dot e d
44:09u. At Yale. Just like
44:10our normal Sorry. Email. Yeah.
44:12Yeah. That's good. Sorry. Time
44:14for my coffee in the
44:15evening, I guess. My other
44:17question was,
44:18so I'm a pathologist,
44:20and if I had like
44:21you mentioned that if if
44:22it is a study that
44:24involves,
44:25using specimens,
44:26like, I'm looking at biopsies
44:28or exigent specimens from patients,
44:30that is exempt.
44:33My question was if
44:35if if I want to
44:36do any kind of molecular
44:37analysis
44:38on those,
44:40specimens,
44:41is that still considered exempt?
44:43I always submit an IRB
44:45for whatever I'm doing because
44:47there is chart review involved,
44:49And I always submitted IRB
44:51for chart review.
44:52Mhmm. But if there are
44:53additional studies that are that
44:55are that I am going
44:56to be performing
44:58on the patient's specimens,
45:01under what category should I
45:03submit it?
45:05Yeah. That's a good question.
45:05So I guess my first
45:06question is the the research
45:08that you're talking about, the
45:09first part of it, are
45:10those
45:11discarded samples or those
45:13samples you're collecting as part
45:14of the research?
45:16No. No. They are, they
45:17are I'm not collecting anything
45:19new,
45:20as part of the research.
45:21It is I see. It
45:22is, it is the specimens
45:24that are already present in
45:26I see. In the lab.
45:27Yeah. Like a registry or
45:28something. Is that Yes. Yeah.
45:30Okay. Okay. Yeah. I would
45:31say that,
45:33that's a good question.
45:34Always submit those types of
45:36projects to the IRB.
45:37We do have a
45:39this wouldn't work in this
45:40case. We have a repository
45:42template that we just created.
45:43I would say in these
45:44cases,
45:45if you don't know the
45:45exact category, I would have
45:47to look at the research
45:47you're submitting before giving you
45:49a category. But that's okay
45:50to just, like, leave it
45:51blank on the form, and
45:52the IRB will help you
45:53decide, like, which category it
45:54falls in based on the
45:55parameters of your research.
45:57Okay. Yeah. And I might
45:58email somebody at this address
46:00to see if they can
46:01help me with what category
46:03it is, giving specific details
46:05about my,
46:06case. Or or I or
46:08you recommend that I just
46:09submit it and leave it
46:10blank, and they'll get back
46:11to me?
46:12I think it's, it's good
46:13to maybe email this, inbox
46:16first because they'll be able
46:17to put you in contact
46:18with the exact person that
46:19you'll will need to answer
46:21that question, and they'll be
46:22super helpful. And then in
46:23the meantime, you can start
46:24working on your application and
46:26get it ready to go.
46:26So once they respond, you
46:28know what category it is.
46:30Sounds great.
46:31I have one more question.
46:32So if I'm doing some
46:33research where I'm collaborating with
46:35an outside institution,
46:37I know I have to
46:37do a material transfer agreement.
46:40Is that separate from the
46:41IRB, or do I have
46:43to include that in the
46:44IRB as well? That's a
46:45great question. That is separate
46:47from the IRB process. Yep.
46:49Okay. But you're totally on
46:50board with that that needing
46:51to happen. Yep. Yeah. And
46:53my last question is, if
46:55I'm collaborating with an outside
46:56company, like, I'm getting funds
46:59from a company to do
47:00this. I know a lot
47:01of research
47:02is funded by federal agencies.
47:05But if if it is
47:06a research that is,
47:07getting,
47:08getting funded by
47:10by a company,
47:12Is there anything different that
47:13I do for the IRB?
47:14I'm, of course, a PI.
47:16No,
47:17PHI or no information is
47:18going to go to the
47:20company,
47:21about this except some,
47:23some of the data that
47:24they will use for sequencing
47:26or some studies. So do
47:27I have to make some
47:28kind of a modification to
47:30the IRB?
47:31Is there a place in
47:32the IRB to include this?
47:34Sure. So is this a
47:35study that is already approved?
47:37No. No. It's something that
47:39I will do in future.
47:40Got you. Yes. So, no,
47:41there's nothing different you would
47:42need to do except for
47:43you would need to list
47:44them as a funding source
47:45in the IRIS IRB application.
47:48And I'm sure you'll work
47:48with the Office of Sponsored
47:50Projects, OSP, who will set
47:52up the award, and it
47:52will actually you'll be able
47:54to link it in the
47:54IRIS IRB system. You'll kinda
47:56be able to pull up
47:57that, funding source in that,
48:00where it says, like, local
48:01funding sources or something. So
48:02that's the only thing that
48:03would be different in this
48:04case. Okay.
48:05Sounds good. Great question. So
48:06much. Yeah. This is very
48:08helpful. I really appreciate it.
48:10Good. Yeah. Let us know
48:10if you have questions.
48:12Okay. Sounds great. Thanks.
48:13Yeah. Thank you.
48:15Those were great. Any other
48:16questions?
48:24Okay.
48:25Well, thank you for your
48:25time. For joining and giving
48:27us all this information.