IRB On Demand: Does My Study Need IRB Review? Part 1

Audio Transcript Auto-generated

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  Good. Hi there, my name is Heather Park May.

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  I'm here to talk to you about how to define

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  human participant research, determining whether your study needs Irby Review

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  to do that.

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  We have to look at the regulatory definitions that that

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  we have to work with defining human participant research.

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  And so I'll talk a bit about that in the

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  first part of our on demand training.

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  And then there's another part two of on demand training

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  that dives a little deeper into how to complete our

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  human participant research determination tool.

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  So um we'll jump right into part one defining a

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  human participant research.

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  The regulations require the research to meet both the definition

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  of a human participant or human subject.

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  The terms the term subject is used in the regulations.

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  However, the I.

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  R. B.

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  Prefers to use the term participant.

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  The two terms are synonymous.

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  So um so you'll see that in um in the

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  regulations and Wednesday Irby policy as well.

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  But the term human human subject, the deaf as defined

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  in the regulations and the definition of research in the

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  regulations. Both need to apply to the project in order

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  for I.

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  O. Be reviewed to be required.

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  So I'm going to look look closely at how a

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  human participant or human subject is defined.

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  The regulations tell us that a human subject is a

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  living living individual about whom an investigator conducting research either

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  obtains information or bio specimens through an intervention or an

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  interaction with the individual.

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  And then uses that that uses studies or analyzes that

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  information. Or it could be um investigator who obtains uses

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  studies, analyzes or generates identifiable private information or identifiable bio

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  specimens. So keep in mind here that use the term

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  uses is in here obtains or uses that's not.

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  An and which means that if the research requires the

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  use of an identify identifiable piece of information um to

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  identify a participant who could be eligible for the study

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  or who meets the criteria for a data collection.

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  Um That use of it, even if the study, even

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  if you're not going to retain the identifiable information, it

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  still does require the use of that information.

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  And so a human participate, the human participant would apply

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  to that project.

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  So let's look more at what an identifiable private information

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  or bio specimen is.

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  Regulations define these two separately.

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  However, they're pretty much the same.

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  Unidentifiable private information is the private information for which the

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  identity of the subject may is or may be readily

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  ascertained by the investigator or associated with the information bio

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  specimen is is the same just with with the use

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  of a bio specimen as opposed to private information.

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  Okay. When we look at what an intervention or interaction

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  is, the definition we have we use for an intervention

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  is a physical procedure by which the information or bio

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  specimens are gathered and manipulations of the participants or the

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  participants environment that are performed for research purposes.

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  Um An interaction here is any communication or in a

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  personal contact with an end with between the investigator in

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  the participant.

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  This can include electronic interaction.

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  Um In cases where you know there's no direct interaction

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  but there may be a electronic survey where you're not

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  you're not having a conversation with the invest with the

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  participant. Um But they're being asked to review information and

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  answer questions using the internet for the research that does

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  still count as an interaction.

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  So if that happens to be the case, the project

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  does involve a human participant.

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  Even if that even if that interaction is anonymous because

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  remember this isn't or it could be obtaining information through

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  an interaction or intervention or obtaining using um studying identifiable

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  information. So now let's go a little deeper into what

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  the definition of researches the regulations tell us that research

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  is a systematic investigation including research, development, testing and evaluation

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  designed to develop or contribute to general Izabal knowledge.

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  So to understand how to apply your study to this

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  um we have to learn, we have to know what

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  do we consider a systematic investigation.

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  So systematic investigation is an activity that involves development testing,

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  evaluation and data collection with either quantitative or qualitative data

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  analysis to search for information and or to answer a

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  question when we look at what is general Izabal knowledge

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  and this is the more more important in determining whether

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  the project involves research or not.

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  Generalize. Herbal knowledge is an activity that draws general conclusions.

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  Um This can be knowledge of knowledge gained that may

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  apply to other populations outside of the study and informs

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  policy or is universally or widely applicable.

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  So this means that a study is research if it's

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  conducted with the intention of drawing conclusions that may have

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  some general applicability and uses a commonly accepted scientific method.

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  The random application or the random collection of information about

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  individuals that has no general applicability is not research.

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  Scientific investigation that leads to general Izabal knowledge is and

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  that information I find to be helpful in understanding general

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  Izabal knowledge comes from the Department of Health and Human

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  Services Office of Research integrity.

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  Yeah. So defined what human participant research is.

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  Now. Let's talk a little bit about some projects that

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  are not human participant research.

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  And this is we have a guidance document that provides

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  a full description of each one of these categories of

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  activities that are not considered human participant research.

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  And the description goes into depth about when this activity

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  what would be considered human participant research.

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  So I encourage you to take a look at the

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  guidance on the resources page of the slide show for

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  more information.

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  Um The case report is one of the first examples

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  in this guidance.

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  A case report is uh is not human participant research

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  when it involves up to three similar unique cases or

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  presentations where you're going to present.

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  Um you know how these unique presentations clinical presentations were

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  diagnosed and treated.

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  It's very difficult to create general Izabal knowledge when the

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  when your end is three or or less.

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  Uh There's not really much of a statistical significance with

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  those numbers and you're just looking at how this case

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  was diagnosed or treated.

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  You're not you're not your aim in this case is

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  not to generalize conclusions based on that information.

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  So this would not be pretty, participant research does not

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  require Irby review.

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  Then a course related activities sometimes cannot, may not consider

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  be considered to be human participant research.

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  In cases when it doesn't contribute to general Izabal knowledge.

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  Take a look at the more detailed description of course

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  related activities and our guidance, um descendants, descendants.

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  Uh This is research involving deceased individuals.

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  Whether it's cadaver research or or or historical summary or

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  additional analysis of an individual who is deceased.

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  Remember in the definition of a human participant, it means

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  it uses the term a living individual.

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  And so if the individual or the particular population group

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  that you're studying are all deceased, then the project does

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  not involve human participant research, journalism, documentary, oral histories.

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  These projects are not generally stable knowledge.

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  If it's being done in a way that's not going

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  to generalize conclusions if you're looking at historical events or

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  or documenting how these events occurred and um the impact

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  of those events most likely are not going to be

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  research because it's not generalize herbal knowledge.

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  Um There are cases when um when this when this

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  can blur the line and cross over to human participant

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  research. But again, the description is in our guidance, quality

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  improvement program evaluation, this is really uh this one can

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  be a little difficult to discern between general Izabal knowledge

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  and and what's quality improvement or program evaluation.

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  Uh The key here is the intent of the project

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  is the intent of a program evaluation to evaluate something

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  and then apply or understand um the knowledge learned to

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  the specific area of being uh that that being targeted

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  where that program is being applied.

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  If that's the case then it's generalized.

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  It's not generalize herbal knowledge.

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  You're looking at a program and you wanted to understand

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  how that has been effective or ineffective and using that

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  information to um to make changes to that program locally.

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  Um So that's that's the really the key difference between

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  program evaluation equality improvement.

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  Part two of this um of this presentation goes into

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  a little bit more depth on this issue.

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  Public use data sets.

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  This is any information that's publicly available without any um

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  without any special access.

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  If you uh if you don't need to request access

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  to data if it's available to anybody um who wishes

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  to access that information Then uh public use data sets

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  does not involve human participant research.

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  And so I will be reviewed.

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  There is not required and then there's public health surveillance.

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  This applies this has come up a lot more frequently

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  in the midst of the COVID-19 pandemic.

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  And this applies for studies that are looking at um

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  gathering data related to a specific public health crisis and

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  when it's done in collaboration with the public health authority

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  and then there's de identified data or bio specimens.

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  This occurs when um there is the data is being

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  de identified before it's ever received by the participant or

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  I'm sorry by the investigator and the investigator does not

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  ever have access to or require the use of identifiable

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  information for the data collection.

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  So if that applies then the purchase the research does

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  not involve a human participant and therefore I.

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  R. B.

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  Review is not required.

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  So that summarizes what I have for Part one.

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  Um Please click on the link for the upcoming Part

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  two. I do want to show you here.

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  The reference links these other references to regulations and guidance

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  and there's an additional link on the education page that'll

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  take you right to um this slide so that you

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  can access those links to the regulations and guidance.

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  And um if you have any questions at all about

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  this information, please send them to uh, to i.

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  R. B.

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  Questions at wayne dot e.

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  D. You and I'd be happy to provide additional information

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  or clarification.